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Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method

Primary Purpose

Common Bile Duct Stone, Malignant Hepatobiliary Neoplasm, Biliary Stricture

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cannulation of ampulla of Vater
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Bile Duct Stone

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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);

    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

Sites / Locations

  • CHA Bundang Medical Center
  • Gangnam Severance Hospital
  • Dongtan Sacred Heart Hospital
  • In Ha University Hospital
  • Soon Chun Hyang University Hospital, Cheonan
  • Gachon University Gil Medical Center
  • Pusan National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Needle knife fistulotomy

conventional cannulation

Arm 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

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

Outcomes

Primary Outcome Measures

Incidence rate of post-endoscopic retrograde cholangiopancreatography

Secondary Outcome Measures

Incidence rate of complications including bleeding, perforation and infection
Success rate of cannulation
Success rate of stone removal

Full Information

First Posted
September 24, 2016
Last Updated
January 29, 2019
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02916199
Brief Title
Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 4, 2016 (Actual)
Primary Completion Date
November 28, 2017 (Actual)
Study Completion Date
November 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Bile Duct Stone, Malignant Hepatobiliary Neoplasm, Biliary Stricture, Pancreatic Diseases, Sphincter of Oddi Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Needle knife fistulotomy
Arm Type
Experimental
Arm 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
Arm Title
conventional cannulation
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
cannulation of ampulla of Vater
Intervention Description
Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices
Primary Outcome Measure Information:
Title
Incidence rate of post-endoscopic retrograde cholangiopancreatography
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Incidence rate of complications including bleeding, perforation and infection
Time Frame
1 week
Title
Success rate of cannulation
Time Frame
1 day
Title
Success rate of stone removal
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHA Bundang Medical Center
City
Seongnam
State/Province
Bundang-gu
ZIP/Postal Code
13496
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06229
Country
Korea, Republic of
Facility Name
Dongtan Sacred Heart Hospital
City
Hwaseong-si
State/Province
Gyeonggi-do
ZIP/Postal Code
18450
Country
Korea, Republic of
Facility Name
In Ha University Hospital
City
Incheon
State/Province
Jung-gu
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital, Cheonan
City
Cheonan
State/Province
Namdong-gu
ZIP/Postal Code
31151
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
State/Province
Namdong-gu
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan-si
State/Province
Seo-gu
ZIP/Postal Code
49241
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31913191
Citation
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.
Results Reference
derived

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Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method

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