Efficacy of Fistulotomy for Biliary Cannulation
Efficacy and Safety of Precut Fistulotomy vs Conventional Cannulation Technique as a Primary Approach to Biliary Access According to the Endoscopist Experience Degree in ERCP
1 other identifier
interventional
320
1 country
1
Brief Summary
Access to the main bile duct is the first step in order to perform a therapeutic maneuver for biliary diseases. Early precut has been shown to ameliorate cannulation success rate, specially in difficult cannulation cases, when compared to guidewire cannulation (which is considered, for most, the standard technique). We aim to perform a randomized clinical trial comparing fistulotomy (F) precut vs guidewire cannulation (CC), as a primary cannulation technique, and compare outcomes between high experienced endoscopists (\> 200 ERCPs\[Endoscopic Retrograde cholangiopancreatography\]) and low experienced endoscopists (\< 200 ERCPs).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2019
CompletedFirst Submitted
Initial submission to the registry
July 26, 2019
CompletedFirst Posted
Study publicly available on registry
July 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
May 1, 2025
April 1, 2025
7.4 years
July 26, 2019
April 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cannulation success rate within 5 minutes
Successful access to the main biliary duct and subsequently to the biliary tree
8 months
Secondary Outcomes (2)
Adverse event rate
8 months
Technical success
8 months
Study Arms (4)
Fistulotomy - High experienced
ACTIVE COMPARATORFistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in high experienced endoscopists.
Fistulotomy - Low experienced
ACTIVE COMPARATORFistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in low experienced endoscopists.
Conventional (guidewire) cannulation- High experience
ACTIVE COMPARATORConventional cannulation with an sphincterotome and 0.035 inch hydrophilic tip guidewire as the primary cannulation technique in high experienced endoscopists.
Conventional (guidewire) cannulation - Low experienced.
ACTIVE COMPARATORConventional cannulation with an sphincterotome and 0.035 inch hydrophilic tip guidewire as the primary cannulation technique in low experienced endoscopists.
Interventions
We will perform a duodenoscopy, once located next to the papilla, we will perform precut fistulotomy on the papillary infundibulum with a needle knife with EBRE, EndoCut I, Effect 2, until biliary fluid exit is seen or the biliary duct is noted, then we will access to the biliary tree to complete de procedure.
We will perform a duodenoscopy, once located next to the papilla, we will perform precut fistulotomy on the papillary infundibulum with a needle knife with EBRE, EndoCut I, Effect 2, until biliary fluid exit is seen or the biliary duct is noted, then we will access to the biliary tree to complete de procedure.
We will perform a duodenoscopy, once located next to the papilla, we will perform cannulation with sphincterotome and hydrophilic tipped guidewire aided by fluoroscopy, once the guidewire reaches de common bile duct (seen on fluoroscopy) we will continue with the procedure according to the patient's indication.
We will perform a duodenoscopy, once located next to the papilla, we will perform cannulation with sphincterotome and hydrophilic tipped guidewire aided by fluoroscopy, once the guidewire reaches de common bile duct (seen on fluoroscopy) we will continue with the procedure according to the patient's indication.
Eligibility Criteria
You may qualify if:
- All patients undergoing ERCP with suspected or confirmed of choledocholithiasis, malignant and benign biliary stenosis.
You may not qualify if:
- patients with previous ERCP, altered gastro-duodenal anatomy by previous surgery, suspicion or diagnosis of ampullary neoplasm, duodenal cancer, periampullary diverticula types 1 and 2, pregnant women, coagulopathy with INR greater than 1.5.
- Elimination Criteria:
- \- Incomplete procedure due to anesthesia adverse events.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Medico Nacional Siglo XXI Hospital de Especialidades
Mexico City, Mexico City, 06700, Mexico
Related Publications (5)
Lopes L, Dinis-Ribeiro M, Rolanda C. Early precut fistulotomy for biliary access: time to change the paradigm of "the later, the better"? Gastrointest Endosc. 2014 Oct;80(4):634-641. doi: 10.1016/j.gie.2014.03.014. Epub 2014 May 6.
PMID: 24814775BACKGROUNDJin YJ, Jeong S, Lee DH. Utility of needle-knife fistulotomy as an initial method of biliary cannulation to prevent post-ERCP pancreatitis in a highly selected at-risk group: a single-arm prospective feasibility study. Gastrointest Endosc. 2016 Nov;84(5):808-813. doi: 10.1016/j.gie.2016.04.011. Epub 2016 Apr 19.
PMID: 27102829BACKGROUNDFuruya CK, Sakai P, Marinho FRT, Otoch JP, Cheng S, Prudencio LL, de Moura EGH, Artifon ELA. Papillary fistulotomy vs conventional cannulation for endoscopic biliary access: A prospective randomized trial. World J Gastroenterol. 2018 Apr 28;24(16):1803-1811. doi: 10.3748/wjg.v24.i16.1803.
PMID: 29713133BACKGROUNDAbu-Hamda EM, Baron TH, Simmons DT, Petersen BT. A retrospective comparison of outcomes using three different precut needle knife techniques for biliary cannulation. J Clin Gastroenterol. 2005 Sep;39(8):717-21. doi: 10.1097/01.mcg.0000173928.82986.56.
PMID: 16082283BACKGROUNDMavrogiannis C, Liatsos C, Romanos A, Petoumenos C, Nakos A, Karvountzis G. Needle-knife fistulotomy versus needle-knife precut papillotomy for the treatment of common bile duct stones. Gastrointest Endosc. 1999 Sep;50(3):334-9. doi: 10.1053/ge.1999.v50.98593.
PMID: 10462652BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oscar V Hernandez Mondragon, MD
Instituto Mexicano del Seguro Social
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The participant will be allocated to one group of the intervention conventional guidewire biliary cannulation or fistulotomy based on program software
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2019
First Posted
July 30, 2019
Study Start
July 3, 2019
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
May 1, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share