Phase II Study for Robot Assisted Distal Gastrectomy

NCT01504997 | Unknown Phase 2 Results DMC

• 2 other identifiers: DaVinci_SCCUMIN000006910
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Gastric Cancer

Keywords

DaVinci; Robot assisted surgery; Gastrectomy; Safety; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• The Incidence of Post-operative Intra-abdominal Infectious Complications

  Participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary Outcomes (4)

• Overall Survival

  5 years

• Relapse Free Survival

  5 years

• Completion Rate of Robot Assisted Surgery

  During the surgery, an expected average of 5 hours

• Incidence of Adverse Events

  Participants will be followed for the duration of hospital stay, an expected average of 10 days

Study Arms (1)

Robot assisted distal gastrectomy

EXPERIMENTAL

patients who received robot assisted distal gastrectomy

Device: Robot assisted distal gastrectomy (DaVinci)

Interventions

Robot assisted distal gastrectomy (DaVinci) DEVICE

patients who received robot assisted distal gastrectomy

Also known as: DaVinci

Robot assisted distal gastrectomy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy specimen from the primary lesion shows adenocarcinoma
• Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography
• Endoscopic submucosal dissection is not indicated
• Tumor was located within lower two thirds of stomach
• Not having duodenal invasion
• Eastern clinical oncology group performance status is 0 or 1
• Body mass index is lower than 30
• No prior laparotomy
• No prior chemotherapy or radiation including those for other cancers
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shizuoka Cancer Center: lead

Study Sites (1)

Shizuoka Cancer Center

Shizuoka, 411-0934, Japan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Results Point of Contact

• Title: Doctor Masanori Tokunaga
• Organization: Shizuoka Cancer Center

m.tokunaga@scchr.jp

81-55098908777

Study Officials

• Masanori Terashima, M.D., Ph.D.

  Division of Gastric Surgery, Shizuoka Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastric Surgery

Study Record Dates

• First Submitted: December 30, 2011
• First Posted: January 6, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2017
• Last Updated: November 29, 2016
• Results First Posted: May 25, 2016

Record last verified: 2016-10

Locations

JP (1)