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Clinical Trials/NCT01569282
NCT01569282WithdrawnNot Applicable

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

Göteborg University6 sites in 1 countryStarted: October 1, 2011Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
6
Primary Endpoint
Morbidity
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Double bypass

Active Comparator

Intervention: Hepaticojejunostomy and gastroenterostomy (Procedure)

Stent Strategy

Active Comparator

Intervention: Stent strategy (Procedure)

Outcomes

Primary Outcomes

Morbidity

Time Frame: Day 1-30 after randomization

Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.

Secondary Outcomes

  • Quality of life(Preop, 1 month postop and every third month)
  • Numbers of readmissions to hospital(Up to two years after the laparotomy)
  • The numbers of Surgical, Radiological or Endoscopical therapeutic re-interventions(Up to 24 months after the randomization)

Investigators

Sponsor
Göteborg University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

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