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

NCT ID: NCT00906802

Last Updated: 2009-07-23

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2010-04-30

Brief Summary

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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%.

Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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R-Y reconstruction

the reconstruction was performed by R-Y anastomosis

Group Type EXPERIMENTAL

R-Y reconstruction

Intervention Type PROCEDURE

The reconstruction was performed by R-Y anastomosis.

conventional reconstruction

the anastomosis was performed by B-II

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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R-Y reconstruction

The reconstruction was performed by R-Y anastomosis.

Intervention Type PROCEDURE

Other Intervention Names

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the cutting R-Y anastmosis

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kochi University

OTHER

Sponsor Role lead

Responsible Party

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Kochi University

Principal Investigators

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Kazuhiro Hanazaki, Prof

Role: STUDY_CHAIR

Kochi University

Locations

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Kochi Medical School

Nankoku, Kochi, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Takehiro Okabayashi, MD, PhD

Role: CONTACT

81-88-880-2370

Kazuhiro Hanazaki, Prof

Role: CONTACT

81-88-880-2370

Facility Contacts

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Takehiro Okabayashi, MD, PhD

Role: primary

81-88-880-2370

Kazuhiro Hanazaki, Prof

Role: backup

81-88-880-2370

Other Identifiers

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RPD Study

Identifier Type: -

Identifier Source: org_study_id

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