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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy or breastfeeding.

Other malignancies within 5 years.

Active infection requiring systemic therapy or fever ≥38°C preoperatively.

Severe psychiatric illness.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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.

    Procedure/Surgery

    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.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Experimental Arm (Group A)Experimental treatment 1 intervention
Group B: Active Comparator Arm (Group B)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
6 months post-operation

Secondary outcomes

1

Reflux Esophagitis (LA Classification)

Time frame
1,3,6,12,24 months
2

EORTC QLQ-C30/STO22 Scores

Time frame
1,3,6,12,24 months
3

Lymph Node Yield/Positivity Rate

Time frame
Intraoperative
4

3-Year Disease-Free Survival

Time frame
36 months

Other outcomes

Sponsors and contacts

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