scholarly journals 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

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Qi-Yue Chen ◽  
Qing Zhong ◽  
Ping Li ◽  
Jian-Wei Xie ◽  
Zhi-Yu Liu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Randomized Controlled Trial ◽  
Lymph Node ◽  
Indocyanine Green ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Tertiary Teaching ◽  
Significant Difference ◽  
Resectable Gastric Cancer ◽  
Optimal Approach

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.

Cosmetic Outcome of Wound Closure between Steri-Strips (3M™ Steri-Strip) and Simple Interrupted Nylon 6-0 Sutures in Out-Patient Cervical Lymph Node Excision: A Randomized Controlled Trial

2021 ◽  
Vol 104 (7) ◽  
pp. 1088-1094
Keyword(s):  
Randomized Controlled Trial ◽  
Lymph Node ◽  
Cervical Lymph Node ◽  
Controlled Trial ◽  
Nylon 6 ◽  
Lymph Node Excision ◽  
Skin Closure ◽  
Randomized Controlled ◽  
Significant Difference ◽  
The Aesthetic

Objective: To compare the aesthetic outcome of cervical lymph node excision skin closure between Steri-Strips closure and simple interrupted sutures using Nylon 6-0. Materials and Methods: The present study was a single-blinded randomized controlled trial of forty patients with cervical lymph node excision. They were randomized into two groups of twenty. The first group was allocated to close the skin by simple interrupted sutures with Nylon 6-0, the other group received the Steri-Strips for skin closure. Complications were observed at the first and second week. The aesthetic outcomes for skin closure were evaluated at 12 weeks postoperatively using the predetermined Sakka’s cosmetic assessment criteria and scoring system. Results: There was no statistically significant difference between the two groups in terms of gender, age, length of surgical wound, and pathology. The Steri-Strips group showed significantly lower Sakka’s aesthetic score compared to the 6-0 Nylon sutures group (6.25±0.85 and 7.75 ±1.33, p<0.001). There was no significant difference in aesthetic outcomes between genders. Moreover, the operative time of the Steri-Strips group was significantly less than that of the 6-0 Nylon sutures group (2.2±0.41 and 4.75±0.44 minutes, p<0.001). Conclusion: Skin closure with Steri-Strips gave better aesthetic outcomes compared to the 6-0 Nylon sutures (p<0.001). However, the aesthetic outcomes were assessed by physicians, so the patients’satisfaction could not be assessed. Keywords: Lymph node biopsy; Hypertrophic scar; Keloid; Cosmetic outcome; Steri-strip

Randomized controlled trial of omental bursectomy for resectable cT2-3 gastric cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 72-72 ◽  
Author(s):  
Y. Kurokawa ◽  
Y. Fujiwara ◽  
S. Takiguchi ◽  
J. Fujita ◽  
H. Imamura ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Randomized Controlled Trial ◽  
Interim Analysis ◽  
Statistical Power ◽  
Controlled Trial ◽  
Final Analysis ◽  
Morbidity Rate ◽  
Randomized Controlled ◽  
Resectable Gastric Cancer ◽  
Gastric Cancer Patients

72 Background: Omental bursectomy, a traditional surgical procedure to dissect the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon, has often been performed against resectable gastric cancer. We have conducted a multi- institutional randomized controlled trial to elucidate the safety and usefulness of this procedure. Methods: Patients with cT2 or cT3 gastric adenocarcinoma were intraoperatively randomized to radical gastrectomy plus D2 lymphadenectomy either with or without bursectomy. The primary endpoint was overall survival (OS). The planned sample size was 464, with an alpha error of 0.05 and statistical power of 80% to detect a 10% margin of non-inferiority for the non-bursectomy group. The first interim analysis was conducted on Sep 2008, and we decided the preliminary data release according to Korn's proposal (J Clin Oncol. 2005). Results: Between Jul 2002 and Jan 2007, a total of 210 patients were randomized to either the bursectomy group or the non-bursectomy group. Background characteristics were well balanced. Intraoperative blood loss was greater in the bursectomy group than in the non-bursectomy group (median, 475 mL vs. 350 mL, p=0.047), while other surgical factors did not vary significantly. The overall morbidity rate was 14%, the same between two groups. The hospital mortality rate was 0.95%; one patient per group. In the first interim analysis, the 3-year OS were 86% in bursectomy group and 79% in non-bursectomy group, and the hazard ratio was 1.55 (95% CI: 0.84-2.84). The non-bursectomy group had more patients with peritoneal recurrences than the bursectomy group (14% vs. 8%). Conclusions: Experienced surgeons could safely perform a D2 gastrectomy with an additional bursectomy. First interim analysis suggested the survival advantage of omental bursectomy for cT2-3 gastric cancer patients. Final analysis will be conducted in 2012. No significant financial relationships to disclose.

Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial

2016 ◽  
Vol 34 (12) ◽  
pp. 1350-1357 ◽  
Author(s):  
Yanfeng Hu ◽  
Changming Huang ◽  
Yihong Sun ◽  
Xiangqian Su ◽  
Hui Cao ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Randomized Controlled Trial ◽  
Advanced Gastric Cancer ◽  
Distal Gastrectomy ◽  
Controlled Trial ◽  
Clinical Stage ◽  
Morbidity And Mortality ◽  
D2 Lymphadenectomy ◽  
Randomized Controlled ◽  
Significant Difference

Purpose The safety and efficacy of radical laparoscopic distal gastrectomy (LG) with D2 lymphadenectomy for the treatment of advanced gastric cancer (AGC) remain controversial. We conducted a randomized controlled trial to compare laparoscopic and conventional open distal gastrectomy with D2 lymph node dissections for AGC. Patients and Methods Between September 2012 and December 2014, 1,056 patients with clinical stage T2-4aN0-3M0 gastric cancer were eligible for inclusion. They were randomly assigned to either the LG with D2 lymphadenectomy group (n = 528) or the open gastrectomy (OG) with D2 lymphadenectomy group (n = 528). Fifteen experienced surgeons from 14 institutions in China participated in the study. The morbidity and mortality within 30 days after surgery between the LG (n = 519) and the OG (n = 520) groups were compared on the basis of the modified intention-to-treat principle. Postoperative complications were stratified according to the Clavien-Dindo classification. Results The compliance rates of D2 lymphadenectomy were similar between the LG and OG groups (99.4% v 99.6%; P = .845). The postoperative morbidity was 15.2% in the LG group and 12.9% in OG group with no significant difference (difference, 2.3%; 95% CI, –1.9 to 6.6; P = .285). The mortality rate was 0.4% for the LG group and zero for the OG group (difference, 0.4%; 95% CI, –0.4 to 1.4; P = .249). The distribution of severity was similar between the two groups (P = .314). Conclusion Experienced surgeons can safely perform LG with D2 lymphadenectomy for AGC.

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