Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy
Conditions
Gastric Cancer
Conditions: Keywords
near infrared, fluorescence imaging, indocyanine green, gastrectomy
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy
Type: Procedure
Overall Status
Recruiting
Summary
Lymph node dissection in gastric cancer surgery is a very important factor not only for exact acquisition of stage but also proper treatment. Realistically, it is impossible to identify complete removal of lymph node in dissected nodal station by naked eye. The investigators can assess the route of lymphatic drainage and identify residual lymph nodes in dissected area. In the field of gastric cancer treatment, ICG and near infra-red fluorescence imaging was used only detection of sentinel lymph nodes. However, this novel concept can help to understand lymphatic drainage and make surgeons to perform D1+ or D2 lymph node dissection completely.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- Males or Females, aged≥20 years and ≤80 years

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry

- American Society of Anesthesiologists (ASA) score of 1 to 3

- Histologically confirmed adenocarcinoma in stomach

- The patient has curatively resectable disease

- The patient has given their written informed consent to participate in the study

Exclusion Criteria:

- M1 status

- Experience of previous gastric resection

- Complication due to gastric cancer, such as complete obstruction or perforation

- History of anti-cancer therapy (chemotherapy or radiotherapy) for current gastric cancer

- History of surgery, chemotherapy or radiotherapy for primary carcinoma of other organ in 5 years
Location
Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine
Seoul, Korea, Republic of
Status: Recruiting
Contact: Woo Jin Hyung, MD - 82-2-2228-2100 - wjhyung@yuhs.ac
Start Date
August 2013
Completion Date
September 2014
Sponsors
Yonsei University
Source
Yonsei University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page