The Possible Range of No.12a Lymph Node Dissection of Locally Advanced Gastric Cancer
Sponsor
Tianjin Medical University Cancer Institute and Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06033482
Collaborator
(none)
100
1
19
5.3
Study Details
Study Description
Brief Summary
The main purpose of this study is to evaluate the reasonable range of No.12a lymph node dissection of locally advanced gastric cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Single Center, Prospective Study on the Possible Range of No.12a Lymph Node Dissection of Locally Advanced Gastric Cancer
Actual Study Start Date
:
Jun 1, 2023
Anticipated Primary Completion Date
:
Jul 1, 2024
Anticipated Study Completion Date
:
Dec 31, 2024
Outcome Measures
Primary Outcome Measures
- The lymph node metastasis rates in No.12aa and No.12av groups. [100 cases enrolled within 1 year]
Observation of lymph node metastasis in different No.12a subgroups12 years
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- ≥ 18 and ≤ 75 years of age; Preoperative gastric cancer patients with pathologically confirmed; Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16); Willing and able to comply with the program during the study period; Physical condition and organ function allows to tolerable abdominal surgery; Written informed consent provided; Under radical laparoscopic distal subtotal gastrectomy With more than a 6-month life expectancy; No other serious concomitant diseases; Sufficient organ functions; No previous history of chemotherapy or radiotherapy; Clinical stage: T2-4aNxM0; Karnofsky performance status (KPS)>60; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1.
Exclusion Criteria:
- Pregnancy or breast feeding; Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms, such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency; Organ transplantation patients need immunosuppressive therapy; Severe recurrent infections were not controlled or with other serious concomitant diseases; Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years; Psychiatric disease which require treatment; Have the history of organ transplantation; Within 6 months before study starts and in the process of this study, patients participate in other clinical researches.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Gastric cancer, Tianjin Medical University Cancer Institute & Hospital, | Tianjin | None Selected | China | 300060 |
Sponsors and Collaborators
- Tianjin Medical University Cancer Institute and Hospital
Investigators
- Study Director: Bin Ke, MD, Department of Gastric cancer, Tianjin Medical University Cancer Institute & Hospital
- Study Director: Peng Ru Zhang, MD, Department of Gastric cancer, Tianjin Medical University Cancer Institute & Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT06033482
Other Study ID Numbers:
- E20230548
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: