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

NCT ID: NCT01544413

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-09-30

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.

Detailed Description

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Conditions

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Early Gastric Cancer

Keywords

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laparoscopic sentinel lymph node biopsy quality control study early gastric cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic sentinel lymph node biopsy

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.

Group Type EXPERIMENTAL

Laparoscopic sentinel lymph node biopsy

Intervention Type PROCEDURE

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.

Interventions

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Laparoscopic sentinel lymph node biopsy

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.

Intervention Type PROCEDURE

Other Intervention Names

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Tc 99m HSA (Frosstimage) indocyanine green (IC-GREENā„¢ (Akorn)) laparoscopic probe (neoprobeĀ® GDS gamma detection system)

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Keun Won Ryu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Keun Won Ryu, Doctor

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

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Chonnam National University Hwasun Hospital

Hwasun, Chonnam, South Korea

Site Status

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, South Korea

Site Status

Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Site Status

Gyeongsang National University

Jinju, Gyeongsangnam-do, South Korea

Site Status

Korea University Guro Hospital

Seoul, Seoul, South Korea

Site Status

Yonsei Univeristy College of Medicine

Seoul, Seoul, South Korea

Site Status

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status

Soonchunhyang University Bucheon Hospital

Bucheon-si, , South Korea

Site Status

Dong-A University College of Medicine

Busan, , South Korea

Site Status

Dongnam Institute of Radiological and Medical Science

Busan, , South Korea

Site Status

Keimyung University School of Medicine

Daegu, , South Korea

Site Status

Korea University College of Medicine

Seoul, , South Korea

Site Status

Kyung Hee University Gangdong Hospital

Seoul, , South Korea

Site Status

Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

Yeouido St. Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SENORITA-2012

Identifier Type: -

Identifier Source: org_study_id