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A phase II study of robot assisted distal and total gastrectomy with nodal dissection for clinical stage IA and IB gastric cancer

A phase II study of robot assisted distal and total gastrectomy with nodal dissection for clinical stage IA and IB gastric cancer - RDG phase II

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013860
Enrollment
42
Registered
2014-05-01
Start date
2014-05-22
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

Patients with Stage IA and IB gastric cancer

Interventions

Sponsors

Saitama Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Biopsy specimen from the primary lesion shows adenocarcinoma 2) Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography 3) Endoscopic submucosal dissection is not indicated 4) Tumor was located within lower two thirds of stomach 5) Not having duodenal invasion 6) Eeatern clinical oncology group performans status is 0 or 1 7) Body mass index is lower than 30 8) No previous laparotomy 9) No previous chemotherapy or radiation including those for other cancers 10) Fulfil all following conditions WBC > 3,000/mm3 Plt > 100,000/mm3 AST < 100 IU/L ALT < 100IU/L T.Bil < 2.0 g/dl Cre < 1.5mg/dl

Exclusion criteria

Exclusion criteria: 1) Having other active cancers 2) Possibly pregnant, or breast feeding woman 3) with psychiatric disorder 4) Receiving steroids 5) With Acute myocardial infaction in 6 months or with unstable ungina 6) With uncontrolled hypertention 7) With uncontrolled diabetes mellitus 8) With pulmonary disease and require continuous oxygen therapy

Design outcomes

Primary

MeasureTime frame
The incidence of post-operative intra-abdominal infectious complications (anastomotic leakage, pancreas related infection, and intra-abdominal abscess)

Secondary

MeasureTime frame
Oveall survival Relapse free survival Completion rate of robot assised surgery The incidence of adverse event

Countries

Japan

Contacts

Public ContactEhara Kazuhisa

Saitama Cancer Center Division of Gastric Surgery

kehara@cancer-c.pref.saitama.jp048-722-1111

Outcome results

None listed

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