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

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

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.
  • 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.

Treatment groups

76 Participants
are divided into 2 treatment groups

Sponsors and collaborators