Pancreatic Stump Closure After Distal Pancreatic Resection | NCT02113046

Studies
Pancreatic Stump Closure After Distal Pancreatic Resection

NCT02113046

Sponsor

Tampere University Hospital

Status

Terminated

Last Update Posted

Apr 14, 2014Estimated

Enrollment

47Actual

Phase

Not Applicable

Conditions

Distal Pancreatic Resections

Interventions

pancreatico-jejunal anastomosis
traditional anastomosis

Countries

Finland

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

Apr 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

interim analysis does not show good results

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Mar 26, 2014

First Submission Date that Met QC Criteria

Apr 9, 2014

First Posted Date

Apr 14, 2014Estimated

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

Apr 9, 2014

Last Update Posted Date

Apr 14, 2014Estimated

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

The aim of this study is to investigate whether finnish binding pancreatico-jejunal anastomosis is feasible and prevents the risk for post operative pancreatic fistula after distal pancreeatectomy.

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

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pancreatico-jejunal anastomosis	Active Comparator	patients in which the finnish binding pancreatico-jejunal anastomosis is techically possible to perfom during distal pancreatic resektion	Procedure: pancreatico-jejunal anastomosis
traditional anastomosis	Active Comparator	pancreatic resections with traditional stump closure	Procedure: traditional anastomosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pancreatico-jejunal anastomosis	Procedure		pancreatico-jejunal anastomosis
traditional anastomosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative pancreatic fistula rata		30 days

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with resection margin on the left side of portal vein as a measure of feasibility.		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patiens which the distal pancreatic resektions
the type of resections that is techically possible with finnish binding panceatico-jejunal anastomosis

Exclusion Criteria:

if the pancreas is not suitable for this kind of anastomosis

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University hospital		Tampere	Pirkanmaa	33521	Finland