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

December 14, 2014 updated by: Keun Won Ryu, National Cancer Center, Korea

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of
        • Hallym University Sacred Heart Hospital
      • Bucheon, Korea, Republic of
        • Soonchunhyang University Bucheon Hospital
      • Busan, Korea, Republic of
        • Dong-A University College of Medicine
      • Busan, Korea, Republic of
        • Dongnam Institute of Radiological and Medical Science
      • Daegu, Korea, Republic of
        • Keimyung University School of Medicine
      • Seoul, Korea, Republic of
        • Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Korea University College of Medicine
      • Seoul, Korea, Republic of
        • Yeouido St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Kyung Hee University Gangdong Hospital
      • Seoul, Korea, Republic of
        • Yonsei Univeristy College of Medicine
    • Chonnam
      • Hwasun, Chonnam, Korea, Republic of
        • Chonnam National University Hwasun Hospital
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center, Korea
      • Suwon, Gyeonggi-do, Korea, Republic of
        • Ajou University School of Medicine
    • Gyeongsangnam-do
      • Jinju, Gyeongsangnam-do, Korea, Republic of
        • Gyeongsang National University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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.
Other Names:
  • Tc 99m HSA (Frosstimage)
  • indocyanine green (IC-GREEN™ (Akorn))
  • laparoscopic probe (neoprobe® GDS gamma detection system)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completement of performance of laparoscopic sentinel lymph node biopsy
Time Frame: within 24 hours after operation
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
Time Frame: upto 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Keun Won Ryu, Doctor, National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 28, 2012

First Posted (Estimate)

March 5, 2012

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 14, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SENORITA-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Gastric Cancer

Clinical Trials on Laparoscopic sentinel lymph node biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe