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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT03530527
Eligibility Criteria:
Inclusion Criteria: I) Patients aged \> 18 years. II) Clinical, laboratory data, imaging and or histology suggestive of malignant distal bile duct strictures that occurs as a result of pancreatic adenocarcinoma, cholangiocarcinoma, ampullary carcinoma, duodenal carcinoma, gallbladder cancer and metastasis malignant bile duct obstruction III) Inoperability by tumor staging, medically unfit or patient wishes
1. distant metastasis
2. major vascular involvement (unreconstructible Superior mesenteric vein/Portal vein, superior mesenteric artery, common hepatic artery and celiac artery)
3. metastasis to lymphnode beyond the field or surgery IV) Jaundice, total bilirubin ≥15 mg/dl and/ or Common bile duct diameter ≥12 mm
Exclusion Criteria: I) pregnancy II) uncorrectable coagulopathy ( international normalized ratio ≥ 1.5 ) III) thrombocytopenia (platelet count \< 50,000 ) IV) extremely poor general condition, ERCP with stent insertion impossible for ethical reasons V) an extension of stricture to the main biliary confluent (hilum) or the existence of obstructive duodenal invasion VI) active suppurative cholangitis VI) surgically altered anatomy (i.e. Billroth II or Roux-en-Y reconstruction ) VII ) previous treatment with bile duct stent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03530527
Study Brief:
Protocol Section:
NCT03530527