Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01926743

Enrollment

Registered

2013-08-21

Start date

2013-08-01

Completion date

2014-01-31

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

near infrared, fluorescence imaging, indocyanine green, gastrectomy

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.

Interventions

PROCEDURENear infrared fluorescence imaging during laparoscopic or robotic gastrectomy

0.75mg of ICG injection around tumor each four direction by endoscopy on one or two days before surgery. NIR fluorescence imaging application during laparoscopic or robotic gastrectomy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To compare the number of retrieved lymph node in each nodal station after additional application of near infra-red fluorescence imaging	About 7 days after operation when pathologic result was reported

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026