NCT07260461

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stomach Neoplasms
• Adenocarcinoma - Gastroesophageal Junction (GEJ)
• Gastroesophageal Junction Cancer

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic Proximal Gastrectomy with Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF)	Experimental group (tbROSF group): Participants will undergo laparoscopic proximal gastrectomy (LPG), with esophagogastric reconstruction performed using tubulized-stomach right-open single-flap valvuloplasty (tbROSF). Control group (LTG group): Participants will undergo laparoscopic total gastrectomy (LTG), with digestive tract reconstruction performed using a standard Roux-en-Y anastomosis.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2025-12-03
• Last updated: 2025-12-03