Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT04559867
Eligibility Criteria:
Inclusion Criteria:
1. Patients, greater than, or equal to 18 years of age, 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: other benign biliary duct diseases including strictures, primary sclerosing cholangitis and Mirizzi's syndrome requiring biliary decompression. 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,
3. Ability to follow-up in a reliable manner.
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. P2Y12 inhibitors not held for 5 days prior to the procedure,
4. Prior biliary sphincterotomy,
5. Concurrent pancreatitis (with inability to tolerate oral intake and requiring pain management),
6. Altered upper GI tract anatomy (e.g. prior gastric bypass surgery such as Roux-en-Y or Billroth 2 gastrojejunostomy),
7. Inability to achieve adequate sedation,
8. Evidence of malignant infiltration of the ampulla or peri-ampullary area,
9. Pregnancy,
10. Operator inability to access and identify intra-duodenal portion of the bile duct,
11. Presumptive diagnosis of sphincter of Oddi dysfunction,
12. Inability to access intraduodenal segment due to altered anatomy (eg. ampulla within deep diverticulum),
13. Requirement for pancreatogram or pancreatic intervention,
14. Inability to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04559867
Study Brief:
Protocol Section:
NCT04559867