Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer

Conditions
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Pancreatic Carcinoma

Intervention / Treatment
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* Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System


Participation Criteria
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Eligibility Criteria
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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 90 days Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System<br>Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent) | Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System<br> <br> |
| No Intervention: None (No Pre-Operative Biliary Drainage)<br>Patients in this group will not receive pre-operative biliary drainage with a study SEMS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Last | The primary end point was all serious adverse events (SAEs), including all preoperative, operative and postoperative adverse events reported from the time of randomization to 120 days post-randomization or 30 days post-CIS (up to 150 days post-randomization), whichever occurred later. | 120 to 150 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Placement Success | 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) | Procedure | 
| Number of Patients With Biliary Re-interventions | Count of patients with biliary interventions after baseline | 120 to 150 days | 
| Success Rate of Curative Intent Surgery | This is the number of patients that had successful resection | 4 weeks | 
| All-cause Mortality | Mortality which occurs within 150 days of baseline | 150 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic, Periampullary Cancer, Preoperative Biliary Drainage, Resectable