search
Back to results

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

Primary Purpose

Early Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Laparoscopic sentinel lymph node biopsy
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Gastric Cancer focused on measuring laparoscopic sentinel lymph node biopsy, quality control study, early gastric cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonnam National University Hwasun Hospital
  • National Cancer Center, Korea
  • Ajou University School of Medicine
  • Gyeongsang National University
  • Hallym University Sacred Heart Hospital
  • Soonchunhyang University Bucheon Hospital
  • Dong-A University College of Medicine
  • Dongnam Institute of Radiological and Medical Science
  • Keimyung University School of Medicine
  • Korea University College of Medicine
  • Korea University Guro Hospital
  • Kyung Hee University Gangdong Hospital
  • Seoul St. Mary's Hospital
  • Yeouido St. Mary's Hospital
  • Yonsei Univeristy College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Laparoscopic sentinel lymph node biopsy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 16, 2012
Last Updated
December 14, 2014
Sponsor
National Cancer Center, Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT01544413
Brief Title
Quality Control Study of Laparoscopic Sentinel Node Biopsy in Early Gastric Cancer
Official Title
Quality Control Study for Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Gastric Cancer
Keywords
laparoscopic sentinel lymph node biopsy, quality control study, early gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic sentinel lymph node biopsy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic sentinel lymph node biopsy
Other Intervention Name(s)
Tc 99m HSA (Frosstimage), indocyanine green (IC-GREEN™ (Akorn)), laparoscopic probe (neoprobe® GDS gamma detection system)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completement of performance of laparoscopic sentinel lymph node biopsy
Description
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 Outcome Measure Information:
Title
Detection rate of laparoscopic sentinel lymph node, learning curve
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keun Won Ryu, Doctor
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Chonnam
Country
Korea, Republic of
Facility Name
National Cancer Center, Korea
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Ajou University School of Medicine
City
Suwon
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Gyeongsang National University
City
Jinju
State/Province
Gyeongsangnam-do
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
Country
Korea, Republic of
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Dong-A University College of Medicine
City
Busan
Country
Korea, Republic of
Facility Name
Dongnam Institute of Radiological and Medical Science
City
Busan
Country
Korea, Republic of
Facility Name
Keimyung University School of Medicine
City
Daegu
Country
Korea, Republic of
Facility Name
Korea University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Gangdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yeouido St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei Univeristy College of Medicine
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs