Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01569282
Recruitment Status : Withdrawn (Difficulties to recruit patients)
First Posted : April 3, 2012
Last Update Posted : April 21, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Periampullary Tumor Procedure: Hepaticojejunostomy and gastroenterostomy Procedure: Stent strategy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Double Bypass vs Stent Strategy in Peroperatively Diagnosed Irresectable Pancreatic Cancer - A Prospective Randomized Multicenter Study
Study Start Date : October 2011
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Morbidity [ Time Frame: Day 1-30 after randomization ]
    Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Preop, 1 month postop and every third month ]
    Using the EORTC:s QLQ-C30 and QLQ-PAN26 questionaries

  2. Numbers of readmissions to hospital [ Time Frame: Up to two years after the laparotomy ]
  3. The numbers of Surgical, Radiological or Endoscopical therapeutic re-interventions [ Time Frame: 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"

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01569282

Department of Surgery, Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Department of surgery, University Hospital
Linköping, Sweden
Department of Surgery, Skane University Hospital
Lund, Sweden
Gastro Center Surgery, Karolinska University Hospital
Stockholm, Sweden
Department of Surgery, University Hospital
Umeå, Sweden
Department of Surgery, University Hospital
Örebro, Sweden
Sponsors and Collaborators
Göteborg University
Study Chair: Lars Fändriks, Professor Göteborg University
Principal Investigator: Claes Jönsson, Ass. Prof. Gothenburg Universitity

Responsible Party: Göteborg University Identifier: NCT01569282     History of Changes
Other Study ID Numbers: Double bypass vs Stent
First Posted: April 3, 2012    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

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

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