Dataset Information

Robotic versus laparoscopic gastrectomy with lymph node dissection for gastric cancer: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Laparoscopic gastrectomy (LG) has several benefits as a treatment of gastric cancer (GC), including reduced pain, early recovery of intestinal function, and shorter hospital stay. LG still has several drawbacks, however, including limited range of movement, amplification of hand tremors, and inconvenient surgical positioning. Around the peripancreatic area, laparoscopic lymph node dissection, therefore, remains challenging; postoperative pancreatic fistula occurs in around 4-7% of patients undergoing LG. Robotic surgery, on the other hand, plays a role in ergonomics and offers several advantages, including 7° of wrist-like motion, less fatigue, tremor filtering, motion scaling, and three-dimensional vision. In our previous retrospective study, we compared the safety and feasibility of surgical outcomes of LG and robotic gastrectomy (RG) for patients with GC. In our previous results, in the LG group, intra-abdominal infectious complications were found in 11%. In the RG group, however, none were found. Our RG procedure may be associated with decreased incidence of intra-abdominal infectious complications. Prospective randomized controlled trials (RCTs) comparing LG and RG are required, however. We begin an RCT to compare short-term surgical and long-term oncological outcomes of LG and RG for GC patients.

Methods

This is a randomized, single-center clinical trial. All included patients are adults with primary carcinoma of the stomach, in whom the tumor is considered surgically resectable (stages I-III). Included in this trial are 240 patients with GC. The primary endpoint is to assess the incidence of postoperative intra-abdominal infectious complications including pancreatic fistula, intra-abdominal abscess, and anastomotic leakage. Secondary endpoints include the incidence of any complications (both related and unrelated to surgery), surgical results, postoperative course, and oncological outcomes.

Discussion

Although its short-term outcomes have been proven comparable to LG in comparative studies, use of RG remains restricted, partly due to the lack of informative RCTs pertaining to it. To evaluate the surgical and oncological outcomes of RG, we therefore undertake a prospective RCT. The obtained results will be useful for reducing the restrictions and for adaptive expansion of RG for patients with GC.

Trial registration

University Hospital Medical Information Network Clinical Trials Registry, ID: UMIN000031536 . Registered on 1 March 2017.

SUBMITTER: Ojima T

PROVIDER: S-EPMC6069719 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Publications

Robotic versus laparoscopic gastrectomy with lymph node dissection for gastric cancer: study protocol for a randomized controlled trial.

Ojima Toshiyasu T Nakamura Masaki M Nakamori Mikihito M Hayata Keiji K Katsuda Masahiro M Kitadani Junya J Maruoka Shimpei S Shimokawa Toshio T Yamaue Hiroki H

Trials 20180731 1

<h4>Background</h4>Laparoscopic gastrectomy (LG) has several benefits as a treatment of gastric cancer (GC), including reduced pain, early recovery of intestinal function, and shorter hospital stay. LG still has several drawbacks, however, including limited range of movement, amplification of hand tremors, and inconvenient surgical positioning. Around the peripancreatic area, laparoscopic lymph node dissection, therefore, remains challenging; postoperative pancreatic fistula occurs in around 4-7 ...[more]

PMID: 30064474

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Project description:Background and Objectives: Gastrectomy with D2 lymphadenectomy is the standard surgical treatment with curative intent for patients with gastric cancer (GC). Over the last three decades, surgeons have been increasingly adopting laparoscopic surgery for GC, due to its better short-term outcomes. In particular, laparoscopic gastrectomy (LG) has been routinely used for early gastric cancer (EGC) treatment. However, LG suffers from technical limitations and drawbacks, such as a two-dimensional surgical field of view, limited movement of laparoscopic tools, unavoidable physiological tremors and discomfort for operating surgeon. Therefore, robotic surgery has been developed to address such limitations. Materials and Methods: We performed a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyzes (PRISMA) guidelines in order to investigate the benefits and harms of robotic gastrectomy (RG) compared to the LG. PubMed/MEDLINE, Scopus, Cochrane Library (Cochrane Database of Systematic Re-views, Cochrane Central Register of Controlled Trials-CENTRAL) and Web of Science (Science and Social Science Citation Index) databases were used to search all related literature. Results: The 7 included meta-analyses covered an approximately 20 years-study period (2000-2020). Almost all studies included in the meta-analyses were retrospective ones and originated from Asian countries (China and Korea, in particular). Examined overall population ranged from 3176 to 17,712 patients. If compared to LG, RG showed both operative advantages (operative time, estimated blood loss, number of retrieved lymph nodes) and perioperative ones (time to first flatus, time to restart oral intake, length of hospitalization, overall complications, Clavien-Dindo (CD) ≥ III complications, pancreatic complications), in the absence of clear differences of oncological outcomes. However, costs of robotic approach appear significant. Conclusions: It is impossible to make strong recommendations, due to the statistical weakness of the included studies. Further randomized, possibly multicenter trials are strongly recommended, if we want to have our results confirmed.

Project description:BackgroundLaparoscopic gastrectomy and robotic gastrectomy are the most widely adopted treatment of choice for gastric cancer. To systematically assess the safety and effectiveness of robotic gastrectomy for gastric cancer, we carried out a systematic review and meta-analysis on short-term and long-term outcomes of robotic gastrectomy.MethodsIn order to find relevant studies on the efficacy and safety of robotic gastrectomy (RG) and laparoscopic gastrectomy (LG) in the treatment of gastric cancer, numerous medical databases including PubMed, Medline, Cochrane Library, Embase, Google Scholar, and China Journal Full-text Database (CNKI) were consulted, and Chinese and English studies on the efficacy and safety of RG and LG in the treatment of gastric cancer published from 2012 to 2022 were screened according to inclusion and exclusion criteria, and a meta-analysis was conducted using RevMan 5.4 software.ResultsThe meta-analysis inlcuded 48 literatures, with 20,151 gastric cancer patients, including 6,175 in the RG group and 13,976 in the LG group, respectively. Results of our meta-analysis showed that RG group had prololonged operative time (WMD = 35.72, 95% CI = 28.59-42.86, P < 0.05) (RG: mean ± SD = 258.69 min ± 32.98; LG: mean ± SD = 221.85 min ± 31.18), reduced blood loss (WMD = -21.93, 95% CI = -28.94 to -14.91, P < 0.05) (RG: mean ± SD = 105.22 ml ± 62.79; LG: mean ± SD = 127.34 ml ± 79.62), higher number of harvested lymph nodes (WMD = 2.81, 95% CI = 1.99-3.63, P < 0.05) (RG: mean ± SD = 35.88 ± 4.14; LG: mean ± SD = 32.73 ± 4.67), time to first postoperative food intake shortened (WMD = -0.20, 95% CI = -0.29 to -0.10, P < 0.05) (RG: mean ± SD = 4.5 d ± 1.94; LG: mean ± SD = 4.7 d ± 1.54), and lower length of postoperative hospital stay (WMD = -0.54, 95% CI = -0.83 to -0.24, P < 0.05) (RG: mean ± SD = 8.91 d ± 6.13; LG: mean ± SD = 9.61 d ± 7.74) in comparison to the LG group. While the other variables, for example, time to first postoperative flatus, postoperative complications, proximal and distal mar gin, R 0 resection rate, mortality rate, conversion rate, and 3-year overall survival rate were all found to be statistically similar at P > 0.05.ConclusionsIn the treatment of gastric cancer, robotic gastrectomy is a safe and effective procedure that has both short- and long-term effects. To properly evaluate the advantages of robotic surgery in gastric cancer, more randomised controlled studies with rigorous research methodologies are needed.

Project description:BackgroundTraditional laparoscopic No.12a lymph node dissection in radical gastrectomy for gastric cancer may damage the peripheral blood vessels, and is not conducive to the full exposure of the portal vein and the root ligation of the left gastric vein. We recommend a new surgical procedure, the portal vein approach, to avoid these problems.Methods25 patients with advanced gastric cancer underwent radical laparoscopic gastrectomy and No.12a lymph node were dissected by portal vein approach, including 7 cases with total gastrectomy, 18 cases with distal gastric resection, 14 males and 11 females. Operative time, intraoperative blood loss, time to first flatus, postoperative hospital stay, number of total lymph node dissection and No.12a lymph node dissection, No.12a lymph node metastasis rate and postoperative complications were statistically observed.ResultsAll the patients were operated successfully and No.12a lymph node were cleaned by portal vein approach. A total of 683 lymph nodes were dissected, with the average number of lymph nodes dissection and positive lymph nodes were (27.3 ± 12.7) and (3.8 ± 5.6) respectively. The average number of No.12a lymph node dissection was (2.4 ± 1.95) and the metastasis rate of No.12a lymph node was 16% (4/25). The average operation time of radical laparoscopic distal and total gastrectomy were (239.2 ± 51.4) min and (295.1 ± 27.7) min respectively. The mean intraoperative blood loss was (134.0 ± 65.7) ml, and postoperative first anal exhaust time was (2.24 ± 0.86) d. The mean time to fluid intake was (4.2 ± 1.7) d, and postoperative hospitalization time was (9.6 ± 5.0) d. Without portal vein injure, anastomotic leakage, gastrointestinal bleeding, intestinal obstruction and other complications were observed in all patient.ConclusionOur results show that the laparoscopic No.12a lymph node dissection by portal vein approach for gastric cancer is safe, feasible and has certain clinical application value.

Project description:IntroductionLaparoscopic surgery has been adopted in some parts of the world as an innovative approach to the resection of gastric cancers. However, in the modern era of surgical oncology, to overcome intrinsic limitations of the traditional laparoscopy, the robotic approach is advocated as able to facilitate the lymph node dissection and complex reconstruction after gastrectomy, to assure oncologic safety also in advanced gastric cancer patients. Previous meta-analyses highlighted a lower complication rate as well as bleeding in the robotic approach group when compared with the laparoscopic one. This potential benefit must be balanced against an increased time of intervention. The aim of this umbrella review is to provide a comprehensive overview of the literature for surgeons and policymakers in order to evaluate the potential benefits and harms of robotic gastrectomy (RG) compared with the laparoscopic approach for gastric cancer.Methods and analysisWe will perform a comprehensive search of the PubMed, Cochrane and Embase databases for all articles published up to May 2019 and reference list of relevant publications for systematic review and meta-analyses comparing the outcomes of RG and laparoscopic gastrectomy in patients with gastric cancer. Studies will be selected by two independent reviewers based on prespecified eligibility criteria and the quality will be assessed according to AMSTAR (A MeaSurement Tool to Assess systematic Reviews) checklist. All information will be collected using piloted and standardised data-extraction forms in DistillerSR developed following the Joanna Briggs Institute's recommended extraction items.Ethics and disseminationThis umbrella review will inform clinical and policy decisions regarding the benefits and harms of RG for treating gastric cancer. The results will be disseminated through a peer-reviewed publication, conference presentations and the popular press. Formal ethical approval is not required as primary data will not be collected.Prospero registration numberCRD42019139906.

Project description:BackgroundRobot-assisted radical prostatectomy (RARP) with extended lymphadenectomy (ePLND) is the gold standard for surgical treatment of prostate cancer (PCa). Recently, the en-bloc ePLND has been proposed but no studies reported on the standardization of the technique. The aim of the study is to describe different standardized en-bloc ePLND, the antegrade and the retrograde ePLND, and to compare their surgical and oncological outcomes.Materials & methodsFrom January 2018 to September 2019, all patients subjected to RARP plus ePLND by one single surgeon were enrolled. ePLND was performed in a retrograde fashion by starting laterally to the medial umbilical ligament from the internal inguinal ring proceeding towards the ureter, or in an antegrade way by starting from the ureter at its crossing with the common iliac artery and proceeding towards the femoral canal. Patients' demographic data, clinical and surgical data were collected. Each en-bloc ePLND was categorized as "efficient" or "inefficient" by the operator, as surrogate of surgeon's satisfaction.ResultsAntegrade and retrograde ePLND were performed in 41/105 (group A) and 64/105 (group R) patients, respectively. The two groups (A vs R) had similar median (IQR) number of lymph nodes retrieved [20 (16.25-31.5) vs 19 (15-26.25); p = 0.18], ePLND time [33.5 (29.5-38.5) min vs 33.5 (26.5-37.5) min; p = 0.4] and post-operative complications [8/41 (19.5%) vs 9/64 (14.1%); p = 0.61]. In group A, 3/41 (7.3%) clinically significant lymphoceles were reported, while 1/64 (1.6%) in group R (p = 0.3). 33/41 (80.5%) and 28/64 (44%) procedures were scored as efficient 59 in group A and R, respectively (p = 0.01). On multivariate regression, only BMI (B = 0.93; 95% CI 0.29-1.56; p = 0.005) was associated with a longer ePLND time.ConclusionsThe study indicates that antegrade and retrograde en-bloc extended pelvic lymph node dissection (ePLND) have comparable surgical and oncologic outcomes, supporting the importance of standardizing the procedure rather than focusing on the direction. Although both techniques aligned with current evidence regarding lymph node invasion and complications, the antegrade approach was subjectively perceived as safer due to early isolation of critical anatomical landmarks. Encouragement for the use of en-bloc ePLND, regardless of direction, is emphasized to improve prostate cancer staging accuracy and procedural standardization.

Project description:BACKGROUND:To date, robotic surgery has been widely used worldwide. We conducted a systematic review and meta-analysis to evaluate short-term and long-term outcomes of robotic gastrectomy (RG) in gastric cancer patients to determine whether RG can replace laparoscopic gastrectomy (LG). METHODS:The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was applied to perform the study. Pubmed, Cochrane Library, WanFang, China National Knowledge Infrastructure (CNKI), and VIP databases were comprehensively searched for studies published before May 2020 that compared RG with LG. Next, two independent reviewers conducted literature screening and data extraction. The quality of the literature was assessed using the Newcastle-Ottawa Scale (NOS), and the data analyzed using the Review Manager 5.3 software. Random effects or fixed effects models were applied according to heterogeneity. RESULTS:A total of 19 studies including 7275 patients were included in the meta-analyses, of which 4598 patients were in the LG group and 2677 in the RG group. Compared with LG, RG was associated with longer operative time (WMD = -32.96, 95% CI -42.08 ~ -23.84, P < 0.001), less blood loss (WMD = 28.66, 95% CI 18.59 ~ 38.73, P < 0.001), and shorter time to first flatus (WMD = 0.16 95% CI 0.06 ~ 0.27, P = 0.003). There was no significant difference between RG and LG in terms of the hospital stay (WMD = 0.23, 95% CI -0.53 ~ 0.98, P = 0.560), overall postoperative complication (OR = 1.07, 95% CI 0.91 ~ 1.25, P = 0.430), mortality (OR = 0.67, 95% CI 0.24 ~ 1.90, P = 0.450), the number of harvested lymph nodes (WMD = -0.96, 95% CI -2.12 ~ 0.20, P = 0.100), proximal resection margin (WMD = -0.10, 95% CI -0.29 ~ 0.09, P = 0.300), and distal resection margin (WMD = 0.15, 95% CI -0.21 ~ 0.52, P = 0.410). No significant differences were found between the two treatments in overall survival (OS) (HR = 0.95, 95% CI 0.76 ~ 1.18, P = 0.640), recurrence-free survival (RFS) (HR = 0.91, 95% CI 0.69 ~ 1.21, P = 0.530), and recurrence rate (OR = 0.90, 95% CI 0.67 ~ 1.21, P = 0.500). CONCLUSIONS:The results of this study suggested that RG is as acceptable as LG in terms of short-term and long-term outcomes. RG can be performed as effectively and safely as LG. Moreover, more randomized controlled trials comparing the two techniques with rigorous study designs are still essential to evaluate the value of the robotic surgery for gastric cancer.

Dataset Information

Robotic versus laparoscopic gastrectomy with lymph node dissection for gastric cancer: study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Robotic versus laparoscopic gastrectomy with lymph node dissection for gastric cancer: study protocol for a randomized controlled trial.

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