Evaluation of Four Reconstructions After Total Gastrectomy - Full Text View

Sponsor:	Tang-Du Hospital
Collaborator:	Fourth Military Medical University
Information provided by:	Tang-Du Hospital
ClinicalTrials.gov Identifier:	NCT00677456

Purpose

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.

Condition	Intervention	Phase
Gastric Cancer Nutrition	Procedure: R-Y reconstruction after total gastrectomy Procedure: P-Y reconstruction after total gastrectomy Procedure: Pouch reconstruction after total gastrectomy Procedure: P-I reconstruction after total gastrectomy	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer

U.S. FDA Resources

Further study details as provided by Tang-Du Hospital:

Primary Outcome Measures:

Patients should live for 6 months at least, and with acceptable life quality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

There are significant differences among life qualities of the four reconstructions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Patients will receive R-Y reconstruction after total gastrectomy as intervention	Procedure: 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. Other Name: R-Y reconstruction
Active Comparator: 2 Patients will receive P-Y reconstruction after total gastrectomy as intervention	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. Other Name: P-Y reconstruction
Active Comparator: 3 Patients will receive Pouch reconstruction after total gastrectomy as intervention.	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. Other Name: Pouch reconstruction
Active Comparator: 4 Patients will receive P-I reconstruction after total gastrectomy as intervention.	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. Other Name: P-I reconstruction

Eligibility

Ages Eligible for Study:	30 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677456

Contacts

Contact: Xian Li He, doctor	86-029-8477-7432	wanghe@fmmu.edu.cn
Contact: Guo Qiang Bao, doctor	86-029-8477-7731	guoqiangbao@163.com

Locations

China, Shaanxi
Department of general surgery,Tangdu hospital	Recruiting
Xi'an, Shaanxi, China, 710038
Contact: GuoQiang Bao, doctor 86-029-8477-7731 guoqiangbao@163.com
Contact: JiKai Yin, doctor 86-029-8477-7732 yjkfmmuu@hotmail.com
Principal Investigator: XianLi He, doctor
Principal Investigator: GuoQiang Bao, doctor
Principal Investigator: JiKai Yin, doctor

Sponsors and Collaborators

Tang-Du Hospital

Fourth Military Medical University

Investigators

Principal Investigator:

XianLi He, doctor

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

More Information

No publications provided

Responsible Party:	He XianLi/director of department of Gastrointestinal Surgery, Tang-Du Hospital, Department of Gastrointestinal Surgery, Tang-Du Hospital
ClinicalTrials.gov Identifier:	NCT00677456 History of Changes
Other Study ID Numbers:	TDH00431
Study First Received:	May 12, 2008
Last Updated:	May 12, 2008
Health Authority:	China: Ministry of Health

Keywords provided by Tang-Du Hospital:

Gastric Cancer
total gastrectomy
reconstruction
life quality

Additional relevant MeSH terms:

Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on February 12, 2012