Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer (SNNS)

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Procedure: Laparoscopic sentinel node navigation surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01441310

SNUBHGS01

Details and patient eligibility

About

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.

Full 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)

Enrollment: 101 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

Laparoscopic sentinel node navigation surgery

Experimental group

Description:

Laparoscopic sentinel node navigation surgery

Treatment:

Procedure: Laparoscopic sentinel node navigation surgery