Phase II Study for Robot Assisted Distal Gastrectomy (RADGphaseII)

Shizuoka Cancer Center

Status and phase: Unknown; Phase 2

Conditions: Early Gastric Cancer

Treatments: Device: Robot assisted distal gastrectomy (DaVinci)

Study type: Interventional

Funder types: Other

Identifiers

NCT01504997

DaVinci_SCC

UMIN000006910 (Other Identifier)

Details and patient eligibility

About

The aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph node dissection in patients with stage Ia early gastric cancer.

Enrollment: 23 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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. Eastern clinical oncology group performance status is 0 or 1
7. Body mass index is lower than 30
8. No prior laparotomy
9. No prior 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

1. Having other active cancers
2. Possibly pregnant, or breast feeding woman
3. with psychiatric disorder
4. Receiving steroids
5. With Acute myocardial infarction in 6 months or with unstable angina
6. With uncontrolled hypertension
7. With uncontrolled diabetes mellitus
8. With pulmonary disease which require continuous oxygen therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

23 participants in 1 patient group

Robot assisted distal gastrectomy

Experimental group

Description:

patients who received robot assisted distal gastrectomy

Treatment:

Device: Robot assisted distal gastrectomy (DaVinci)