The Efficacy and Safety of Laparoscopic Proximal Gastrectomy With LPG-tbROSF Versus LTG for Localized Proximal Gastric Cancer.

NCT07260461 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-09-01
Completion
2028-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07260461 on ClinicalTrials.gov