Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

Study Overview
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Brief Summary
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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
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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)

Official Title
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Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Laparoscopic sentinel node navigation surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic sentinel node navigation surgery<br>Laparoscopic sentinel node navigation surgery | Procedure: Laparoscopic sentinel node navigation surgery<br>* Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 Year disease free survival | Recurrence evaluation by eddoscopy, computed tomography and Positron emission tomography if needed. | Postoperative 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric cancer, Sentinel node navigation surgery, Dual method, Recurrence