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New Type of a Pancreaticojejunostomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by University of Tampere.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00471627
First Posted: May 10, 2007
Last Update Posted: June 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Tampere
  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 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Type of a Pancreaticojejunostomy - a Pilot Study

Resource links provided by NLM:


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:
    Procedure: Pancreaticojejunostomy without stiches through the pancreas
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00471627     History of Changes
Other Study ID Numbers: R06088
First Submitted: May 9, 2007
First Posted: May 10, 2007
Last Update Posted: June 10, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Pancrelipase
Pancreatin
Gastrointestinal Agents