JPRN-jRCTs031200195Completed未知
Evaluation of intraoperative localization by indocyanine green (ICG) injection for laparoscopic colorectal cancer surgery -Single-center prospective study
SHIGEKI YAMAGUCHI0 sites38 target enrollmentStarted: November 11, 2020Last updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 38
Study Overview
Brief Summary
ICG injection is a useful tool for determining tumor localization. Since no adverse events were observed, it is considered a safe method for intraoperative tumor localization diagnosis.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- > 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1. Patients who are hospitalized or hospitalized for department of surgery, institute of gastroenterology, Tokyo Women's Medical University.
- •2. Men and women over the age of 20 at the time of obtaining consent.
- •3. Patients diagnosed with colon cancer and rectal cancer.
- •4. Patients scheduled for laparoscopic or robot-assisted surgery for colon cancer and rectal cancer
- •5. Patients who can undergo lower gastrointestinal endoscopy and local injection 2-3 days before surgery
- •6. Patients who have a thorough understanding after receiving a sufficient explanation for participation in this study and have the free written consent of the patient.
- •7. For all inspection items, use the latest inspection values within 56 days before registration. Inspection on the same day 8 weeks before the registration date is allowed. )
- •A) White blood cell count 3,000 /mm3 or less
- •B) Platelet count100,000 /mm3 or less
- •C) AST 100 IU/L or more, ALT 100 IU/L or more
- •D) Total bilirubin2.0 g/dl ore more
- •E) Serum creatinine1.5 mg/dl or more
Exclusion Criteria
- •1. Patients with iodine and ICG allergies.
- •2. Cases of emergency surgery, cases of severe stenosis, cases of colonic stent placement, and cases judged to be in poor general condition by the principal investigator are excluded.
- •3. Patients who are judged to be inappropriate by the principal investigator.
Investigators
Similar Trials
Active, not recruiting
Phase 1
Study to observe where we will find Indocyanine Green (ICG) in the cancerous tissues from patients with peritoneal carcinomatosis from colorectal cancer, after intravenous injection of ICG.EUCTR2014-003512-37-BEJules Bordet Institute
Not yet recruiting
Phase 4
Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic LeaksLymphoceleProstate CancerNCT06258486Kaiser Permanente100
Active, not recruiting
Not Applicable
Study of the possibility to visualize and define margins of breast tumours with a near-infrared camera thanks to the IV injection of Indocyanine Green, a fluorescent molecule.imaging of tumours and their margins after intravenous injection of Indocyanine Green to breast cancer patientsEUCTR2013-004496-12-BEInstitut Jules Bordet
Recruiting
Phase 2
Intraoperative Tumor Margin Identification With ICG Dye ImagingBenign NeoplasmMalignant NeoplasmNCT04752137Massachusetts General Hospital100
Completed
Phase 2
Study of the ICG Distribution in the Margins of Breast Cancer After TumorectomyBreast CancerNCT02027818Jules Bordet Institute20