Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer
Conditions
Pancreatic Carcinoma
Conditions: official terms
Pancreatic Neoplasms
Conditions: Keywords
Pancreatic, Periampullary Cancer, Preoperative Biliary Drainage, Resectable
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: WallFlex™ Biliary RX Fully Covered/Uncovered Stent System
Type: Device
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 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
Westmead Hospital
Westmead, New South Wales, Australia
Status: Recruiting
Contact: Rebecca Sonson - +61 411 533 126 - bec2153@gmail.com
ULB Erasme Hospital
Brussels, Belgium
Status: Recruiting
Contact: Mona Hammam - 32 25 55 36 22 - Mona.Hammam@erasme.ulb.ac.be
Centre hospitalier de l Université de Montréal
Montreal, Quebec, Canada
Status: Withdrawn
Prince of Wales Hospital, the Chinese University of Hong Kong
Hong Kong, China
Status: Recruiting
Contact: Kim Au - kimau@surgery.cuhk.edu.hk
Hopital Edouard Herriot
Lyon, France
Status: Recruiting
Contact: Hadjira Ouadfel - +33-610133675 - hadjira.ouadfel@chu-lyon.fr
Asian Institute of Gastroenterology
Hyderabad, India
Status: Recruiting
Contact: Suresh Gundelli - suri.aigindia@gmail.com
Università Cattolica del Sacro Cuore Policlinico A. Gemelli
Rome, Italy
Status: Recruiting
Contact: Carolina Gualtieri - +39 (06) 35511515 - c.gualtieri@eetc.it
Tokyo Medical University
Tokyo, Japan
Status: Recruiting
Contact: Takao Itoi, MD - 81-3-33426111 - itoi@tokyo-med.ac.jp
Start Date
February 2013
Completion Date
April 2018
Sponsors
Boston Scientific Corporation
Source
Boston Scientific Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page