NCT07260461Not yet recruiting
The Efficacy and Safety of Laparoscopic Proximal Gastrectomy With LPG-tbROSF Versus LTG for Localized Proximal Gastric Cancer.
A Multicenter, Prospective, Randomized Controlled Clinical Trial on the Efficacy and Safety of Laparoscopic Proximal Gastrectomy With Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF) Versus Laparoscopic Total Gastrectomy for Localized Proximal Gastric Cancer.
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
This clinical trial is evaluating a new, function-preserving surgical technique for patients with early-stage cancer in the upper part of the stomach. The current standard treatment is a Laparoscopic Total Gastrectomy (LTG), which involves the complete removal of the stomach. This study compares the standard LTG with an innovative procedure called Laparoscopic Proximal Gastrectomy combined with a novel anti-reflux reconstruction (LPG-tbROSF). This new technique removes only the cancerous upper portion of the stomach, aiming to preserve digestive functions and reduce post-surgery complications like acid reflux. The main goal is to see if patients who receive the new, stomach-preserving surgery experience less body weight loss one year after the procedure compared to those who undergo the standard total gastrectomy. The research will also compare the two surgeries in terms of post-operative quality of life, nutritional status, acid reflux symptoms, safety, and long-term cancer outcomes. The study is a multi-center, prospective, randomized controlled trial that plans to enroll 120 patients with localized cancer in the upper stomach.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 10 Sept 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- NCT number
- NCT07260461
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Jan 2026 to the primary completion date, 1 Sept 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous major gastric or upper abdominal surgery (such as subtotal gastrectomy, esophagogastric anastomosis, etc.) affecting the reconstruction method;
- Received preoperative neoadjuvant chemoradiotherapy or targeted therapy (unless specifically permitted by the study design);
Other illness
- Concurrent with other active malignant tumors, or a history of other malignant tumors within 5 years (excluding basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Severe cardiovascular diseases: such as NYHA class Ⅲ and above cardiac dysfunction, recent myocardial infarction (within 6 months), refractory hypertension or arrhythmia;
- Severe respiratory diseases: severe impairment of lung function (FEV1%\<50%) or chronic respiratory failure;
- patients complicated with other major chronic diseases, such as active tuberculosis, rheumatoid, systemic lupus erythematosus and other autoimmune diseases that affect surgical tolerance;
- Complicated with other upper gastrointestinal diseases, such as active gastric ulcer, pyloric obstruction, persistent bleeding, which seriously affect the operation;
- Patients with mental disorders, cognitive impairment, poor compliance, inability to understand the study content, or inability to cooperate with the follow-up;
- Other individual conditions deemed unsuitable for enrollment by the investigator (e.g., poor willingness to cooperate, high risk of loss to follow-up, etc.).
Lab values
- Severe liver and kidney dysfunction: ALT/AST \> 3 times the upper limit of normal, or eGFR \< 30 mL/min/1.73m²;
- Severe malnutrition before surgery: BMI \< 16 kg/m² or albumin \< 25 g/L;
Other
- Tumor imaging suggested the presence of distant metastasis (M1) or regional lymph node involvement, and the tumor was unresectable.
- Pregnant or lactating women;
Who the study is looking for
- Aged from 18 to 75 years old;
- Histologically confirmed proximal gastric adenocarcinoma, CT1-2N0M0 stage;
- The tumor was located in the proximal third of the stomach.
- ECOG score of 0 or 1;
- D1+ or D2 dissection according to guidelines (depending on tumor location and intraoperative evaluation).
- ASA grade I to III;
- The preoperative nutritional status of the patients was good without severe malnutrition.
- Voluntarily sign informed consent.
Age in the registry: 15 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.