RecruitingNot ApplicableNCT06300879

A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique

A Prospective Study on the Perioperative Safety and Short-Term Quality of Life in Totally Laparoscopic Proximal Gastrectomy With Esophagogastrostomy by Fissure Technique

Sponsor

Huashan Hospital

Enrollment

30 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer Adenocarcinoma of Esophagogastric Junction

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a new surgical technique for connecting the esophagus (food pipe) to the stomach after removing early-stage stomach or junction tumors. The technique aims to reduce complications like leaks or strictures that can occur after this type of surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed to have adenocarcinoma (a type of cancer) of the upper stomach or where the esophagus meets the stomach - Your cancer is at an early clinical stage with no distant spread - You have not had upper abdominal surgery before (other than laparoscopic gallbladder removal) - You have not received chemotherapy, radiation, or immunotherapy before surgery **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or other organs - You have had previous upper abdominal surgery - You have received pre-operative cancer treatments - Your general health or organ function is too poor to safely undergo surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPerforming 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.

Locations(1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT06300879

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