Colo-rectal CancerPhase 3AVOIDNCT04712032
Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates
A Phase 3 study testing ICG-guided bowel perfusion assessment in people with Colo-rectal Cancer and Crohn Disease, run by Leiden University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer, Crohn Disease, Resectable Colorectal Carcinoma
- What is being tested?
- ICG-guided bowel perfusion assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 978 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2020to 1 Oct 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis;
- Patients aged over 18 years old;
- Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;
- Signed informed consent prior to any study-mandated procedure;
Who cannot join
- Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;
- Severe liver or kidney insufficiency;
- Hyperthyroidism or a benign thyroid tumour;
- Pregnant or breastfeeding women;
- Scheduled for palliative surgery or terminal ill
- Scheduled for a diverting stoma
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- 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;
- Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
Ruben Meijer, MD, +31 71 526 9111, r.p.j.meijer@lumc.nl
Robin Faber, r.a.faber@lumc.nl
About this study
Official title: 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.
- Being tested
- ICG-guided bowel perfusion assessment
- Medical subject headings
- Colonic Neoplasms, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-guided bowel perfusion assessmentDrug
ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.
| Study group | Role | What they receive |
|---|---|---|
| Image Guided Bowel Anastomosis group | Experimental | ICG-guided perfusion assessment Receives: Drug: ICG-guided bowel perfusion assessment |
| Conventional Bowel Anastomosis group | No intervention | conventional perfusion assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-days Anastomotic Leakage (AL) rate
Anastomotic leakage rate
Measured: 90 days
Secondary outcomes (4)
30-days Anastomotic Leakage ( AL) rate
Anastomotic leakage rate
Measured: 30 days
complication rate
Measured: 90 days
mortality
Measured: 90 days
days in hospital stay
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Jul 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 978 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Center Haaglanden, Catharina Ziekenhuis Eindhoven, Haga Hospital, Jeroen Bosch Ziekenhuis, Amphia Hospital, Alrijne Hospital, IJsselland Hospital
- Responsible party
- Principal investigator, Alexander Vahrmeijer, Leiden University Medical Center
- Investigators
- Alexander Vahrmeijer, MD, PhD, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712032
- Sponsor's protocol ID
- P19.079
- Acronym
- AVOID
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faber RA, Meijer RPJ, Droogh DHM, Jongbloed JJ, Bijlstra OD, Boersma F, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Holman FA, Mieog JSD, Neijenhuis PA, van Staveren E, Bloemen JG, Burger JWA, Aukema TS, Brouwers MAM, Marinelli AWKS, Westerterp M, Doornebosch PG, van der Weijde A, Bosscha K, Handgraaf HJM, Consten ECJ, Sikkenk DJ, Burggraaf J, Keereweer S, van der Vorst JR, Hutteman M, Peeters KCMJ, Vahrmeijer AL, Hilling DE. Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):924-934. doi: 10.1016/S2468-1253(24)00198-5. Epub 2024 Aug 13.
PubMed 39151436Meijer 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.
PubMed 35365509
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES
- ClinicalTrials.gov ID
- NCT04712032
- Acronym / sponsor ID
- AVOID / P19.079
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 978 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Medical Center Haaglanden, Catharina Ziekenhuis Eindhoven, Haga Hospital, Jeroen Bosch Ziekenhuis, Amphia Hospital, Alrijne Hospital, IJsselland Hospital
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- National randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Image Guided Bowel Anastomosis group | Experimental | Drug: ICG-guided bowel perfusion assessmentICG-guided perfusion assessment |
| Conventional Bowel Anastomosis group | No intervention | –conventional perfusion assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis;
- Patients aged over 18 years old;
- Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;
- Signed informed consent prior to any study-mandated procedure;
Key exclusion criteria (9 listed)
- Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;
- Severe liver or kidney insufficiency;
- Hyperthyroidism or a benign thyroid tumour;
- Pregnant or breastfeeding women;
- Scheduled for palliative surgery or terminal ill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICG-guided bowel perfusion assessmentICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel. | Drug | Image Guided Bowel Anastomosis group |
Primary outcome
90-days Anastomotic Leakage (AL) rate
Time frame: 90 days
Anastomotic leakage rate
4 secondary outcomes
30-days Anastomotic Leakage ( AL) rate
Time frame: 30 days
complication rate
Time frame: 90 days
mortality
Time frame: 90 days
days in hospital stay
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Derived from this study: PubMed 39151436Faber RA, Meijer RPJ, Droogh DHM, Jongbloed JJ, Bijlstra OD, Boersma F, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Holman FA, Mieog JSD, Neijenhuis PA, van Staveren E, Bloemen JG, Burger JWA, Aukema TS, Brouwers MAM, Marinelli AWKS, Westerterp M, Doornebosch PG, van der Weijde A, Bosscha K, Handgraaf HJM, Consten ECJ, Sikkenk DJ, Burggraaf J, Keereweer S, van der Vorst JR, Hutteman M, Peeters KCMJ, Vahrmeijer AL, Hilling DE. Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):924-934. doi: 10.1016/S2468-1253(24)00198-5. Epub 2024 Aug 13.
- Derived from this study: PubMed 35365509Meijer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Vahrmeijer, MD, PhD principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ICG-guided bowel perfusion assessment in people with Colo-rectal Cancer and Crohn Disease, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Vahrmeijer, MD, PhD (071 526 9111, a.l.vahrmeijer@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-days Anastomotic Leakage (AL) rate (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04712032, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.