Health Condition 1: null- Pancreatic Carcinoma Resectable
Conditions
Interventions
Intervention1: WallFlexâ?¢ Biliary RX Fully Covered Stent System: Patients in this group will receive a study SEMS (self-expanding metal stent, default choice for patients who are randomized to biliar
Sponsors
Boston Scientific
Eligibility
Inclusion criteria
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 μmol 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 2 cm 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
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 90 days Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of serious pre-operative, operative and post-operative adverse events to 120 days post randomization or to 30 days post-surgery, whichever comes lastTimepoint: 120 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Amount of intraoperative blood loss and blood transfusions, duration of surgeryTimepoint: At time of surgery;Biliary obstructive symptoms assessmentTimepoint: Baseline - 120 days;Curative Intent Surgery details pertaining to intraoperative assessment of resectability, surgical resection and reconstruction techniquesTimepoint: Baseline to 4 weeks;Duration of hospital and ICU admissionsTimepoint: Procedure - 120 days;Improvement of liver function test (LFT) levels as relative to baselineTimepoint: Week 2 - 120 days;Number of adverse events. Adverse events will be assessed in terms of rate, severity, seriousness, relatedness to stent or endoscopic or surgical procedure, impact on time of surgery, length of hospitalization and ICU stayTimepoint: Procedure - 120 days;Number of hospital and ICU admissionsTimepoint: Procedure - 120 days;Number, type, reason, and timing of biliary re-interventionsTimepoint: Baseline - 120 days;Stent placement success: ability to deploy the stent in satisfactory position across the stricture (For patients who are randomized to biliary drainage with a metal stent)Timepoint: Procedure;Stent removal success: successful SEMS removal, either en bloc at time of surgery or endoscopically prior to surgery without stent removal related SAEs (For patients who are randomized to biliary drainage with a metal stent)Timepoint: At time of surgery or prior to surgery if re-intervention is needed;Time to surgeryTimepoint: Baseline to 4 weeks | — |
Countries
Australia, Belgium, Canada, China, France, India, Italy, Japan, United States of America
Contacts
Public ContactNageshwar Reddy
Asian Institute of Gastroenterology
Outcome results
None listed