Safety and validity of robot-assisted laparoscopic gastrectomy using the da Vinci Xi operation system combined with ICG fluorescence navigation surgery for early gastric cancer.

Not Applicable

• Conditions: Gastric cancer

• Registration Number: JPRN-UMIN000031886
• Lead Sponsor: Tokyo Metropolitan Tama Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-01
• Study Completion: 2020-03-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Patients with active multiple primary cancers (simultaneous or metachronous with disease-free period within 5 years). (2) Patients who have a history of frequent laparotomy and are expected to have severe intraperitoneal adhesions. (3) Patients with a history of ICG hypersensitivity. (4) Patients with severe complications (liver disease, renal disease, heart disease, blood disease, metabolic disease). (5) Possible pregnancy or lactating female patients. (6) Patients undergoing continuous systemic administration (ingestion or intravenous) of corticosteroids. (7) Patients who are complicated of psychosis or psychiatric symptoms and judged to be difficult to participate in the exam. (8) Patients judged inappropriate for participation in this study by the research director.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative complication rate of Grade 2 or higher according to Clavien-Dindo classification.

Secondary Outcome Measures

Name	Time	Method
Completion rate of robot assisted gastrectomy, operation time, volume of blood loss, intraoperative complication rate of Grade 3 or higher according to CTCAE classification, Postoperative complication rate of Grade 3 or higher according to Clavien-Dindo classification, postoperative course evaluated by Inflammatory findings (WBC, CRP), body temperature, drain amylase value, number of days to post-operative flatus, postoperative hospital days), presence or absence of malignant tumor on dissected resected surface in pathological examination, number of excised lymph nodes.