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Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

This study is currently recruiting participants.
Verified April 2013 by Göteborg University
Sponsor:
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01569282
First received: March 16, 2012
Last updated: April 5, 2013
Last verified: April 2013
History of Changes

March 16, 2012
April 5, 2013
October 2011
October 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01569282 on ClinicalTrials.gov Archive Site
  • 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"
Same as current
Not Provided
Not Provided
 
Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer
Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study

Double bypass (hepaticojejunostomy + gastrojejunostomy) is compared to stent strategy in patients planned for curative pancreatic resection in whom peroperative findings makes resection impossible.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pancreatic Cancer
  • Periampullary Tumor
  • Procedure: Hepaticojejunostomy and gastroenterostomy
    Standard surgical techniques
    Other Names:
    • Biliodigestive anastomosis
    • Gastrojenunal anastomosis
  • Procedure: Stent strategy
    Biliary and/or enteral stents on demand
    Other Names:
    • Bile duct stent
    • Gastroduodenal stent
    • Enteral stent
  • Active Comparator: Double bypass
    Intervention: Procedure: Hepaticojejunostomy and gastroenterostomy
  • Active Comparator: Stent Strategy
    Intervention: Procedure: Stent strategy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
October 2015
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: Claes Jönson, MD PhD +46313428345 claes.jonson@vgregion.se
Contact: Lars Fandriks, Professor +46313421000 Lars.Fandriks@gastro.gu.se
Sweden
 
NCT01569282
Double bypass vs Stent
No
Göteborg University
Göteborg University
Not Provided
Study Chair: Lars Fändriks, Professor Göteborg University
Principal Investigator: Claes Jönsson, Ass. Prof. Gothenburg Universitity
Göteborg University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP