TerminatedNot Applicable

SEMS Placement Before Surgery in Unblocking Bile Duct in Patients With Periampullary Pancreatic Cancer With Severe Obstructive Jaundice

Stopped: Interest in this study changed and it was decided to end enrollment early

United States4 participantsStarted 2017-09-01

Plain-language summary

This trial studies the side effects of self expanding metal stent (SEMS) placement before surgery in unblocking the bile duct in patients with periampullary pancreatic cancer with severe obstructive jaundice. SEMS placement unblocks the bile duct and may help in improving bile drainage prior to surgery in patients with periampullary pancreatic cancer with severe obstructive jaundice.

Who can participate

Age range

19 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: * Diagnosis of operable peri-ampullary pancreatic cancer as determined by the Department of Surgery per their standard of care * Serum bilirubin \> 10 mg/dl * Adequate birth control Exclusion Criteria: * Patients with evidence of distant metastasis on computed tomography (CT) or magnetic resonance imaging (MRI) * Patients anticipated to require vascular reconstruction * Patients with cholangitis * Patients for whom surgery is deemed inappropriate by surgeon * Patients with bilirubin less than 10 mg/dL or greater than 20 mg/dL * Patients who previously underwent biliary decompression for cholangitis by ERCP or percutaneous transhepatic cholangiography (PTC) * Patients with low performance score (Karnofsky performance status scale \< 50) * Patients with known preexisting liver disease with associated elevated bilirubin * Patients who are pregnant or actively breast feeding

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

Complication Rates of Grade III or Higher

Timeframe: At 30 days post-surgery

Intraoperative Estimated Blood Loss

Timeframe: At time of surgery

Trial details

NCT IDNCT03820544

SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-24

Results submitted2019-08-08

View on ClinicalTrials.gov More Pancreatic Cancer trials