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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108445
Enrollment
Unknown
Registered
2025-08-29
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal gastric cancer

Interventions

Control Group:The subjects undergo laparoscopic proximal gastrectomy (LPG), with esophagogastric reconstruction performed using the right-sided overlap and single-flap valvuloplasty (ROSF) on the tubu
Experimental Group:The subjects undergo laparoscopic proximal gastrectomy (LPG), with esophagogastric reconstruction performed using the right-sided overlap and single-flap valvuloplasty (ROSF) on the

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 75 years old; 2. Histologically confirmed proximal gastric adenocarcinoma, CT1-2N0M0 stage; 3. The tumor was located in the proximal third of the stomach. 4. ECOG score of 0 or 1; 5. D1+ or D2 dissection according to guidelines (depending on tumor location and intraoperative evaluation). 6. ASA grade I to III; 7. The preoperative nutritional status of the patients was good without severe malnutrition. 8. Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. 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); 2. Severe cardiovascular diseases: such as NYHA class ? and above cardiac dysfunction, recent myocardial infarction (within 6 months), refractory hypertension or arrhythmia; 3. Severe respiratory diseases: severe impairment of lung function (FEV1% 3 times the upper limit of normal, or eGFR < 30 mL/min/1.73m²; 5. patients complicated with other major chronic diseases, such as active tuberculosis, rheumatoid, systemic lupus erythematosus and other autoimmune diseases that affect surgical tolerance; 6. Tumor imaging suggested the presence of distant metastasis (M1) or regional lymph node massive fusion and unresectable; 7. Complicated with other upper gastrointestinal diseases, such as active gastric ulcer, pyloric obstruction, persistent bleeding, which seriously affect the operation; 8. Previous major gastric or upper abdominal surgery (such as subtotal gastrectomy, esophagogastric anastomosis, etc.) affecting the reconstruction method; 9. Received preoperative neoadjuvant chemoradiotherapy or targeted therapy (unless specifically permitted by the study design); 10. Pregnant or lactating women; 11. Patients with mental disorders, cognitive impairment, poor compliance, inability to understand the study content, or inability to cooperate with the follow-up; 12. Severe malnutrition before surgery: BMI < 16 kg/m² or albumin < 25 g/L; 13. Other individual conditions deemed unsuitable for enrollment by the investigator (e.g., poor willingness to cooperate, high risk of loss to follow-up, etc.).

Design outcomes

Primary

MeasureTime frame
Percentage of weight loss at 12 months postoperatively;STO22;

Secondary

MeasureTime frame
3-year Disease-Free Survival, DFS;3-year Overall Survival, OS;Post-operative Complications;Vit.B12;Serum albumin, prealbumin, and hemoglobin levels.;GERD-Q;EORTC QLQ-C30;Upper Arm Circumference;BMI;Grip strength;

Countries

China

Contacts

Public ContactXiaolei Chen

The First Affiliated Hospital of Wenzhou Medical University

chenxiaolei2@sina.com+86 139 6887 5558

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026