Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Boston Scientific

Status: Completed

Conditions: Pancreatic Carcinoma

Treatments: Device: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01774019

90914721

E7059 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 284 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

WallFlex™ Biliary RX Fully Covered/Uncovered Stent System

Active Comparator group

Description:

Patients in this group will receive a fully covered or uncovered study SEMS (self-expanding metal stent)

Treatment:

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

None (No Pre-Operative Biliary Drainage)

No Intervention group

Description:

Patients in this group will not receive pre-operative biliary drainage with a study SEMS