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 | Recruiting

• 2 other identifiers: TLPG-CBVP2023-2839
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Gastric Cancer

Keywords

Esophagogastric Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Gastric half-emptying time of solid food at 6 months postoperatively (minutes, measured by gastric emptying test)

  6 months post-operation

Secondary Outcomes (4)

• Reflux Esophagitis (LA Classification)

  1,3,6,12,24 months

• EORTC QLQ-C30/STO22 Scores

  1,3,6,12,24 months

• Lymph Node Yield/Positivity Rate

  Intraoperative

• 3-Year Disease-Free Survival

  36 months

Study Arms (2)

Experimental Arm (Group A)

EXPERIMENTAL

Total laparoscopic proximal gastrectomy with preservation of hepatic and celiac branches of the vagus nerve. Reconstruction by double-tract anastomosis.

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

Active Comparator Arm (Group B)

ACTIVE COMPARATOR

Procedure: Total laparoscopic proximal gastrectomy with preservation of hepatic branch but without preservation of the celiac branch of the vagus nerve. Reconstruction by double-tract anastomosis.

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.

Interventions

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

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).

Experimental Arm (Group A)

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. PROCEDURE

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.

Active Comparator Arm (Group B)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years.
• Histologically confirmed gastric adenocarcinoma or esophagogastric junction adenocarcinoma (papillary, tubular, mucinous, poorly cohesive including signet-ring cell carcinoma, or mixed type).
• Primary tumor located in the upper third of the stomach, or esophagogastric junction cancer with tumor size ≤4 cm.
• Clinical stage cT1bN0M0 without lymph node metastasis.
• BMI \<30 kg/m².
• No history of upper abdominal surgery (except laparoscopic cholecystectomy).
• No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
• ECOG performance status 0-1.
• ASA class I-III.
• Adequate organ function.
• Signed informed consent.

You may not qualify if:

• Pregnancy or breastfeeding.
• Other malignancies within 5 years.
• Active infection requiring systemic therapy or fever ≥38°C preoperatively.
• Severe psychiatric illness.
• Severe respiratory disease.
• Severe hepatic or renal dysfunction.
• Unstable angina or myocardial infarction within 6 months.
• Stroke or intracranial hemorrhage within 6 months.
• Long-term systemic glucocorticoid therapy within 1 month (local use excluded).
• Complications of gastric cancer (bleeding, perforation, obstruction).
• Participation in another clinical study within 6 months.
• R0 resection not achieved, change of procedure to total gastrectomy or PPG, combined surgery for other diseases, severe perioperative complications, emergency surgery required, patient withdrawal of consent, or protocol violation.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

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

Fuzhou, Fujian, 350014, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Zaisheng Ye, doctoral

CONTACT

+86 591 13950203076; flyingengel@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

CN (1)