MedTrace Logo

A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

NCT06300879 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-02

No results posted yet for this study

Summary

This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III).

The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22.

Conditions

Interventions

PROCEDURE

Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique

Surgical Operation: 1. Gastric Resection Range:Proximal gastrectomy, preserving 2/3 of the distal stomach. 2. Lymph Node Dissection Range:D1+ to D2 lymph node dissection. 3. Anastomosis Method: esophagogastrostomy by fissure technique. 4. Anastomosis Risk Management Plan:For a rupture with a maximum diameter less than or equal to 5mm, repair with 4-0/3-0 absorbable sutures and proceed with the anastomosis.For a rupture with a maximum diameter greater than 5mm or failed anastomosis, resect that part of the remaining stomach, change to proximal gastrectomy, and perform double-channel anastomosis. 5. Surgical Approach:Totally laparoscopic proximal gastrectomy.

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06300879 on ClinicalTrials.gov