Esophageal Neoplasms, Gastroesophageal Junction Cancer, Stomach Neoplasms
Conditions
Keywords
Siewert Type II, Siewert Type III, Proximal Gastrectomy, Total Gastrectomy, Gastric Cancer Surgery
Brief 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.
Detailed description
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.
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.
Sponsors
Nurettin Şahin
Ankara City Hospital Bilkent
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomized in a parallel design to undergo either proximal gastrectomy or total gastrectomy with D2 lymphadenectomy. Surgical approach (open, laparoscopic, or robotic) will be selected according to patient suitability and surgeon preference.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-Year Disease-Free Survival | 3 years | Disease-free survival defined as the time from surgery to tumor recurrence or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Mortality | 90 days | All-cause mortality occurring within 90 days after surgery. |
| Postoperative Complications | 90 days | Incidence of postoperative complications including anastomotic leak, surgical site infection, bleeding, and pulmonary complications. |
| Number of Metastatic Lymph Nodes | At time of surgery | Total number of pathologically confirmed metastatic lymph nodes retrieved during surgery. |
Countries
Turkey (Türkiye)
Contacts
CONTACTTurgut Donmez, MD
CONTACTTolga Dinc, MD
PRINCIPAL_INVESTIGATORTurgut Donmez, MD
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Outcome results
None listed