Benefit of Roux-en-Y (R-Y) Reconstruction After Pancreaticoduodenectomy

July 22, 2009 updated by: Kochi University

Benefit of R-Y Reconstruction After Pancreaticoduodenectomy

One of the most common complications of pancreaticoduodenectomy (PD) is delayed gastric emptying (DGE), otherwise known as "gastroparesis," which is not fatal but results in prolonged hospital stay and increased hospital costs. Delayed gastric emptying is defined as nasogastric decompression after postoperative day (POD) 10 or a failure to tolerate a regular diet after POD 14. The incidence of DGE has been reported to range from 5% to 72%.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We hypothesized that the hand-sewn, two-layered, or continuous suture, could induce anastomotic edema to indeed the afferent peristalsis, which is one of the causes of DGE.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kochi
      • Nankoku, Kochi, Japan, 783-8505
        • Recruiting
        • Kochi Medical School
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • These patients were to undergo elective pancreatic head resection for the treatment of periampullary mass

Exclusion Criteria:

  • A body weight loss greater than 10% during the six months prior to surgery
  • The presence of distant metastases
  • Seriously impaired function of vital organs due to respiratory, renal or heart disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: R-Y reconstruction
the reconstruction was performed by R-Y anastomosis
Procedure: R-Y reconstruction
The reconstruction was performed by R-Y anastomosis.
Other Names:
  • the cutting R-Y anastmosis
NO_INTERVENTION: conventional reconstruction
the anastomosis was performed by B-II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence of DGE
Time Frame: 3-6 months
3-6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
the incidence of other complication associated with reconstruction
Time Frame: 3-6 months
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kochi University

Investigators

  • Study Chair: Kazuhiro Hanazaki, Prof, Kochi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (ANTICIPATED)

April 1, 2010

Study Completion (ANTICIPATED)

April 1, 2010

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (ESTIMATE)

May 21, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 23, 2009

Last Update Submitted That Met QC Criteria

July 22, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RPD Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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