When performed by an experienced surgeon, laparoscopic surgery is a safe alternative to open surgery for patients with stage I gastric cancer, a randomized trial from China indicated.
Among 214 patients undergoing total gastrectomy with lymphadenectomy, no significant differences were observed between the two groups in rates of morbidity and mortality, or intraoperative and postoperative complications, reported Yihong Sun, MD, PhD, of Zhongshan Hospital at Fudan University in Shanghai, and colleagues.
“This study provides baseline evidence for future oncological safety studies of LTG [laparoscopic total gastrectomy] for early gastric cancer, and even more so for advanced gastric cancer,” the authors wrote in JAMA Oncology.
Findings from the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group CLASS02 trial echo those of an earlier CLASS study in locally advanced distal gastrectomy, which showed the laparoscopic method to be non-inferior to open surgery for disease-free survival at 3 years.
In the current investigation, the researchers randomized 227 patients from 2017 to 2019 to either laparoscopic (n=113) or open (n=114) total gastrectomy with lymphadenectomy at 13 gastric centers across China.
For the study’s primary outcome, overall rates of morbidity and mortality within 30 days of surgery were 19.1% in the laparoscopic group and 20.2% in the open surgery group (rate difference -1.1%, 95% CI -11.8% to 9.6%).
For secondary outcomes, intraoperative complications occurred in three patients in the laparoscopic group (2.9%) and four in the open surgery group (3.7%), a non-significant difference (-0.8%, 95% CI -6.5% to 4.9%), and postoperative complication rates were 18.1% versus 17.4%, respectively (rate difference 0.7%, 95% CI -9.6% to 11%), with a similar distribution of complication severity.
Severe complications (grade ≥3) were numerically greater in the laparoscopic group (7.6% vs 3.8% on the Clavien-Dindo classification system, P=0.52), which may have been due to the relative inexperience of some surgeons performing laparoscopic total gastrectomy, a complicated procedure with a fairly steep learning curve, according to the investigators. They added that this incidence of severe complications with laparoscopic total gastrectomy was lower than that of the recent phase II KLASS03 feasibility study in stage 1 gastric cancer (9.4%), and that more experience could further narrow the gap between the severe complications with open surgery.
One patient who received laparoscopic surgery died from intra-abdominal bleeding secondary to splenic artery hemorrhage, but there was no significant overall difference in mortality between the arms (rate difference 1.0%, 95% CI -2.5% to 5.2%).
Curtis Wray, MD, a gastrointestinal surgeon at McGovern Medical School at UTHealth in Houston, said that although gastric cancer is not as prevalent in the U.S. as in Asia, the findings of this study are still relevant.
“Specialty and tertiary-care centers are already doing laparoscopic and robotic surgery for gastric cancer, even though it is not as likely to be diagnosed at an early stage as in Asia, where it is screened for,” said Wray, who was not involved in the research.
Although operating room costs might be higher for laparoscopic total gastrectomy, said Wray, the overall costs in terms of time to recovery, days in hospital, and time to resumption of regular activities could result in lower costs overall.
In the study, however, post-surgical recovery — including time to ambulation, first flatus, and first liquid intake — were similar between the two arms, and average hospital stays were 10.9 days in the laparoscopic group and 9.6 days with open surgery. Average surgical time was significantly longer with laparoscopic surgery (230.5 vs 190.4 minutes).
“Although the laparoscopic approach took a significantly longer operative time, and had more severe complications, the oncologic resections and overall outcomes were not significantly different between the two groups,” noted Diya Alaedeen, MD, of the Cleveland Clinic in Ohio. “However, the complication rate remained at almost 20% in both groups. This highlights the difficulty of this operation and its inherent risks.”
“We have come a long way in our utilization of minimally invasive techniques to address the many benign and malignant diseases of the gastrointestinal tract,” said Alaedeen, who also wasn’t involved in the study. “The CLASS02 trial validates this approach, but also highlights the need to improve on outcomes, as we strive to reduce postoperative complications, and enhance patient safety and quality care.”
For the present analysis from Sun’s group, 214 patients were evaluable for morbidity and mortality. Average patient age was 59.8 years (SD 9.4) in the laparoscopic group and 59.4 years (9.2) in the open surgery group. Most patients in the study were men at 71.4% and 73.4%, respectively.
Addressing study limitations, the authors acknowledged that 20 patients in the laparoscopic group and 18 in the open surgery group were preoperatively misclassified as having early gastric cancer, and five patients with distant metastases had to be excluded. Some poorly differentiated types, they explained, can seed and spread extensively in the mucosa and/or submucosa of the stomach and result in distant metastases not always detectable on endoscopy and CT scans.
In addition, they noted, some cancers in the series were small and confined to the upper and middle stomach and were therefore given proximal or distal rather than radical gastrectomy.
This work was supported by grants from the Clinical Trial Fund of Zhongshan Hospital and Johnson & Johnson Medical.
The investigators disclosed no competing interests.
Wray and Alaedeen reported no conflicts of interest in relation to their comments.