Randomized Clinical Trial
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Apr 28, 2018; 24(16): 1803-1811
Published online Apr 28, 2018. doi: 10.3748/wjg.v24.i16.1803
Papillary fistulotomy vs conventional cannulation for endoscopic biliary access: A prospective randomized trial
Carlos Kiyoshi Furuya, Paulo Sakai, Fabio Ramalho Tavares Marinho, Jose Pinhata Otoch, Spencer Cheng, Lívia Lemes Prudencio, Eduardo Guimarães Hourneaux de Moura, Everson Luiz de Almeida Artifon
Carlos Kiyoshi Furuya, Paulo Sakai, Fabio Ramalho Tavares Marinho, Spencer Cheng, Eduardo Guimarães Hourneaux de Moura, Department of Gastrointestinal Endoscopy Unit, University of Sao Paulo, Sao Paulo 05409001, Brazil
Jose Pinhata Otoch, Lívia Lemes Prudencio, Department of Surgery, University of Sao Paulo, Sao Paulo 05403000, Brazil
Everson Luiz de Almeida Artifon, Department of Gastroenterology and Radiology, University of Sao Paulo, Sao Paulo 04107-030, Brazil
Author contributions: Furuya CK designed and performed the research; Sakai P, Marinho FRT and Prudencio LL wrote the paper; Otoch JP and de Moura EGH analyzed the data; Artifon EL performed the research and analyzed the data.
Institutional review board statement: The study was reviewed and approved by Ethics Committee for Research Project Analysis of Clinics Hospital, University of Sao Paulo and UNILUS Ethics Subcommittee.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors declare no potential conflicting interests related to this paper.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Carlos Kiyoshi Furuya, MD, PhD, Medical Assistant, Department of Gastrointestinal Endoscopy Unit, University of Sao Paulo, Av. Dr. Eneas de Carvalho Aguiar, 255 Predio dos Ambulatorios-6 andar-Bloco 3, Sao Paulo 5409001, Brazil. carloskfjr@gmail.com
Telephone: +55-11-30697579
Received: February 25, 2018
Peer-review started: February 26, 2018
First decision: March 9, 2018
Revised: March 12, 2018
Accepted: March 25, 2018
Article in press: March 25, 2018
Published online: April 28, 2018
Research background

Successfully cannulating the biliary tract is important in the diagnosis and treatment of biliopancreatic diseases with endoscopic retrograde cholangiopancreatography (ERCP), but it can be associated with severe complications and mortality.

Research motivation

The number of papers regarding comparison between conventional cannulation versus fistulotomy is small. Our study is a well-designed approach in its matter.

Research objectives

To compare the cannulation success, biochemical profile, and complications of the papillary fistulotomy technique versus catheter and guidewire standard access.

Research methods

Patients were prospectively randomized into two groups: cannulation with a catheter and guidewire (Group I) and papillary fistulotomy (Group II). Amylase, lipase and C-reactive protein at T0 as well as 12 h and 24 h after ERCP, and complications (pancreatitis, bleeding, perforation) were recorded. Comparison was made of the cannulation success, biochemical profile and complications of the papillary fistulotomy technique vs catheter and guidewire standard access.

Research results

We included 102 patients, and Groups I and II had 51 patients each. The successful cannulation rates were 76.5% and 100%, respectively (P = 0.0002). Twelve patients (23.5%) in GroupI had a difficult cannulation and underwent fistulotomy, which led to successful secondary biliary access (Failure Group). The complication rate was 13.7% (2 perforations and 5 mild pancreatitis) in Group I versus 2.0% (1 patient with perforation and pancreatitis) in Group II (P = 0.0597).

Research conclusions

Papillary fistulotomy was more effective than guidewire cannulation, and it was associated with a lower profile of amylase and lipase. Complications were similar in both groups.

Research perspectives

The fistulotomy demonstrated safety similar to conventional cannulation and less local trauma into the ampulla, according to the levels of the amylase, lipase and C-reactive protein.