Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2013

Detailed Description

Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early gastric cancer.

Laparoscopic SNNS:

1. ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative endoscopy

2. Sentinel node basin identification and dissection

3. Sentinel nodes picking in back table

4. Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry for cytokeratin)

5. 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)

Interventions

  • Procedure: Laparoscopic sentinel node navigation surgery
    • Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections

Arms, Groups and Cohorts

  • Experimental: Laparoscopic sentinel node navigation surgery
    • Laparoscopic sentinel node navigation surgery

Clinical Trial Outcome Measures

Primary Measures

  • 3 Year disease free survival
    • Time Frame: Postoperative 3 year
    • Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed.

Secondary Measures

  • Sentinel node detection rate, occurrence of complication ,Qualtity of life and remnant stomach function evaluation.
    • Time Frame: postoperative 1, 3, 6, 12 month
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Bundang Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hyung-Ho Kim, Principal Investigator – Seoul National University Bundang Hospital
  • Overall Official(s)
    • Hyung-Ho Kim, M.D.Ph.D., Principal Investigator, Seoul National University Bundang Hospital

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