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

National Cancer Center, Korea112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Early Gastric Cancer

Interventions

Laparoscopic sentinel lymph node biopsyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (15)

Chonnam National University Hwasun Hospital

Hwasun, Chonnam, South Korea

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Ajou University School of Medicine

Outcomes

Primary Outcomes

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.

Time frame: within 24 hours after operation

Secondary Outcomes

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.

Time frame: upto 2 years

Data from ClinicalTrials.gov

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