New Type of a Pancreaticojejunostomy

Phase 1

• Conditions: Pancreaticojejunostomy After Pancreatic Head Resection

• Registration Number: NCT00471627
• Lead Sponsor: Tampere University

Brief Summary

Previously we have demonstrated in animal experiments,that pancreas is extremely vulnerable to handling, reacting with the development of pancreatitis. In human pancreatic surgery, post-operative pancreatitis mediates many other post-operative complications. A new anastomosis was developed to diminish the injury, as being without any stitches going through the pancreas. The aims were to study up to 30 patients as phase one study, with an interim analysis in this open uncontrolled trial after the first few patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-05-09
• Study First Submitted QC: 2007-05-09
• Study First Posted: 2007-05-10
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-09
• Last Update Posted: 2008-06-10
• Primary Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients scheduled to undergo peancreatic head resection

Exclusion Criteria

• Those who refuse from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pancreatic fistula, other complications	One year from operation

Secondary Outcome Measures

Name	Time	Method
Patency of the pancreaticojejunostomy	One year

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland