New Type of a Pancreaticojejunostomy | NCT00471627

Studies
New Type of a Pancreaticojejunostomy

NCT00471627

Sponsor

Tampere University

Status

Unknown status

Last Update Posted

Jun 10, 2008Estimated

Enrollment

30Estimated

Phase

Phase 1

Conditions

Pancreaticojejunostomy After Pancreatic Head Resection

Interventions

Pancreaticojejunostomy without stiches through the pancreas

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Dec 2008Estimated

Completion Date

Not provided

First Submitted Date

May 9, 2007

First Submission Date that Met QC Criteria

May 9, 2007

First Posted Date

May 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2008

Last Update Posted Date

Jun 10, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pancreaticojejunostomy without stiches through the pancreas	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pancreatic fistula, other complications		One year from operation

Secondary Outcomes

Measure	Description	Time Frame
Patency of the pancreaticojejunostomy		One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled to undergo peancreatic head resection

Exclusion Criteria:

Those who refuse from the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Isto H Nordback, M.D.	Contact	+358-3-31164608		isto.nordback@pshp.fi

Overall Officials

Name	Affiliation	Role
Isto H Nordback, M.D.	Tampere University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital	Recruiting	Tampere		33520	Finland

Intervention Browse Module

MeSH Terms

ID	Term
D010193	Pancreaticojejunostomy

Ancestor Terms

ID	Term
D000714	Anastomosis, Surgical
D013514	Surgical Procedures, Operative
D013505	Digestive System Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided