Preoperative Biliary Drainage With Metal Versus Plastic Stents in Periampullary Cancer (NCT02787512) | Clinical Trial Compass
CompletedNot Applicable
Preoperative Biliary Drainage With Metal Versus Plastic Stents in Periampullary Cancer
South Korea60 participantsStarted 2016-06
Plain-language summary
Currently, routine preoperative biliary drainage (PBD) was not recommended. However, PBD is still necessary in case of patients with cholangitis or very high level of bilirubin or patients who are expected to receive delayed surgery.
The aim of this clinical trial is to demonstrate non-inferiority of uncovered self-expandable metal stent to plastic stent for PBD by endoscopic retrograde cholangiopancreatography in patients with periampullary cancer undergoing curative intent pancreaticoduodenectomy.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
A. Patients 20-80 years old B. Patients with surgically resectable periampullary cancer on CT scans with or without MRI or PET-CT scans C. ECOG Performance score 0 or 1 D. Patients who need preoperative biliary drainage (PBD) because of one or more of following causes
* Cholangitis defined as revised Tokyo guidelines
* Level of total bilirubin \>= 10mg/dL
* Expected time to operation \>= 7 days
Exclusion Criteria:
A. Patients who received previous endoscopic biliary drainage or percutaneous biliary drainage B. Patients with acute pancreatitis before PBD
C. Patients with bleeding tendency or coagulopathy or anticoagulation therapy as follows:
* Patients who take clopidogrel within 5 days before PBD
* Patients who take warfarin within 2 days before PBD
* Patients who receive heparin within 1 days before PBD D. Patients with pregnancy or suspected pregnancy E. Patients who are currently enrolled in another investigational trials that would directly interfere with current study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reintervention rate until operation
Timeframe: Between preoperative biliary drainage and surgery