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Is Needle Knife Fistulotomy An Effective First Step Strategy For All ERCPs?

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ClinicalTrials.gov Identifier: NCT03698266
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Lawrence Charles Hookey, Queen's University

Tracking Information
First Submitted Date  ICMJE October 4, 2018
First Posted Date  ICMJE October 5, 2018
Last Update Posted Date November 28, 2018
Actual Study Start Date  ICMJE November 23, 2018
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
Post-ERCP pancreatitis [ Time Frame: Up to 7 days post-procedure ]
The primary objective to be examined is the incidence of post-ERCP pancreatitis
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03698266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
Technical success [ Time Frame: Day of procedure ]
Determined by successful cannulation of the CBD as evidenced on cholangiogram
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 4, 2018)
  • Total procedure time [ Time Frame: Day of procedure ]
    Measured for completed procedures from the time of esophageal intubation to the time of scope withdrawal from the patient mouth
  • Time to successful cannulation [ Time Frame: Day of procedure ]
    Measured from the time of identification of the papilla to successful CBD cannulation as evident by the cholangiogram
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Is Needle Knife Fistulotomy An Effective First Step Strategy For All ERCPs?
Official Title  ICMJE Is Needle Knife Fistulotomy An Effective First Step Strategy For All ERCPs?
Brief Summary

Participants in this study will be undergoing a procedure called an endoscopic retrograde cholangiopancreatography (ERCP). This procedure is most commonly performed to help treat conditions affecting specific areas of the digestive system called the pancreas and bile ducts.

Patients will consent to allow the study physician to access these areas of the digestive system by making a cut using a technique called a needle-knife fistulotomy. If the physician is unable to gain access through this method, they will make the cut using a technique called a sphincterotomy.

Detailed Description

The ERCP procedure enables doctors to examine the regions of the digestive system called the pancreas and bile ducts. After sedating a patient, a bendable tube with a light (called an endoscope), is inserted through the mouth and into the digestive system. Within the digestive system, the doctor is able to identify the opening to where the gallbladder drains into the small bowel called the ampulla. Using the endoscope, a small plastic tube is then placed in the opening and dye (also called contrast material) is injected bile duct (where bile leaves the liver from). X-ray pictures can then be taken to provide further information to the doctor.

Sometimes it is necessary to make a cut to enlarge the opening to allow easier removal of stones from the bile duct or to place plastic tubes (stents) in the bile duct. To make this cut, there are two different approaches that the doctor can take:

  1. The standard way of making the cut is referred to as a "sphincterotomy". Using this method, a heated metal wire cuts the opening to the bile duct after a wire has been passed into it.
  2. The second way of making the cut is referred to as a "pre-cut". There are various types of "pre-cut" techniques; the technique being evaluated in this study is called the "needle knife fistulotomy". When using this technique, the doctor makes a cut directly into the bile duct using a tiny knife called a "needle knife".

Currently, there is not a standard that tells doctors what cutting technique to use. The decision is entirely up to the individual doctor.

Patients that participate in this study give their permission to allow the study doctor to use the "needle knife fistulotomy" cutting technique first to gain access to the bile ducts. If the study doctor is unable to gain access through this method, then they will use the standard sphincterotomy technique.

The purpose of this study, called a feasibility study, is to determine if the needle-knife fistulotomy is at least as safe and effective as the standard access technique, if not safer.

If it can be shown that the needle-knife fistulotomy is safer and/or more effective, then it could change the way that doctors conduct this procedure in Canada and the rest of the world.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
All patients enrolled in the study will consent to a needle knife fistulotomy as a starting technique to gain access to the biliary system.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • ERCP
  • Biliary Disease Tract
  • Biliary Disease
Intervention  ICMJE Procedure: Needle knife fistulotomy
A needle knife fistulotomy uses a tiny knife to cut directly into the ampulla to gain access to the biliary system in patients undergoing ERCP
Study Arms  ICMJE All Enrolled Patients
Receive needle knife fistulotomy as a starting technique to gain access to the biliary system
Intervention: Procedure: Needle knife fistulotomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 4, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients, ages > 18, with an intact sphincter undergoing ERCP by at Kingston Health Sciences Center for therapeutic purposes who can provide informed consent. This includes patients who have confirmed choledocholithiasis on imaging and those who have a high suspicion of it based on imaging and lab values. Patients with and without a high suspicion for cholangitis will be eligible for the study. Other indications include: type 1 sphincter of Oddi dysfunction, gallstone pancreatitis or other benign pancreaticobiliary duct diseases including strictures, primary sclerosing cholangitis and Mirizzi's syndrome. Furthermore, patients with suspected diagnosis of biliary leak following cholecystectomy will also be considered for enrollment in this study.
  2. Ability to read and understand the English language

Exclusion criteria:

  1. Bleeding disorder (Von Willebrand disorder, platelet count <100 000, or INR >1.5)
  2. Therapeutic level anticoagulation with low molecular weight heparin (LMWH), warfarin, or a direct-acting oral anticoagulant (DOAC)
  3. Prior biliary sphincterotomy
  4. Altered upper GI tract anatomy (e.g. prior gastric bypass surgery such as Roux-en-Y or Billroth 2 gastrojejunostomy)
  5. Evidence of Malignant infiltration of the ampulla or peri-ampullary area.
  6. Inability to identify intra-duodenal portion of the bile duct, including deep peri-ampullary diverticulum.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Connie E Taylor 613-544-3400 ext 3320 connie.taylor2@kingstonhsc.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03698266
Other Study ID Numbers  ICMJE DMED-2175-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lawrence Charles Hookey, Queen's University
Study Sponsor  ICMJE Queen's University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lawrence C Hookey, MD Queen's University
PRS Account Queen's University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP