Laparoscopic vs Open Distal Gastrectomy With D2 Lymphadenectomy for Clinical T4a Gastric Cancer: The UMC-UPPERGI-01 Randomized Clinical Trial.
| Title: | Laparoscopic vs Open Distal Gastrectomy With D2 Lymphadenectomy for Clinical T4a Gastric Cancer: The UMC-UPPERGI-01 Randomized Clinical Trial. |
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| Authors: | Dat TQ; Department of Gastrointestinal Surgery, University Medical Center, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Thong DQ; Department of Gastrointestinal Surgery, University Medical Center, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Nguyen DT; Department of Gastrointestinal Surgery, University Medical Center, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Hai NV; Department of Gastrointestinal Surgery, University Medical Center, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Phuoc TD; Department of Gastrointestinal Surgery, University Medical Center, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Anh NVT; Department of General Surgery, Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Bac NH; Department of Gastrointestinal Surgery, University Medical Center, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Department of General Surgery, Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Long VD; Department of Gastrointestinal Surgery, University Medical Center, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam.; Department of General Surgery, Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam. |
| Source: | JAMA surgery [JAMA Surg] 2026 Jan 01; Vol. 161 (1), pp. 9-18. |
| Publication Type: | Comparative Study; Journal Article; Randomized Controlled Trial |
| Language: | English |
| Journal Info: | Publisher: American Medical Association Country of Publication: United States NLM ID: 101589553 Publication Model: Print Cited Medium: Internet ISSN: 2168-6262 (Electronic) Linking ISSN: 21686254 NLM ISO Abbreviation: JAMA Surg Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Chicago, IL : American Medical Association, [2013]- |
| MeSH Terms: | Gastrectomy*/methods ; Laparoscopy*/methods ; Lymph Node Excision*/methods ; Stomach Neoplasms*/surgery ; Stomach Neoplasms*/pathology ; Stomach Neoplasms*/mortality; Postoperative Complications/epidemiology ; Aged ; Female ; Humans ; Male ; Middle Aged ; Neoplasm Staging ; Treatment Outcome |
| Abstract: | Importance: No prospective trial on laparoscopy has been specifically designed for clinical T4a gastric cancer (GC); evidence of the safety and efficacy of laparoscopy for T4a GC is currently insufficient.; Objective: To compare the short-term surgical outcomes between laparoscopic distal gastrectomy (LDG) and open distal gastrectomy (ODG) with D2 lymph node dissection for patients with clinical T4a GC.; Design, Setting, and Participants: The UMC-UPPERGI-01 randomized clinical trial (RCT) was a single-center, open-label, noninferiority RCT conducted at a tertiary hospital in Ho Chi Minh City, Vietnam, among patients with clinical T4a GC. The study was conducted from June 2020 to April 2025. Interim and short-term results analyses were conducted in October 2023 and June 2025, respectively.; Interventions: Patients were randomly assigned 1:1 to undergo LDG or ODG with D2 lymph node dissection as the full analysis set of the UMC-UPPERGI-01 trial. The procedures were performed exclusively by qualified surgeons.; Main Outcomes and Measures: Short-term outcomes included surgical results, pathological characteristics, 30-day postoperative morbidity and mortality (Clavien-Dindo classification), and postoperative recovery parameters.; Results: A total of 208 patients who underwent curative-intent distal gastrectomy with D2 lymphadenectomy were included in the full analysis set, with 104 patients in each group. There was no crossover between the 2 groups. Patients in the LDG group had a mean (SD) age of 61.1 (10.0) years and included 25 female patients (24.0%). Patients in the ODG group had a mean (SD) age of 60.0 (10.7) years and included 29 female patients (27.9%). No significant differences were found between the LDG and ODG groups in 30-day morbidity and mortality, including rates of any postoperative complication (22.1% vs 21.2%; P = .87) and severe complications (2.9% vs 3.8%; P > .99). The LDG group showed nonsignificant differences regarding surgical complications (21.2% vs 16.4%; P = .37) and general complications (3.9% vs 10.6%; P = .11) compared to the ODG group. The LDG group had significantly longer mean (SD) operative time (220.0 [42.4] minutes vs 153.7 [36.7] minutes; P |
| Comments: | Comment in: JAMA Surg. 2026 Jan 1;161(1):18-19. doi: 10.1001/jamasurg.2025.4938.. (PMID: 41222943) |
| Molecular Sequence: | ClinicalTrials.gov NCT04384757 |
| Entry Date(s): | Date Created: 20251112 Date Completed: 20260114 Latest Revision: 20260209 |
| Update Code: | 20260209 |
| PubMed Central ID: | PMC12613089 |
| DOI: | 10.1001/jamasurg.2025.4929 |
| PMID: | 41222957 |
| Database: | MEDLINE |
Comparative Study; Journal Article; Randomized Controlled Trial