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JOURNAL ONKOLOGIE – STUDIE

Objective Perfusion Rate Assessment by Near-infrared Fluorescence in Ileal Pouch Formation and Ileal-pouch-anal Anastomosis

Rekrutierend

NCT-Nummer:
NCT04695964

Studienbeginn:
Februar 2019

Letztes Update:
15.01.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Adenomatous Polyposis Coli, Crohn Disease, Colitis, Colitis, Ulcerative, Ulcer

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Charite University, Berlin, Germany

Collaborator:
-

Kontakt

Studienlocations
(1 von 1)

Charité Campus Benjamin Franklin
12203 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Benjamin Weixler, MD PD
Phone: +49 30 450 622798
E-Mail: benjamin.weixler@charite.de

Leonard Lobbes, MD
Phone: +49 30 450 622789
E-Mail: leonard.lobbes@charite.de
» Ansprechpartner anzeigen

Studien-Informationen

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 (ICG, 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.

Real-time intraoperative visualization is performed with the SpectrumTM Fluorescence Imaging

Platform (Quest Innovations, Middenmeer, The Netherlands) directly after each ICG injection

assessing bowel perfusion at three different time points respectively: before and after

J-Pouch construction by stapler anastomosis and after ileoanal anastomosis formation.

Postoperative NIRF-perfusion rate assessment Using the Quest Research SoftwareTM, the

recordings before and after anastomosis formation will be analysed for their perfusion rate.

This analysis will provide objective, quantitative data on the perfusion for a certain time

frame which is determined by the length of the video recording. This data will be collected

for statistical analysis and correlation with anastomotic leak as well as postoperative

outcome.

Clinical data and follow-up Clinical data will be collected from all patients regarding

anastomotic leak, bowel ischemia and necrosis as well as 30 day postoperative morbidity,

mortality and length and cost of hospital stay.

Further data analysis will be performed using Microsoft Excel® and IBM SPSS®.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- age ≥ 18

- capability of signing the informed consent

- diagnosis of therapy resistent ulcerative colitis, colorectal cancer, Crohn's disease,

familial adenomatous polyposis

- restorative proctocolectomy (RPC) with reconstruction through ileal pouch formation

and ileal pouch-anal anastomosis (IPAA) is possible and medically indicated

- ASA (American Society of Anesthesiologists) Physical Status Classification System

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

Studien-Rationale

Primary outcome:

1. anastomotic leak (Time Frame - 30 days):
occurence anastomotic leak within 30 days of operation



Secondary outcome:

1. Operative and post-operative complications (Time Frame - 30 days):
Clavien-Dindo for complication-level classification

2. Length of post-operative hospital stay (Time Frame - 100 days):
length in days

Geprüfte Regime

  • ICG-NIRF Imaging plus ingress and egress analysis:
    intraoperative NIRF Imaging using the fluorescence agent ICG (indocyanine-green) at regions of interest before (T1) + after pouch construction (T2) + after ileoanal anastomosis (T3) Additional ingress and egress analysis (inflow and outflow analysis) of specificities regions of interest at regions of interest before (T1) + after pouch construction (T2) + after ileoanal anastomosis (T3)

Quelle: ClinicalTrials.gov


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