Clinical trial NCT04712032: Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates
Official title: A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colo-rectal Cancer
Crohn Disease
Resectable Colorectal Carcinoma
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Medical Center Haaglanden
name: Catharina Ziekenhuis Eindhoven
name: Haga Hospital
name: Jeroen Bosch Ziekenhuis
name: Amphia Hospital
name: Alrijne Hospital
name: IJsselland
First posted: 2021-01-15
Enrollment: 978
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: National randomized controlled trial.
Primary purpose: PREVENTION

Brief summary: Anastomotic leakage (AL) is one of the major complications after gastrointestinal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Indocyanine green (ICG) combined with fluorescent near infrared imaging has proven to be a feasible and reproducible application for real-time intraoperative quantification of the tissue perfusion and cohort studies showed reduced leakage rate. Unfortunately, these studies were not randomized. Therefore, we propose a nationwide randomized controlled trial to identify the value of ICG for AL in colorectal anastomosis.


Eligibility criteria: Inclusion Criteria:

1. Scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis;
2. Patients aged over 18 years old;
3. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;
4. Signed informed consent prior to any study-mandated procedure;

Exclusion Criteria:

1. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;
2. Severe liver or kidney insufficiency;
3. Hyperthyroidism or a benign thyroid tumour;
4. Pregnant or breastfeeding women;
5. Scheduled for palliative surgery or terminal ill
6. Scheduled for a diverting stoma
7. Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives (following a detailed medical history and physical examination;
8. Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;
9. Emergency surgery

Primary outcomes:
measure: 90-days Anastomotic Leakage (AL) rate
timeFrame: 90 days
Secondary outcomes:
measure: 30-days Anastomotic Leakage ( AL) rate
timeFrame: 30 days
measure: complication rate
timeFrame: 90 days
measure: mortality
timeFrame: 90 days
measure: days in hospital stay
timeFrame: 90 days
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: LUMC
name: Alexander Vahrmeijer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meijer RPJ, Faber RA, Bijlstra OD, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Mieog JSD, Burggraaf K, Vahrmeijer AL, Hilling DE; AVOID study group. AVOID; a phase III, randomised controlled trial using indocyanine green for the prevention of anastomotic leakage in colorectal surgery. BMJ Open. 2022 Apr 1;12(4):e051144. doi: 10.1136/bmjopen-2021-051144.