Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method

Study Overview

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.

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.

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

DEVICE: cannulation of ampulla of Vater

3-2017-0092

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-09-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-01-29
First Submitted that Met QC Criteria 2016-09-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-01-30
First Posted (ACTUAL) 2016-09-27	Results First Posted N/A	Last Verified 2019-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

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 cholangiopancreat	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 cholangio	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

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 cholangiopancreat

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 cholangio

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

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

Secondary Outcome Measures	Measure Description	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

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);

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);

Patients who have improper ampulla shape as bellows;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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.

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Clinical Trial Record