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Feasibility, safety, effectiveness, and economical efficiency of robotic gastrectomy for resectable gastric cancer: a multi-institutional historically controlled prospective cohort study

Robotic gastrectomy for gastric cancer

330

- Median age and BMI of 326 patients (201 males and 125 females) were 66 years old (range: 26-85) and 22.4 kg/m^2 (range: 15.0-31.5), respectively. - cStage IA: 242 patients (74.2%), IB: 47 patients (14.4%), IIA: 22 patients (6.8%) and IIB: 15 patients (4.6%).

- October 2014 and December 2016, 330 patients at 15 institutions were registered into this study. - Protocol treatment was discontinued in four patients due to intraoperative findings and operator finger injuries. - 326 patients completed the protocol treatment and their short- and long-term outcome were analyzed.

- Intraoperative adverse events were noted in 5 patients (1.5%, redo of reconstruction: 2, injury to surrounding organs: 2, and others: 1). No severe intraoperative adverse event. - Conversion rate was 0.3% (one patient). - Postoperative complications were seen in 113 patients (34.7%), Clavien-Dindo classification Grade I: 65 patients (19.9%), Grade II: 61 patients (18.7%), Grade III: 7 patients (2.2%), Grade IV: one patient (0.3%, intraperitoneal bleeding [Grade IVa]). - Serious adverse events occurred in 25 patients (7.7%). - No surgical related mortality was noted.

<Primary endpoint> Postoperative complications rate (C-D grade IIIa or higher) with robotic gastrectomy (2.45% [8/326]) was significantly lower than that of the laparoscopic gastrectomy (historical control: 6.4%), p = 0.0018. <Secondary endpoints> - Percentage without postoperative complications (C-D grade II or higher) was 79.75% (95% CI: 74.98-83.98). - The median operative time, estimated blood loss, No. of dissected nodes and postoperative hospital stay were 313 min (range: 167-587), 20 mL (range: 0-612), 38.5 (range: 10-103) and nine days (range: 6-62), respectively. - The relapse-free survival rate and overall survival rate at 3 years after surgery were 94.45% (95% CI: 91.33-96.46) and 97.22% (95% CI: 94.73-98.54).

The clinical usefulness (reduction of complications) and oncological safety of robotic gastrectomy for cStage I or II resectable gastric cancer were shown.

Oct. 21, 2020

Dec. 03, 2018

https://doi.org/10.1007/s10120-018-00906-8

No

N/A

https://jrct.mhlw.go.jp/latest-detail/jRCTs042180129

Uyama Ichiro

Fujita Health University Hospital

1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi, Japan

iuyama@fujita-hu.ac.jp

Suda Koichi

Fujita Health University Hospital

1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi, Japan

+81-562-93-9254

ko-suda@fujita-hu.ac.jp

Complete

Oct. 01, 2014

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Operable patients under general anesthesia
Histologically diagnosed gastric adenocarcionoma
cStage I or II disease curably treated with total, distal, or proximal gastrectomy with D1+ or D2 lymph node dissection
Not indicated for endoscopic resection
Age over 18
Informed consent is obtained

Patients with mental disorders
Preoperative use of chemotherapy

Both

Gastric Cancer

Robotic gastrectomy

Postoperative complications greater than Grade III according to Clavien-Dindo classification

Postoperative Complications grater than Grade II according to Clavien-Dindo classification,
Health outcomes measured by EuroQol 5 Dimension (EQ-5D)
Total Medical Cost
Overall survival
Disease free survival
Robotic gastrectomy success rate
Conversion to laparotomy
Intraoperative adverse effects
Surgical outcomes
Postoperative courses
Surgery-Related Mortality

+81-562-93-2865

Feb. 14, 2019

none