Evaluating lymph node dissection in advanced gastric cancer
A Single Center, Prospective Study on the Possible Range of No.12a Lymph Node Dissection of Locally Advanced Gastric Cancer
This study is testing how removing certain lymph nodes during surgery can affect the outcomes for patients with locally advanced gastric cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tianjin, None Selected) |
| Trial ID | NCT06033482 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the reasonable range of No.12a lymph node dissection in patients with locally advanced gastric cancer. It focuses on preoperative patients who have undergone radical resection and evaluates their eligibility based on specific criteria, including age, performance status, and absence of serious concomitant diseases. The study will gather data to better understand the implications of lymph node dissection on patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with pathologically confirmed gastric cancer who are eligible for radical laparoscopic surgery.
Not a fit: Patients with serious concomitant diseases or those who have undergone previous chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical approaches and outcomes for patients with locally advanced gastric cancer.
How similar studies have performed: While similar studies have explored lymph node dissection in gastric cancer, the specific focus on the No.12a range is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tianjin, None Selected
- Department of Gastric cancer, Tianjin Medical University Cancer Institute & Hospital, — Tianjin, None Selected, China (Recruiting)
Study contacts
- Study coordinator: Bin Ke, MD
- Email: binke@tmu.edu.cn
- Phone: +86 022-23340123-1061
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.