Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

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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)

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

Trial documents
2

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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