Subjective Near-infrared Fluorescence Guidance in Perfusion Assessment of Ileal Pouch Formation and Ileal-pouch-anal Anastomosis
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|ClinicalTrials.gov Identifier: NCT04695184|
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Colorectal Cancer Crohn Disease Familial Adenomatous Polyposis Crohn Colitis Ileal Pouch||Diagnostic Test: ICG-NIRF Imaging||Not Applicable|
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.
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.
Clinical data and follow-up Clinical data is 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.
Subjective data analysis will performed using Microsoft Excel® and IBM SPSS®.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a non randomised prospective cohort study design.|
|Masking:||None (Open Label)|
|Official Title:||The Value of Subjective Near-infrared Fluorescence Guidance in Assessment of Perfusion During Restorative Ileal Pouch Formation and Ileal-pouch-anal Anastomosis|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
ICG-NIRF imaging is used intraoperatively to visualise precisely the blood supply and bowel perfusion rate in the area of ileal pouch formation and the ileal pouch-anal anastomosis.
Diagnostic Test: ICG-NIRF Imaging
intraoperative NIRF Imaging using the fluorescence agent ICG (indocyanine-green) at regions of interest before (T1) + after pouch construction (T2) + after ileoanal anastomosis (T3)
- anastomotic leak [ Time Frame: 30 days ]occurrence of anastomotic leak within 30 days of surgery
- Operative and post-operative complications [ Time Frame: 30 days ]Clavien-Dindo for complication-level classification
- Length of post-operative hospital stay [ Time Frame: 100 days ]length in days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04695184
|Contact: Benjamin Weixler, MD PD||+49 30 450 622 email@example.com|
|Contact: Leonard Lobbes, MD||+49 30 450 622 firstname.lastname@example.org|