Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer - Full Text View

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:

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

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:

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.
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

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:	April 5, 2013
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 June 17, 2013