Evaluation of Four Reconstructions After Total Gastrectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Tang-Du Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fourth Military Medical University
Information provided by:
Tang-Du Hospital
ClinicalTrials.gov Identifier:
NCT00677456
First received: May 12, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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 1

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on October 23, 2014