New Type of a Pancreaticojejunostomy

Condition(s) targeted: Pancreaticojejunostomy After Pancreatic Head Resection

Intervention: Pancreaticojejunostomy without stiches through the pancreas (Procedure)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Tampere

Official(s) and/or principal investigator(s):
Isto H Nordback, M.D., Principal Investigator, Affiliation: TampereUH

Overall contact:
Isto H Nordback, M.D., Phone: +358-3-31164608, Email: isto.nordback@pshp.fi

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.

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

Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: Pancreatic fistula, other complications

Secondary outcome: Patency of the pancreaticojejunostomy

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients scheduled to undergo peancreatic head resection

Exclusion Criteria:

- Those who refuse from the study

Isto H Nordback, M.D., Phone: +358-3-31164608, Email: isto.nordback@pshp.fi

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

Starting date: December 2006
Last updated: June 9, 2008