Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method

Sponsor

Gangnam Severance Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02916199

Collaborator

(none)

207

Enrollment

Locations

Arms

13.8

Actual Duration (Months)

29.6

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Common Bile Duct Stone Malignant Hepatobiliary Neoplasm Biliary Stricture Pancreatic Diseases Sphincter of Oddi Dysfunction	Device: cannulation of ampulla of Vater	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

207 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method in Patients With High Risk of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicenter Randomized Controlled Trial

Actual Study Start Date :

Oct 4, 2016

Actual Primary Completion Date :

Nov 28, 2017

Actual Study Completion Date :

Nov 28, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence rate of post-endoscopic retrograde cholangiopancreatography [1 week]

Secondary Outcome Measures

Incidence rate of complications including bleeding, perforation and infection [1 week]
Success rate of cannulation [1 day]
Success rate of stone removal [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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);

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

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);

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)
Flat or crooked or asymmetric ampulla
Ampulla with peri-ampullary diverticulum type I or II

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHA Bundang Medical Center	Seongnam	Bundang-gu	Korea, Republic of	13496
2	Gangnam Severance Hospital	Seoul	Gangnam-gu	Korea, Republic of	06229
3	Dongtan Sacred Heart Hospital	Hwaseong-si	Gyeonggi-do	Korea, Republic of	18450
4	In Ha University Hospital	Incheon	Jung-gu	Korea, Republic of	22332
5	Soon Chun Hyang University Hospital, Cheonan	Cheonan	Namdong-gu	Korea, Republic of	31151
6	Gachon University Gil Medical Center	Incheon	Namdong-gu	Korea, Republic of	21565
7	Pusan National University Hospital	Busan-si	Seo-gu	Korea, Republic of	49241

Sponsors and Collaborators

Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sung III Jang, Assistant professor, Gangnam Severance Hospital

ClinicalTrials.gov Identifier:

NCT02916199

Other Study ID Numbers:

3-2017-0092

First Posted:

Sep 27, 2016

Last Update Posted:

Jan 30, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Pancreatic Diseases

Sphincter of Oddi Dysfunction

Study Results

No Results Posted as of Jan 30, 2019