TOPLINE:

In a randomized trial of patients with clinical T4a gastric cancer, laparoscopic distal gastrectomy (LDG) yielded similar rates of 30-day overall morbidity, 30-day mortality, and severe complications compared with open distal gastrectomy (ODG). Despite longer operative times and higher median blood loss, LDG showed equivalent safety and feasibility when performed by qualified surgeons.

METHODOLOGY:

• Clinical T4a gastric cancer involves serosal invasion and warrants a higher level of operative complexity. Because prior trials have underrepresented T4a tumors, evidence on the use of LDG for this subgroup is limited. This randomized trial assessed whether LDG with D2 lymphadenectomy offers short-term safety comparable to that of open surgery.
• Researchers conducted a single-center, open-label, noninferiority randomized clinical trial involving 208 patients with lower- or middle-third gastric adenocarcinoma, staged as clinical T4aN0-3M0, who were randomly assigned to undergo either LDG (n = 104; mean age, 61 years) or ODG (n = 104; mean age, 60 years), both with D2 lymph node dissection.
• Five qualified surgeons, each with experience of more than 100 cases of both LDG and ODG with D2 lymphadenectomy, performed all procedures using standardized techniques.
• Short-term outcomes included surgical results, pathologic characteristics, 30-day postoperative morbidity and mortality (classified using the Clavien-Dindo classification), surgical complications, and postoperative recovery parameters.

TAKEAWAY:

• The mean operative time was significantly longer in the LDG group than in the ODG group (220.0 minutes vs 153.7 minutes; P < .001), with a higher median blood loss during surgery (80 mL vs 50 mL; P = .003).
• No significant differences were found between the LDG and ODG groups in 30-day morbidity (22.1% vs 21.2%; P = .87), 30-day mortality (1.0% vs 1.9%; P > .99), and major complications (2.9% vs 3.8%; P > .99). Similarly, no significant differences were found in rates of surgical complications including wound infection, paralytic ileus, and postoperative pancreatic fistula (21.2% vs 16.4%; P = .37) and general complications (3.9% vs 10.6%; P = .11).
• Postoperative recovery outcomes, including time to the first flatus (mean time, 3.0 vs 3.1 days; P = .95), length of hospital stay (mean length, 7.4 vs 7.5 days; P = .13), and time to initiation of adjuvant chemotherapy (33 vs 34 days; P = .30), were comparable between groups.
• Regarding pathologic characteristics, the median number of retrieved lymph nodes was similar in the LDG and ODG groups (32.5 vs 33.0; P = .53), and rates of positive resection margin (1.0% vs 1.9%) and lymph node metastasis (74.0% vs 76.9%) were comparable. A multivariate analysis identified comorbidity as an independent risk factor for postoperative complications (odds ratio, 2.42; 95% CI, 1.11-5.30; P = .03).

IN PRACTICE:

“Findings in this noninferiority RCT [randomized clinical trial] demonstrate that LDG is both feasible and safe in the serosa-invasive subgroup when performed by qualified surgeons,” the authors of the study wrote. “This RCT fulfills a critical evidence gap regarding the application of LDG for locally advanced GC and supports the potential of this approach as an alternative for cT4a GC [gastric cancer].”

Arto Kokkola, MD, PhD; Johanna Louhimo, MD, PhD; and Pauli Puolakkainen, MD, PhD, Helsinki University Hospital and University of Helsinki, Helsinki, Finland, described some limitations of the study in an invited commentary. “Preoperative staging was performed with preoperative imaging (computed tomography scan) only,” but according to the current guidelines, “diagnostic laparoscopy including peritoneal lavage cytology is highly recommended for comprehensive preoperative staging” and “perioperative chemotherapy was an exclusion criteria in the study,” they wrote. The authors of the study “show little superiority and benefit, if any, in the studied parameters from using LDG,” they said.

SOURCE:

The study, led by Tran Quang Dat, MD, MSc, University Medical Center, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam, was published online in JAMA Surgery.

LIMITATIONS:

The trial was a single-center study and was performed by experienced surgeons at high-volume institutions, which limited generalizability to centers with less experience in advanced LDG. Additionally, preoperative CT staging imperfectly identified serosal invasion, and a small proportion of patients were pathologically T1-T2, which may have diluted T4a-specific effects.

DISCLOSURES:

The study reported receiving support through a grant from the University Medical Center, University of Medicine and Pharmacy. The authors reported having no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.