Pancreatic Stump Closure After Distal Pancreatic Resection

April 9, 2014 updated by: Anne Antila, Tampere University Hospital

Prospective Randomized Study to Decrease Pancreatic Fistula Rate

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pancreatico-jejunal anastomosis
patients in which the finnish binding pancreatico-jejunal anastomosis is techically possible to perfom during distal pancreatic resektion
Procedure: pancreatico-jejunal anastomosis
Active Comparator: traditional anastomosis
pancreatic resections with traditional stump closure
Procedure: traditional anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative pancreatic fistula rata
Time Frame: 30 days
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Estimate)

April 14, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R09131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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