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
NCT ID: NCT07142122
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
76 participants
INTERVENTIONAL
2025-01-01
2029-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Arm (Group A)
Total laparoscopic proximal gastrectomy with preservation of hepatic and celiac branches of the vagus nerve. Reconstruction by double-tract anastomosis.
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).
Active Comparator Arm (Group B)
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.
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed gastric adenocarcinoma or esophagogastric junction adenocarcinoma (papillary, tubular, mucinous, poorly cohesive including signet-ring cell carcinoma, or mixed type).
3. Primary tumor located in the upper third of the stomach, or esophagogastric junction cancer with tumor size ≤4 cm.
4. Clinical stage cT1bN0M0 without lymph node metastasis.
5. BMI \<30 kg/m².
6. No history of upper abdominal surgery (except laparoscopic cholecystectomy).
7. No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
8. ECOG performance status 0-1.
9. ASA class I-III.
10. Adequate organ function.
11. Signed informed consent.
Exclusion Criteria
2. Other malignancies within 5 years.
3. Active infection requiring systemic therapy or fever ≥38°C preoperatively.
4. Severe psychiatric illness.
5. Severe respiratory disease.
6. Severe hepatic or renal dysfunction.
7. Unstable angina or myocardial infarction within 6 months.
8. Stroke or intracranial hemorrhage within 6 months.
9. Long-term systemic glucocorticoid therapy within 1 month (local use excluded).
10. Complications of gastric cancer (bleeding, perforation, obstruction).
11. Participation in another clinical study within 6 months.
Exclusion During Study (Removal Criteria):
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.
18 Years
75 Years
ALL
No
Sponsors
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Fujian Cancer Hospital
OTHER_GOV
Responsible Party
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Locations
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420 Fuma Road, Jin'an District, Fuzhou City, Fujian Province
Fuzhou, Fujian, China
Countries
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Central Contacts
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Other Identifiers
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2023-2839
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
TLPG-CBVP
Identifier Type: -
Identifier Source: org_study_id
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