Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Choledocholithiasis; Cholangitis | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatitis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional (guidewire) cannulation- High experienced | Procedure | — | UNRESOLVED |
| Conventional (guidewire) cannulation - Low experienced | Procedure | — | UNRESOLVED |
| Fistulotomy - High experienced. | Procedure | — | UNRESOLVED |
| Fistulotomy - Low experienced. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Fistulotomy - High experienced
- description
- Fistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in high experienced endoscopists.
- interventionNames
- Procedure: Fistulotomy - High experienced.
- type
- ACTIVE_COMPARATOR
- label
- Fistulotomy - Low experienced
- description
- Fistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in low experienced endoscopists.
- interventionNames
- Procedure: Fistulotomy - Low experienced.
- type
- ACTIVE_COMPARATOR
- label
- Conventional (guidewire) cannulation- High experience
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * All patients undergoing ERCP with suspected or confirmed of choledocholithiasis, malignant and benign biliary stenosis. Exclusion Criteria: * 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.
References
Publications (5)
- BACKGROUNDLopes 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 24814775
- BACKGROUNDJin 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 27102829
- BACKGROUNDFuruya 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 29713133
- BACKGROUNDAbu-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 16082283
- BACKGROUNDMavrogiannis 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 10462652