NCT01441310

Brief Summary

There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer sentinel node mapping. The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 9, 2017

Status Verified

January 1, 2017

Enrollment Period

3.1 years

First QC Date

September 25, 2011

Last Update Submit

January 6, 2017

Conditions

Gastric Cancer

Keywords

Gastric cancerSentinel node navigation surgeryDual methodRecurrence

Outcome Measures

Primary Outcomes (1)

  • 3 Year disease free survival

    Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed.

    Postoperative 3 year

Secondary Outcomes (1)

  • Sentinel node detection rate, occurrence of complication ,Qualtity of life and remnant stomach function evaluation.

    postoperative 1, 3, 6, 12 month

Study Arms (1)

Laparoscopic sentinel node navigation surgery

EXPERIMENTAL

Laparoscopic sentinel node navigation surgery

Procedure: Laparoscopic sentinel node navigation surgery

Interventions

Laparoscopic sentinel node navigation surgeryPROCEDURE

Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections

Laparoscopic sentinel node navigation surgery

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-80
  • Informed consent
  • No other malignancies
  • cT1N0 stage gastric cancers \< 4cm
  • no allergic history of isotope

You may not qualify if:

  • Patients eligible for endoscopic submucosal dissection(ESD) with absolute indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Stomach NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hyung-Ho Kim, M.D.Ph.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

September 25, 2011

First Posted

September 27, 2011

Study Start

July 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2016

Last Updated

January 9, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)