Billroth II Versus Roux-en-Y for the Gastrojejunostomy in the Pancreatoduodenectomy

NCT ID: NCT01984216

Last Updated: 2016-08-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-08-31

Brief Summary

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The purpose of this study is to compare the safety and superiority of Roux-Y versus Billroth II gastrojejunostomy reconstruction on delayed gastric emptying after pancreatoduodenectomy.

Detailed Description

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Conditions

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Pancreatoduodenectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Roux-en-Y

Roux-en-Y for the gastrojejunostomy reconstruction

Group Type EXPERIMENTAL

Roux-en-Y for the gastrojejunostomy reconstruction

Intervention Type PROCEDURE

Billroth II

Billroth II for the gastrojejunostomy reconstruction

Group Type ACTIVE_COMPARATOR

Billroth II for the gastrojejunostomy reconstruction

Intervention Type PROCEDURE

Interventions

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Roux-en-Y for the gastrojejunostomy reconstruction

Intervention Type PROCEDURE

Billroth II for the gastrojejunostomy reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Consecutive series of patients undergoing pancreaticoduodenectomy (PD).
* Given informed consent.

Exclusion Criteria

* Inability to perform pancreatogastrostomy.
* Resection of other organs, except the superior mesenteric-portal vein.
* Previous gastric surgery.
* Preoperative gastric or duodenal obstruction.
* Previous complex abdominal surgery.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion Miguel Servet

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francisco Javier Herrera, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario de Navarra

Locations

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Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Site Status

Countries

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Spain

Related Links

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http://www.navarrabiomed.es

Navarrabiomed: the biomedical research branch of Complejo Hospitalario de Navarra

Other Identifiers

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2013-000693-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CIRUGIA-CHN

Identifier Type: -

Identifier Source: org_study_id

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