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A Phase II study of robot assisted laparoscopic distal gastrectomy for clinical stage IA gastric cancer

A Phase II study of robot assisted laparoscopic distal gastrectomy for clinical stage IA gastric cancer - A Phase II study of robot assisted gastrectomy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016496
Enrollment
25
Registered
2015-02-10
Start date
2015-02-13
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 with cStage IA

Interventions

Robot assisted laparoscopic distal gastrectomy

Sponsors

Kitasato University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically proven gastric adenocarcinoma 2) Diagnosed as cStageIA(T1N0) by endoscopy and contrast enhanced CT 3) Not applicable for endoscopic submucosal dissection 4) Regarded as curatively resected by distal gastrectomy with tumor location being M, L, ML, or LM 5) Performance status of 0 or 1 6) Body Mass Index of less than 30 7) No prior surgery in the upper abdomen 8) No prior chemotherapy or radiation therapy for cancers including gastric cancer 9) Informed consent obtained from the patient

Exclusion criteria

Exclusion criteria: 1) Active mutiple primary cancers (carcinoma in situ or mucosal cancer were not included in active cancers) 2) Being pregnant or brestfeeding 3) Continuous steroid use (oral or intravenous) 4) With myocardial infarction in 6 months or with unstable angina 5) With uncontrollable hypertension 6) With uncontrollable diabetes mellitus 7) With respiratory disorder requiring continuous oxgen therapy

Design outcomes

Primary

MeasureTime frame
Incidence rate of intra-abdominal complications requiring treatment (postoperative bleeding, anastomotic leakage, intraabdominal abscess, pancreatic fistula)

Secondary

MeasureTime frame
Overall survival, Relapse-free survival, Completion rate of robot assisted laparoscopic surgery, Proportion of open conversion, Short-term postoperative course

Countries

Japan

Contacts

Public ContactKei Hosoda

Kitasato University Department of surgery

k.hosoda@kitasato-u.ac.jp042-778-8111

Outcome results

None listed

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