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

Официальное название

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

Обзор

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.

Подробное описание

Gastroesophageal junction cancers represent a challenging oncological entity, particularly in patients with locally advanced Siewert type II-III tumors. Total gastrectomy has traditionally been considered the standard surgical treatment; however, proximal gastrectomy has gained increasing interest in recent years due to potential advantages in postoperative functional outcomes and reduced surgical morbidity. Nevertheless, concerns remain regarding the adequacy of oncological clearance and lymph node dissection with proximal gastrectomy.

This multicenter prospective randomized clinical trial is designed to evaluate the safety, feasibility, and oncological outcomes of proximal gastrectomy compared with total gastrectomy in patients with locally advanced Siewert type II-III gastroesophageal junction cancer. Patients diagnosed through endoscopic and histopathological evaluation and deemed operable after multidisciplinary tumor board discussion will be included. Following informed consent, participants will be randomized in a parallel design to undergo either proximal gastrectomy or total gastrectomy with D2 lymph node dissection (D2 lymphadenectomy). Surgical procedures may be performed via open, laparoscopic, or robotic approaches based on surgeon preference and patient suitability.

Baseline demographic characteristics, perioperative variables, pathological findings, postoperative morbidity and mortality, and long-term oncological outcomes will be prospectively recorded. The primary endpoint is 3-year disease-free survival (DFS), while secondary endpoints include postoperative complications, mortality, and the number of metastatic lymph nodes. Patients will be followed at predefined intervals for up to five years after surgery. The results of this study are expected to provide high-level evidence to guide surgical decision-making in the management of locally advanced gastroesophageal junction cancers.

Вмешательства

• Процедура Proximal 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.
• Процедура Total 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.

Первичные конечные точки

• 3-Year Disease-Free Survival [Срок оценки: 3 years]

Вторичные конечные точки (3)

• Postoperative Mortality [Срок оценки: 90 days]
• Postoperative Complications [Срок оценки: 90 days]
• Number of Metastatic Lymph Nodes [Срок оценки: At time of surgery]

Критерии участия

Критерии включения

• Age between 18 and 90 years
• Histologically confirmed locally advanced Siewert type II-III gastroesophageal junction cancer
• Considered operable after multidisciplinary tumor board evaluation
• Candidate for curative surgical resection with D2 lymphadenectomy
• Provision of written informed consent

Критерии исключения

• Early-stage gastroesophageal junction cancer
• Gastric cancers located in the antrum or corpus
• Severe anesthetic risk (American Society of Anesthesiologists \[ASA\] class IV or higher)
• Pregnancy
• Patients unwilling or unable to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Bakirkoy Dr. Sadi Konuk Training and Research Hospital — Istanbul

Публикации

• Zhu G, Jiao X, Zhou S, Zhu Q, Yu L, Sun Q, Li B, Fu H, Huang J, Lang W, Lang X, Zhai S, Xiong J, Fu Y, Liu C, Qu J. Can proximal gastrectomy with double-tract reconstruction replace total gastrectomy? a meta-analysis of randomized controlled trials and propensity score-matched studies. BMC Gastroenterol. 2024 Jul 23;24(1):230. doi: 10.1186/s12876-024-03323-7. PMID 39044132
• Yang X, Zeng Z, Liao Z, Zhu C, Wang H, Wu H, Cao S, Liang W, Li X. Comparison of proximal gastrectomy and total gastrectomy in proximal gastric cancer: a meta-analysis of postoperative health condition using the PGSAS-45. BMC Cancer. 2024 Oct 15;24(1):1282. doi: 10.1186/s12885-024-13046-3. PMID 39407137

Идентификаторы

NCT: NCT07482566 · SIEWERT-RCT-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗