Clinical trial · Interventional
Needle Knife Fistulotomy Versus Partial Ampullary Endoscopic Mucosal Resection for Difficult Biliary Cannulation
NCT05068739CI-TRIAL-00061398completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aims of this study are to compare the needle knife fistulotomy (NKF) technique versus the partial ampullary endoscopic mucosal resection (PA-EMR) technique in patients with difficult biliary cannulation and to assess the incidence rate of complications between these cannulation methods.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Disease | — | UNRESOLVED | — |
| Biliary Stricture | — | UNRESOLVED | — |
| Common Bile Duct Calculi | — | UNRESOLVED | — |
| Malignant Hepatobiliary Neoplasm | Malignant Hepatobiliary Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NKF | Procedure | — | UNRESOLVED |
| PA-EMR | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PA-EMR (Partial ampullary endoscopic mucosal resection)
- description
- Partial ampullary endoscopic mucosal resection
- interventionNames
- Procedure: PA-EMR
- type
- ACTIVE_COMPARATOR
- label
- NKF(Needle knife fistulotomy)
- description
- Needle knife fistulotomy
- interventionNames
- Procedure: NKF
Primary outcomes (1)
- measure
- Success rate of cannulation
- timeFrame
- 1 day
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patient who submitted a written informed consent for this trial, and aged between 18-90 years old * Patient who have naïve papilla (no previous procedure was performed at ampulla) * Patient who is suspected to have a biliary obstruction or biliary disease * Patient who is needed to have endoscopic retrograde cholangiopancreatography for treatment of biliary obstruction * Patient who have risks of post-endoscopic retrograde cholangiopancreatography p Exclusion Criteria: * Patient who is pregnant * Patient with mental retardation * Patient allergic to contrast agents * Patient who received sphincterotomy or pancreatobiliary operation previously * Patient who have ampulla of Vater cancer * Patient who have difficulty for the approach to ampulla due to abdominal surgery including stomach cancer with Billroth II anastomosis * Patient who have pancreatic diseases as bellow (at least one more); * acute pancreatitis within 30days before enrollment * idiopathic acute recurrent pancreatitis * pancreas divisum * obstructive chronic pancreatitis * pancreatic cancer * Patients with Type-1, non-protruding Type-2 and Type-4 papilla
References
Publications (4)
- BACKGROUNDTestoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14. PMID 27299638
- BACKGROUNDHaraldsson E, Lundell L, Swahn F, Enochsson L, Lohr JM, Arnelo U; Scandinavian Association for Digestive Endoscopy (SADE) Study Group of Endoscopic Retrograde Cholangio-Pancreaticography. Endoscopic classification of the papilla of Vater. Results of an inter- and intraobserver agreement study. United European Gastroenterol J. 2017 Jun;5(4):504-510. doi: 10.1177/2050640616674837. Epub 2016 Oct 17. PMID 28588881
- BACKGROUNDKatsinelos P, Lazaraki G, Chatzimavroudis G, Zavos C, Kountouras J. The endoscopic morphology of major papillae influences the selected precut technique for biliary access. Gastrointest Endosc. 2015 Apr;81(4):1056. doi: 10.1016/j.gie.2014.11.018. No abstract available. PMID 25805488
- BACKGROUNDSriram PV, Rao GV, Nageshwar Reddy D. The precut--when, where and how? A review. Endoscopy. 2003 Aug;35(8):S24-30. doi: 10.1055/s-2003-41528. No abstract available. PMID 12929050