Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01569282
• Other study ID #: Double bypass vs Stent
• Status: Withdrawn
• Phase: N/A
• Start date: October 2011
• Est. completion date: October 31, 2015

Study information

• Verified date: March 2019
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 31, 2015
• Est. primary completion date: April 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Periampullary Tumor

Intervention

Procedure:
• Hepaticojejunostomy and gastroenterostomy
Standard surgical techniques
• Stent strategy
Biliary and/or enteral stents on demand

Locations

Country	Name	City	State
Sweden	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	Department of Surgery, University Hospital	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity	Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.	Day 1-30 after randomization
Secondary	Quality of life	Using the EORTC:s QLQ-C30 and QLQ-PAN26 questionaries	Preop, 1 month postop and every third month
Secondary	Numbers of readmissions to hospital		Up to two years after the laparotomy
Secondary	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