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NECIMAGINENCT05734118

Safety and Feasibility of Indocyanine Green Fluorescence for Intraoperative Assessment of Intestinal Perfusion in Young Infants and Neonates

A study testing Perfusion assessment by means of the SPY-PHI camera in people with NEC and Atresia, run by University Medical Center Groningen.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to test the use of the SPY-PHI device for the purpose of ICG-mediated intestinal perfusion visualization during gastrointestinal surgery in neonates and young infants (<3 months old) undergoing surgery for NEC, atresia, SIP or malrotation. Read more about this study

Who is it for?
Ages Up to 3 months
Conditions the study is for
NEC, Atresia, Malrotation
What is being tested?
Perfusion assessment by means of the SPY-PHI camera
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Aug 2023to Aug 2024
Phase
Interventional
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 Up to 3 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Written informed consent is obtained by both patient's parents or legal guardians (as applicable);
  • Patient is a neonate (< 1 month of age) or young infant (<3 months of age);
  • Patient is suffering from necrotizing enterocolitis, atresia, malrotation or spontaneous intestinal perforation;
  • Patient requires laparotomy for management of the disease.

Who cannot join

  • Patient is suffering from clinically significant (treatment necessary) hyperbilirubinemia;
  • Patient is suffering from thyroid or liver disease;
  • Patient is allergic to the active substance indocyanine green or sodium iodide or iodine;
  • Patient has abdominal wall defects;
  • Patient can be treated non-surgically;
  • During the preoperative multidisciplinary meeting with the team, including the pediatric anesthetist, patient is deemed not stable enough hemodynamically to perform the ICG-FU measurements
  • Patient is assessed unstable by operating team intraoperatively.

Trial locations and contacts

No sites are listed yet.

Eline Breuking, MB, LLB contact

0887554070

e.a.breuking2@students.uu.nl

Otis van Varsseveld, MD contact

0503614796

o.c.van.varsseveld@umcg.nl

About this study

Official title: Indocyanine Green Fluorescence Angiography Mediated Assessment of Gastro-Intestinal Perfusion in Neonates

The goal of this clinical trial is to test the use of the SPY-PHI device for the purpose of ICG-mediated intestinal perfusion visualization during gastrointestinal surgery in neonates and young infants (<3 months old) undergoing surgery for NEC, atresia, SIP or malrotation. The main question[s] it aims to answer are:

  • Is ICG-FA feasible for intraoperative use in neonates and young infants undergoing laparotomy for NEC, atresia, SIP or malrotation?
  • Is ICG-FA is safe to use in neonates during surgery?
Read more

Participants will undergo surgical care for their diseases within the standard of care. During laparotomy, the pediatric surgeon will assess bowel perfusion in two ways. First, by visual inspection (the conventional method). Second, the intestine will be analyzed with indocyanine green fluorescence angiography (ICG-FA) by means of the hand-held SPY-PHI camera. For this purpose, the patients will be administered ICG intravenously. Afterwards, the intestinal perfusion will be assessed by means of the SPY-PHI device in 5 to 10 minutes.

Specifically, the feasibility and safety for use of ICG-FA in neonates undergoing laparotomy as treatment for necrotizing enterocolitis (NEC), atresia, spontaneous intestinal perforation (SIP) and malrotation will be investigated.

If ICG-FA turns out to be feasible and safe for the population investigated in this study, a follow-up study will be conducted with the aim to explore the potential benefits of this technique on the postoperative outcome and intraoperative decision-making.

Read the detailed description

This study aims to investigate whether the intraoperative use of indocyanine green fluorescence angiography (ICG-FA) is feasible and safe in neonates. Feasibility is therein defined as practically possible use of ICG-FA, resulting in clear and interpretable results, with the future potential to improve clinical outcome and benefits for the patient.

Specifically, the feasibility and safety for use of ICG-FA in neonates undergoing laparotomy as treatment for necrotizing enterocolitis (NEC), atresia, spontaneous intestinal perforation (SIP) and malrotation will be investigated.

If ICG-FA turns out to be feasible and safe for the population investigated in this study, a follow-up study will be conducted with the aim to explore the potential benefits of this technique on the postoperative outcome and intraoperative decision-making.

The primary endpoint of this study is assessing the feasibility and safety of intraoperative ICG-FA imaging in neonates undergoing laparotomy for NEC, atresia, SIP, or malrotation. The secondary endpoint of this study is postoperative comparison of the images; standard visual inspection (conventional image) with the corresponding fluorescence image.

During laparotomy, first the pediatric surgeon performs the visual inspection of the predetermined areas (mid jejunum, ileum, ascending colon and sigmoid) as well as regions of interest such as ischemic lesions in NEC and malrotation with volvulus. In case of intestinal necrosis, both edges of the parts that will be resected must be marked with a suture. Second, the intestine will be analyzed using ICG-FA. This analysis will cover the predetermined areas as well as regions of interest.

To this end, the ICG should be injected intravenously by the one member of the anesthetic team. This will only be done if the operating team, consisting of both the consultant surgeon and consultant pediatric anesthesiologist, consider it safe to do so. Utilizing the mobile unit with computer and camera head, the fluorescence angiography system can measure tissue perfusion. Before the start of the procedure in which the SPY-PHY camera will be used intraoperatively, the camera will be covered with sterile drapes. The pediatric surgeon will first make conventional video images with the camera of the predetermined areas and the region of interest and second, the surgeon will make images of the ICG-FA with the camera, which both will be recorded to be analyzed later.

The ICG-FA images do not alter the decision on what type of surgical procedure will be performed and/or how much length of bowel will be resected. In case of a difficult decision, a second pediatric surgeon will be consulted, which is routine clinical practice in both centers anyway.

Being tested
Perfusion assessment by means of the SPY-PHI camera
Keywords
Neonate, Infant, ICG, Fluorescence, Image-guided surgery, Pediatric Surgery, Intestinal perfusion, Anastomosis, Safety, Feasibility, Bowel ischemia
Medical subject headings
Volvulus Of Midgut, Intestinal Perforation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perfusion assessment by means of the SPY-PHI cameraDevice

    Minutes after injection of ICG, the intestinal perfusion can and will be assessed using the SPY-PHI camera by Stryker Endoscopy. The operative plan will not be changed based on the results of the perfusion assessment. Images will be recorded and evaluated postoperatively.

Study groups in NCT05734118
Study groupRoleWhat they receive
Intraoperative perfusion assessment using ICG-FAExperimentalSurgical procedure within standard of care. Intraoperatively, the vitality of the bowel will be assessed visually (the conventional method). Afterwards, participants will be administered indocyanine green intravenously.
Receives: Device: Perfusion assessment by means of the SPY-PHI camera

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of ICG-FA for intraoperative assessment of intestinal perfusion

    1. Possibility for the researchers to assess intestinal perfusion based on the intraoperative ICG-FA images (clarity: yes/no);

    Measured: 10 minutes intraoperatively (recording)

  2. Feasibility of ICG-FA for intraoperative assessment of intestinal perfusion

    1. Possibility for the researchers to point out a specific location for resection of the bowel based on visualization of perfusion in the ICG-FA images (interpretability: yes/no);

    Measured: 10 minutes intraoperatively (recording)

  3. Feasibility of ICG-FA for intraoperative assessment of intestinal perfusion

    1. Comparison of the number of procedures in which it was a priori possible to perform ICG-FA imaging and the number of procedures in which the device was eventually used intraoperatively (applicability);

    Measured: 10 minutes intraoperatively (recording)

  4. Feasibility of ICG-FA for intraoperative assessment of intestinal perfusion

    1. Interference with intraoperative Near Infrared Spectroscopy (NIRS) brain monitoring (compatibility: brain monitoring not interfered with/possible despite interference/impossible due to interference);

    Measured: 10 minutes intraoperatively (recording)

  5. Safety of intraoperative ICG-FA in gastrointestinal surgery for young infants and neonates

    1. Number of complications directly related to use of the device or extension of operative time for ICG-FA imaging, occurring within 24 hours after surgery in the patients involved in this study;

    Measured: 24 hours

  6. Safety of intraoperative ICG-FA in gastrointestinal surgery for young infants and neonates

    1. Measurement of the prolonged OR time associated with intraoperative ICG-FA in minutes;

    Measured: 24 hours

Secondary outcomes (1)

  1. Comparison of conventional and ICG-FA mediated assessment

    1. Comparing whether the perfusion assessment of ICG-FA can provide more certainty on the perfusion status of intestinal sections than conventional visual assessment (by comparing ICG-FA images with normal view images) in order to identify whether ICG-FA, if applied for decision-making, would have confirmed or altered intraoperative decision making.

    Measured: Through study completion, on average within 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2023
  2. Study startAug 2023 (estimated)
  3. Primary completionAug 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

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 N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05734118
Sponsor's protocol ID
IMAGINE
Acronym
IMAGINE
Status last verified
May 2023
First submitted
27 Nov 2022
Last updated
12 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Cahill RA, Ris F, Mortensen NJ. Near-infrared laparoscopy for real-time intra-operative arterial and lymphatic perfusion imaging. Colorectal Dis. 2011 Nov;13 Suppl 7:12-7. doi: 10.1111/j.1463-1318.2011.02772.x.

    PubMed 22098511

  • Jafari MD, Wexner SD, Martz JE, McLemore EC, Margolin DA, Sherwinter DA, Lee SW, Senagore AJ, Phelan MJ, Stamos MJ. Perfusion assessment in laparoscopic left-sided/anterior resection (PILLAR II): a multi-institutional study. J Am Coll Surg. 2015 Jan;220(1):82-92.e1. doi: 10.1016/j.jamcollsurg.2014.09.015. Epub 2014 Sep 28.

    PubMed 25451666

  • Ris F, Liot E, Buchs NC, Kraus R, Ismael G, Belfontali V, Douissard J, Cunningham C, Lindsey I, Guy R, Jones O, George B, Morel P, Mortensen NJ, Hompes R, Cahill RA; Near-Infrared Anastomotic Perfusion Assessment Network VOIR. Multicentre phase II trial of near-infrared imaging in elective colorectal surgery. Br J Surg. 2018 Sep;105(10):1359-1367. doi: 10.1002/bjs.10844. Epub 2018 Apr 16.

    PubMed 29663330

  • Liu D, Liang L, Liu L, Zhu Z. Does intraoperative indocyanine green fluorescence angiography decrease the incidence of anastomotic leakage in colorectal surgery? A systematic review and meta-analysis. Int J Colorectal Dis. 2021 Jan;36(1):57-66. doi: 10.1007/s00384-020-03741-5. Epub 2020 Sep 18.

    PubMed 32944782

  • Lin J, Zheng B, Lin S, Chen Z, Chen S. The efficacy of intraoperative ICG fluorescence angiography on anastomotic leak after resection for colorectal cancer: a meta-analysis. Int J Colorectal Dis. 2021 Jan;36(1):27-39. doi: 10.1007/s00384-020-03729-1. Epub 2020 Sep 4.

    PubMed 32886195

  • Mok HT, Ong ZH, Yaow CYL, Ng CH, Buan BJL, Wong NW, Chong CS. Indocyanine green fluorescent imaging on anastomotic leakage in colectomies: a network meta-analysis and systematic review. Int J Colorectal Dis. 2020 Dec;35(12):2365-2369. doi: 10.1007/s00384-020-03723-7. Epub 2020 Aug 26.

    PubMed 32845390

  • van den Bos J, Al-Taher M, Schols RM, van Kuijk S, Bouvy ND, Stassen LPS. Near-Infrared Fluorescence Imaging for Real-Time Intraoperative Guidance in Anastomotic Colorectal Surgery: A Systematic Review of Literature. J Laparoendosc Adv Surg Tech A. 2018 Feb;28(2):157-167. doi: 10.1089/lap.2017.0231. Epub 2017 Nov 6.

    PubMed 29106320

  • Alekseev M, Rybakov E, Shelygin Y, Chernyshov S, Zarodnyuk I. A study investigating the perfusion of colorectal anastomoses using fluorescence angiography: results of the FLAG randomized trial. Colorectal Dis. 2020 Sep;22(9):1147-1153. doi: 10.1111/codi.15037. Epub 2020 Apr 6.

    PubMed 32189424

  • Wales PW, de Silva N, Kim JH, Lecce L, Sandhu A, Moore AM. Neonatal short bowel syndrome: a cohort study. J Pediatr Surg. 2005 May;40(5):755-62. doi: 10.1016/j.jpedsurg.2005.01.037.

    PubMed 15937809

  • Breuking EA, van Varsseveld OC, Harms M, Tytgat SHAJ, Hulscher JBF, Ruiterkamp J. Safety and Feasibility of Indocyanine Green Fluorescence Angiography in Pediatric Gastrointestinal Surgery: A Systematic Review. J Pediatr Surg. 2023 Aug;58(8):1534-1542. doi: 10.1016/j.jpedsurg.2022.10.045. Epub 2022 Oct 24.

    PubMed 36404183

  • Hirayama Y, Iinuma Y, Yokoyama N, Otani T, Masui D, Komatsuzaki N, Higashidate N, Tsuruhisa S, Iida H, Nakaya K, Naito S, Nitta K, Yagi M. Near-infrared fluorescence cholangiography with indocyanine green for biliary atresia. Real-time imaging during the Kasai procedure: a pilot study. Pediatr Surg Int. 2015 Dec;31(12):1177-82. doi: 10.1007/s00383-015-3799-4. Epub 2015 Oct 6.

    PubMed 26439370

  • Rentea RM, Halleran DR, Ahmad H, Sanchez AV, Gasior AC, McCracken K, Hewitt GD, Alexander V, Smith C, Weaver L, Wood RJ, Levitt MA. Preliminary Use of Indocyanine Green Fluorescence Angiography and Value in Predicting the Vascular Supply of Tissues Needed to Perform Cloacal, Anorectal Malformation, and Hirschsprung Reconstructions. Eur J Pediatr Surg. 2020 Dec;30(6):505-511. doi: 10.1055/s-0039-1700548. Epub 2019 Dec 13.

    PubMed 31858494

  • Clements KE, Fisher M, Quaye K, O'Donnell R, Whyte C, Horgan MJ. Surgical site infections in the NICU. J Pediatr Surg. 2016 Sep;51(9):1405-8. doi: 10.1016/j.jpedsurg.2016.04.002. Epub 2016 Apr 11.

    PubMed 27132541

  • Eeftinck Schattenkerk LD, Musters GD, Nijssen DJ, de Jonge WJ, de Vries R, van Heurn LWE, Derikx JPM. The incidence of abdominal surgical site infections after abdominal birth defects surgery in infants: A systematic review with meta-analysis. J Pediatr Surg. 2021 Sep;56(9):1547-1554. doi: 10.1016/j.jpedsurg.2021.01.018. Epub 2021 Jan 17.

    PubMed 33485614

  • Iinuma Y, Hirayama Y, Yokoyama N, Otani T, Nitta K, Hashidate H, Yoshida M, Iida H, Masui D, Manabe S. Intraoperative near-infrared indocyanine green fluorescence angiography (NIR-ICG AG) can predict delayed small bowel stricture after ischemic intestinal injury: report of a case. J Pediatr Surg. 2013 May;48(5):1123-8. doi: 10.1016/j.jpedsurg.2013.03.067.

    PubMed 23701792

Questions about this trial

What is this clinical trial studying?

A study testing Perfusion assessment by means of the SPY-PHI camera in people with NEC and Atresia, run by University Medical Center Groningen.

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 7 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 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

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.

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 Eline Breuking, MB, LLB (0887554070, e.a.breuking2@students.uu.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of ICG-FA for intraoperative assessment of intestinal perfusion (time frame: 10 minutes intraoperatively (recording)). The study lists 6 primary outcomes in all. 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 NCT05734118, which also lists 17 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 12 May 2023.

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