New Type of a Pancreaticojejunostomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Tampere.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00471627
First received: May 9, 2007
Last updated: June 9, 2008
Last verified: June 2008
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014