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Sponsored by: |
University of Tampere |
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Information provided by: | University of Tampere |
ClinicalTrials.gov Identifier: | NCT00471627 |
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 |
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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 |
Estimated Enrollment: | 30 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Isto H Nordback, M.D. | +358-3-31164608 | isto.nordback@pshp.fi |
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. |
Principal Investigator: | Isto H Nordback, M.D. | TampereUH |
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: National Agency for Medicines |
Pancrelipase |
Therapeutic Uses Gastrointestinal Agents Pancrelipase Pharmacologic Actions |