The Value of Subjective Near-infrared Fluorescence Guidance in Assessment of Perfusion During Restorative Ileal Pouch Formation and Ileal-pouch-anal Anastomosis
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- anastomotic leak
Study Overview
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 three time points during ileal pouch reconstruction. The intraoperative imaging findings are then analysed and correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak of the pouch.
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 perfusion.
The investigators hypothesise that ICG-NIRF is a suitable, reliable and precise method of visualisation of the blood supply and bowel perfusion in the area of ileal pouch formation and the ileal pouch-anal anastomosis.
In this prospective, non-randomized cohort study, restorative proctocolectomy with ileal pouch reconstruction and ileal pouch-anal anastomosis is performed according to standard of care for medically-refractory ulcerative colitis (UC), UC-associated neoplasia, medically-refractory Crohn´s colitis, colorectal carcinoma or familial adenomatous polyposis (FAP) in open or laparoscopic surgery, according to the surgeon's choice.
Written informed consent for participation and ICG-administration is obtained one day before surgery.
Intraoperatively, Indocyanine Green (VerDye, Diagnostic Green GmbH, Aschheim Germany, 25 mg vials) is dissolved in 5 mL sterile water to yield a 5 mg/mL concentration. It will then be administered intravenously at three consecutive time points as a bolus of 2 ml per time point at the most. The overall dose of ICG will amount to no more than 30mg of ICG per patient.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •capability of signing the informed consent
- •diagnosis of therapy resistent ulcerative colitis, colorectal cancer, Crohn's disease, familial adenomatous polyposis
- •restaurative proctocolectomy (RPC) with reconstruction through ileal pouch formation and ileal pouch-anal anastomosis (IPAA) is possible and medically indicated
- •ASA score ≤ 3
Exclusion Criteria
- •coexistent malignant tumor of a different ethology
- •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
Outcomes
Primary Outcomes
anastomotic leak
Time Frame: 30 days
occurrence of anastomotic leak within 30 days of surgery
Secondary Outcomes
- Operative and post-operative complications(30 days)
- Length of post-operative hospital stay(100 days)
Investigators
Benjamin Weixler
Attending Physician, Assistant Professor
Charite University, Berlin, Germany