Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates (AVOID)

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

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.

Study Overview

• Status: Unknown
• Conditions: Crohn Disease; Colo-rectal Cancer; Resectable Colorectal Carcinoma
• Intervention / Treatment: Drug: ICG-guided bowel perfusion assessment

• Study Type: Interventional
• Enrollment (Anticipated): 978
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Recruiting
      • Leiden University Medical Center
      • Contact: Ruben Meijer, MD; Phone Number: +31 71 526 9111; Email: r.p.j.meijer@lumc.nl
      • Contact: Robin Faber; Email: r.a.faber@lumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Image Guided Bowel Anastomosis group; ICG-guided perfusion assessment	Drug: ICG-guided bowel perfusion assessment; ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.
No Intervention: Conventional Bowel Anastomosis group; conventional perfusion assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
90-days Anastomotic Leakage (AL) rate	Anastomotic leakage rate	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality		90 days
30-days Anastomotic Leakage ( AL) rate	Anastomotic leakage rate	30 days
complication rate		90 days
days in hospital stay		90 days

Collaborators and Investigators

• Sponsor: Leiden University Medical Center
• Collaborators: Catharina Ziekenhuis Eindhoven; Medical Center Haaglanden; Haga Hospital; Jeroen Bosch Ziekenhuis; Alrijne Hospital; Amphia Hospital; IJsselland
• Investigators: Principal Investigator: Alexander Vahrmeijer, MD, PhD, LUMC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Inflammatory Bowel Diseases; Colorectal Neoplasms; Crohn Disease
• Other Study ID Numbers: P19.079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No