8
I n recent years, rapidly emerging technologies and improved techniques have brought minimally invasive endoscopic sur- gery closer to a once-elusive goal: incisionless surgery. At the forefront of this trend, Columbia and Weill Cornell physicians at NewYork-Presbyterian Hospital have been developing NOTES™ (natural orifice translumenal endoscopic surgery) in both research and clinical settings. NOTES uses various body orifices as points of entry, including the vagina, rectum, and mouth, instead of initiating an operation from the skin. The hope is that NOTES which is being even less invasive than laparoscopic surgery, will be able to reduce or eliminate pain, leave no scars, and shorten recovery time. Possible applications include appendix operations and biopsies, as well as more significant operations such as removing parts of the stomach and intestine. The method challenges the basic paradigm of surgery: the idea that cut- ting across the lumen of an organ into the patient’s abdominal cavity is to be avoided. “Surgeons are always taught not to cross those walls unless they’re operating on that specific organ,” said Marc Bessler, MD. “The big issue we’ve addressed is how to close the organ you’re going through, safely.” DIGESTIVE DISEASES N EW Y ORK –P RESBYTERIAN Affiliated with COLUMBIA UNIVERSITY COLLEGE OF PHYSICIANS AND SURGEONS DIGESTIVE DISEASES Fall 2007 N EW Y ORK –P RESBYTERIAN Affiliated with COLUMBIA UNIVERSITY COLLEGE OF PHYSICIANS AND SURGEONS and WEILL CORNELL MEDICAL COLLEGE Hepatitis C 2 The Center for the Study of Hepatitis C is coordinating research investigating new drug, dosing schedules. Pancreatic Disease 4 Researchers are using endoscopic ultrasound as a resource in diagnosis and treatment. Duodenal Polyps 5 NewYork-Presbyterian Hospital researchers develop detailed protocols for treatment. INSIDE Update in Gasteroenterology, Hepatology & Nutrition November 30 & December 1, 2007 NewYork-Presbyterian Hospital First Annual International NOTES™ Course December 10-11, 2007 Advances in Colorectal Cancer Therapies Webcast "Pure" laparoscopic versus "hand-assisted" laparoscopic surgery; new approaches to minimally invasive surgery. Pediatric Capsule Endoscopy Webcast For more information, please visit www.nypdigestive.org UPDATES EUS Provides New View of Pancreas F or patients with pancreatic tumors, clinical management has become increasingly complex, with the advances in surgical, oncologic, and endo- scopic techniques. At NewYork- Presbyterian Hospital, endoscopic ultra- sound (EUS) is not only vital to provid- ing surgeons with crucial information regarding treatment options for patients with pancreatic diseases, but it is also expanding therapeutic options. Pancreatic cysts are increasingly identi- fied and referred for evaluation. EUS is used both to image the cyst for morphol- ogy and to aspirate fluid for analysis by cytology and chemistries. In addition to routine studies, in borderline cases fluid can be sent for DNA analysis to determine a variety of features, including the DNA content and quality, the presence of K-ras mutations and the loss of heterozygosity, according to Peter D. Stevens, MD. The Hospital has established a database of all pancreatic cysts for ongoing study. “It’s very important that we study these cysts over time so we can recognize their natural history,” added Mark Pochapin, MD. Therapeutic interventions are also being developed for EUS. EUS guidance has been used to inject alcohol into cysts, which causes them to regress. “It looks favorable in the correct subset of patients,” said Felice Schnoll-Sussman, MD. “You have to be very selective of the patient population. This would be an appropriate procedure to contemplate for patients who have a truly defined see EUS, page 6 see Endoscopic, page 7 Photo courtesy of Mark Bessler, MD NewYork-Presbyterian Hospital used NOTES techniques and laparascopic assistance to complete the first flexible endoscopic transvaginal cholecystectomy in the United States. Hospital Researchers Pursue Incisionless Endoscopic Surgery

DIGESTIVE DISEASES NEWYORK ... - NewYork-Presbyterian · NOTES™ (natural orifice translumenal endoscopic surgery) in both research and clinical settings. NOTES uses various body

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I n recent years, rapidly emerging technologies and improvedtechniques have brought minimally invasive endoscopic sur-gery closer to a once-elusive goal: incisionless surgery. At the

forefront of this trend, Columbia and Weill Cornell physicians at NewYork-Presbyterian Hospital have been developingNOTES™ (natural orifice translumenal endoscopic surgery) in both research and clinical settings.

NOTES uses various body orifices as points of entry, including the vagina, rectum, andmouth, instead of initiating an operationfrom the skin. The hope is that NOTESwhich is being even less invasive thanlaparoscopic surgery, will be able to reduceor eliminate pain, leave no scars, and shortenrecovery time. Possible applications includeappendix operations and biopsies, as well as moresignificant operations such as removing parts ofthe stomach and intestine. The method challengesthe basic paradigm of surgery: the idea that cut-ting across the lumen of an organ into the patient’sabdominal cavity is to be avoided.

“Surgeons are always taught not to cross those walls unless they’re operating on thatspecific organ,” said Marc Bessler, MD. “The big issue we’ve addressed is how to closethe organ you’re going through, safely.”

DIGESTIVE DISEASESN E W Y O R K – P R E S B Y T E R I A N

Affiliated with COLUMBIA UNIVERSITY COLLEGE OF PHYSICIANS AND SURGEONS

DIGESTIVE DISEASESFall 2007

N E W Y O R K – P R E S B Y T E R I A N

Affiliated with COLUMBIA UNIVERSITY COLLEGE OF PHYSICIANS AND SURGEONS and WEILL CORNELL MEDICAL COLLEGE

Hepatitis C

2 The Center for the Study of Hepatitis Cis coordinating research investigating

new drug, dosing schedules.

Pancreatic Disease

4 Researchers are using endoscopicultrasound as a resource in diagnosis

and treatment.

Duodenal Polyps

5NewYork-Presbyterian Hospitalresearchers develop detailed

protocols for treatment.

INS

IDE

Update in Gasteroenterology, Hepatology & NutritionNovember 30 & December 1, 2007

NewYork-Presbyterian HospitalFirst Annual International NOTES™ CourseDecember 10-11, 2007

Advances in Colorectal Cancer TherapiesWebcast"Pure" laparoscopic versus "hand-assisted" laparoscopic surgery; new approaches to minimally invasive surgery.

Pediatric Capsule EndoscopyWebcast

For more information, please visitwww.nypdigestive.org

UPDATE

S

EUS ProvidesNew View ofPancreas

F or patients with pancreatic tumors,clinical management has becomeincreasingly complex, with the

advances in surgical, oncologic, and endo-scopic techniques. At NewYork-Presbyterian Hospital, endoscopic ultra-sound (EUS) is not only vital to provid-ing surgeons with crucial informationregarding treatment options for patientswith pancreatic diseases, but it is alsoexpanding therapeutic options.

Pancreatic cysts are increasingly identi-fied and referred for evaluation. EUS isused both to image the cyst for morphol-ogy and to aspirate fluid for analysis bycytology and chemistries. In addition toroutine studies, in borderline cases fluidcan be sent for DNA analysis to determinea variety of features, including the DNAcontent and quality, the presence of K-rasmutations and the loss of heterozygosity,according to Peter D. Stevens, MD. TheHospital has established a database of allpancreatic cysts for ongoing study. “It’svery important that we study these cystsover time so we can recognize their naturalhistory,” added Mark Pochapin, MD.

Therapeutic interventions are alsobeing developed for EUS. EUS guidancehas been used to inject alcohol into cysts,which causes them to regress. “It looksfavorable in the correct subset ofpatients,” said Felice Schnoll-Sussman,MD. “You have to be very selective of the patient population. This would be an appropriate procedure to contemplatefor patients who have a truly defined

see EUS, page 6

see Endoscopic, page 7

Pho

to co

urtes

y of

Mar

k B

essler

, MD

NewYork-Presbyterian Hospital usedNOTES techniques and laparascopic assistance to complete the first flexible endoscopic transvaginal cholecystectomy in the United States.

Hospital Researchers PursueIncisionless Endoscopic Surgery

T he Center for the Study of Hepatitiscontinues to be actively involved inboth clinical and basic science

research in an effort to identify newtreatments for patients infected with thehepatitis C virus (HCV). A multidiscipli-nary approach is central to efforts at theCenter, which is a collaborative endeavorof Weill Cornell clinicians andresearchers at NewYork-PresbyterianHospital along with colleagues atNewYork-Presbyterian Hospital/Columbia University Medical Center andresearchers at Rockefeller University.Clinical trials are conducted at a highlevel of quality using an extensive infra-structure. The Center is involved in abroad spectrum of trials ranging fromPhase 1 (first in human) to the fullgamut of later-stage trials—encompass-ing Phase I through Phase IV studies.Clinical investigators at the Center arealso working with industry to helpdesign early phase trials for drug testing,including first-in-human studies.

“We have nurse practitioners and nurseswho are coordinators for our trials andwork directly with our patients, and wehave an extensive administrative and tech-nical support staff,” said Ira M. Jacobson,MD. In January 2007, according to Dr.Jacobson, a large space on the DigestiveDisease floor of the new Weill-GreenbergCenter was set aside to house the staffneeded to support the administration andexecution of clinical trials for hepatitis C.

“Ongoing and anticipated trialsinclude those focusing on HCV proteaseand polymerase inhibitors, drugs withother novel mechanisms of action, andrefinements of the currently used drugsinterferon and ribavirin, such as albu-min-bound interferon and taribavirin,”said Dr. Jacobson.

Antiviral agents included in the HCVtrials program are telapravir (VX-950),bocepravir (SCH-503034), HCV-796,GS-9190, and others.

Faculty members focused on hepatitisC and working in the new Weill-Greenberg Center, adjacent to NewYork-Presbyterian Hospital/Weill CornellMedical Center, have built a large refer-ral practice attracting patients from thesurrounding New York metropolitanarea. Several years ago Andrew Talal,MD, MPH, founded a liver clinic thatspecializes in the care of patients withHCV and patients who are coinfectedwith HIV/HCV. Dr. Talal has recentlypublished novel findings derived frompatient samples obtained at his clinic (JAcquir Immune Defic Syndr 2007;45:262-268). Other clinicians at the Center whosee a large volume of patients with HCVinclude Dr. Jacobson, Maya Gambarin,MD, and Samuel Sigal, MD. Dr. Sigal isalso a member of the Center for LiverDisease and Transplantation atNewYork-Presbyterian Hospital. Inaddition, Brian Edlin, MD, performsnationally recognized epidemiologicstudies on hepatitis C.

NewYork-Presbyterian Hospital servedas the central site in the WIN-R trial,the largest United States hepatitis Cstudy to date. More than 4,900 patientsat 225 centers nationwide took part inthe WIN-R trial. The study led to anumber of important findings, noted Dr.Jacobson, who served as principal investi-gator and was joined by co-principalinvestigator Robert Brown, Jr, MD, of

NewYork-Presbyterian Hospital/Columbia University Medical Center andMedical Director of the Center for LiverDisease and Transplantation, which has athriving clinical trials program in viralhepatitis and in other areas of hepatology,including transplantation. The WIN-Rstudy found that weight-based dosing ofribavirin resulted in significantly higherrates of sustained virologic response thanusing a flat dose of ribavirin (44% vs.41%; P=0.01). This was particularly truefor patients with HCV genotype 1 (34%vs. 29%; P=0.004). The findings alsorevealed that 24 weeks of treatment wasas effective as the standard 48 weeks oftreatment for patients with HCV geno-type 2 or 3. The shorter course of therapyalso had better tolerability. Several publi-cations derived from the WIN-R studyare expected to be published in the peer-reviewed literature shortly.

“The philosophy here is similar to thephilosophy behind weight-based dosingof chemotherapy,” noted Dr. Brown. “Weknew that weight-based dosing in hepa-titis C therapy was important, because ofthe potential impact fat in the liver canhave on disease progression and drugabsorption. It just hadn’t been proved.What we essentially found is that theadditional risk for drug toxicity incurredwith weight-based dosing is worth itgiven the increased efficacy.”

When it comes to scientific researchefforts, NewYork-Presbyterian Hospitalcontinues to work closely with theLaboratory of Virology and InfectiousDiseases at Rockefeller University, whichfocuses on HCV studies and is under thedirection of Charles Rice, PhD. Researchefforts include a current collaborativestudy examining whether patients withundetectable virus who complete treat-

New Drugs, Dosing Highlight NewApproaches to Hepatitis C

Table. Sustained Virologic Response With Ribavirin

Source: Jacobson I, Brown Jr. R, Freilich B, et al, the WIN-R Study Group. Weight based ribavirin dosing(WBD) increases sustained viral response (SVR) in patients with chronic hepatitis C (CHC): final results of theWIN-R study, a U.S. community-based trial. Hepatology. 2007. In press.

800 to 1400,weight-baseddose

44 34 32 62

800, fixed dose 41 29 27 60

Ribavirin (mg/d) All, (%)

Genotype 1, (%)

Genotype 1 With High Viral Load, (%)

Genotypes 2 and 3,(%)

DIGESTIVE DISEASESN E W Y O R K – P R E S B Y T E R I A N

2 www.nypdigestive.org

ment with interferon and ribavirin arecured or whether tiny traces of the viruscan still be found. Other ongoing collab-orative studies involving Dr. Rice andLynn Dustin, PhD, at RockefellerUniversity, are examining how theimmune system interacts with the HCV.

Because HCV-associated end-stage liverdisease is the leading indication for livertransplantation in the United States,studies to better understand how thevirus affects the liver are also ongoing.NewYork-Presbyterian Hospital’s livertransplant program performed more livertransplants in 2006 than any other hospi-tal in the New York metropolitan area.Researchers at NewYork-Presbyterian/Weill Cornell and the Center for LiverDisease and Transplantation at NewYork-Presbyterian/Columbia have spearheadedefforts to acquire large samples of livertissue from transplant patients at theColumbia site to determine the percent-age of liver cells that are infected and theviral count in infected cells. The acquiredspecimens are sent to colleagues atRockefeller University. “These are pre-cious samples because they yield largeamounts of tissue as opposed to smallliver biopsy specimens,” said Dr.Jacobson. In addition, researchers atNewYork-Presbyterian/Columbia are alsostudying several new agents for the treat-ment of hepatitis C, including the pro-tease inhibitor VX-950, potentially thefirst oral HCV treatment, and a drug Dr.Brown calls “the next big step forward.”

Robert S. Brown, Jr., MD, MPH, isMedical Director, Center for Liver Diseaseand Transplantation, and Chief, Division ofAbdominal Organ Transplantation atNewYork-Presbyterian Hospital/ColumbiaUniversity Medical Center, and is AssociateProfessor of Medicine and Pediatrics atColumbia University College of Physiciansand Surgeons. E-mail: [email protected].

Ira M. Jacobson, MD, is Chief, Division ofGastroenterology and Hepatology atNewYork-Presbyterian Hospital/WeillCornell Medical Center and is Vincent AstorProfessor of Clinical Medicine and MedicalDirector of the Center for the Study ofHepatitis C at Weill Cornell Medical College. E-mail: [email protected].

NewYork-Presbyterian Digestive Diseases is a publication of the Digestive Diseases Centers of NewYork-Presbyterian Hospital. The Digestive Diseases Centers areat the forefront of research and practice in the areas of gastroenterology; GI surgery; and liver, bile duct, and pancreat-ic disorders. NewYork-Presbyterian Hospital/Columbia University Medical Center and NewYork-PresbyterianHospital/Weill Cornell Medical Center are respectively affiliated with Columbia University College of Physicians andSurgeons and Weill Cornell Medical College.

NewYork-Presbyterian Digestive Diseases Editorial Board

John Chabot, MDChief, Division of GI and Endocrine Surgery

NewYork-Presbyterian/ColumbiaAssociate Professor of Clinical Surgery

Columbia University College of Physicians and [email protected]

Dennis Fowler, MDVice President and Medical Director, Perioperative Services

NewYork-Presbyterian/ColumbiaU.S. Surgical Professor of Clinical Surgery

Columbia University College of Physicians and [email protected]

Ira Jacobson, MDChief, Division of Gastroenterology and Hepatology

NewYork-Presbyterian/Weill CornellVincent Astor Professor of Clinical Medicine

Weill Cornell Medical College [email protected]

Fabrizio Michelassi, MDSurgeon-in-Chief

NewYork-Presbyterian/Weill CornellLewis Atterbury Stimson Professor and Chairman

Department of SurgeryWeill Cornell Medical [email protected]

Jeffrey Milsom, MDChief, Section of Colorectal Surgery

NewYork-Presbyterian/Weill CornellProfessor of Surgery, Colon and Rectal Surgery Section

Weill Cornell Medical College [email protected]

Paul Miskovitz, MDAttending Physician

NewYork-Presbyterian/Weill CornellClinical Professor of Medicine, Division of Gastroenterology

and HepatologyWeill Cornell Medical College [email protected]

Mark Pochapin, MDDirector, The Jay Monahan Center for Gastrointestinal HealthChief, Gastrointestinal Endoscopy Division of Gastroenterology

and HepatologyNewYork-Presbyterian/Weill Cornell

Associate Professor of Clinical MedicineWeill Cornell Medical College [email protected]

Ellen J. Scherl, MDDirector, Jill Roberts Center for Inflammatory Bowel Disease

NewYork-Presbyterian/Weill CornellAssociate Professor of Medicine

Division of Gastroenterology and HepatologyWeill Cornell Medical College [email protected]

Lewis Schneider, MDAssistant Attending Physician

NewYork-Presbyterian/ColumbiaAssistant Professor of Clinical Medicine

Columbia University College of Physicians and Surgeons(212) 326-8426

Peter D. Stevens, MDDirector, Gastrointestinal Endoscopy DepartmentClinical Director, Division of Digestive and Liver Diseases

NewYork-Presbyterian/ColumbiaAssistant Professor of Clinical Medicine

Columbia University College of Physicians and [email protected]

Timothy C. Wang, MDChief, Division of Digestive and Liver Diseases

NewYork-Presbyterian/ColumbiaDorothy L. and Daniel H. Silberberg Professor of Medicine

Columbia University College of Physicians and [email protected]

Richard L. Whelan, MDChief, Section of Colon and Rectal Surgery, Herbert Irving

Comprehensive Cancer CenterNewYork-Presbyterian/Columbia

Associate Professor of SurgeryColumbia University College of Physicians and [email protected]

3

E sophageal cancer rates have risen600% since 1975, with theAmerican Cancer Society predicting

that 15,560 people will be diagnosed withesophageal cancer in 2007. To address thiscrucial public health need, physicians atNewYork-Presbyterian Hospital have col-laborated to create the new EsophagealDisorders Center.

“We have a number of physicians—including gastroenterologists, surgeons,radiation oncologists, and medicaloncologists—who are working togetheron the spectrum of disease from gastroe-sophageal reflux disease (GERD) toBarrett’s esophagus (BE) to esophagealcancer,” said Marc Bessler, MD.

The underlying philosophy of theCenter is to treat patients for esophagealdisorders as early and as noninvasivelyas possible. Additional team membersinclude Peter D. Stevens, MD (interven-tional gastroenterology), Joshua Sonett,MD (thoracic surgery), Mark Stoopler,MD (oncology), Shermian Woodhouse,MD (radiation oncology), David D.Markowitz, MD (esophageal function),Charles Lightdale, MD (gastroenterology/BE), and Julian Abrams, MD(gastroenterology/BE).

Most esophageal adenocarcinomaoriginates from damage caused by acidreflux. For these patients, NewYork-Presbyterian Hospital physicians can use adevice called the NDO Plicator to recreatethe valve at the gastroesophageal junctionand limit acid reflux by 50% to 70%.

“Treatment for reflux by most physicians includes everything from

over-the-counter to prescription medica-tions, as well as diet and lifestyle modifi-cation,” Dr. Bessler explained. “We canthen go from medications that might notbe helping to using other combinations ofmedication or endoscopic techniques.”

If the endoscopic option is insufficient,patients can undergo fundoplication, aminimally invasive surgical therapy thatwraps a small cuff of stomach around theesophagus to strengthen the sphincter.This procedure, which can be done

laparoscopically, is approximately 95% effective at getting rid of reflux,according to Dr. Bessler.

In some patients with GERD, repeatedcontact with gastric acid transforms theiresophageal cells from normal squamousepithelium to abnormal intestinalizedcolumnar epithelium, a complicationthat is known as BE. Until recently,physicians mainly used photodynamictherapy to blast away the damaged cells.But Charles Lightdale, MD, has been atthe forefront of developing a new devicecalled Barrx, which first measures theesophagus’ inner diameter with an endo-scopic balloon, then ablates cells withradiofrequency energy. He recently

participated in a multicenter trial, pub-lished in Gastrointestinal Endoscopy(2007;65:185-195), which found thatBarrx can completely eliminate nondys-

plastic BE in 70% of patients at 1-yearfollow-up. Newer results show, withadditional treatment, the completeremoval of BE in 98% of patients, whowere followed for 2.5 years.

“It’s a very precise removal, so it doesn’t damage the deeper layers of theesophageal wall,” said Dr. Lightdale, who3 years ago became the first physician inNew York State to use Barrx. “Strictures,where the esophagus gets scar tissue, arevery unusual.”

For patients with BE who developsmall nodules, specialists employ endo-scopic ultrasound. The information fromthis diagnostic and staging tool is usedto judge whether endoscopic mucosal

resection (EMR) is appropriate. “Beforewe do endoscopic resection, we always do this to make sure it’s not a big cancerwe’re just seeing the tip of,” said Dr. Lightdale. The abnormal tissueremoved during EMR can then be evaluated by a pathologist.

Among those patients who need tohave cancer removed, minimally invasiveesophagectomy can reduce the trauma,pain, and recovery time. The procedureinvolves several small incisions and theuse of a scope, rather than making largeincisions in the abdomen and chest.

Having BE greatly increases the risk ofdeveloping esophageal cancer. Currently,there are no proven ways to prevent thisprogression, so close surveillance is theonly option. To examine a possiblechemopreventive approach, Columbiaand Weill Cornell researchers atNewYork-Presbyterian Hospital areinvolved in a multicenter Phase Ib studydeveloped by the National CancerInstitute (NCI)–sponsored Cancer

Hospital Researchers Create NewEsophageal Disorders Center

see Esophageal, page 6

DIGESTIVE DISEASESN E W Y O R K – P R E S B Y T E R I A N

4 www.nypdigestive.org

Table. Summary of Efficacy Results: Barrx Trial

Mean patient age, years 55.7

*N=69 BE, Barrett’s esophagus Source: Lightdale C. Gastrointest Endosc. 2007;65:185-195.

Patients, n 70 (52 men, 18 women)

Cure Rate for BE at 12 mo* 70%

Median symptom scores, 0-100 scale (day 4) 0

“Polyphenon E holds particular promise for

esophageal disorders.”

—Felice Schnoll-Sussman, MD

C omplications of duodenal polypsinclude duodenal perforation andpancreatitis, and failure to ade-

quately treat carcinoma can be life-threatening for patients. As treatmentmodalities evolve, physicians mustremain aware of these possibilities whiletrying to avoid excessively invasiveapproaches. The key to successful mod-ern management of these problems,according to physicians and surgeons atNewYork-Presbyterian Hospital, is multidisciplinary teamwork.

“One of the strategies we employ isthat the surgeons and the endoscopistswork very closely together,” said JohnChabot, MD. “We review every case,and we come to a consensus decisionabout how to approach each lesion.”Although endoscopy offers patients aquicker recovery without a large

incision, the decision to use an endo-scopic approach should not be based onthis factor alone.

“It is great to do all of these thingswith minimal invasion and minimalrecovery time, but if you push too far,you hurt people,” cautioned Dr. Chabot,adding that complications can arise thatresult in death. “Size and location in theduodenum tend to predict whether wetreat them with an operation or removethem endoscopically. When cancer ispresent, we almost always use tradition-al surgery. Sometimes, we will follow upan endoscopic resection with surgery ifan unsuspected cancer is diagnosed.”

A recent study, entitled “Charac-teristics of Duodenal Neoplasms thatImpact the Decision of Endoscopic orSurgical Management: Experience at aLarge, Tertiary Referral Center,” by Dr.Chabot and colleagues Harold Frucht,

MD, Stavros N. Stavropoulos, MD,Peter D. Stevens, MD, Caroline Hwang,MD, and Christopher DiMaio, MD,examined if size, location, and the histo-logic traits of duodenal lesions affect thedecision regarding surgical or endoscop-ic management. The study findingswere presented at this year’s DigestiveDisease Week.

The study consisted of a retrospectivereview of 158 patients who had biopsy-proven duodenal neoplasms between2000 and 2005. The results indicatedthat ampullary lesions were more likelyto contain advanced histology and bemanaged surgically than non-ampullaryneoplasms. Non-ampullary lesions aremore often treated endoscopically than surgically.

The study also found that patientswith duodenal neoplasms undergoing

surgery were more likely to have large,ampullary lesions with advanced histol-ogy than were patients undergoingendoscopic treatment. The mean size oflesions that were surgically removed was25.6±7.3 mm, and the mean size ofthose removed endoscopically was18.4±12.1 mm. In 85% of patientsrequiring surgery, the lesions wereampullary, whereas they were ampullaryin 52% of patients who were endoscopi-cally managed. Additionally, the studyresults indicated that advanced lesionsare more likely to be large andampullary and more likely to requiresurgical treatment than are lessadvanced lesions. The mean size oflesions with advanced histology was27.4±13.1 mm, whereas the mean sizeof lesions with less advanced histologywas 17.7±11.1 mm. Of the lesions withadvanced histology, 61% were

ampullary and 55% were managed sur-gically. Of those lesions with lessadvanced histology, 49% wereampullary and 19% were treated surgi-cally. Endoscopic treatment was used in22% of patients with advanced lesionsand in 64% of patients with lesions ofless advanced histology.

Currently, large periampullary duode-nal neoplasms with advanced histologyare often managed surgically rather thanendoscopically. Dr. Chabot believes thatwith further advances in endoscopy, itwill be possible to manage such lesionsendoscopically, with surgery reserved forthose proven to be cancerous.

“Certainly, as we get better at it andas new approaches develop, I think moreand more of them will be handled endo-scopically,” noted Dr. Chabot. “It isimportant to have a very close working

relationship between the endoscopistand the surgeon and for them to look ateach case together because it’s hard toreduce these decisions to specific guide-lines and numbers. There’s still some artthat goes into it. These are challengingdecisions, and it takes a close workingrelationship to do it well.”

John Chabot, MD, is Chief, Division of GI and Endocrine Surgery at NewYork-Presbyterian Hospital/Columbia UniversityMedical Center and is Associate Professor ofClinical Surgery at Columbia UniversityCollege of Physicians and Surgeons. E-mail: [email protected].

Surgery Versus Endoscopy for Duodenal Polyps: Researchers Evaluate Options and Outcomes

“It is important to have a very close working relationship between the endoscopist and

the surgeon... because it’s hard to reduce these decisions to specific guidelines....”

—John Chabot, MD

5

Prevention Clinical Trials Consortium.This randomized, double-blind, dose-escalation study is examining greentea extract’s safety and efficacy in theprevention of esophageal cancer amongpatients with BE. The extract,Polyphenon E, which is a minimally caf-feinated green tea mixture containingepigallocatechin-3-gallate (EGCG), hasbeen shown to inhibit carcinogenesis in avariety of preclinical cell culture and ani-mal models. The trial, which beganrecruiting patients in 2006, will studyPolyphenon E in doses of 200, 400, and

600 mg, or a placebo, taken twice dailyfor 6 months. After the medication phase,patients will be followed for an additional6 months to assess via endoscopy andbiopsy how their BE changes over theyear. Study results are expected in 2009.

“Polyphenon E holds particular prom-ise for esophageal disorders,” noted FeliceSchnoll-Sussman, MD. “It has beenshown to accumulate mainly in the gas-trointestinal mucosa and is therefore feltto be a strong candidate for the preven-tion of gastrointestinal malignancies.”

Marc Bessler, MD, is Director, LaparoscopicSurgery at NewYork-Presbyterian Hospital/Columbia University Medical Center, and is

Assistant Professor of Surgery at ColumbiaUniversity College of Physicians and Surgeons.E-mail: [email protected].

Charles Lightdale, MD, is AttendingGastroenterologist NewYork-PresbyterianHospital/Columbia University Medical Center,and is Professor of Clinical Medicine atColumbia University College of Physicians andSurgeons. E-mail: [email protected].

Felice Schnoll-Sussman, MD, isGastroenterologist, The Jay Monahan Centerfor Gastrointestinal Health, Division ofGastroenterology and Hepatology atNewYork-Presbyterian Hospital/Weill CornellMedical Center, and is Assistant Professor ofMedicine and Linda Horowitz Cancer ResearchFoundation Clinical Scholar in Gastroen-terology at Weill Cornell Medical College. E-mail: [email protected].

Esophagealcontinued from page 4

premalignant cyst in the pancreas whoare either not candidates for surgery orwho are reluctant to undergo surgery.”

For inflammatory fluid collectionssuch as pseudocysts and organized pancreatic necrosis, the use of EUS toguide endoscopic drainage makes it pos-sible to drain most cysts directly into theGI tract without the need for surgery orexternal drainage catheters. Using similartechniques, EUS is being used to placestents directly from the stomach into thepancreatic duct or from the duodenuminto the bile duct to provide drainage,according to Dr. Stevens. This procedureis being performed in patients whoseanatomy is difficult because of the pres-ence of a tumor and in those who havealready undergone a resection such as aWhipple procedure.

EUS-guided therapeutic injection isfinding increasing applications in the pan-creas. The pain of some patients withadvanced, unresectable pancreatic cancercan be managed with EUS-guided neurol-ysis of the celiac plexus. EUS is used tolocate the celiac plexus and insert scleros-ing agents, which ablate the nerve fibersand relieve pain, according to Dr. Schnoll-

Sussman. Injection of other agents underEUS guidance is a possibility.

“It is my hope for the future that wemove forward to inject new chemothera-peutic agents,” added Dr. Pochapin.

EUS continues to play an essential rolein diagnostic analysis. It is used to detectcancer in small pancreatic masses that arenot revealed by CT. When other imagingmodalities suggest the presence of a pan-creatic mass, EUS has good negative pre-dictive value, and if a mass is confirmedby EUS, a biopsy specimen can be simul-taneously obtained.

In patients at high risk for pancreaticcancer because of familial clustering,EUS is used to detect the earliest indications of cancer. At NewYork-

Presbyterian/Columbia UniversityMedical Center, Harold Frucht, MD,serves as the principal investigator of astudy examining a registry of high-riskpatients. Dr. Schnoll-Sussman, mean-while, uses EUS and other diagnostic/screening modalities as principal inves-tigator of the NewYork-Presbyterian/Weill Cornell Medical Center registryon familial pancreatic cancer. EUS alsoassists in the diagnosis of chronic pan-creatitis. In patients with gallstone pancreatitis, EUS can be used to con-firm the presence of stones in the common bile duct or gallbladder.

“In many patients who have had pan-creatitis of unknown etiology, a largeproportion of them actually have stonedisease,” said Dr. Schnoll-Sussman.“With EUS, we have a much more sensi-tive modality to be able to look at thecommon bile duct or gallbladder andclarify the diagnosis.”

In addition to its diagnostic and thera-peutic roles, EUS provides surgeons withcrucial information regarding pancreaticsurgery and treatment. “It helps surgeonsmake decisions as to who should havesurgery, and it helps us make decisions,for example, about whether we should beconsidering preoperative chemotherapy,”

EUScontinued from page 1

see EUS, page 8

DIGESTIVE DISEASESN E W Y O R K – P R E S B Y T E R I A N

“EUS has been per-

fected [so] that we

can localize tumors

and determine

whether there is vas-

cular invasion....”

—Mark Pochapin, MD

6 www.nypdigestive.org

This Spring at NewYork-PresbyterianHospital/Columbia University MedicalCenter, Dr. Bessler and his colleaguesDennis L. Fowler, MD, and Peter D.Stevens, MD, used NOTES techniquesand laparoscopic assistance to completethe first flexible endoscopic transvaginalcholecystectomy in the United States.They inserted an endoscope through thepatient’s vaginal wall, then into her bodycavity. Using that scope, they detachedher gallbladder and removed it throughthe vagina, which they then sutured. Toensure that the technique was performedas safely as possible, the team usedlaparoscopic assistance. The first opera-tion involved a few incisions. Soon after-ward, the doctors conducted the samesurgery on a second patient and madeonly 1 navel incision measuring 5 mm,which is just wide enough to insert thesmallest available standard clip used inlaparoscopy.

Based on the successful outcomes ofthese 2 cases, NOTES seems promising,according to Dr. Bessler. The secondpatient went home the same day as hersurgery and did not need pain medica-tion. Although the idea of operatingthrough a sexual organ might make somepeople feel uneasy, he explained, the pro-cedure focuses on an area of the vaginalwall near the cervix that has minimalpain sensation and is not involved in sex-ual function. Dr. Bessler plans to evaluateoutcomes after every 10 patients andhopes to soon move into a comparativetrial that randomly assigns patients togallbladder removal by either laparoscopyor NOTES.

At NewYork-PresbyterianHospital/Weill Cornell Medical Center,colorectal surgeons are tailoring theNOTES approach to the large intestine,entering the patient’s body via the rectum.“We’re trying to develop means by whichdiseases of the large intestine can beentirely treated through the channels ofthe large intestine,” said Jeffrey W.Milsom, MD. “We’re doing hybrid endo-scopic and laparoscopic procedures using 2or 3 tiny incisions in the abdomen to aug-ment this capability of removing lesionsfrom inside the colon, which would other-

wise require bowel resections.”The NewYork-Presbyterian/Weill

Cornell team consists of Dr. Milsomalong with Toyooki Sonoda, MD, SangLee, MD, and Alfons Pomp, MD.Together, they have carried out thehybrid procedure in nearly 40 patients.The group is also conducting lab researchin animal and cadaver models to developcompletely incisionless procedures, tech-niques that will eventually treat a vari-ety of diseases includingbenign intestinal growths,rectal prolapse, stric-tures, infections thatlie adjacent to thecolon, and possiblyeven cancer.

Additionally,Dr. Milsom’steam is collabo-rating with bio-engineers atNewYork-Presbyterian/WeillCornell to formMinimally-Invasive NewTechnologies (MINT), a projectthat explores how technology canexpand minimally invasive surgery. For example, imaging modalities such as3-dimensional CT scanning, ultrasound,and MRI might couple with endoscopyin the operating room, or newly designedscopes could have improved optics andgive surgeons better access to insert necessary tools.

“NOTES is the next natural evolutionof what we’ve been doing over the past15-plus years,” said Dr. Milsom, who

bases his current work on the more than3,000 laparoscopic colon resections hehas completed during his career. “Surgeryis becoming more and more minimized,as the optics and tools used to carry outsurgical actions are all becoming moreminiaturized. So, it’s more evolutionarythan revolutionary.”

Editor’s Note: On December 10 and 11,2007, Columbia and Weill Cornell physi-

cians will co-host the NewYork-Presbyterian Hospital First

Annual InternationalNOTES™ Course. For

more information, visitwww.nypdigestive.org.

Marc Bessler, MD,is Director,LaparoscopicSurgery andDirector, Obesity

Surgery at NewYork-Presbyterian Hospital/

Columbia UniversityMedical Center, and is

Assistant Professor ofSurgery at Columbia University

College of Physicians and Surgeons. E-mail: [email protected].

Jeffrey W. Milsom, MD, is Section Chief,Colon and Rectal Surgery at NewYork-Presbyterian Hospital/Weill Cornell MedicalCenter and is Jerome J. DeCosse Professor ofColon and Rectal Surgery at Weill CornellMedical College. E-mail: [email protected].

Endoscopiccontinued from page 1

NOTES uses various orifices as points of entry, including the mouth, instead of initiating an operation from the skin.

Center right photo courtesy of Marc Bessler, MD.

“This is the natural evolution of what we’ve been

doing.... Surgery is becoming more minimized.”

—Jeffrey W. Milsom, MD

Marc Bessler, MD, hopes to soon move into a trial

that randomly assigns patients to gallbladder removal

by either laparoscopy or NOTES.

7

said John Chabot, MD. “Years ago, oftenwe didn’t have a definitive diagnosiswhen performing pancreatic surgery.”

Whereas other modalities such as CTand magnetic resonance imaging are usedto stage disease in the vascular system,EUS has proved effective in clearly indi-cating vascular invasion. Many patientsare found to have unresectable disease atEUS. With accurate staging, unneces-sary exploratory surgery is prevented.

“The technique of EUS has been per-fected to the point that we can localizetumors and determine whether there isvascular invasion with a high degree ofaccuracy. We can help the surgeonsdetermine what type of surgery needs tobe done,” said Dr. Pochapin. Patientsalso benefit from the procedure. “Thebiggest value for patients is avoidingunnecessary surgery,” said Dr. Stevens.“It’s a devastating setback for the familyand the patients when they wake up tofind out they are unresectable. We tryto avoid that at all costs.”

In addition to preventing unnecessarysurgery and the associated risks, EUSkeeps patients with unresectable diseasefrom being sidetracked from their defin-itive treatments of chemotherapy andradiation. Patients whose disease isfound to be unresectable at EUS “areable to avoid the potential morbidityand risk of mortality associated withsurgery,” said Dr. Schnoll-Sussman.

John Chabot, MD, is Chief, Division of GI and Endocrine Surgery at NewYork-Presbyterian Hospital/Columbia UniversityMedical Center, and is Associate Professor ofClinical Surgery at Columbia UniversityCollege of Physicians and Surgeons. E-mail: [email protected].

Mark Pochapin, MD, is Director, The JayMonahan Center for Gastrointestinal Health,and Chief, Gastrointestinal Endoscopy,Division of Gastroenterology and Hepatologyat NewYork-Presbyterian Hospital/WeillCornell Medical Center, and is AssociateProfessor of Clinical Medicine at Weill Cornell Medical College. E-mail: [email protected].

Felice Schnoll-Sussman, MD, isGastroenterologist, The Jay Monahan Centerfor Gastrointestinal Health, Division ofGastroenterology and Hepatology atNewYork-Presbyterian Hospital/WeillCornell Medical Center, and is AssistantProfessor of Medicine and Linda HorowitzCancer Research Foundation Clinical Scholarin Gastroenterology at Weill Cornell MedicalCollege. E-mail: [email protected].

Peter D. Stevens, MD, is Director,Gastrointestinal Endoscopy Department, andClinical Director, Division of Digestive andLiver Diseases at NewYork-PresbyterianHospital/Columbia University MedicalCenter, and is Assistant Professor of ClinicalMedicine at Columbia University College ofPhysicians and Surgeons. E-mail: [email protected].

EUScontinued from page 6

NONPROFIT ORG.U.S. Postage PAID

Permit No. 37

Utica, NY

Important news from the Digestive Diseases Services Centers of NewYork-Presbyterian

Hospital, leading the way in treatment and research in gastrointestinal, liver and bile

duct, pancreatic, and nutritional disorders.

NewYork-Presbyterian Hospital • Columbia University College of Physicians and Surgeons • Weill Cornell Medical College

Fall 2007

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Endoscopic ultrasound of the pancreas: In patients with pancreatic cysts, EUS is used both to image the cyst for morphology and to aspirate fluid for analysis by cytology and chemistries.