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:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT03698266
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03698266
Study Brief:
Protocol Section:
NCT03698266