New Type of a Pancreaticojejunostomy - Full Text View

Sponsor:	University of Tampere
Information provided by:	University of Tampere
ClinicalTrials.gov Identifier:	NCT00471627

Purpose

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.

Condition	Intervention	Phase
Pancreaticojejunostomy After Pancreatic Head Resection	Procedure: Pancreaticojejunostomy without stiches through the pancreas	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	New Type of a Pancreaticojejunostomy - a Pilot Study

Resource links provided by NLM:

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by University of Tampere:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Patency of the pancreaticojejunostomy [ Time Frame: One year ]

Estimated Enrollment:	30
Study Start Date:	December 2006
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

The pancreas is cut with knife, without electric cautery and without stay sutures. Bleeding is controlled with 2-3 exactly placed stiches. The pancreatic stump is sunk inside the jejunum, which is tightened around the pancreas with a purse string. A biodegradable stent is left into the pancreatic duct to prevent its occlusion when tightning the purse string.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients scheduled to undergo peancreatic head resection

Exclusion Criteria:

Those who refuse from the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471627

Contacts

Contact: Isto H Nordback, M.D.

+358-3-31164608

isto.nordback@pshp.fi

Locations

Finland
Tampere University Hospital	Recruiting
Tampere, Finland, 33520
Contact: Erkki Wuolijoki, Director of the research unit +358-3-31169130 erkki.wuolijoki@pshp.fi
Principal Investigator: Isto H Nordback, M.D.

Sponsors and Collaborators

University of Tampere

Investigators

Principal Investigator:

Isto H Nordback, M.D.

Tampere University Hospital

More Information

No publications provided

Study ID Numbers:	R06088
Study First Received:	May 9, 2007
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00471627 History of Changes
Health Authority:	Finland: Ministry of Social Affairs and Health; Finland: Finnish Medicines Agency

Additional relevant MeSH terms:

Therapeutic Uses
Gastrointestinal Agents
Pancrelipase
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010