RCT Comparing Reduced-port Robotic and Conventional Laparoscopic Subtotal Gastrectomy

Sponsor
Yonsei University
Study ID
NCT07467174
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • conventional laparoscopy gastrectomy group (Port > 3) — PROCEDURE
    Subtotal gastrectomy with D1+ lymph node dissection performed via the laparoscopic approach.
  • reduced-port robotic group (Port ≤ 3) — PROCEDURE
    Subtotal gastrectomy with D1+ lymph node dissection performed via the robotic approach using a reduced-port technique (involving three or fewer trocars).

Study Details

"Study objective The objective of this study is to evaluate whether reduced-port robotic subtotal gastrectomy demonstrates non-inferiority in safety, specifically regarding the incidence of postoperative complications, compared to conventional laparoscopic subtotal gastrectomy in patients with early gastric cancer. Additionally, the study aims to assess differences in efficacy between the two surgical approaches as secondary endpoints. Study design overview This study is a multicenter, randomized controlled trial involving patients with early gastric cancer. Participants will be randomly assigned in a 1:1 ratio to either the reduced-port robotic surgery group or the conventional laparoscopic surgery group. Outcomes to be observed over a 30-day postoperative period include the incidence of complications, operative time, blood loss, pain levels, length of hospital stay, and quality of life. Investigational Product/Medical Device Robotic surgical platform Laparoscopic surgical platform Target Sample Size and Rationale The study aims to demonstrate that reduced-port robotic subtotal gastrectomy (experimental group) is non-inferior to conventional laparoscopic subtotal gastrectomy (control group) with respect to the incidence of postoperative complications of grade ≥ 3. Previous studies have reported that the complication rate for minimally invasive subtotal gastrectomy in early gastric cancer is approximately 4%. For the non-inferiority test based on comparison of proportions, the following assumptions were used to calculate the required sample size: * Complication rate in the control group (pC): 4% * Complication rate in the experimental group (pT): 4% * Non-inferiority margin (Δ): 5% * Significance level (α): 2.5% (one-sided) * Statistical power (1-β): 80% * Allocation ratio: 1:1 * Expected dropout rate: 10% Based on these assumptions, the calculated sample size is 242 patients per group. Considering a 10% dropout rate, the adjusted sample size is 269 patients per group, totaling 538 patients for the entire study.Inclusion: Patients aged 20 to 80 years diagnosed with early gastric cancer (cT1N0) who are eligible for distal subtotal gastrectomy based on endoscopic or imaging findings. Exclusion: Presence of distant metastasis Diagnosis of advanced gastric cancer Suspected lymph node metastasis History of previous gastrectomy ASA physical status score \> 3 Pregnancy or withdrawal of informed consent Randomization will be performed preoperatively using a web-based system. Surgical procedures will be conducted in accordance with standardized operative guidelines. Follow-up assessments will be conducted at discharge, on postoperative day 30, and at 3 and 6 months postoperatively. Endpoints Primary Endpoint: Incidence of postoperative complications of Clavien-Dindo grade ≥ III within 30 days after surgery Secondary Endpoints: Operative time Estimated blood loss Number of harvested lymph nodes Length of hospital stay Postoperative pain scores Quality of life (including wound-related discomfort and dietary function) Three-year disease-free survival rate Data analysis and statistical Methods Analyses will be conducted on an intention-to-treat (ITT) basis. Categorical variables will be analyzed using the χ² test or Fisher's exact test, as appropriate. Continuous variables will be analyzed using either the t-test or the Mann-Whitney U test, depending on the distribution of the data. Survival analyses will be performed using Kaplan-Meier curves and compared with the log-rank test. Non-inferiority testing will be based on comparisons of 95% confidence intervals.

Key Dates

First listed
Mar 12, 2026
Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
538 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Convetional laparoscopy group
    conventional laparoscopy gastrectomy group (Port \> 3)
  • Active Comparator: reduced-port robotic group
    reduced-port robotic group (Port ≤ 3)

Primary Outcome Measure

Incidence of postoperative complications of Clavien-Dindo grade ≥ III within 30 days after surgery [ Time Frame: postoperative 30 days ]

Central Contacts

Find similar trials

Nationwide
Gastric cancer trialsOncology trialsGI oncology trials

Related Studies