NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041220017

Registered date:18/05/2022

Evaluation of the efficacy and safety of ICG Fluorescence navigation surgery

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedgastric cancer/ esophageal cancer
Date of first enrollment29/07/2022
Target sample size310
Countries of recruitment
Study typeInterventional
Intervention(s)A small volume of the dilluted ICG solution was injected into submucosa using gastrointesitinal endoscopy

Outcome(s)

Primary OutcomeEvaluate the number of lymph node dissections
Secondary OutcomeOperative time, amount of blood loss, organ damage, adverse events

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1 Patients who were diagnosed with gastric cancer or esophageal cancer(StageI-III) 2 Over 20 years old 3 Patients determined to be ready for general anesthesia and surgery 4 Performance Status (ECOG) 0 or 1 5 Objective procedure: Thoracoscopic esophagectomy, laparoscopic gastrectomy (including robot-assisted surgery) 6 Historical control: Patients who received surgery in Kanazawa University Hospital from January 2018 to October 2021(StageI-III) 7 Patients for whom informed consents were taken
Exclude criteria1 History of hypersensitivity to ICG 2 Hypersensitivity to iodine 3History of asthma or drug allergy 4 Judged to be difficult to participate in the study because of mental disorder 5 Inappropriate case determined by the principal invstigator/researcher

Related Information

Contact

Public contact
Name Toshikatsu Tsuji
Address 13-1 Takara-machi, Kanazawa, Ishikawa 920-8641 , Japan Ishikawa Japan 920-8641
Telephone +81-76-265-2000
E-mail toshi_toshi25@yahoo.co.jp
Affiliation Department of Gastrointestinal Surgery, Kanazawa University Hospital
Scientific contact
Name Noriyuki Inaki
Address 13-1 Takara-machi, Kanazawa, Ishikawa 920-8641 , Japan. Ishikawa Japan 920-8641
Telephone +81-76-265-2000
E-mail n.inaki@med.kanazawa-u.ac.jp
Affiliation Department of Gastrointestinal Surgery, Kanazawa University Hospital