Double Bypass Versus Stent-treatment In Irresectable Pancreatic Cancer

Study Overview

Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

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

N/A

Pancreatic Cancer
Periampullary Tumor

PROCEDURE: Hepaticojejunostomy and gastroenterostomy
PROCEDURE: Stent strategy

Double bypass vs Stent

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-03-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-03-20
First Submitted that Met QC Criteria 2012-03-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-03-22
First Posted (ACTUAL) 2012-04-03	Results First Posted N/A	Last Verified 2019-03

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Double bypass	PROCEDURE: Hepaticojejunostomy and gastroenterostomy Standard surgical techniques
ACTIVE_COMPARATOR: Stent Strategy	PROCEDURE: Stent strategy Biliary and/or enteral stents on demand

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Double bypass

PROCEDURE: Hepaticojejunostomy and gastroenterostomy

Standard surgical techniques

ACTIVE_COMPARATOR: Stent Strategy

PROCEDURE: Stent strategy

Biliary and/or enteral stents on demand

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

Secondary Outcome Measures	Measure Description	Time Frame
Quality of life	Using the EORTC:s QLQ-C30 and QLQ-PAN26 questionaries	Preop, 1 month postop and every third month
Numbers of readmissions to hospital		Up to two years after the laparotomy
The numbers of Surgical, Radiological or Endoscopical therapeutic re-interventions	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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

Investigators

STUDY_CHAIR: Lars Fändriks, Professor, Göteborg University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record