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Digestive and Liver Disease 45 (2013) 700– 702

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Digestive and Liver Disease

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omment to “Sixty- versus thirty-seconds papillary balloon dila-ion after sphincterotomy for the treatment of large bile ducttones: A randomized controlled trial”

ear Sir,

I read with great interest the report by Paspatis et al. [1] whichhowed the similar effectiveness of endoscopic papillary large bal-oon dilation (EPLBD) for 60 s versus 30 s after sphincterotomy inatients with large bile duct stones. In their prospective study

ncluding 124 patients, the secondary objectives were to evaluatehe complications of the procedure as well as the potential reasonsf procedural failure. They reported failure of stone removal in 18ases, while the tapered distal common bile duct (OR: 25.6) andtone size (OR: 1.4) were the predictors of failure in multivariatenalysis. I usually perfom EPLBD in my daily practice as a valuableethod for large biliary stones with some failures. I have an ongo-

ng hesitation of perforation, despite a very low figures in previouseports which were reviewed by myself [2] and other colleauges3]. Although I did not encounter any case of perforation (not yet!),wo recent papers raised this concern again [4,5]. I appreciate thefforts of the authors and would like to comment to uncover themportance of “tapered” common bile duct which appears to be aisk for both perforation and procedural failure.

Recently, Park et al. [4] reported a multicenter, retrospectivetudy included 946 patients who underwent EPLBD. In this studyuodenal perforation was the most serious adverse events of EPLBD

ncluding one mild, four moderate and four severe cases (9.5%).hree of the four patients with perforations of moderate severitynd all four patients with fatal severe lateral wall perforations hadnderlying distal CBD strictures, a persistent balloon waist in thealloon during dilation, or a long-segment tapering distal CBD. Theyuggested that never fully dilated waist might be one of the factorsausing fatal perforation.

In the present study [1], in 9 cases, the distal CBD was too taperedesulting in the failure of its removal. Complete removal of bileuct stones was significantly lower in those patients with taperedistal bile duct (10/19) compared to those without tapering96/105), p < 0.0001. What is the exact meaning of “tapered” whichaused failed stone extraction in some cases (n: 9) but did notmpede successful extraction in the remaining (n: 10)? What washe details of such cases specifically length of the distal stricture,iagnostic pitfalls of distal stricture, presence or absence of balloonaist during inflation?

Finally, I congratulate the efforts of the authors for enlighteninghe obscure features of EPLBD and their further comments will beery valuable on “tapered” cases.

eferences

1] Paspatis GA, Konstantinidis K, Tribonias G, et al. Sixty- versus thirty-secondspapillary balloon dilation after sphincterotomy for the treatment of large bile

590-8658/$36.00 © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier

duct stones: a randomized controlled trial. Digestive and Liver Disease 2012,http://dx.doi.org/10.1016/j.dld.2012.10.015.

2] Ozaslan E. Large-balloon dilation after sphincterotomy: anatomical and techni-cal issues. Gastrointestinal Endoscopy 2011;74:723–4.

3] Meine GC, Baron TH. Endoscopic papillary large-balloon dilation combined withendoscopic biliary sphincterotomy for the removal of bile duct stones (withvideo). Gastrointestinal Endoscopy 2011;74:1119–26.

4] Park SJ, Kim JH, Hwang JC, et al. Factors predictive of adverse events followingendoscopic papillary large balloon dilation: results from a multicenter series.Digestive Diseases and Sciences 2012 [Epub ahead of print] PubMed PMID:23225136.

5] Voudoukis E, Vardas E, Theodoropoulou A, et al. Conservative treatment of perfo-ration following balloon dilation of the papilla after sphincterotomy. Endoscopy2012;44:E292–3.

Ersan Ozaslan ∗

Ankara Numune Education and Research Hospital,Department of Gastroenterology, Ankara, Turkey

∗ Correspondence address: C ukurambar Mah. 1429,Cad. 24/2, C ankaya, Ankara, Turkey.

Tel.: +90 312 2873882; fax: +90 312 3125026.E-mail address: er72@hotmail.com

Available online 13 March 2013

http://dx.doi.org/10.1016/j.dld.2013.02.004

Author reply: Comment to “Sixty versus thirty seconds papillaryballoon dilation after sphincterotomy for the treatment of largebile duct stones: A randomized controlled trial”

Sir,

We thank Ozaslan for his comments on our paper on “sixty-versus thirty-second of endoscopic papillary large balloon dilation(EPLBD) for the treatment of large bile duct stones” [1]. In this studythe 30-s EPLBD was equally effective as the 60-s EPLBD, with similarrate of post procedural complications. Complete stone removal wassignificantly lower in those patients with tapered distal commonbile duct (CBD) (10/19) compared to those without duct tapering(96/105, p < 0.0001).

In our study we considered the CBD tapered, in that its dis-tal part gradually narrows, like a funnel towards the papilla for alength of at least 2 cm. We do accept that this term includes a partof subjectivity especially in the length of the tapered part.

Since in all EPLBDs we used a balloon catheter (CREEsophageal/Pyloric, maximum diameter 15, 18, or 20 mm; length5 cm, Boston Scientific, Natick, MA) and the middle of the balloonwas placed at the site of the papilla, the dilation of the distal CBDwas extended up 2–3 cm in length.

We consider that the higher failure rate in the subgroup ofpatients with the tapered CBD might be due to the unsuccessfuldilation of the distal part of the CBD, although the papilla wassuccessfully dilated.

Ltd. All rights reserved.

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In our cases the size of the balloon was chosen according to theransverse diameter of the stones and never exceeded the maxi-

um diameter of the CBD.Although it might be aggressive to dilate the lower part of

he CBD according to the size of the upper CBD diameter, we didot experience any perforation in the subgroup of patients withapered CBD.

To our knowledge, EPLBD is not related with increased rates oferforation, and the few perforations that we dealt with were allreated conservatively, with no serious occurrences [2,3].

As we have already commended in the discussion of our paper,he EPLBD in the subgroup of patients with tapered CBD needsurther evaluation.

Finally, we do appreciate Ozaslan comments on the subgroupf patients with tapered CBD and hope future clinical studies willlarify the unanswered questions.

onflict of interest statementone declared.

eferences

1] Paspatis GA, Konstantinidis K, Tribonias G, et al. Sixty- versus thirty-secondspapillary balloon dilation after sphincterotomy for the treatment of large bileduct stones: a randomized controlled trial. Digestive and Liver Disease 2012,http://dx.doi.org/10.1016/j.dld.2012.10.015.

2] Voudoukis E, Vardas E, Theodoropoulou A, et al. Conservative treatment of perfo-ration following balloon dilation of the papilla after sphincterotomy. Endoscopy2012;44:E292–3.

3] Ozaslan E. Large-balloon dilation after sphincterotomy: anatomical and techni-cal issues. Gastrointestinal Endoscopy 2011;74:723–4.

Gregorios A. Paspatis ∗

Department of Gastroenterology, Benizelion GeneralHospital, Heraklion, Crete, Greece

Konstantina ParaskevaKonstantopoulio General Hospital, Athens, Greece

∗ Corresponding author at: Benizelion GeneralHospital, Department of Gastroenterology,L.Knossou, Heraklion, Crete 71409, Greece.

Tel.: +30 2810 368017; fax: +30 2810 368017.E-mail address: paspati@admin.teiher.gr

(G.A. Paspatis)

Available online 6 April 2013

ttp://dx.doi.org/10.1016/j.dld.2013.02.014

omment to “Vinyl chloride exposure and cirrhosis: A system-tic review and meta-analysis”

ear Editor,

In a recently published article Frullanti et al. [1] reviewed thevailable literature on the association between vinyl chloride (VC)nd liver cirrhosis; it seems however that they rather examinednly mortality cohort studies concluding for absence of increasedirrhosis risk in workers exposed to VC.

Since an occupational cohort might include both highly exposednd non-exposed workers, a single crude outcome from a cohorttudy could hide excess health risks in highly exposed categories.or example, while the risk of cirrhosis was lower than unity in thehole Porto Marghera cohort, when cohort data were re-analyzedsing an internal comparison group of non-exposed workers, the

elative risk for cirrhosis was 2.8 (95% confidence interval, CI:.90–76) among the group with highest VC exposure [2]. However,nly the former but not the latter risk estimate was included in theeview by Frullanti et al. [1].

r Disease 45 (2013) 700– 702 701

In addition, mortality cohort studies rely on death certificateswhere cirrhosis is coded as the underlying cause of death in theabsence of other medical conditions. The coding rules primarilytake into account cancer if other conditions were present with cir-rhosis at death. Since VC exposure is a known risk factor for livercarcinoma and angiosarcoma, cirrhosis listed on the death certifi-cate as “other medical condition” would be neglected.

Frullanti et al. did not consider recent and compelling evidencebased on case–control and cross-sectional studies. For example,40 cases of cirrhosis (including subjects with hepatocellular car-cinoma) were compared with 139 subjects without chronic liverdiseases or cancer in a case–control study from a cohort of 1658 VCworkers. By adjusting for confounding factors at logistic regressionanalysis, each extra increase of 1000 ppm years of VC cumula-tive exposure was found to increase the risk of cirrhosis by 37%(OR = 1.37; CI: 1.13–1.69) [3]. Furthermore, in a cross-sectionalanalysis on 347 workers with occupational exposure to VC, liverfibrosis was defined in subjects with pre-cirrhosis and cirrhosisof liver diagnosed by ultrasonography. Multiple logistic regressionmodels were used to assess whether VC exposure, viral hepatitis,body mass index, alcohol consumption and tobacco smoking wereassociated with liver fibrosis. Significantly increased risk of devel-oping liver fibrosis was found in workers with high exposure jobs(OR = 5.5; CI: 1.7–25.4) when compared with non-exposed work-ers [4]. The above studies were confirmed by historical and recentevidence.

Finally, in earlier studies (see: Information Section, British Jour-nal of Industrial Medicine, 1977, 34, 70–84) pathologic findingsof extensive non-alcoholic cirrhosis in addition to angiosarcomaand/or hepatocarcinoma in the same liver were described in VCworkers. Liver biopsies obtained during 1974–1977 and frozenserum samples described steatohepatitis (80% prevalence) andfibrosis (44%) in non-obese non-drinking highly exposed VCworkers [5]. The clinical entity was termed toxicant-associatedsteatohepatitis (TASH); total serum cytokeratine 18 was ele-vated, suggesting liver cell necrosis rather than apoptosis. Outof three subjects undergoing repeated liver biopsies follow-ing removal from workplace, two had progressive liver fibrosis[5].

In conclusion, a more careful review of the literature does sug-gest an increased risk of cirrhosis in highly exposed VC workers.

Conflict of interestNone to declare.

References

1] Frullanti E, La Vecchia C, Boffetta P, Zocchetti C. Vinyl chloride exposure andcirrhosis: a systematic review and meta-analysis. Digestive and Liver Disease2012;44(September (9)):775–9.

2] Gennaro V, Ceppi M, Crosignani P, Montanaro F. Reanalysis of updated mortalityamong vinyl and polyvinyl chloride workers: confirmation of historical evidenceand new findings. BMC Public Health 2008;8:21.

3] Mastrangelo G, Fedeli U, Fadda E, et al. Increased risk of hepatocellular car-cinoma and liver cirrhosis in vinyl chloride workers: synergistic effect ofoccupational exposure with alcohol intake. Environmental Health Perspectives2004;112(August (11)):1188–92.

4] Hsiao TJ, Wang JD, Yang PM, Yang PC, Cheng TJ. Liver fibrosis in asymp-tomatic polyvinyl chloride workers. Journal of Occupational and EnvironmentalMedicine 2004;46:962–6.

5] Cave M, Falkner KC, Ray M, et al. Toxicant-associated steatohepatitis in vinylchloride workers. Hepatology 2010;51:474–81.

Giuseppe MastrangeloPadua University, Department of Molecular

Medicine, Padua, Italy

Luca Cegolon a,b,∗a Padua University, Department of Molecular

Medicine, Padua, Italy