Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

Crohn Disease Clinical Trial

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Official title:

A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04712032
• Other study ID #: P19.079
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2021
• Source: Leiden University Medical Center
• Contact: Alexander Vahrmeijer, MD, PhD
• Phone: 071 526 9111
• Email: a.l.vahrmeijer[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 978
• Est. completion date: October 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Colorectal Neoplasms
• Crohn Disease
• Resectable Colorectal Carcinoma

Intervention

Drug:
• ICG-guided bowel perfusion assessment
ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (8)

Lead Sponsor	Collaborator
Leiden University Medical Center	Alrijne Hospital, Amphia Hospital, Catharina Ziekenhuis Eindhoven, Haga Hospital, IJsselland, Jeroen Bosch Ziekenhuis, Medical Center Haaglanden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-days Anastomotic Leakage (AL) rate	Anastomotic leakage rate	90 days
Secondary	30-days Anastomotic Leakage ( AL) rate	Anastomotic leakage rate	30 days
Secondary	complication rate		90 days
Secondary	mortality		90 days
Secondary	days in hospital stay		90 days