New Type of a Pancreaticojejunostomy - Tabular View

Tracking Information

First Received Date ^ICMJE

May 9, 2007

Last Updated Date

June 9, 2008

Start Date ^ICMJE

December 2006

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pancreatic fistula, other complications [ Time Frame: One year from operation ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00471627 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Patency of the pancreaticojejunostomy [ Time Frame: One year ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

New Type of a Pancreaticojejunostomy

Official Title ^ICMJE

New Type of a Pancreaticojejunostomy - a Pilot Study

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Pancreaticojejunostomy After Pancreatic Head Resection

Intervention ^ICMJE

Procedure: Pancreaticojejunostomy without stiches through the pancreas

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients scheduled to undergo peancreatic head resection

Exclusion Criteria:

Those who refuse from the study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Isto H Nordback, M.D.

+358-3-31164608

isto.nordback@pshp.fi

Location Countries ^ICMJE

Finland

Administrative Information

NCT ID ^ICMJE

NCT00471627

Responsible Party

Study ID Numbers ^ICMJE

R06088

Study Sponsor ^ICMJE

University of Tampere

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Isto H Nordback, M.D.

Tampere University Hospital

Information Provided By

University of Tampere

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP