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New Type of a Pancreaticojejunostomy

New Type of a Pancreaticojejunostomy - a Pilot Study

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00471627
Enrollment
30
Registered
2007-05-10
Start date
2006-12-31
Completion date
Unknown
Last updated
2008-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreaticojejunostomy After Pancreatic Head Resection

Brief summary

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.

Interventions

PROCEDUREPancreaticojejunostomy 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.

Sponsors

Tampere University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients scheduled to undergo peancreatic head resection

Exclusion criteria

* Those who refuse from the study

Design outcomes

Primary

MeasureTime frame
Pancreatic fistula, other complicationsOne year from operation

Secondary

MeasureTime frame
Patency of the pancreaticojejunostomyOne year

Countries

Finland

Contacts

Primary ContactIsto H Nordback, M.D.
isto.nordback@pshp.fi+358-3-31164608

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026