Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

April 7, 2023 updated by: Boston Scientific Corporation

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
  • Belgium
      • Brussels, Belgium, 1070
        • ULB Erasme Hospital
  • China
      • Beijing, China
        • Beijing Friendship Hospital
      • Xi'an, China
        • Xijing Hospital of Digestive Diseases Fourth Military Medical University
  • France
      • Lyon, France, 69437
        • Hopital Edouard Herriot
  • Hong Kong
      • Kowloon, Hong Kong
        • Queen Elizabeth Hospital
      • Sha Tin, Hong Kong
        • Prince of Wales Hospital, The Chinese University of Hong Kong
  • India
      • Hyderabad, India, 500 082
        • Asian Institute of Gastroenterology
  • Italy
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli
  • Japan
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University
  • United States
    • California
      • Stanford, California, United States, 94305
        • Standford University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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
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
No Intervention: None (No Pre-Operative Biliary Drainage)
Patients in this group will not receive pre-operative biliary drainage with a study SEMS

What is the study measuring?

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
Time Frame: 120 to 150 days
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
Time Frame: Procedure
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
Time Frame: 120 to 150 days
Count of patients with biliary interventions after baseline
120 to 150 days
Success Rate of Curative Intent Surgery
Time Frame: 4 weeks
This is the number of patients that had successful resection
4 weeks
All-cause Mortality
Time Frame: 150 days
Mortality which occurs within 150 days of baseline
150 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2013

Primary Completion (Actual)

December 13, 2021

Study Completion (Actual)

December 13, 2021

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

January 18, 2013

First Posted (Estimate)

January 23, 2013

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 7, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90914721
  • E7059 (Other Identifier: Boston Scientific)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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