Potential Advantages of Robotic Total Gastrectomy in Advanced Middle-Upper Gastric Cancer: A Multicenter Propensity Score Matching Analysis

Potential Advantages of Robotic Total Gastrectomy in Advanced Middle-Upper Gastric Cancer

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.

Study Overview

• Status: Completed
• Conditions: Advanced Gastric Cancer
• Intervention / Treatment: Procedure: Robotic Total Gastrectomy and Laparoscopic Total Gastrectomy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1099

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Department of Gastric Surgery， Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

- Diagnosed with middle or upper gastric cancer (GC)

Pathological stage T2-T4a, N0-N3b, M0 (postoperative)

Underwent radical total gastrectomy

Exclusion Criteria:

- American Society of Anesthesiologists (ASA) class > 3

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RTG; Patients who underwent robotic 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.; Other Names: RTG and LTG
LTG; 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.; Other Names: RTG and LTG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year overall survival (OS)	Overall survival was defined as the time from the date of surgery to death or last follow-up	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.	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.	Up to 3 years after surgery

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Robotic surgery; Perioperative outcomes; Total gastrectomy; Oncologic outcomes; advanced middle-upper gastric cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: FJMU0416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No