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Endoscopy 2016; 48(06): 530-535
DOI: 10.1055/s-0042-102250
Original article
© Georg Thieme Verlag KG Stuttgart · New York

Early precut sphincterotomy for difficult biliary access to reduce post-ERCP pancreatitis: a randomized trial

Alberto Mariani
1   Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy
,
Milena Di Leo
1   Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy
,
Nicola Giardullo
2   Gastroenterology and Gastrointestinal Endoscopy Unit, S.G. Moscati Hospital, Avellino, Italy
,
Antonella Giussani
1   Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy
,
Mario Marini
3   Gastroenterology Unit, A.O.U.S. Policlinico S.Maria alle Scotte, Siena, Italy
,
Federico Buffoli
4   Digestive Endoscopy and Gastroenterology Unit, A.O. Istituti Ospitalieri di Cremona, Italy
,
Livio Cipolletta
5   Gastroenterology, Maresca Hospital, Torre del Greco, Italy
,
Franco Radaelli
6   Division of Gastroenterology, Valduce Hospital, Como, Italy
,
Paolo Ravelli
7   Digestive Endoscopy Unit, Department of Gastroenterology, Papa Giovanni XXIII Hospital, Bergamo, Italy
,
Giovanni Lombardi
8   Digestive Endoscopy Unit, A. Cardarelli Hospital, Napoli, Italy
,
Vittorio D’Onofrio
2   Gastroenterology and Gastrointestinal Endoscopy Unit, S.G. Moscati Hospital, Avellino, Italy
,
Raffaele Macchiarelli
3   Gastroenterology Unit, A.O.U.S. Policlinico S.Maria alle Scotte, Siena, Italy
,
Elena Iiritano
4   Digestive Endoscopy and Gastroenterology Unit, A.O. Istituti Ospitalieri di Cremona, Italy
,
Marco Le Grazie
1   Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy
,
Giuseppe Pantaleo
9   UniSR-Social.Lab (Research Methods), San Raffaele University of Milan, Faculty of Psychology, Milan, Italy
,
Pier Alberto Testoni
1   Gastroenterology and Gastrointestinal Endoscopy Unit, Vita-Salute San Raffaele University, Scientific Institute San Raffaele Milan, Italy
› Author Affiliations
Further Information

Publication History

submitted 05 May 2015

accepted after revision 28 December 2015

Publication Date:
18 March 2016 (online)

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Background and study aim: Precut sphincterotomy is a technique usually employed for difficult biliary cannulation during endoscopic retrograde cholangiopancreatography (ERCP) for the treatment of bile duct disease. It is a validated risk factor for post-ERCP pancreatitis (PEP), but it is not clear whether the risk is related to the technique itself or to the repeated biliary cannulation attempts preceding it. The primary aim of the study was to assess the incidence of PEP in early precut compared with the standard technique in patients with difficult biliary cannulation. Secondary aims were to compare complications and cannulation success.

Patients and methods: In this prospective, multicenter, randomized, clinical trial, patients who were referred for therapeutic biliary ERCP and difficult biliary cannulation were randomized to early precut (Group A) or repeated papillary cannulation attempts followed, in cases of failure, by late precut (Group B). PEP was defined as the onset of upper abdominal pain associated with an elevation in serum pancreatic enzymes of at least three times the normal level at more than 24 hours after the procedure. No rectal indomethacin or diclofenac was used for prevention of PEP.

Results: A total of 375 patients were enrolled. PEP developed in 10 of the 185 patients (5.4 %) in Group A and 23 of the 190 (12.1 %) in Group B (odds ratio [OR] 0.35; 95 % confidence interval [CI] 0.16 – 0.78). The incidence of PEP was significantly lower in the early precut group (10/185, 5.4 %) than in the delayed precut subgroup (19/135 [14.1 %]; OR 0.42, 95 %CI 0.17 – 1.07). There were no differences in biliary cannulation success rates, bleeding, perforation, and cholangitis.

Conclusions: In patients with difficult biliary cannulation, early precut is an effective technique and can significantly reduce the incidence of PEP. Repeated biliary cannulation attempts are a real risk factor for this complication.

 

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