Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: Laparoscopic sentinel node navigation surgery

• Registration Number: NCT01441310
• Lead Sponsor: Seoul National University Bundang Hospital

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:

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)

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-09-25
• Study First Submitted QC: 2011-09-25
• Study First Posted: 2011-09-27
• Primary Completion: 2013-08
• Study Completion: 2016-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic sentinel node navigation surgery	Laparoscopic sentinel node navigation surgery	Laparoscopic sentinel node navigation surgery

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of