CompletedNot Applicable

Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

United States, Australia, Belgium284 participantsStarted 2013-02-20

Plain-language summary

The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.

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 * Willing and able to comply with the study procedures and provide written informed consent to participate in the study * Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required) * Biliary obstructive symptoms or signs * Bilirubin level at/above 100 umol per liter (5.8 mg/dL) * Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy * Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum * Patients deemed as resectable by pancreatic protocol CT or MRI * Surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion * Surgery intent within 4 weeks * Endoscopic and surgical treatment to be provided by same team Exclusion Criteria: * Biliary strictures caused by confirmed benign tumors * Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers * Surgically altered biliary tract anatomy, not including prior cholecystectomy * Neoadjuvant chemotherapy for current malignancy * Palliative indication due to reasons other than surgical candidate status * Previous biliary drainage by ERCP/PTC * Patients for whom endoscopic techniques are contraindicated * Participation in another investigational trial within …

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

Number of Serious Pre-operative, Operative and Post-operative Adverse Events to 120 Days Post Randomization or to 30 Days Post Surgery, Whichever Comes Last

Timeframe: 120 to 150 days

Trial details

NCT IDNCT01774019

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-13

Results submitted2022-12-07

View on ClinicalTrials.gov More Pancreatic Carcinoma trials

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.