Clinical trial · Interventional
Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method
Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method in Patients With High Risk of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicenter Randomized Controlled Trial
- 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 aim of this study are to evaluate the feasibility of needle knife fistulotomy (NKF) as an initial procedure for biliary access in patients with biliary disease who are at increased risk for post-endoscopic retrograde endoscopic retrograde cholangiopancreatography (PEP) and to assess the incidence rate of complications including PEP between NKF and conventional 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 Stricture | — | UNRESOLVED | — |
| Common Bile Duct Stone | — | UNRESOLVED | — |
| Malignant Hepatobiliary Neoplasm | Malignant Hepatobiliary Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Diseases | — | UNRESOLVED | — |
| Sphincter of Oddi Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cannulation of ampulla of Vater | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Needle knife fistulotomy
- description
- Device: Needle knife fistulotomy Disease: Common bile duct stone, Malignant biliary stricture, Benign biliary stricture, Benign pancreatic disease, biliary sphincter of Oddi dysfunction Indication: High risk of post-endoscopic retrograde cholangiopancreatography pancreatitis \- Intervention: canulation of ampulla of Vater Intervention: canulation of ampulla of Vater
- interventionNames
- Device: cannulation of ampulla of Vater
- type
- ACTIVE_COMPARATOR
- label
- conventional cannulation
- description
- Device: conventional canulation catheter Disease: Common bile duct stone, Malignant biliary stricture, Benign biliary stricture, Benign pancreatic disease, biliary sphincter of Oddi dysfunction Indication: High risk of post-endoscopic retrograde cholangiopancreatography pancreatitis \- Intervention: canulation of ampulla of Vater Intervention: canulation of ampulla of Vater
- interventionNames
- Device: cannulation of ampulla of Vater
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patient who submitted a written informed consent for the this trial, and 18 \~ 90 years old * Patient who have naïve ampulla (no previous procedure was performed at ampulla) * Patient who is suspected to have 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 pancreatitis among bellows (at least one more); 1. suspected biliary sphincter of Oddi dysfunction 2. young age (18\~50 years) 3. female 4. normal common bile duct diameter (≤9mm) 5. normal serum bilirubin level 6. Obesity (body mass index \> 30) 7. Past history of acute pancreatitis Exclusion Criteria: * Patient who is below 18 year old * Patient who is pregnant * Patient with mental retardation * Patient is sensitive to contrast agents * Patient who received sphincterotomy or pancreatobiliary operation previously * Patient who have ampulla of Vater cancer * Patient who have difficulty for 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); 1. Patient who have acute pancreatitis within 30days before enrollment 2. Patient who have idiopathic acute recurrent pancreatitis 3. Patient who have pancreatic divisum 4. Patient who have obstructive chronic pancreatitis 5. Patient who pancreatic cancer * Patients who have improper ampulla shape as bellows; 1. Small ampulla (ampulla without oral protrusion) 2. Flat or crooked or asymmetric ampulla 3. Ampulla with peri-ampullary diverticulum type I or II
References
Publications (1)
- DERIVEDJang SI, Kim DU, Cho JH, Jeong S, Park JS, Lee DH, Kwon CI, Koh DH, Park SW, Lee TH, Lee HS. Primary Needle-Knife Fistulotomy Versus Conventional Cannulation Method in a High-Risk Cohort of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis. Am J Gastroenterol. 2020 Apr;115(4):616-624. doi: 10.14309/ajg.0000000000000480. PMID 31913191