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Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer (SNNS)

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laparoscopic sentinel node navigation surgery
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Sentinel node navigation surgery, Dual method, Recurrence

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laparoscopic sentinel node navigation surgery

Arm Description

Laparoscopic sentinel node navigation surgery

Outcomes

Primary Outcome Measures

3 Year disease free survival
Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed.

Secondary Outcome Measures

Sentinel node detection rate, occurrence of complication ,Qualtity of life and remnant stomach function evaluation.
Sentinel node detection rate and occurrence of complication of SNNS using dual method for gastric cancer were evaluated QoL questennaire and remnant stomach function were evaluated for the evaluation of patient's quality of life

Full Information

First Posted
September 25, 2011
Last Updated
January 6, 2017
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01441310
Brief Title
Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer
Acronym
SNNS
Official Title
Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early gastric cancer. Laparoscopic SNNS: ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative endoscopy Sentinel node basin identification and dissection Sentinel nodes picking in back table Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry for cytokeratin) If the sentinel node biopsy by frozen section is negative, limited gastrectomy will be performed or if positive, radical D2 gastrectomy will be performed. Sample size: 100 cases Study duration: 5 years( 2year enrollment, 3 year follow-up)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric cancer, Sentinel node navigation surgery, Dual method, Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic sentinel node navigation surgery
Arm Type
Experimental
Arm Description
Laparoscopic sentinel node navigation surgery
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sentinel node navigation surgery
Intervention Description
Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections
Primary Outcome Measure Information:
Title
3 Year disease free survival
Description
Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed.
Time Frame
Postoperative 3 year
Secondary Outcome Measure Information:
Title
Sentinel node detection rate, occurrence of complication ,Qualtity of life and remnant stomach function evaluation.
Description
Sentinel node detection rate and occurrence of complication of SNNS using dual method for gastric cancer were evaluated QoL questennaire and remnant stomach function were evaluated for the evaluation of patient's quality of life
Time Frame
postoperative 1, 3, 6, 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20-80 Informed consent No other malignancies cT1N0 stage gastric cancers < 4cm no allergic history of isotope Exclusion Criteria: Patients eligible for endoscopic submucosal dissection(ESD) with absolute indication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyung-Ho Kim, M.D.Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

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