Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07142122

Safety Comparison of Total Laparoscopic Proximal Gastrectomy With or Without Preservation of the Celiac Branch of the Vagus Nerve for Early Upper Gastric Cancer: A Randomized Controlled Clinical Trial

Led by Fujian Cancer Hospital · Updated on 2025-08-26

76

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This prospective, single-center, randomized, controlled, non-inferiority clinical trial aims to compare the safety and postoperative quality of life of early upper gastric cancer patients undergoing total laparoscopic proximal gastrectomy (TLPG) with preservation of both the hepatic and celiac branches of the vagus nerve versus preservation of the hepatic branch only. The primary endpoint is gastric emptying half-time of solid food at 6 months after surgery. Secondary outcomes include incidence of reflux esophagitis, quality of life scores (EORTC QLQ-C30/STO22), number and positivity rate of lymph nodes retrieved, and 3-year disease-free survival. The study will provide evidence for optimizing minimally invasive surgical strategies for early upper gastric cancer.

CONDITIONS

Official Title

Safety Comparison of Total Laparoscopic Proximal Gastrectomy With or Without Preservation of the Celiac Branch of the Vagus Nerve for Early Upper Gastric Cancer: A Randomized Controlled Clinical Trial

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-75 years
  • Histologically confirmed gastric adenocarcinoma or esophagogastric junction adenocarcinoma
  • Primary tumor located in the upper third of the stomach or esophagogastric junction with tumor size 4 cm
  • Clinical stage cT1bN0M0 without lymph node metastasis
  • BMI less than 30 kg/m
  • No history of upper abdominal surgery except laparoscopic cholecystectomy
  • No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy
  • ECOG performance status of 0-1
  • ASA class I-III
  • Adequate organ function
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Other malignancies within the past 5 years
  • Active infection requiring systemic therapy or fever 386C before surgery
  • Severe psychiatric illness
  • Severe respiratory disease
  • Severe liver or kidney dysfunction
  • Unstable angina or myocardial infarction within the past 6 months
  • Stroke or brain hemorrhage within the past 6 months
  • Long-term systemic glucocorticoid therapy within 1 month (excluding local use)
  • Gastric cancer complications such as bleeding, perforation, or obstruction
  • Participation in another clinical trial within the past 6 months

AI-Screening

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Trial Site Locations

Total: 1 location

1

420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province

Fuzhou, Fujian, China, 350014

Actively Recruiting

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Research Team

Z

Zaisheng Ye, doctoral

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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