Dataset Information

Comparison of submucosal and subserosal approaches toward optimized indocyanine green tracer-guided laparoscopic lymphadenectomy for patients with gastric cancer (FUGES-019): a randomized controlled trial.

ABSTRACT:

Background

Application of indocyanine green (ICG) fluorescence imaging is effective in guiding laparoscopic radical lymphadenectomy for gastric cancer. However, the optimal approach for indocyanine green injection is controversial. Therefore, the objective of this study was aimed to compare the efficacy and ICG injection between the preoperative submucosal and intraoperative subserosal approaches for lymph node (LN) tracing during laparoscopic gastrectomy.

Method

This randomized controlled trial (ClinicalTrials.gov, NCT04219332) included 266 patients with potentially resectable gastric cancer (cT1-T4a, N0/+, M0) enrolled from a tertiary teaching center between December 2019 and October 2020. The primary endpoint was total number of retrieved LNs.

Results

In total, 259 patients (n = 130 and n = 129 in the submucosal and subserosal groups, respectively) were included in the per-protocol analysis. There are no significant differences in total number of retrieved LNs between the two groups (49.8 vs. 49.2, P = 0.713). The rate of LN noncompliance in the submucosal group was comparable to that in the subserosal group (32.3% vs. 33.3%, P = 0.860). No significant difference was found between the submucosal and subserosal groups in terms of the incidence (17.7% vs. 16.3%; P = 0.762) or severity of postoperative complications. The mean fluorescence cost in the submucosal group was higher than that in the subserosal group ($335.3 vs. $182.4; P < 0.001). The overall treatment satisfaction score was lower in the submucosal group than in the subserosal group (70.5 vs. 76.1%, P = 0.048).

Conclusion

ICG administered by subserosal injection was comparable to that administered by submucosal injection for lymph node tracing in gastric cancer. However, the former approach imposed a lower economic and mental burden on patients undergoing laparoscopic D2 lymphadenectomy.

Trial registration

ClinicalTrials.gov, NCT04219332 .

SUBMITTER: Chen QY

PROVIDER: S-EPMC8549272 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Comparison of submucosal and subserosal approaches toward optimized indocyanine green tracer-guided laparoscopic lymphadenectomy for patients with gastric cancer (FUGES-019): a randomized controlled trial.

Chen Qi-Yue QY Zhong Qing Q Li Ping P Xie Jian-Wei JW Liu Zhi-Yu ZY Huang Xiao-Bo XB Lin Guang-Tan GT Wang Jia-Bin JB Lin Jian-Xian JX Lu Jun J Cao Long-Long LL Lin Mi M Zheng Qiao-Ling QL Tu Ru-Hong RH Huang Ze-Ning ZN Zheng Chao-Hui CH Huang Chang-Ming CM

BMC medicine 20211027 1

<h4>Background</h4>Application of indocyanine green (ICG) fluorescence imaging is effective in guiding laparoscopic radical lymphadenectomy for gastric cancer. However, the optimal approach for indocyanine green injection is controversial. Therefore, the objective of this study was aimed to compare the efficacy and ICG injection between the preoperative submucosal and intraoperative subserosal approaches for lymph node (LN) tracing during laparoscopic gastrectomy.<h4>Method</h4>This randomized c ...[more]

PMID: 34702260

Similar Datasets

Project description:BackgroundAn adequate resection margin and lymph node dissection are important factors for successful radical gastrectomy. The presence of near-infrared camera imaging with indocyanine green (ICG) gives new insight into radical gastrectomy. Laparoscopic radical gastrectomy with ICG is still in its initial stages and requires more evidence-based medical research. The aim of the present study was to evaluate the safety and availability of lymph node dissection and precise gastrectomy for gastric cancer patients undergoing radical resection under laparoscope with ICG, in the hope of providing evidence of application of ICG tracer fluorescence technique in radical gastrectomy.MethodsA retrospective cohort study was performed with 56 patients who underwent laparoscopic radical gastrectomy. The patients were categorized into the ICG (n=18) or the non-ICG (n=38) group based on whether preoperative endoscopic mucosal ICG injection was performed. Their clinical characteristics (age, tumor size, location, TNM stage and so on) were compared as baseline data. Perioperative outcomes (blood loss, time of first intestinal exhaust, early or long-term complications and so on) were used to assess safety. The status of lymph node dissection and tumor localization were analyzed to testify efficacy. SPSS version 26.0 was used for the statistical analysis.ResultsThere was no difference in clinical data at baseline. From the safety point of view, there was no difference in perioperative outcomes (operative time, blood loss, time of first intestinal exhaust and so on) between the two groups (all P>0.05). From the efficacy point of view, the number of lymph nodes <5 mm (21.84±1.86 vs. 16.24±2.10, P<0.001), the total number of lymph nodes (34.61±5.87 vs. 29.92±5.27, P=0.004), the number of lymph nodes dissected in perigastric regions (groups 1-7, 22.89±3.64 vs. 20.29±3.00, P=0.007), and the number of lymph nodes in extraperigastric regions (groups 8-12, 11.72±3.06 vs. 9.61±3.18, P=0.022) were greater in ICG group compared with non-ICG group. In ICG group, the average vertical distances between the top and bottom of the fluorescent edge and neoplastic edge were 2.65±0.58 and 2.67±0.65 cm, respectively. Fluorescent edge pathology was negative.ConclusionsICG fluorescence could be conducive to lymph node dissection and precise gastrectomy in laparoscopic radical gastrectomy.

Dataset Information

Comparison of submucosal and subserosal approaches toward optimized indocyanine green tracer-guided laparoscopic lymphadenectomy for patients with gastric cancer (FUGES-019): a randomized controlled trial.

Background

Method

Results

Conclusion

Trial registration

Publications

Comparison of submucosal and subserosal approaches toward optimized indocyanine green tracer-guided laparoscopic lymphadenectomy for patients with gastric cancer (FUGES-019): a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets