Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

March 20, 2019 updated by: Göteborg University

Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study

Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in patients planned for curative pancreatic resection in whom peroperative findings makes resection impossible.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Department of surgery, Sahlgrenska University Hospital
      • Linköping, Sweden
        • Department of Surgery, University Hospital
      • Lund, Sweden
        • Department of surgery, Skåne university hospital
      • Stockholm, Sweden
        • Gastro Center Surgery, Karolinska University Hospital
      • Umeå, Sweden
        • Department of Surgery, University Hospital
      • Örebro, Sweden
        • Department of Surgery, University Hospital

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

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Preoperatively

    • Patients with stent treated tumor in the pancreatic head or periampullary planned for pancreaticoduodenectomy
    • The patient jaundice should have worn off and there should be no signs of duodenal obstruction
    • The patient has given informed consent after verbal and written information in accordance with approved ethics application
    • The patient has no anatomical conditions making endoscopic therapy impossible such as previous Billroth II or Gastric Bypass.

  2. Intraoperatively

    • Peroperative findings of of carcinomatosis, metastases or local irresectability who oppose radical surgery
    • Surgical double bypass should be technically feasible
    • The patient has given informed consent after verbal and written information in accordance with approved ethics application

Exclusion Criteria:

  • Peroperative signs of dysfunction on biliary stent
  • Peroperative findings of gastric outlet obstruction
  • Surgical double bypass not technically feasible

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Double bypass
Procedure: Hepaticojejunostomy and gastroenterostomy
Standard surgical techniques
Other Names:
  • Biliodigestive anastomosis
  • Gastrojenunal anastomosis
Active Comparator: Stent Strategy
Procedure: Stent strategy
Biliary and/or enteral stents on demand
Other Names:
  • Bile duct stent
  • Gastroduodenal stent
  • Enteral stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: Day 1-30 after randomization
Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.
Day 1-30 after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Preop, 1 month postop and every third month
Using the EORTC:s QLQ-C30 and QLQ-PAN26 questionaries
Preop, 1 month postop and every third month
Numbers of readmissions to hospital
Time Frame: Up to two years after the laparotomy
Up to two years after the laparotomy
The numbers of Surgical, Radiological or Endoscopical therapeutic re-interventions
Time Frame: Up to 24 months after the randomization
The numbers of surgical, radiological or endoscopical interventions due to jaundice or gastric outlet obstruction from date of randomization until the date of death from any cause, whichever came first, assessed up to 24 months"
Up to 24 months after the randomization

Collaborators and Investigators

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

Sponsor

Göteborg University

Investigators

  • Study Chair: Lars Fändriks, Professor, Göteborg University
  • Principal Investigator: Claes Jönsson, Ass. Prof., Gothenburg Universitity

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

October 1, 2011

Primary Completion (Anticipated)

April 30, 2015

Study Completion (Anticipated)

October 31, 2015

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 3, 2012

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Double bypass vs Stent

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.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Hepaticojejunostomy and gastroenterostomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe