Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

Gastric Cancer Clinical Trial

— SNNS  

Official title:

Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441310
• Other study ID #: SNUBHGS01
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2011
• Last updated: January 6, 2017
• Start date: July 2010
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 2016
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 Year disease free survival	Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed.	Postoperative 3 year	Yes
Secondary	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	postoperative 1, 3, 6, 12 month	Yes