Clinical trial NCT01926743: Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: near infrared
fluorescence imaging
indocyanine green
gastrectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 40
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: 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.


Eligibility criteria: Inclusion Criteria:

1. Males or Females, aged≥20 years and ≤80 years
2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry
3. American Society of Anesthesiolosists (ASA) score of 1 to 3
4. Histologically confirmed adenocarcinoma in stomach
5. Clinical stage I (T1N0M0, T2N0M0, T1N1M0)

5. The patient has curatively resectable disease 6. The patient has given their written informed consent to participate in the study

Exclusion Criteria:

1. M1 status
2. Experience of previous gastric resection
3. Complication due to gastric cancer, such as complete obstruction or perforation
4. History of anti-cancer therapy (chemotherapy or radiotherapy) for current gastric cancer
5. History of surgery, chemotherapy or radiotherapy for primary carcinoma of other organ in 5 years

Primary outcomes:
measure: To compare the number of retrieved lymph node in each nodal station after additional application of near infra-red fluorescence imaging
timeFrame: About 7 days after operation when pathologic result was reported
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine
Study officials:
References:
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