New Type of a Pancreaticojejunostomy - Full Text View

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

ChemIDplus related topics:

Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Official Title:	New Type of a Pancreaticojejunostomy - a Pilot Study

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.	TampereUH

More Information

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

Study placed in the following topic categories:

Pancrelipase

Additional relevant MeSH terms:

Therapeutic Uses

Gastrointestinal Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

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