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New Type of a Pancreaticojejunostomy

NCT00471627 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2008-06-10

No results posted yet for this study

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.

Conditions

  • Pancreaticojejunostomy After Pancreatic Head Resection

Interventions

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.

Sponsors & Collaborators

  • Tampere University

    lead OTHER

Principal Investigators

  • Isto H Nordback, M.D. · Tampere University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00471627 on ClinicalTrials.gov