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Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

Primary Purpose

Pancreatic Cancer, Periampullary Tumor

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Hepaticojejunostomy and gastroenterostomy
Stent strategy
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Surgical bypass, Hepaticojejunostomy, Gastrojejunostomy, Biliary stent, Enteral stent

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery, Sahlgrenska University Hospital
  • Department of surgery, University Hospital
  • Department of Surgery, Skane University Hospital
  • Gastro Center Surgery, Karolinska University Hospital
  • Department of Surgery, University Hospital
  • Department of Surgery, University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Double bypass

Stent Strategy

Arm Description

Outcomes

Primary Outcome Measures

Morbidity
Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.

Secondary Outcome Measures

Quality of life
Using the EORTC:s QLQ-C30 and QLQ-PAN26 questionaries
Numbers of readmissions to hospital
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"

Full Information

First Posted
March 16, 2012
Last Updated
March 20, 2019
Sponsor
Göteborg University
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1. Study Identification

Unique Protocol Identification Number
NCT01569282
Brief Title
Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer
Official Title
Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulties to recruit patients
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 30, 2015 (Anticipated)
Study Completion Date
October 31, 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Periampullary Tumor
Keywords
Surgical bypass, Hepaticojejunostomy, Gastrojejunostomy, Biliary stent, Enteral stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double bypass
Arm Type
Active Comparator
Arm Title
Stent Strategy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Hepaticojejunostomy and gastroenterostomy
Other Intervention Name(s)
Biliodigestive anastomosis, Gastrojenunal anastomosis
Intervention Description
Standard surgical techniques
Intervention Type
Procedure
Intervention Name(s)
Stent strategy
Other Intervention Name(s)
Bile duct stent, Gastroduodenal stent, Enteral stent
Intervention Description
Biliary and/or enteral stents on demand
Primary Outcome Measure Information:
Title
Morbidity
Description
Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.
Time Frame
Day 1-30 after randomization
Secondary Outcome Measure Information:
Title
Quality of life
Description
Using the EORTC:s QLQ-C30 and QLQ-PAN26 questionaries
Time Frame
Preop, 1 month postop and every third month
Title
Numbers of readmissions to hospital
Time Frame
Up to two years after the laparotomy
Title
The numbers of Surgical, Radiological or Endoscopical therapeutic re-interventions
Description
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"
Time Frame
Up to 24 months after the randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Fändriks, Professor
Organizational Affiliation
Göteborg University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Claes Jönsson, Ass. Prof.
Organizational Affiliation
Gothenburg Universitity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Department of surgery, University Hospital
City
Linköping
Country
Sweden
Facility Name
Department of Surgery, Skane University Hospital
City
Lund
Country
Sweden
Facility Name
Gastro Center Surgery, Karolinska University Hospital
City
Stockholm
Country
Sweden
Facility Name
Department of Surgery, University Hospital
City
Umeå
Country
Sweden
Facility Name
Department of Surgery, University Hospital
City
Örebro
Country
Sweden

12. IPD Sharing Statement

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Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

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