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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Keun Won Ryu, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01544413
First received: February 16, 2012
Last updated: December 14, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Early Gastric Cancer
Procedure: Laparoscopic sentinel lymph node biopsy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Quality Control Study for Multicenter Phase III Trial of Laparoscopic Sentinel Node Biopsy and Stomach Preserving Surgery in Early Gastric Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Completement of performance of laparoscopic sentinel lymph node biopsy [ Time Frame: within 24 hours after operation ] [ Designated as safety issue: No ]
    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 [ Time Frame: upto 2 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 112
Study Start Date: February 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544413

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasun, Chonnam, Korea, Republic of
National Cancer Center, Korea
Goyang, Gyeonggi-do, Korea, Republic of, 410-769
Ajou University School of Medicine
Suwon, Gyeonggi-do, Korea, Republic of
Gyeongsang National University
Jinju, Gyeongsangnam-do, Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Dong-A University College of Medicine
Busan, Korea, Republic of
Dongnam Institute of Radiological and Medical Science
Busan, Korea, Republic of
Keimyung University School of Medicine
Daegu, Korea, Republic of
Korea University College of Medicine
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Kyung Hee University Gangdong Hospital
Seoul, Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Yeouido St. Mary's Hospital
Seoul, Korea, Republic of
Yonsei Univeristy College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Keun Won Ryu, Doctor National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Keun Won Ryu, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01544413     History of Changes
Other Study ID Numbers: SENORITA-2012
Study First Received: February 16, 2012
Last Updated: December 14, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by National Cancer Center, Korea:
laparoscopic sentinel lymph node biopsy
quality control study
early gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on August 31, 2015