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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Diseases; Sphincter of Oddi Dysfunction; Biliary Stricture; Malignant Hepatobiliary Neoplasm; Common Bile Duct Stone
• Intervention / Treatment: Device: cannulation of ampulla of Vater

Detailed Description

Endoscopic retrograde endoscopic retrograde cholangiopancreatography (ERCP) is widely used for the diagnosis and treatment of pancreatic and biliary tract disease. However, post-ERCP pancreatitis (PEP) is the most common adverse event following the procedure, ranging from 2% to 10% in nonselective cases, and it can cause substantial morbidity, mortality, or high medical costs. Recent advances in cannulation technique and accessories for biliary cannulation have contributed to reduce the incidence of PEP, but biliary cannulation can fail in 5% to 20% of cases of ERCP. Suprapapillary needle-knife fistulotomy (NKF), with or without large-diameter balloon dilation, has been used as a rescue method in cases of difficult biliary cannulation, and NKF was recommended as an initial approach to selective biliary cannulation in cases of repetitive unintentional pancreatic cannulation.9 Moreover, difficult biliary cannulation is known to be a risk factor for PEP, and it has been reported that NKF is associated with a low risk of PEP. Thus, we hypothesized that NKF may reduce the risk of PEP in patients who are at increased risk for PEP.

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang-gu
    • Seongnam, Bundang-gu, Korea, Republic of, 13496
      • CHA Bundang Medical Center
  • Gangnam-gu
    • Seoul, Gangnam-gu, Korea, Republic of, 06229
      • Gangnam Severance Hospital
  • Gyeonggi-do
    • Hwaseong-si, Gyeonggi-do, Korea, Republic of, 18450
      • Dongtan Sacred Heart Hospital
  • Jung-gu
    • Incheon, Jung-gu, Korea, Republic of, 22332
      • In Ha University Hospital
  • Namdong-gu
    • Cheonan, Namdong-gu, Korea, Republic of, 31151
      • Soon Chun Hyang University Hospital, Cheonan
    • Incheon, Namdong-gu, Korea, Republic of, 21565
      • Gachon University Gil Medical Center
  • Seo-gu
    • Busan-si, Seo-gu, Korea, Republic of, 49241
      • Pusan National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Needle knife fistulotomy; 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	Device: cannulation of ampulla of Vater; Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices
ACTIVE_COMPARATOR: conventional cannulation; 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	Device: cannulation of ampulla of Vater; Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence rate of post-endoscopic retrograde cholangiopancreatography	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence rate of complications including bleeding, perforation and infection	1 week
Success rate of cannulation	1 day
Success rate of stone removal	1 day

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Publications and helpful links

General Publications

• Jang 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 4, 2016
• Primary Completion (ACTUAL): November 28, 2017
• Study Completion (ACTUAL): November 28, 2017

Study Registration Dates

• First Submitted: September 24, 2016
• First Submitted That Met QC Criteria: September 25, 2016
• First Posted (ESTIMATE): September 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Biliary Dyskinesia; Common Bile Duct Diseases; Sphincter of Oddi Dysfunction; Pancreatic Diseases
• Other Study ID Numbers: 3-2017-0092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO