Double Bypass Versus Stent-treatment in Irresectable Panc... | NCT01569282

Studies
Double Bypass Versus Stent-treatment in Irresectable Pancreatic Cancer

NCT01569282

Sponsor

Göteborg University

Status

Withdrawn

Last Update Posted

Mar 22, 2019Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Pancreatic Cancer
Periampullary Tumor

Interventions

Hepaticojejunostomy and gastroenterostomy
Stent strategy

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulties to recruit patients

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Apr 30, 2015Estimated

Completion Date

Oct 31, 2015Estimated

First Submitted Date

Mar 16, 2012

First Submission Date that Met QC Criteria

Mar 30, 2012

First Posted Date

Apr 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2019

Last Update Posted Date

Mar 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Double bypass	Active Comparator		Procedure: Hepaticojejunostomy and gastroenterostomy
Stent Strategy	Active Comparator		Procedure: Stent strategy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hepaticojejunostomy and gastroenterostomy	Procedure	Standard surgical techniques	Double bypass

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Morbidity	Initial morbidity in association to the laparotomy using the Clavien-Dindo Classification.	Day 1-30 after randomization

Secondary Outcomes

Measure	Description	Time Frame
Quality of life	Using the EORTC:s QLQ-C30 and QLQ-PAN26 questionaries	Preop, 1 month postop and every third month
Numbers of readmissions to hospital		Up to two years after the laparotomy

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Fändriks, Professor	Göteborg University	Study Chair
Claes Jönsson, Ass. Prof.	Gothenburg Universitity	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, Sahlgrenska University Hospital		Gothenburg		413 45	Sweden
Department of surgery, University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005763	Gastroenterostomy

Ancestor Terms

ID	Term
D000714	Anastomosis, Surgical
D013514	Surgical Procedures, Operative
D013505	Digestive System Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided