An observational study in Advanced Gastric Cancer, sponsored by Fujian Medical University. Completed at 1 site in China. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by Fujian Medical University · Observational
This multicenter retrospective cohort study aimed to evaluate the potential advantages of robotic total gastrectomy (RTG) compared to laparoscopic total gastrectomy (LTG) in patients with advanced middle and upper gastric cancer (AMUGC). A total of 1,099 patients who underwent radical total gastrectomy between 2013 and 2020 were included. After strict inclusion and exclusion criteria, propensity score matching (1:1) was conducted to balance baseline characteristics. The primary endpoint was 3-year disease-free survival (DFS), with secondary outcomes including overall survival, recurrence rates and patterns, and perioperative outcomes. All procedures were performed by experienced surgeons following standardized protocols across eight high-volume centers. Data quality was ensured through a centralized electronic system, unified training, and rigorous verification. This study provides real-world evidence on surgical outcomes and long-term prognosis, contributing to clinical decision-making in the treatment of AMUGC.
All patients provided informed consent for the use of their clinical data at admission or prior to surgery, in accordance with the Declaration of Helsinki. The study protocol was approved by the institutional review boards of all eight participating centers and reported in accordance with STROCSS guidelines.
This multicenter registry included patients diagnosed with middle and upper gastric cancer (GC), who underwent radical total gastrectomy with pathological staging of T2-4aN0-3bM0. Exclusion criteria included ASA class >3, residual GC, neoadjuvant chemotherapy, combined organ resection, indocyanine green (ICG) use, concurrent/past malignancies, and loss to follow-up. A total of 1,099 eligible patients were included in the final analysis, with 237 receiving robotic total gastrectomy (RTG) and 862 receiving laparoscopic total gastrectomy (LTG).
To ensure surgical quality, all centers followed standardized protocols. Surgeons had completed their institutional learning curve-defined as independently performing ≥50 laparoscopic gastrectomies with consistent outcomes-before enrolling patients. RTG was performed only by certified surgeons trained in the Da Vinci Robotic System. Surgical procedures adhered to Japanese Gastric Cancer Treatment Guidelines, and pathological staging followed the AJCC 8th edition criteria. Resected specimens were evaluated by experienced gastrointestinal pathologists using uniform histopathological protocols. R1 resection was defined as microscopic tumor presence at the surgical margin.
Patient selection for RTG or LTG was based on shared decision-making, considering tumor stage, comorbidities, surgical risk, cost, and patient preference. Informed consent included agreement to cover any additional costs associated with robotic surgery.
Propensity score matching (PSM) was used to control for baseline differences between groups. A 1:1 nearest-neighbor matching with a caliper of 0.2 was performed using the MatchIt package in R. Thirteen covariates-age, sex, BMI, ASA grade, comorbidities, tumor size/location, histology, pT/pN stage, lymphadenectomy extent, adjuvant chemotherapy, and year of surgery-were included. Matching balance was evaluated using standardized mean differences (SMDs), with \<0.1 considered acceptable.
The registry incorporated a structured follow-up system. Patients were followed every 3-6 months in the first two years, every 6-12 months between years 3-5, and annually thereafter. Follow-up assessments included physical exams, lab tests, imaging (X-ray, ultrasound, or CT), and annual endoscopy. Telephone follow-up was used to supplement outpatient visits. Recurrence was confirmed through clinical history, imaging, and pathology (preferably biopsy).
Data integrity was ensured through multiple layers of quality control. All participating centers used a standardized electronic data capture (EDC) system. Data entry was performed by trained personnel and verified by designated staff. Regular audits, backtracking of missing data, and cross-checking by two independent researchers were conducted before data export. These procedures ensured accuracy, completeness, and consistency of the registry data.
Statistical analyses were performed using SPSS v26.0 and R v4.4.1. Continuous variables were analyzed via t-tests or Mann-Whitney U tests; categorical variables via chi-square or Fisher's exact tests. Survival was assessed using Kaplan-Meier and Cox regression models, with competing risk models used for recurrence. All tests were two-sided, with a significance level of P\<0.05.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 1,099 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Fujian Medical University is the lead sponsor of 144 studies on the registry; 49 are open to participants now.
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Patients diagnosed with middle or upper gastric cancer who underwent radical total gastrectomy at one of eight high-volume surgical centers in China between 2015 and 2019. Eligible patients had pathologically confirmed stage T2-4aNO-3bмоdisease, with no history of neoadjuvant therapy or other malignancies. All patients were treated according to standardized surgical and pathological protocols and had complete follow-up data for postoperative outcomes and survival analysis.
Pathological stage T2-T4a, N0-N3b, M0 (postoperative)
Underwent radical total gastrectomy
Exclusion Criteria:
Residual gastric cancer
Use of indocyanine green (ICG) during surgery
Received neoadjuvant chemotherapy
History of concurrent or previous malignancies
Combined resection of other organs
Lost to follow-up
Patients who underwent robotic total gastrectomy
Procedure: Robotic Total Gastrectomy and Laparoscopic Total Gastrectomy
Patients who underwent laparoscopic total gastrectomy
Procedure: Robotic Total Gastrectomy and Laparoscopic Total Gastrectomy
RTG:Robotic total gastrectomy with D2 lymphadenectomy performed using the Da Vinci Surgical System, following the Japanese Gastric Cancer Treatment Guidelines. LTG:Laparoscopic total gastrectomy with D2 lymphadenectomy performed by experienced surgeons following standardized procedures, based on the Japanese Gastric Cancer Treatment Guidelines.
Also known as: RTG and LTG
3-year Disease-Free Survival (DFS)
Disease-free survival was defined as the time between the date of surgery and date of the last follow-up for recurrence, death, or no recurrence
Time frame: 3 years after surgery
3-year overall survival (OS)
Overall survival was defined as the time from the date of surgery to death or last follow-up
Time frame: 3 years after surgery
3-year Cumulative Incidence of Recurrence (CIR)
The cumulative incidence of recurrence, including local recurrence, peritoneal, liver, multiple, or other metastatic sites. Competing risk model is used with death from other causes as a competing event.
Time frame: 3 years after surgery
Recurrence Patterns
First recurrence location classified as local, peritoneal, hepatic, multiple-site, or other/unspecified. Determined via imaging, pathology during follow-up.
Time frame: Up to 3 years after surgery
Plan to share: No
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Fujian Medical University