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Prospective cohort study on the safety and effectiveness of robot-assisted laparoscopic gastrectomy and laparoscopic gastrectomy in gastric cancer patients.

Prospective cohort study on the safety and effectiveness of robot-assisted laparoscopic gastrectomy and laparoscopic gastrectomy in gastric cancer patients. - Prospective cohort study on the safety and effectiveness of RAG and LAG in gastric cancer patients.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000052213
Enrollment
500
Registered
2023-09-16
Start date
2019-03-06
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

None listed

Sponsors

Osaka International Cancer Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Gastric cancer was diagnosed by histological examination of an endoscopic biopsy specimen. 2) The lesion does not meet the indication of endoscopic resection but surgical resection. 3) The tumor has been diagnosed as potentially resectable by comprehensive diagnosis using endoscopy and preoperative imaging (endoscopy or abdominal/pelvic CT). 4) The age of subjects are over 20 years old. 5) ECOG-PS is 0, 1, or 2. 6) All of the following conditions are met. (All test items are used the latest test values taken within 56 days before registration. Testing on the same day of the week 8 weeks before the registration date is acceptable.) 1. White blood cell count >=3,000/mm3 2. Platelet count >=100,000/mm3 3. AST<=100IU/L, ALT<=100IU/L 4. Total bilirubin <=2.0 g/dl 5. Serum creatinine <=1.5mg/dl 6. Written consent has been obtained from the subject to participate in the study.

Exclusion criteria

Exclusion criteria: 1) Subjects with distant metastasis to other organs or peritoneal dissemination 2) Subjects who have previously undergone intra-abdominal surgery for other diseases and are expected to have severe adhesions. 3) The subjects have active multiple cancers (synchronous multiple cancers and metachronous multiple cancers with a disease-free period of 5 years or less). However, the lesions equivalent to carcinoma in situ (carcinoma in situ) or intramucosal cancer that can be cured by local treatment are not included in active double cancer. 4) Women who may be pregnant or are breastfeeding. 5) Subjects with mental illness or psychiatric symptoms . 6) Subjects receiving continuous systemic administration of steroids (orally or intravenously). 7) History of myocardial infarction within 6 months or unstable angina. 8) Concomitant with poorly controlled hypertension. 9) Currently being treated with insulin or having uncontrolled diabetes. 10) Subjects have a respiratory disease that requires continuous oxygen administration. 11) Other patients deemed unsuitable as subjects by the research director

Design outcomes

Primary

MeasureTime frame
Total complication rate

Secondary

MeasureTime frame
Completion rate of the robotassisted laparoscopic or laparoscopic gastrectmy, operative time, blood loss, number of lymph nodes dissected, length of postoperative hospital stay, postoperative pain evaluated by VAS, medical costs, relase free survival , overall survival

Countries

Japan

Contacts

Public ContactNaoki Shinno

Osaka International Cancer Institute Division of gastroenterological surgery

naoki.shinno@oici.jp0669451181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026