Status:
UNKNOWN
Perfusion Rate Assessment by Near-infrared Fluorescence in Gastrointestinal Anastomoses
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Bowel Obstruction
Bowel Ischemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at two to three time po...
Detailed Description
Near-infrared-fluorescence by indocyanine green (ICG-NIRF) utilises the fluorescent property of intravenously injected indocyanine green (ICG) as an intravascular indicator of tissue and bowel perfusi...
Eligibility Criteria
Inclusion
- Age ≥ 18
- capability of signing informed consent
- diagnosis of malignancies of the upper gastrointestinal tract (GI), or malignancies of the lower GI, or malignancies of the hepatobiliary system, refractory ulcerative colitis, or Crohn's disease, or acute, inflammatory, degenerative functional or anatomical disorders
- Surgery possible and medically indicated to the diagnosis (esophageal resection, or subtotal or total gastrectomy, or Y-Roux reconstruction, or right or left colonic interposition, or small bowel segment resection, or ileocecal resection, or colectomy, or proctectomy with restorative ileoanal pouch (one or two-stage), or left or right hemicolectomy, or sigmoid resection, or rectal resection (deep anterior resection (TAR)), or proctectomy with colo-anal anastomosis, or abdominoperineal resection, or stoma closure, or pancreaticoduodenectomy
Exclusion
- liver disfunction (MELD score \> 10)
- ICG (indocyanine green) specific exclusion criteria as per literature (intolerance to indocyanine green or sodium iodide, iodine allergy, hyperthyroidism, autonomous thyroid adenoma, focal or diffuse autonomies of the thyroid, previously badly tolerated injection of ICG)
- pregnancy or breastfeeding
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04709445
Start Date
March 1 2020
End Date
December 1 2021
Last Update
January 14 2021
Active Locations (1)
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1
Charité Campus Benjamin Franklin
Berlin, Germany, 12203