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Fistulotomy Technique for Biliary Tract Disease
N/A
Waitlist Available
Led By Robert Bechara, MD
Research Sponsored by Lawrence Charles Hookey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 days
Awards & highlights
Study Summary
This trial will help researchers learn more about the safety and effectiveness of two different methods of accessing the pancreas and bile ducts during an ERCP.
Who is the study for?
This trial is for adults over 18 who need an ERCP procedure at Kingston Health Sciences Center and can give informed consent. It's open to those with certain bile duct conditions like stones, strictures, or leaks after surgery. People with bleeding disorders, on strong blood thinners, prior biliary surgeries, pancreatitis, altered GI anatomy, pregnancy or unable to be sedated are excluded.Check my eligibility
What is being tested?
The study compares two techniques used during ERCP: needle knife fistulotomy versus sphincterotomy. Participants will be randomly assigned to one of these methods for accessing the digestive system areas needing treatment.See study design
What are the potential side effects?
Potential side effects may include bleeding, infection risk at the cut site, pain where the incision is made in the digestive tract and possible complications related to anesthesia such as reactions or difficulty waking up.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-ERCP pancreatitis
Secondary outcome measures
Ampullary morphology
Cannulation Success Rate
Difficulty of cannulation
+4 moreTrial Design
2Treatment groups
Active Control
Group I: Needle Knife FistulotomyActive Control1 Intervention
The study doctor will gain access to the bile ducts using the cutting technique called a needle knife fistulotomy. When using this technique, the study doctor makes a cut directly into the bile duct.
Group II: SphincterotomyActive Control1 Intervention
The study doctor will gain access to the bile ducts using the cutting technique called a sphincterotomy. Using this method, a heated metal wire cuts the opening to the bile duct after a wire has been passed into it.
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Who is running the clinical trial?
Lawrence Charles HookeyLead Sponsor
6 Previous Clinical Trials
1,149 Total Patients Enrolled
Queen's UniversityLead Sponsor
365 Previous Clinical Trials
119,879 Total Patients Enrolled
Robert Bechara, MDPrincipal InvestigatorQueen's University
1 Previous Clinical Trials
25 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older, need an ERCP for a bile duct issue, and can agree to participate.I have a bleeding disorder or my blood doesn't clot properly.I am on blood thinners like LMWH, warfarin, or DOAC.I have pancreatitis and can't eat or manage my pain without help.I haven't stopped taking P2Y12 inhibitors 5 days before the procedure.I have had a procedure to open my bile duct.I have had surgery that changed the structure of my upper digestive system.My cancer has spread to the area around my bile duct.My doctor cannot reach or see the part of my bile duct inside my duodenum.I have been diagnosed with a problem in my digestive system's valve.I cannot have certain procedures due to changes in my digestive system's structure.I need a procedure to examine or treat my pancreas.
Research Study Groups:
This trial has the following groups:- Group 1: Needle Knife Fistulotomy
- Group 2: Sphincterotomy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals is this trial taking on as participants?
"Affirmative. Clinicaltrials.gov records suggest that, as of September 16th 2020, this trial is actively recruiting participants from 1 location with a total enrollment goal of 538 individuals."
Answered by AI
Are recruitment efforts still underway for this research project?
"Affirmative. As per the details provided on clinicaltrials.gov, this study is actively seeking participants and was initially posted on September 10th 2020 before being updated on September 16th of that same year. At present, 538 patients are required from one single location for recruitment purposes."
Answered by AI
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