CompletedNot Applicable

Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy

United States, Belgium, Canada119 participantsStarted 2015-03-24

Plain-language summary

The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.

Who can participate

Age range

18 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 or older * Patient indicated for biliary metal stent placement for the treatment of jaundice and/or cholestasis * Willing and able to comply with the study procedures and provide written informed consent to participate in the study * Suspicion of pancreatic adenocarcinoma * Likely indicated for neoadjuvant treatment * Distal biliary obstruction consistent with pancreatic cancer * Location of distal biliary obstruction such that it would allow the proximal end of a stent to be positioned at least 2 cm from the hilum * Endoscopic and surgical treatment to be provided at the same institution Exclusion Criteria: * Benign biliary strictures * Malignancy secondary to Intraductal Papillary Mucinous Neoplasm * Surgically altered anatomy where ERCP is not possible * Previous biliary drainage using a SEMS or multiple plastic stents * Contraindications for endoscopic techniques * Patients who are currently enrolled in another investigational trial that would directly interfere with the current study * 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

Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms

Timeframe: From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)

Trial details

NCT IDNCT02238847

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-02-21

Results submitted2019-07-25

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