Clinical trial NCT01544413: 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
Overall status: COMPLETED
Phase: NA
Conditions: Early Gastric Cancer
Keywords: laparoscopic sentinel lymph node biopsy
quality control study
early gastric cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2012-03-05
Enrollment: 112
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Completement of performance of laparoscopic sentinel lymph node biopsy
timeFrame: within 24 hours after operation
Secondary outcomes:
measure: Detection rate of laparoscopic sentinel lymph node, learning curve
timeFrame: upto 2 years
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Chonnam
city: Goyang
country: Korea, Republic of
facility: National Cancer Center, Korea
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
state: Gyeonggi-do
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University
state: Gyeongsangnam-do
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University College of Medicine
city: Busan
country: Korea, Republic of
facility: Dongnam Institute of Radiological and Medical Science
city: Daegu
country: Korea, Republic of
facility: Keimyung University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Korea University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Gangdong Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yeouido St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei Univeristy College of Medicine
Study officials:
affiliation: National Cancer Center, Korea
name: Keun Won Ryu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: