Phase II Study for Robot Assisted Distal Gastrectomy

Early Gastric Cancer Clinical Trial

— RADGphaseII  

Official title:

A Phase II Study of Robot Assisted Distal Gastrectomy With Nodal Dissection for Clinical Stage Ia Gastric Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01504997
• Other study ID #: DaVinci_SCC
• Secondary ID: UMIN000006910
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 30, 2011
• Last updated: January 9, 2013
• Start date: December 2011
• Est. completion date: December 2017

Study information

• Verified date: January 2013
• Source: Shizuoka Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: December 2017
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

Intervention

Device:
• Robot assisted distal gastrectomy (DaVinci)
patients who received robot assisted distal gastrectomy

Locations

Country	Name	City	State
Japan	Shizuoka Cancer Center	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Shizuoka Cancer Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of post-operative intra-abdominal infectious complications		Participants will be followed for the duratin of hospital stay, an expected average of 10 days	Yes
Secondary	Overall survival		5 years	No
Secondary	Relapse free survival		5 years	No
Secondary	Completion rate of robot assisted surgery		During the surgery, an expected average of 5 hours	No
Secondary	Incidence of adverse events		Participants will be followed for the duration of hospital stay, an expected average of 10 days	Yes