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

Gastroesophageal-junction Cancer Clinical Trial

Official title:

A Single-center, Prospective, Single-arm Clinical Study of Laparoscopic Proximal Gastrectomy Based on an Original Esophagogastric Anastomose (PTST,Parachute- Tunnel- Style Technique)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06217991
• Other study ID #: XKT-Y-20221148
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: January 2024
• Source: Tang-Du Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal-junction Cancer

Intervention

Procedure:
• PTST(parachute-tunnel-style technique)for esophagogastrostomy
Suture the gastric remnant at the mark on the back wall of the esophagus.(Don't tighten the suture); Pull the esophageal stump out of the tunnel meanwhile tighten the suture and the gastric stump to close the back wall of the esophagus and the gastric stump together;Cut the back esophageal wall close to the esophageal stump,cut the front gastric wall along line B. Suture the back esophageal wall and the upper edge of the front gastric wall incision from right to left;Remove residual esophageal nail, and suture the back esophageal wall and the lower edge of the gastric incision from right to left. Suture the anterior wall of the stomach at the lower edge of the tunnel with the serosa layer at the lower edge of the front wall of the esophagus stomach anastomosis;Suture the upper edge of the tunnel with the front wall of the esophagus and the left and right lateral walls at the gastric stump suture of the original posterior wall of the esophagus. (all use 3-0 barbed suture continuously)

Locations

Country	Name	City	State
China	General Surgery Gastrointestinal Department,Tang-Du of Fourth Military Medical University	Xi'an	Shannxi Province

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence rate of anastomotic stenosis	morbidity(%)	one month after surgery
Primary	occurrence rate of reflux esophagitis	Visick score after surgery; Los Angeles rating	three month after surgery; six month after surgery