Phase II Study for Robot Assisted Distal Gastrectomy

NCT ID: NCT01504997

Last Updated: 2016-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Early Gastric Cancer

Keywords

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DaVinci Robot assisted surgery Gastrectomy Safety Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robot assisted distal gastrectomy

patients who received robot assisted distal gastrectomy

Group Type EXPERIMENTAL

Robot assisted distal gastrectomy (DaVinci)

Intervention Type DEVICE

patients who received robot assisted distal gastrectomy

Interventions

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Robot assisted distal gastrectomy (DaVinci)

patients who received robot assisted distal gastrectomy

Intervention Type DEVICE

Other Intervention Names

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DaVinci

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shizuoka Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Masanori Terashima

Head of Gastric Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Masanori Terashima, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Division of Gastric Surgery, Shizuoka Cancer Center

Locations

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Shizuoka Cancer Center

Shizuoka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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UMIN000006910

Identifier Type: OTHER

Identifier Source: secondary_id

DaVinci_SCC

Identifier Type: -

Identifier Source: org_study_id