NCT06941168

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,099

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2025

Completed
Last Updated

April 23, 2025

Status Verified

April 1, 2025

Enrollment Period

4.4 years

First QC Date

April 16, 2025

Last Update Submit

April 16, 2025

Conditions

Keywords

Robotic surgeryadvanced middle-upper gastric cancerTotal gastrectomyPerioperative outcomesOncologic outcomes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 3-year overall survival (OS)

    3 years after surgery

  • 3-year Cumulative Incidence of Recurrence (CIR)

    3 years after surgery

  • Recurrence Patterns

    Up to 3 years after surgery

Study Arms (2)

RTG

Patients who underwent robotic total gastrectomy

Procedure: Robotic Total Gastrectomy and Laparoscopic Total Gastrectomy

LTG

Patients who underwent laparoscopic total gastrectomy

Procedure: Robotic Total Gastrectomy and Laparoscopic Total Gastrectomy

Interventions

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
LTGRTG

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- Diagnosed with middle or upper gastric cancer (GC)
  • Pathological stage T2-T4a, N0-N3b, M0 (postoperative)
  • Underwent radical total gastrectomy

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastric Surgery, Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

MeSH Terms

Interventions

ezogabine

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Gastric Cancer Surgery

Study Record Dates

First Submitted

April 16, 2025

First Posted

April 23, 2025

Study Start

January 1, 2015

Primary Completion

June 1, 2019

Study Completion

August 1, 2024

Last Updated

April 23, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations