RCT Comparing Reduced-port Robotic and Conventional Laparoscopic Subtotal Gastrectomy

"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.

Sex

All

Minimum age

20 Years

Maximum age

85 Years

Inclusion Criteria:

1. Patients aged between 20 and 80 years diagnosed with early gastric cancer (cT1N0)
2. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. Patients with an American Society of Anesthesiologists (ASA) physical status classification of Class I to III
4. Patients with a histologically confirmed diagnosis of gastric adenocarcinoma by endoscopic biopsy prior to surgery
5. Patients with early gastric cancer suspected to have submucosal invasion limited to less than the muscularis propria based on preoperative examinations
6. Patients deemed eligible for distal subtotal gastrectomy based on preoperative assessment
7. Patients who have received a full explanation of the study purpose and procedures, and who voluntarily sign the written informed consent approved by the Institutional Review Board (IRB)

exclusion Criteria:

1. Patients determined to have advanced gastric cancer rather than early gastric cancer based on preoperative endoscopy or computed tomography
2. Patients with confirmed distant metastasis on preoperative examinations
3. Patients with a history of previous gastrectomy
4. Patients with complications from gastric cancer, such as significant obstruction or perforation
5. Patients who have received chemotherapy or radiotherapy for the current gastric cancer diagnosis prior to surgery
6. Patients who have undergone surgery or received chemotherapy or radiotherapy for another primary malignancy within the past 5 years (with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix)
7. Vulnerable subjects, including individuals lacking decision-making capacity, pregnant women, or those planning pregnancy
8. Patients who have participated in another clinical trial within the past 6 months or who are currently enrolled in another clinical trial
9. Patients with active synchronous multiple primary malignancies

Exclusion Criteria:

1. Patients determined to have advanced gastric cancer rather than early gastric cancer based on preoperative endoscopy or computed tomography
2. Patients with confirmed distant metastasis on preoperative examinations
3. Patients with a history of previous gastrectomy
4. Patients with complications from gastric cancer, such as significant obstruction or perforation
5. Patients who have received chemotherapy or radiotherapy for the current gastric cancer diagnosis prior to surgery
6. Patients who have undergone surgery or received chemotherapy or radiotherapy for another primary malignancy within the past 5 years (with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix)
7. Vulnerable subjects, including individuals lacking decision-making capacity, pregnant women, or those planning pregnancy
8. Patients who have participated in another clinical trial within the past 6 months or who are currently enrolled in another clinical trial
9. Patients with active synchronous multiple primary malignancies

• BACKGROUNDPaterson JM, Smith SM, Simpson J, Grace OC, Sosunov AA, Bell JE, Antoni FA. Characterisation of human adenylyl cyclase IX reveals inhibition by Ca(2+)/Calcineurin and differential mRNA plyadenylation. J Neurochem. 2000 Oct;75(4):1358-67. doi: 10.1046/j.1471-4159.2000.0751358.x. PMID 10987815