Status:
UNKNOWN
Study on the Peristaltic Direction of GI Anastomosis in Roux-en-Y Reconstruction
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Peristaltic Direction
Roux-en-Y Gastrointestinal Anastomosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The aim of this study is intending to provide the optimal procedures of the peristaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gast...
Detailed Description
In this study, all 148 the included patients will underwent the distal curative gastrectomy for gastric cancer and will be performed the Roux-en-Y reconstruction for gastrointestinal anastomosis. Of t...
Eligibility Criteria
Inclusion
- 1\) Pathological examination confirmation the adenocarcinoma of stomach before surgery
- 2\) Physical conditions compliance with the requirements for curative gastrectomy
- 3\) Consent to undergo the D2 lymphadenectomy, and the dissected proportion of stomach no less than 2/3
- 4\) Comply with the protocol during the whole study period
- 5\) No neoadjuvant therapy administration
- 6\) Sign informed consent and permission of withdraw in the whole study period
- 7\) Consent to provide the tissue specimens after surgery for this study
- 8\) Estimation the overall survival after surgery no less than 6 months
- 9\) No anesthesia or operation contraindication disease
- 10\) cT1-4N0-2M0 stage demonstration by CT and endoscopic ultrasonography examinations
- 11\) Negative cytological detection in operation
- 12\) No seriously concomitance's diseases
- 13\) Karnofsky Performance Scores (KPS) more than 60
- 14\) Examined lymph node count no less than 16
Exclusion
- 1\) Women during pregnant stage and breast-feed stage
- 2\) Women of childbearing age without any contraceptive measures
- 3\) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
- 4\) Immunosuppressive therapists for organ transplantation
- 5\) Seriously uncontrolled recurrent infection
- 6\) other malignant tumors
- 7\) No abilities of self-knowledge or mental disorders
- 8\) Participating in other clinical trials
- 9\) Siewert I and II esophagogastric junction tumors
- 10\) Serious internal diseases obstruction surgery
Key Trial Info
Start Date :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT04801459
Start Date
April 2 2021
End Date
March 31 2024
Last Update
March 22 2022
Active Locations (1)
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1
Cancer Hospital of Tianjin Medical University
Tianjin, China, 300060