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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

NCT07142122 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-08-26

No results posted yet for this study

Summary

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

Interventions

PROCEDURE

Total laparoscopic proximal gastrectomy with preservation of both the hepatic and celiac branches of the vagus nerve, followed by double-tract reconstruction.

Total laparoscopic proximal gastrectomy with meticulous preservation of the hepatic branch of the vagus nerve (via fenestration of the lesser omentum) and the celiac branch (via skeletonization of the left gastric artery). The esophagus was transected ≥3 cm proximal to the tumor, preserving \>50% of the residual stomach. Double-tract reconstruction was then performed: an end-to-side esophagojejunostomy was created first, followed by a side-to-side gastrojejunostomy between the residual stomach and jejunum, and finally a side-to-side jejunojejunostomy approximately 40 cm distal to the gastrojejunal anastomosis. This approach achieves oncological resection while maximizing preservation of digestive physiology (gallbladder contraction, reduced dumping syndrome, and partial gastric reservoir function).

PROCEDURE

Total laparoscopic proximal gastrectomy with preservation of the hepatic branch of the vagus nerve but deliberate resection of the celiac branch, followed by double-tract reconstruction.

Total laparoscopic proximal gastrectomy with meticulous preservation of the hepatic branch of the vagus nerve (via lesser omentum fenestration adjacent to the liver edge), while deliberately not preserving the celiac branch (by direct transection at the root of the left gastric artery). The esophagus was transected ≥3 cm proximal to the tumor with preservation of \>50% gastric remnant. Double-tract reconstruction was then executed: end-to-side esophagojejunostomy (circular stapler) → side-to-side gastrojejunostomy (linear cutter) → side-to-side jejunojejunostomy approximately 40 cm distal to the gastrojejunal anastomosis. This technique achieves oncological resection while utilizing the residual stomach and dual-pathway design to minimize postoperative dumping syndrome and preserve partial gastric function.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2029-01-01
Completion
2029-01-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07142122 on ClinicalTrials.gov