Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Göteborg University
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01569282
First received: March 16, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Pancreatic Cancer
Periampullary Tumor
Procedure: Hepaticojejunostomy and gastroenterostomy
Procedure: Stent strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Morbidity [ Time Frame: Day 1-30 after randomization ] [ Designated as safety issue: No ]
    Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: Preop, 1 month postop and every third month ] [ Designated as safety issue: No ]
    Using the EORTC:s QLQ-C30 and QLQ-PAN26 questionaries

  • Numbers of readmissions to hospital [ Time Frame: Up to two years after the laparotomy ] [ Designated as safety issue: No ]
  • The numbers of Surgical, Radiological or Endoscopical therapeutic re-interventions [ Time Frame: Up to 24 months after the randomization ] [ Designated as safety issue: No ]
    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"


Estimated Enrollment: 80
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569282

Contacts
Contact: Claes Jönson, MD PhD +46313428345 claes.jonson@vgregion.se
Contact: Lars Fandriks, Professor +46313421000 Lars.Fandriks@gastro.gu.se

Locations
Sweden
Department of Surgery, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, 413 45
Contact: Claes Jönson    46313428345    claes.jonson@vgregion.se   
Principal Investigator: Claes Jönson, Ass.Prof.         
Department of surgery, University Hospital Recruiting
Linköping, Sweden
Contact: Thomas Gasslander, Md PhD       thomas.gasslander@liu.se   
Principal Investigator: Thomas Gasslander, MD PhD         
Department of Surgery, Skane University Hospital Recruiting
Lund, Sweden
Contact: Bobby Tingstedt, Ass. Prof       bobby.tingstedt@skane.se   
Principal Investigator: Bobby Tingstedt, Ass. Prof.         
Gastro Center Surgery, Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Ralf Segersvärd       ralf.segersvard@ki.se   
Principal Investigator: Ralf Segersvard, MD PhD         
Department of Surgery, University Hospital Recruiting
Umeå, Sweden
Contact: Mikael Öhman, MD PhD       Mikael.Oman@surgery.umu.se   
Principal Investigator: Mikael Öhman, MD PhD         
Department of Surgery, University Hospital Recruiting
Örebro, Sweden
Contact: Göran Ågren, MD       goran.agren@orebroll.se   
Principal Investigator: Göran Ågren, MD         
Sponsors and Collaborators
Göteborg University
Investigators
Study Chair: Lars Fändriks, Professor Göteborg University
Principal Investigator: Claes Jönsson, Ass. Prof. Gothenburg Universitity
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01569282     History of Changes
Other Study ID Numbers: Double bypass vs Stent
Study First Received: March 16, 2012
Last Updated: June 25, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:
Surgical bypass
Hepaticojejunostomy
Gastrojejunostomy
Biliary stent
Enteral stent

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 26, 2014