Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

Not Applicable

Withdrawn

• Conditions: Pancreatic Cancer; Periampullary Tumor
• Interventions: Procedure: Stent strategy; Procedure: Hepaticojejunostomy and gastroenterostomy

• Registration Number: NCT01569282
• Lead Sponsor: Göteborg University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-03
• Primary Completion: 2015-04-30
• Study Completion: 2015-10-31
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stent Strategy	Stent strategy	-
Double bypass	Hepaticojejunostomy and gastroenterostomy	-

Primary Outcome Measures

Name	Time	Method
Morbidity	Day 1-30 after randomization	Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Department of Surgery, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Department of surgery, University Hospital; 🇸🇪 Linköping, Sweden

Department of Surgery, Skane University Hospital; 🇸🇪 Lund, Sweden

Department of Surgery, University Hospital; 🇸🇪 Örebro, Sweden

Gastro Center Surgery, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden