Evaluation of Four Reconstructions After Total Gastrectomy

NCT ID: NCT00677456

Last Updated: 2008-05-14

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2013-01-31

Brief Summary

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There are four capital reconstructions after total gastrectomy which is widely used in China. Life quality is the only standard to evaluate postoperative results of different reconstructions. In order to determine the best reconstruction after total gastrectomy, we designed this study to compare life qualities of four reconstructions.

Detailed Description

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Conditions

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Gastric Cancer Nutrition

Keywords

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Gastric Cancer total gastrectomy reconstruction life quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Patients will receive R-Y reconstruction after total gastrectomy as intervention

Group Type ACTIVE_COMPARATOR

R-Y reconstruction after total gastrectomy

Intervention Type PROCEDURE

Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.

2

Patients will receive P-Y reconstruction after total gastrectomy as intervention

Group Type ACTIVE_COMPARATOR

P-Y reconstruction after total gastrectomy

Intervention Type PROCEDURE

Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the P-Y.

3

Patients will receive Pouch reconstruction after total gastrectomy as intervention.

Group Type ACTIVE_COMPARATOR

Pouch reconstruction after total gastrectomy

Intervention Type PROCEDURE

Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border, the distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.

4

Patients will receive P-I reconstruction after total gastrectomy as intervention.

Group Type ACTIVE_COMPARATOR

P-I reconstruction after total gastrectomy

Intervention Type PROCEDURE

Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels.To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border,The pouch was 20 cm long, with a 10-cm jejunal loop with the P-I.

Interventions

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R-Y reconstruction after total gastrectomy

Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.

Intervention Type PROCEDURE

P-Y reconstruction after total gastrectomy

Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. The distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the P-Y.

Intervention Type PROCEDURE

Pouch reconstruction after total gastrectomy

Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels. To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border, the distance of the esophagojejunostomy to the jejunojejunostomy was 40 cm for the R-Y.

Intervention Type PROCEDURE

P-I reconstruction after total gastrectomy

Following curative total gastrectomy and systematic lymphadenectomy, the jejunum was divided 20 cm distal to the Treitz ligament with preservation of the nerve along the marginal vessels.To make the jejunal pouch, jejunojejunostomy was done with a linear stapler at the antimesenteric border,The pouch was 20 cm long, with a 10-cm jejunal loop with the P-I.

Intervention Type PROCEDURE

Other Intervention Names

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R-Y reconstruction P-Y reconstruction Pouch reconstruction P-I reconstruction

Eligibility Criteria

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Inclusion Criteria

* Patients should be younger than 80 years old with adequate renal, pulmonary, and heart functions.

Exclusion Criteria

* death or other reason which cause information discontinue
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Gastrointestinal Surgery, Tang-Du Hospital

Principal Investigators

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XianLi He, doctor

Role: PRINCIPAL_INVESTIGATOR

Department of general surgery, Tangdu hospital of fourth military medical university

Locations

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Department of general surgery,Tangdu hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xian Li He, doctor

Role: CONTACT

Phone: 86-029-8477-7432

Email: [email protected]

Guo Qiang Bao, doctor

Role: CONTACT

Phone: 86-029-8477-7731

Email: [email protected]

Facility Contacts

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GuoQiang Bao, doctor

Role: primary

JiKai Yin, doctor

Role: backup

Other Identifiers

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TDH00431

Identifier Type: -

Identifier Source: org_study_id