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Completed

NCT Number: NCT06941168

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

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastric Surgery, Fujian Medical University Union Hospital

Fuzhou, Fujian, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic Total Gastrectomy and Laparoscopic Total Gastrectomy

Procedure

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

Primary outcomes

  1. 3-year Disease-Free Survival (DFS)

    Time frame: 3 years after surgery

    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

Secondary outcomes

  1. 3-year overall survival (OS)

    Time frame: 3 years after surgery

    Overall survival was defined as the time from the date of surgery to death or last follow-up

  2. 3-year Cumulative Incidence of Recurrence (CIR)

    Time frame: 3 years after surgery

    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. Recurrence Patterns

    Time frame: Up to 3 years after surgery

    First recurrence location classified as local, peritoneal, hepatic, multiple-site, or other/unspecified. Determined via imaging, pathology during follow-up.

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2024
First posted
Apr 23, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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