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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
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.
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.
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Istanbul, Turkey (Türkiye)
RECRUITING3-Year Disease-Free Survival
Disease-free survival defined as the time from surgery to tumor recurrence or death from any cause.
Time frame: 3 years
Postoperative Mortality
All-cause mortality occurring within 90 days after surgery.
Time frame: 90 days
Postoperative Complications
Incidence of postoperative complications including anastomotic leak, surgical site infection, bleeding, and pulmonary complications.
Time frame: 90 days
Number of Metastatic Lymph Nodes
Total number of pathologically confirmed metastatic lymph nodes retrieved during surgery.
Time frame: At time of surgery
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