NCT01569282

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2011

Typical duration for not_applicable pancreatic-cancer

Geographic Reach
1 country

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 3, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2015

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

3.6 years

First QC Date

March 16, 2012

Last Update Submit

March 20, 2019

Conditions

Pancreatic CancerPeriampullary Tumor

Keywords

Surgical bypassHepaticojejunostomyGastrojejunostomyBiliary stentEnteral stent

Outcome Measures

Primary Outcomes (1)

  • Morbidity

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

    Day 1-30 after randomization

Secondary Outcomes (3)

  • 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

Study Arms (2)

Double bypass

ACTIVE COMPARATOR
Procedure: Hepaticojejunostomy and gastroenterostomy

Stent Strategy

ACTIVE COMPARATOR
Procedure: Stent strategy

Interventions

Hepaticojejunostomy and gastroenterostomyPROCEDURE

Standard surgical techniques

Also known as: Biliodigestive anastomosis, Gastrojenunal anastomosis
Double bypass
Stent strategyPROCEDURE

Biliary and/or enteral stents on demand

Also known as: Bile duct stent, Gastroduodenal stent, Enteral stent
Stent Strategy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Peroperative signs of dysfunction on biliary stent
  • Peroperative findings of gastric outlet obstruction
  • Surgical double bypass not technically feasible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Surgery, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Department of surgery, University Hospital

Linköping, Sweden

Location

Department of Surgery, Skane University Hospital

Lund, Sweden

Location

Department of Surgery, University Hospital

Örebro, Sweden

Location

Gastro Center Surgery, Karolinska University Hospital

Stockholm, Sweden

Location

Department of Surgery, University Hospital

Umeå, Sweden

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gastroenterostomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Lars Fändriks, Professor

    Göteborg University

    STUDY CHAIR

  • Claes Jönsson, Ass. Prof.

    Gothenburg Universitity

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2012

First Posted

April 3, 2012

Study Start

October 1, 2011

Primary Completion

April 30, 2015

Study Completion

October 31, 2015

Last Updated

March 22, 2019

Record last verified: 2019-03

Locations

SE(6)