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New Type of a Pancreaticojejunostomy

NCT ID: NCT00471627

Last Updated: 2008-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreaticojejunostomy After Pancreatic Head Resection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to undergo peancreatic head resection

Exclusion Criteria

* Those who refuse from the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University

OTHER

Sponsor Role lead

Principal Investigators

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Isto H Nordback, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Isto H Nordback, M.D.

Role: CONTACT

Phone: +358-3-31164608

Email: [email protected]

Facility Contacts

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Erkki Wuolijoki, Director of the research unit

Role: primary

Other Identifiers

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R06088

Identifier Type: -

Identifier Source: org_study_id