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Robotic gastrectomy versus laparoscopic gastrectomy in patients with gastric cancer: A randomized Phase III trial

Robotic gastrectomy versus laparoscopic gastrectomy in patients with gastric cancer: A randomized Phase III trial - Robotic gastrectomy vs. laparoscopic gastrectomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031536
Enrollment
240
Registered
2018-03-01
Start date
2018-04-01
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

Resectable gastric cancer

Interventions

A: Laparoscopic gastrectomy with lymph node dissection B: Robotic gastrectomy with lymph node dissection

Sponsors

Second Department of Surgery, Wakayama Medical University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically proven gastric carcinoma 2) Resectable gastric cancer 3) Not applicable of ESD according to the Japanese classification 4) Excluding esophageal invasion (thoracic esophagus) or duodenal invasion (second portion) 5) Aged 20 to 90 year 6) PS (ECOG) 0 or 1 7) BMI < 35 8) No history of gastrointestinal surgery 9) No history of chemotherapy or radiotherapy 10) Normal function of the major organs; indicated by a leukocyte count of over 3000 mm3, a platelet count of over 100 000 mm3, aspartate aminotransferase and alanine aminotransferase levels less than 200 IU/L, total bilirubin less than 3 g/dl and creatinine levels less than 2 mg/dl. 11) Proven written informed consent

Exclusion criteria

Exclusion criteria: 1) Synchronous or metachronous malignancies other than carcinoma in situ 2) Pregnancy or breast-feeding 3) Severe mental disease 4) Continuous systemic steroid therapy 5) History of myocardial infarction or unstable angina pectoris within six months 6) Uncontrollable hypertension 7) Uncontrollable diabetes mellitus or administration of insulin 8) Respiratory disease requiring continuous oxygen therapy 9) History of deep vein thrombosis 10)Doctors decision not to register to this trial

Design outcomes

Primary

MeasureTime frame
Incidence of intra-abdominal infectious complications (pancreatic fistula, intra-abdominal abscess, and anastomotic leakage) with more than Clavien-Dindo grade 2

Secondary

MeasureTime frame
Incidence of postoperative complications, duration of surgery, blood loss, blood transfusion, time to first oral intake, length of stay, relapse-free survival, overall survival rate

Countries

Japan

Contacts

Public ContactToshiyasu Ojima

Wakayama Medical University, School of Medicine Second Department of Surgery

tojima@wakayama-med.ac.jp073-441-0613

Outcome results

None listed

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