RecruitingNot ApplicableNCT07482566

Proximal Versus Total Gastrectomy for Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer

A Multicenter Prospective Randomized Double-Blind Clinical Trial Comparing Proximal Gastrectomy and Total Gastrectomy in Patients With Locally Advanced Siewert Type II-III Gastroesophageal Junction Cancer


Sponsor

Nurettin Şahin

Enrollment

120 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This multicenter prospective randomized clinical trial aims to compare the safety and oncological effectiveness of proximal gastrectomy and total gastrectomy in patients with locally advanced Siewert type II-III gastroesophageal junction cancer. Eligible patients will be randomly assigned to undergo either proximal gastrectomy or total gastrectomy using open, laparoscopic, or robotic surgical approaches according to clinical suitability. The primary outcome of the study is 3-year disease-free survival. Secondary outcomes include postoperative mortality, postoperative complications, and the number of metastatic lymph nodes retrieved. Patients will be followed for up to five years after surgery to evaluate long-term oncological outcomes.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical approaches for treating a specific type of stomach/esophagus junction cancer (Siewert type II–III) that has grown locally but not widely spread: removing only the upper portion of the stomach (proximal gastrectomy) versus removing the entire stomach (total gastrectomy). The goal is to find out which surgery leads to better outcomes and quality of life. **You may be eligible if...** - You are aged 18–90 with a confirmed diagnosis of locally advanced Siewert type II or III gastroesophageal junction cancer (cancer where the esophagus meets the stomach) - A specialist team has confirmed you are fit for surgery - You are a candidate for curative surgery with thorough lymph node removal (D2 dissection) - You can provide written informed consent **You may NOT be eligible if...** - Your cancer is at an early stage - Your tumor is in a different part of the stomach (antrum or corpus) - You are at very high risk from anesthesia (ASA class IV or higher) - You are pregnant - You are unable or unwilling to consent 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

PROCEDUREProximal Gastrectomy

Proximal gastrectomy with D2 lymphadenectomy involving resection of the proximal stomach and gastroesophageal junction. Reconstruction will be performed using esophagogastric or esophagojejunal anastomosis according to surgeon preference. The procedure may be performed via open, laparoscopic, or robotic approach depending on patient suitability.

PROCEDURETotal Gastrectomy

Total gastrectomy with D2 lymphadenectomy involving complete removal of the stomach followed by esophagojejunal reconstruction. The surgical approach (open, laparoscopic, or robotic) will be selected according to patient suitability and surgeon preference.


Locations(1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

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NCT07482566


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