Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Boston Scientific Corporation284 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

284

Conditions

Pancreatic Carcinoma

Interventions

WallFlex™ Biliary RX Fully Covered/Uncovered Stent SystemDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Standford University Medical Center

Stanford, California, United States

Westmead Hospital

Westmead, New South Wales, Australia

ULB Erasme Hospital

Brussels, Belgium

Outcomes

Primary Outcomes

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.

Time frame: 120 to 150 days

Secondary Outcomes

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)

Time frame: Procedure

Number of Patients With Biliary Re-interventions

Count of patients with biliary interventions after baseline

Time frame: 120 to 150 days

Success Rate of Curative Intent Surgery

This is the number of patients that had successful resection

Time frame: 4 weeks

All-cause Mortality

Mortality which occurs within 150 days of baseline

Time frame: 150 days

Data from ClinicalTrials.gov

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