Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.


Condition or disease Intervention/treatment Phase
ERCP Biliary Disease Tract Biliary Disease Procedure: Needle knife fistulotomy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: Is Needle Knife Fistulotomy An Effective First Step Strategy For All ERCPs?
Actual Study Start Date : November 23, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
All Enrolled Patients
Receive needle knife fistulotomy as a starting technique to gain access to the biliary system
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




Primary Outcome Measures :
  1. Post-ERCP pancreatitis [ Time Frame: Up to 7 days post-procedure ]
    The primary objective to be examined is the incidence of post-ERCP pancreatitis


Secondary Outcome Measures :
  1. Technical success [ Time Frame: Day of procedure ]
    Determined by successful cannulation of the CBD as evidenced on cholangiogram


Other Outcome Measures:
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698266


Contacts
Layout table for location contacts
Contact: Connie E Taylor 613-544-3400 ext 3320 connie.taylor2@kingstonhsc.ca

Locations
Layout table for location information
Canada, Ontario
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada, K7L 5G2
Contact: Connie E Taylor         
Sponsors and Collaborators
Queen's University
Investigators
Layout table for investigator information
Principal Investigator: Lawrence C Hookey, MD Queen's University

Publications of Results:
Other Publications:
Freeman ML. Precut (access) sphincterotomy. Techniques in Gastrointestinal Endosocpy. 1999;1(1):40-8.

Layout table for additonal information
Responsible Party: Lawrence Charles Hookey, Associate Professor, Medical Director - Endoscopy Unit, Queen's University
ClinicalTrials.gov Identifier: NCT03698266     History of Changes
Other Study ID Numbers: DMED-2175-18
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lawrence Charles Hookey, Queen's University:
Needle Knife Fistulotomy
Sphincterotomy
Post-ERCP pancreatitis

Additional relevant MeSH terms:
Layout table for MeSH terms
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases