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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03698266|
Recruitment Status : Completed
First Posted : October 5, 2018
Last Update Posted : January 31, 2020
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|
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:
- 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.
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 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)|
|Official Title:||Is Needle Knife Fistulotomy An Effective First Step Strategy For All ERCPs?|
|Actual Study Start Date :||November 23, 2018|
|Actual Primary Completion Date :||January 29, 2020|
|Actual Study Completion Date :||January 30, 2020|
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
- Post-ERCP pancreatitis [ Time Frame: Up to 7 days post-procedure ]The primary objective to be examined is the incidence of post-ERCP pancreatitis
- Technical success [ Time Frame: Day of procedure ]Determined by successful cannulation of the CBD as evidenced on cholangiogram
- 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
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
|Kingston Health Sciences Centre|
|Kingston, Ontario, Canada, K7L 5G2|
|Principal Investigator:||Lawrence C Hookey, MD||Queen's University|