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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Yonsei University Health System, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Anesthesiolosists (ASA) score of 1 to 3
Histologically confirmed adenocarcinoma in stomach
Clinical stage I (T1N0M0, T2N0M0, T1N1M0)

The patient has curatively resectable disease 6. 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

Treatment and study plan

Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy

Procedure

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

Primary outcomes

To compare the number of retrieved lymph node in each nodal station after additional application of near infra-red fluorescence imaging

Time frame: About 7 days after operation when pathologic result was reported

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Aug 21, 2013
Registry last updated: Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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