Quality Control Study of Laparoscopic Sentinel Node Biopsy in Early Gastric Cancer

Study Overview
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Brief Summary
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Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric cancer is less invasive method which can increase quality of life. Multicenter phase III trial is requred to validate this method. In this study all items which are necessary for laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated the performance completement.

Official Title
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Quality Control Study for Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer

Conditions
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Early Gastric Cancer

Intervention / Treatment
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* Procedure: Laparoscopic sentinel lymph node biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gastric adenocarcinoma in preoperative endoscopic biopsy clinical stage T1-2N0 long diameter of tumor <4cm distance between tumor and pylorus or cardia >2cm age: 20-80 ECOG: 1 or 0 patients will undergo laparoscopic gastrectomy Exclusion Criteria: definite criteria of endoscopic submucosal dissection (size<2cm, differentiated type, no ulcer) no indication for surgery for cardiovascular, pulmonary disease pregancy drug allergy or previous abdominal surgery, radiotherpy

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 lymph node biopsy<br>This is a single armed study. After endoscopic marking using Tc99m HSA and indocyanine green fluid, Laparoscopic sentinel lymph node biopsy was performed and evalute at backtable. | Procedure: Laparoscopic sentinel lymph node biopsy<br>* During the operation, endoscopic marking was perfomed using Tc 99m HSA and indocyanine green around tumor. Then we identify the sentinel lymph node with laparoscopic probe. Laparoscopic sentinel lymph nodes were dissedted and evaluated them at the backtable in the operating room.<br>* Other names: laparoscopic probe (neoprobe® GDS gamma detection system);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completement of performance of laparoscopic sentinel lymph node biopsy | Investigators will make out a checklist after operation for evaluating the completement of performance of laparoscopic sentinel lymph node biopsy. The checklist will be made out within 24 hours. | within 24 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of laparoscopic sentinel lymph node, learning curve | Detection rate of laparoscopic sentinel lymph node is evaluated within 7 days after operation by pathological examination. Learning curve can be drawn after all cases' data are collected, so it takes upto 2 years. | upto 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic sentinel lymph node biopsy, quality control study, early gastric cancer