A Clinical Study of Laparoscopic Proximal Gastrectomy Based on PTST(Parachute-tunnel- Style Technique) Esophagogastric Anastomose.

Not Applicable

• Conditions: Proximal Gastrectomy; Gastroesophagostomy; Gastroesophageal-junction Cancer
• Interventions: Procedure: PTST(parachute-tunnel-style technique)for esophagogastrostomy

• Registration Number: NCT06217991
• Lead Sponsor: Tang-Du Hospital

Brief Summary

1. To evaluate the safety, simplicity and effectiveness of the gastric function (anti-reflux) preservation of the innovative "parachute-tunnel-style technique" (PTST) in laparoscopic proximal gastrectomy.

2. To investigate the correlation between anastomotic stenosis and blood supply of serosa-muscle flap,suture after esophagogastric anastomosis.(obtain objective indexes such as blood supply, healing pattern and length change of serosa-muscle flap through animal experiments)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-12-17
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Gastric cancer was confirmed histopathologically;
• Patients who may undergo proximal gastrectomy according to guidelines;
• Early upper gastric cancer, more than 1/2 of the distal gastric remnant remained after resection;
• Esophagogastric junction carcinoma with maximum diameter ≤4 cm;
• Patients with advanced upper gastric cancer (MSI-H) achieved cCR by neoadjuvant immunochemotherapy.

Exclusion Criteria

• Patients with systemic conditions that cannot tolerate laparoscopic surgery;
• Distal gastric remnant was less than 1/2 after proximal gastrectomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PTST anastomose group after proximal gastrectomy	PTST(parachute-tunnel-style technique)for esophagogastrostomy	Standard procedure: Patient placed in a supine position and proximal gastrectomy performed under general anesthesia. 1. Lymph node dissection 2. Cut the esophagus 3. Gymnosis of gastric curvature greater and gastric curvature lesser 4. The specimen removed from the stomach(5cm away) 5. Preparation of serosa-muscle flap: Mark two straight lines, A and B, about 3cm long, with methylene blue on the anterior wall of the stomach about 2cm and 6cm from the gastric stump. The electrocoagulation and cutting power of the electrotome were adjusted to 10 watts, and the serosa-muscle layer of the gastric wall was cut along the marked line with the electrotome. With the help of the assistant, the surgeon separated the gastric parietal serosa-muscle layer from the submucosa along line B to line A. When the dissociation reached the middle point of the tunnel, it should be dissociated along line A to line B, completely dissociated the gastric parietal serosa-muscle layer from the submucosa.

Primary Outcome Measures

Name	Time	Method
occurrence rate of reflux esophagitis	three month after surgery; six month after surgery	* Visick score after surgery; * Los Angeles rating
occurrence rate of anastomotic stenosis	one month after surgery	morbidity(%)

Trial Locations

Locations (1)

General Surgery Gastrointestinal Department,Tang-Du of Fourth Military Medical University; 🇨🇳 Xi'an, Shannxi Province, China