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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 3-Year Disease-Free Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of surgical interventions, surgeons and patients cannot be fully blinded to the procedure. However, outcome assessment and data analysis will be performed by independent investigators who are blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Proximal Gastrectomy
Patients randomized to this arm will undergo proximal gastrectomy with D2 lymphadenectomy. The surgical approach (open, laparoscopic, or robotic) will be selected according to patient suitability and surgeon preference.
干预措施: Proximal Gastrectomy (Procedure)
Total Gastrectomy
Patients randomized to this arm will undergo total gastrectomy with D2 lymphadenectomy. The surgical approach (open, laparoscopic, or robotic) will be selected according to patient suitability and surgeon preference.
干预措施: Total Gastrectomy (Procedure)
结局指标
主要结局
3-Year Disease-Free Survival
时间窗: 3 years
Disease-free survival defined as the time from surgery to tumor recurrence or death from any cause.
次要结局
- Postoperative Mortality(90 days)
- Postoperative Complications(90 days)
- Number of Metastatic Lymph Nodes(At time of surgery)
研究者
Nurettin Şahin
Principal Investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital