Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method

NCT02916199 | Completed DMC

• 1 other identifier: 3-2017-0092
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 7

Brief Summary

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

Common Bile Duct Stone; Malignant Hepatobiliary Neoplasm; Biliary Stricture; Pancreatic Diseases; Sphincter of Oddi Dysfunction

Outcome Measures

Primary Outcomes (1)

• Incidence rate of post-endoscopic retrograde cholangiopancreatography

  1 week

Secondary Outcomes (3)

• Incidence rate of complications including bleeding, perforation and infection

  1 week

• Success rate of cannulation

  1 day

• Success rate of stone removal

  1 day

Study Arms (2)

Needle knife fistulotomy

EXPERIMENTAL

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

conventional cannulation

ACTIVE COMPARATOR

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

Interventions

cannulation of ampulla of Vater DEVICE

Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices

Needle knife fistulotomy; conventional cannulation

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• suspected biliary sphincter of Oddi dysfunction
• young age (18\~50 years)
• female
• normal common bile duct diameter (≤9mm)
• normal serum bilirubin level
• Obesity (body mass index \> 30)
• Past history of acute pancreatitis

You may not qualify if:

• 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);
• Patient who have acute pancreatitis within 30days before enrollment
• Patient who have idiopathic acute recurrent pancreatitis
• Patient who have pancreatic divisum
• Patient who have obstructive chronic pancreatitis
• Patient who pancreatic cancer
• Patients who have improper ampulla shape as bellows;
• Small ampulla (ampulla without oral protrusion)

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (7)

CHA Bundang Medical Center

Seongnam, Bundang-gu, 13496, South Korea

Location

Gangnam Severance Hospital

Seoul, Gangnam-gu, 06229, South Korea

Location

Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, 18450, South Korea

Location

In Ha University Hospital

Incheon, Jung-gu, 22332, South Korea

Location

Soon Chun Hyang University Hospital, Cheonan

Cheonan, Namdong-gu, 31151, South Korea

Location

Gachon University Gil Medical Center

Incheon, Namdong-gu, 21565, South Korea

Location

Pusan National University Hospital

Busan, Seo-gu, 49241, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31913191 DERIVED

MeSH Terms

Conditions

Gallstones; Pancreatic Diseases; Sphincter of Oddi Dysfunction

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Biliary Dyskinesia; Common Bile Duct Diseases; Bile Duct Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 24, 2016
• First Posted: September 27, 2016
• Study Start: October 4, 2016
• Primary Completion: November 28, 2017
• Study Completion: November 28, 2017
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (7)