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April 1995 Pancreatic Disorders A387 ENDOSCOPIC PANCREATIC DUCT (PD) STENT PLACEMENT: FREQUENCY OF CLINICAL COMPLICATIONS. AB Ross., ML Earnest, JE Geenen, MF Catalano, MJ Schmalz, GK Johnson, DJ Geenen, WJ Hogan, St Luke's Hospital, Racine, WI, Pancreatic Biliary Center, St Luke's Medical Center, Medical College of Wisconsin, Milwaukee, WI. Structural alterations following endoscopic pancreatic stent placement have been reported, but the frequency of clinical complications has not been well studied. AIM: To determine the frequency of significant clinical complications in a large cohort of PD stent patients. Methods: 471 patients (304F and 167M) who had PD stents placed endoscopieally during a 5 year period were evaluated. By protocol, stents were replaced in these patients at 3 mo. intervals and therapy completed after 9 months. Patients were seen out of sequence if they had persistent symptoms, new symptoms or pancreatitis. Patients were identified who developed 1 or more of the following stent related problems: 1) recurrent pancreatitis/pain, or 2) pseudocyst/abscess associated with clogged stent, 3) immediate stent intolerance (colicky abdominal pain), pest-placement, 4) stent migration into the pancreatic duct. A total of 969 PD stents were Jlaced and were tracked using a computer database. Results: POST-STENT PATIENTS(471) STENT(969) COMPLICATIONS (n) (%) (n) (%) Pancreatitis/Pain 47 10.0% 68 7.0% Pseudocyst/Abscess 3 0.6 % 3 0.3 % Stent Intolerance 4 0.8% 5 0.5% Stent Migration 17 3.6% 17 1.8% Total Complications 68 14.4% 93 9.6% ~tent-induced pam was resolved with removal of the endoprosthesis m each instance. Of the patients who had inward stent migration, only one required removal operatively. Two patients with pseudocysts required a surgical drainage procedure. Conclusion: Significant clinical complications occurred in 14% of a large group of patients who were treated with PD stents. Most complications were managed conservatively or endoseopicaily and did not require operative intervention. CA 72-4 LEVELS IN THE FLUID OF PANCREATIC CYSTIC LESIONS. Ruszniewski P. Voitot H*, Levy P, Rachid H, Hammel P, Delacoux E*, Bernades P. Departments of Gastroenterology and Biochemistry, Beaujon Hospital, 92118 Clichy Cedex, France. The nature of pancreatic cystic lesions (PCL) is not easily determined by imaging techniques. We have previously shown that the dosage of pancreatic enzymes and carcinoembryonic antigen (CEA) in PCL fluid may be helpful to identify the various types of PCL ; e.g., CEA concentration is less than 5 ng/ml in serous cystadenomas (SC), but not in pseudocysts (PC) and mucinous tumors (MT). Aim of the study. To determine whether the concentration of CA 72-4 in PCL fluid may iaelp to distinguish MT (which should be removed whenever possible) from the other PCL (SC and PC). Patients (ntsl and methods. 34 pts with PCL were studied between 1991 and lCJ93 : 14 PC, 8 SC, 8 mucinous cystadenomas (MC) and 4 cystadenocarcinomas (CK). PC always occurred during the course of a well-documented chronic pancreatitis. Final diagnosis was assessed by surgery in patients with cystic tumors (SC, MC and CK) except in 2 (who had very suggestive findings of SC on imaging techniques and cytology). PCL fluid was obtained by CT scan-guided fine-needle aspiration in every patient. CA 72-4 levels were determined by an immunoenzymatic technique (Enzymun Test® CA 72-4, Boehringer-Mannheim ; normal value in the serum : < 6.7 U/ml). Results. CA 72-4 levels were higher in CK (median value 391 U/ml, range 3.1-6500) and MC (131 U/ml, 3.6-900 +, NS vs CK) than in SC (< 2.5 U/ml, < 2.5-17.7, p < 0.05 vs MC) and PC (< 2.5 U/ml, < 2.5-8.5). CA 72-4 values were higher in MT than in non-MT (SC + PC, p < 0.0001, Wilcoxon test). The criterion "CA 72-4 level higher than 20 U/ml" had a 58 % sensitivity and a 100 % specificity for the diagnosis of MT. Conclusion. A CA 72-4 level higher than 20 U/ml in PCL fluid is 100 % specific for the diagnosis of MT in this series of pts. This dosage is useful for the therapeutic decision and should be performed in addition with the other fluid markers. DO PANCREATIC CALCIFICATIONS (PC) REGRESS DURING THE COURSE OF CHRONIC PANCREATITIS (CP) ?. Ruszniewski P. Nuckcheddy J, *Bretagne JF, Zins M, Vilgrain V, Levy P, *Gosselin M, Bernades P. Beaujon Hospital, 92118 Clichy Cedex and *Pontchaillou Hospital, 35033 Rennes Cedex, France. The evolution of PC during the course of CP is controversial ; regression has been reported in rare studies involving only plain X-ray films of the abdomen. The aim of the study is to determine the evolution of PC seen on CT scan in patients with C15. patients and methods. A retrospective analysis of CT scans was conducted in 32 pts (30 M, 2 F ; mean age 44.4 years, range 22-74) with CP (alcoholic 31). 6 pts had undergone previous pancreatic resection. For each patient, 2 CT scan series with at least a 36- month interval were performed. No lithotripsy or endoscopic removal of PC was attempted. The 64 CT scan series were analyzed by 2 independent well-trained radiologists. The number of PC, the size of the 3 largest PC in each of the 2 pancreatic areas separated by the mesenteric vessels were assessed. Only variations of at least 2 PC, and 20 % variation in size were considered. Results. Mean duration of CP was 7.5 years (range 3-24). Median interval between the 2 CT scan series in individual patients was 48.1 (36-77) months. No significant discrepancies between the 2 radiologists were observed. Evolution of the number and size of PC between the 2 determinations were as follows : No. of PC Size of PC Increase 72 % 72 % Stable 25 % 21% Decrease 3 % 7 % Disappearance 0 % 0 % No difference was found between the left and right parts of the pancreas. Contusion. A decrease in the number and/or size of PC is exceptionally seen during a 4-year CT scan follow-up in patients with chronic pancreatitis. SERUM TRYPSINOGEN-2, A NEW RELIABLE ASSAY FOR THE EARLY DIAGNOSIS AND PREDICTION OF OUTCOME IN ACUTE NECROTIZING PANCREATITIS. Sainio V*, Puolakkainen P*, Kemppainen E*, Hedstrtm J**, Haapiainen R*, Kivisaari L***,Stenman U**, Schrtder T*, Kivilaakso E*. II Dept. of Surg*, Clinical Chemistry** and Radiology***, University of Helsinki, Finland Trypsinogen-2 leaks out of the pancreatic acinar cells in acute pancreatitis. We have developed a new sensitive immunofluorometric assay to measure the concentration of this protein. Between Nov. 1989 and May 1993 serum trypsinogen-2 levels were prospectively analyzed in 52 consecutive patients with necrotizing pancreatitis during the first 48h after admission and their accuracy in diagnosing pancreatitis and predicting the outcome, were assessed. Pancreatic necrosis was verified by contrast enhanced CT, at surgery or autopsy. The patients were allocated into three groups depending on the outcome of the pancreatitis. Group A consisted of 26 patients recovering without major complications, group B of 16 patients with complicated and group C of 10 patients with a fatal course. Fifty patients with abdominal pain caused by diseases other than pancreatitis served as controls. The reference range for serum trypsinogen-2 in healthy adults was 18-90 pg/l. Mean values for the highest serum trypsinogen-2 levels during the first 48 h were 42 pg/l in control patients, 1390 ~g/1 in group A, 3540 gg/l in group B and 3780 ~g/1 in group C. The trypsinogen-2 values differed significantly between groups A and B (p=0.03) and between groups A and C (p=0.02). Using a cut-off-level of 1000 p.g/l the assay had a sensitivityof 100 % with a specificity of 73 % to detect patients in group C. On the same cut-off-level the sensitivity and specificity to detect patients in groups B and C was 88 % and 62 %, respectively. T~p~nogen-2 100000 ~g/L 10000 1000 100 10 O O Controls A a In conclusion, serum trypsinogen-2 is an easy-to-perform, sensitiveand rather specific assay for the early diagnosis and prediction of severity and outcome of the disease in patients with necrotizing pancreatifis

CA 72-4 levels in the fluid of pancreatic cystic lesions

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April 1995 Pancreatic Disorders A387

• ENDOSCOPIC PANCREATIC DUCT (PD) STENT PLACEMENT: FREQUENCY OF CLINICAL COMPLICATIONS. AB Ross., ML Earnest, JE Geenen, MF Catalano, MJ Schmalz, GK Johnson, DJ Geenen, WJ Hogan, St Luke's Hospital, Racine, WI, Pancreatic Biliary Center, St Luke's Medical Center, Medical College of Wisconsin, Milwaukee, WI.

Structural alterations following endoscopic pancreatic stent placement have been reported, but the frequency of clinical complications has not been well studied. AIM: To determine the frequency of significant clinical complications in a large cohort of PD stent patients. Methods: 471 patients (304F and 167M) who had PD stents placed endoscopieally during a 5 year period were evaluated. By protocol, stents were replaced in these patients at 3 mo. intervals and therapy completed after 9 months. Patients were seen out of sequence if they had persistent symptoms, new symptoms or pancreatitis. Patients were identified who developed 1 or more of the following stent related problems: 1) recurrent pancreatitis/pain, or 2) pseudocyst/abscess associated with clogged stent, 3) immediate stent intolerance (colicky abdominal pain), pest-placement, 4) stent migration into the pancreatic duct. A total of 969 PD stents were Jlaced and were tracked using a computer database. Results:

POST-STENT PATIENTS(471) STENT(969) COMPLICATIONS (n) (%) (n) (%)

Pancreatitis/Pain 47 10.0% 68 7.0%

Pseudocyst/Abscess 3 0.6 % 3 0.3 %

Stent Intolerance 4 0.8% 5 0.5%

Stent Migration 17 3.6% 17 1.8%

Total Complications 68 14.4% 93 9.6%

~tent-induced pam was resolved with removal of the endoprosthesis m each instance. Of the patients who had inward stent migration, only one required removal operatively. Two patients with pseudocysts required a surgical drainage procedure. Conclusion: Significant clinical complications occurred in 14% of a large group of patients who were treated with PD stents. Most complications were managed conservatively or endoseopicaily and did not require operative intervention.

CA 72-4 LEVELS IN THE FLUID OF PANCREATIC CYSTIC LESIONS. Ruszniewski P. Voitot H*, Levy P, Rachid H, Hammel P, Delacoux E*, Bernades P. Departments of Gastroenterology and Biochemistry, Beaujon Hospital, 92118 Clichy Cedex, France.

The nature of pancreatic cystic lesions (PCL) is not easily determined by imaging techniques. We have previously shown that the dosage of pancreatic enzymes and carcinoembryonic antigen (CEA) in PCL fluid may be helpful to identify the various types of PCL ; e.g., CEA concentration is less than 5 ng/ml in serous cystadenomas (SC), but not in pseudocysts (PC) and mucinous tumors (MT). A i m o f the s tudy . To determine whether the concentration of CA 72-4 in PCL fluid may iaelp to distinguish MT (which should be removed whenever possible) from the other PCL (SC and PC). Pat ients (ntsl and methods. 34 pts with PCL were studied between 1991 and lCJ93 : 14 PC, 8 SC, 8 mucinous cystadenomas (MC) and 4 cystadenocarcinomas (CK). PC always occurred during the course of a well-documented chronic pancreatitis. Final diagnosis was assessed by surgery in patients with cystic tumors (SC, MC and CK) except in 2 (who had very suggestive findings of SC on imaging techniques and cytology). PCL fluid was obtained by CT scan-guided fine-needle aspiration in every patient. CA 72-4 levels were determined by an immunoenzymatic technique (Enzymun Test® CA 72-4, Boehringer-Mannheim ; normal value in the serum : < 6.7 U/ml). Results. CA 72-4 levels were higher in CK (median value 391 U/ml, range 3.1-6500) and MC (131 U/ml, 3.6-900 +, NS vs CK) than in SC (< 2.5 U/ml, < 2.5-17.7, p < 0.05 vs MC) and PC (< 2.5 U/ml, < 2.5-8.5). CA 72-4 values were higher in MT than in non-MT (SC + PC, p < 0.0001, Wilcoxon test). The criterion "CA 72-4 level higher than 20 U/ml" had a 58 % sensitivity and a 100 % specificity for the diagnosis of MT. Conclus ion. A CA 72-4 level higher than 20 U/ml in PCL fluid is 100 % specific for the diagnosis of MT in this series of pts. This dosage is useful for the therapeutic decision and should be performed in addition with the other fluid markers.

• DO PANCREATIC CALCIFICATIONS (PC) REGRESS DURING THE COURSE OF CHRONIC PANCREATITIS (CP) ?. Ruszniewski P. Nuckcheddy J, *Bretagne JF, Zins M, Vilgrain V, Levy P, *Gosselin M, Bernades P. Beaujon Hospital, 92118 Clichy Cedex and *Pontchaillou Hospital, 35033 Rennes Cedex, France.

The evolution of PC during the course of CP is controversial ; regression has been reported in rare studies involving only plain X-ray films of the abdomen. The a im of the s tudy is to determine the evolution of PC seen on CT scan in patients with C15. patients and methods. A retrospective analysis of CT scans was conducted in 32 pts (30 M, 2 F ; mean age 44.4 years, range 22-74) with CP (alcoholic 31). 6 pts had undergone previous pancreatic resection. For each patient, 2 CT scan series with at least a 36- month interval were performed. No lithotripsy or endoscopic removal of PC was attempted. The 64 CT scan series were analyzed by 2 independent well-trained radiologists. The number of PC, the size of the 3 largest PC in each of the 2 pancreatic areas separated by the mesenteric vessels were assessed. Only variations of at least 2 PC, and 20 % variation in size were considered. Results . Mean duration of CP was 7.5 years (range 3-24). Median interval between the 2 CT scan series in individual patients was 48.1 (36-77) months. No significant discrepancies between the 2 radiologists were observed. Evolution of the number and size of PC between the 2 determinations were as follows :

No. of PC Size of PC Increase 72 % 72 % Stable 25 % 21% Decrease 3 % 7 % Disappearance 0 % 0 % No difference was found between the left and right parts of the pancreas. C o n t u s i o n . A decrease in the number and/or size of PC is exceptionally seen during a 4-year CT scan follow-up in patients with chronic pancreatitis.

• SERUM TRYPSINOGEN-2, A NEW RELIABLE ASSAY FOR THE EARLY DIAGNOSIS AND PREDICTION OF OUTCOME IN ACUTE NECROTIZING PANCREATITIS. Sainio V*, Puolakkainen P*, Kemppainen E*, Hedstrtm J**, Haapiainen R*, Kivisaari L***, Stenman U**, Schrtder T*, Kivilaakso E*. II Dept. of Surg*, Clinical Chemistry** and Radiology***, University of Helsinki, Finland Trypsinogen-2 leaks out of the pancreatic acinar cells in acute pancreatitis. We

have developed a new sensitive immunofluorometric assay to measure the concentration of this protein. Between Nov. 1989 and May 1993 serum trypsinogen-2 levels were

prospectively analyzed in 52 consecutive patients with necrotizing pancreatitis during the first 48h after admission and their accuracy in diagnosing pancreatitis and predicting the outcome, were assessed. Pancreatic necrosis was verified by contrast enhanced CT, at surgery or autopsy. The patients were allocated into three groups depending on the outcome of the pancreatitis. Group A consisted of 26 patients recovering without major complications, group B of 16 patients with complicated and group C of 10 patients with a fatal course. Fifty patients with abdominal pain caused by diseases other than pancreatitis served as controls. The reference range for serum trypsinogen-2 in healthy adults was 18-90 pg/l.

Mean values for the highest serum trypsinogen-2 levels during the first 48 h were 42 pg/ l in control patients, 1390 ~g/1 in group A, 3540 gg/ l in group B and 3780 ~g/1 in group C. The trypsinogen-2 values differed significantly between groups A and B (p=0.03) and between groups A and C (p=0.02). Using a cut-off-level of 1000 p.g/l the assay had a sensitivity of 100 % with a specificity of 73 % to detect patients in group C. On the same cut-off-level the sensitivity and specificity to detect patients in groups B and C was 88 % and 62 %, respectively.

T~p~nogen-2 100000 ~g/L

10000

1000

100

10

O O

Controls A a In conclusion, serum trypsinogen-2 is an easy-to-perform, sensitive and

rather specific assay for the early diagnosis and prediction of severity and outcome of the disease in patients with necrotizing pancreatifis