Back to resultsEvaluation of Four Reconstructions After Total Gastrectomy
Primary Purpose
Gastric Cancer, Nutrition
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
R-Y reconstruction after total gastrectomy
P-Y reconstruction after total gastrectomy
Pouch reconstruction after total gastrectomy
P-I reconstruction after total gastrectomy
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Cancer focused on measuring Gastric Cancer, total gastrectomy, reconstruction, life quality
Eligibility 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
Sites / Locations
- Department of general surgery,Tangdu hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
Patients will receive R-Y reconstruction after total gastrectomy as intervention
Patients will receive P-Y reconstruction after total gastrectomy as intervention
Patients will receive Pouch reconstruction after total gastrectomy as intervention.
Patients will receive P-I reconstruction after total gastrectomy as intervention.
Outcomes
Primary Outcome Measures
Patients should live for 6 months at least, and with acceptable life quality
Secondary Outcome Measures
There are significant differences among life qualities of the four reconstructions
Full Information
NCT ID
NCT00677456
First Posted
May 12, 2008
Last Updated
May 12, 2008
Sponsor
Tang-Du Hospital
Collaborators
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT00677456
Brief Title
Evaluation of Four Reconstructions After Total Gastrectomy
Official Title
Postoperative Life Quality Evaluation of Four Reconstructions After Total Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
January 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tang-Du Hospital
Collaborators
Air Force Military Medical University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Nutrition
Keywords
Gastric Cancer, total gastrectomy, reconstruction, life quality
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients will receive R-Y reconstruction after total gastrectomy as intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients will receive P-Y reconstruction after total gastrectomy as intervention
Arm Title
3
Arm Type
Active Comparator
Arm Description
Patients will receive Pouch reconstruction after total gastrectomy as intervention.
Arm Title
4
Arm Type
Active Comparator
Arm Description
Patients will receive P-I reconstruction after total gastrectomy as intervention.
Intervention Type
Procedure
Intervention Name(s)
R-Y reconstruction after total gastrectomy
Other Intervention Name(s)
R-Y reconstruction
Intervention Description
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
Intervention Name(s)
P-Y reconstruction after total gastrectomy
Other Intervention Name(s)
P-Y reconstruction
Intervention Description
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
Intervention Name(s)
Pouch reconstruction after total gastrectomy
Other Intervention Name(s)
Pouch reconstruction
Intervention Description
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
Intervention Name(s)
P-I reconstruction after total gastrectomy
Other Intervention Name(s)
P-I reconstruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patients should live for 6 months at least, and with acceptable life quality
Time Frame
6 months
Secondary Outcome Measure Information:
Title
There are significant differences among life qualities of the four reconstructions
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xian Li He, doctor
Phone
86-029-8477-7432
Email
wanghe@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Guo Qiang Bao, doctor
Phone
86-029-8477-7731
Email
guoqiangbao@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XianLi He, doctor
Organizational Affiliation
Department of general surgery, Tangdu hospital of fourth military medical university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of general surgery,Tangdu hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GuoQiang Bao, doctor
Phone
86-029-8477-7731
Email
guoqiangbao@163.com
First Name & Middle Initial & Last Name & Degree
JiKai Yin, doctor
Phone
86-029-8477-7732
Email
yjkfmmuu@hotmail.com
First Name & Middle Initial & Last Name & Degree
XianLi He, doctor
First Name & Middle Initial & Last Name & Degree
GuoQiang Bao, doctor
First Name & Middle Initial & Last Name & Degree
JiKai Yin, doctor
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Four Reconstructions After Total Gastrectomy
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