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NCT Number: NCT07183150

The Possible Range of No.4sb Lymph Node Dissection of Locally Advanced Distal Gastric Cancer

The main purpose of this study is to evaluate the reasonable range of No.4sb lymph node dissection of locally advanced distal gastric cancer.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location status: Recruiting

Location contact

Bin Ke, MD.

CONTACT

[email protected]

+86 13622036809

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The lymph node metastasis rates in No.4sb-R, No.4sb-C and No.4d groups.

    Time frame: 400 cases enrolled within 3 years

    Observation of lymph node metastasis in No.4sb-R, No.4sb-C and No.4d groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Ke, MD.

CONTACT

[email protected]

+86 022-23340123-1061

Peng Ru Zhang, MD.

CONTACT

[email protected]

+86 022-23340123-1061

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

A Single Center, Prospective Study on the Possible Range of No.4sb Lymph Node Dissection of Locally Advanced Distal Gastric Cancer

Acronym: Range of 4sb

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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