TerminatedNot Applicable

The Patency Period of the New Plastic Anti-reflux Biliary Stent

Stopped: Issue regarding the stent design

China16 participantsStarted 2008-11

Plain-language summary

The aim of this study is to determine the average patency period of the new anti-reflux biliary stent on patients with malignant bile duct strictures and to determine if this stent remains patent for a longer period of time comparing with the ordinary plastic Tannenbaum biliary stent.

Who can participate

Age range

18 Years – 99 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: * Age 18 years old * Patients who have cholangiographic evidence (on ERCP) consistent with a malignant extrahepatic biliary stricture (below bifurcation of the common hepatic duct) who require plastic stenting * Patients with peri-ampullary tumours, pancreatic tumours, gall bladder cancer and metastatic tumours with suspected extrinsic bile duct compression * Patients with stent or nasobiliary drain in-situ without previous sphincterotomy will qualify for the study if they satisfy the above inclusion criteria. Exclusion Criteria: * Patients fit for surgery. * Patients who have dominant biliary strictures involving the hilum or more proximal biliary segments. * Previous sphincterotomy. * Other medical conditions that will result in a life expectancy of less then 3 months (ASA class \>4) * Pregnancy

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

time-to-occlusion or stent patency period in days

Timeframe: within 25 weeks of device application

Trial details

NCT IDNCT01142921

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-08

View on ClinicalTrials.gov More Pancreatitis trials

Who can participate

Age range

18 Years – 99 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.