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NCT01544413 Clinical Trial

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

Early Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01544413
Other study ID # SENORITA-2012
Secondary ID
Status Completed
Phase N/A
First received February 16, 2012
Last updated December 14, 2014
Start date February 2012
Est. completion date September 2014

Study information
Verified date December 2014
Source National Cancer Center, Korea
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 112
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
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 National Cancer Center, Korea Goyang Gyeonggi-do
Korea, Republic of Chonnam National University Hwasun Hospital Hwasun Chonnam
Korea, Republic of Gyeongsang National University Jinju Gyeongsangnam-do
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 Ajou University School of Medicine Suwon Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. within 24 hours after operation No
Secondary 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. upto 2 years No
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