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

NCT05734118 | Unknown FDA Device

• 1 other identifier: IMAGINE
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. 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? 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.

Conditions

NEC; Atresia; Malrotation; Intestinal Perforation

Keywords

Neonate; Infant; ICG; Fluorescence; Image-guided surgery; Pediatric Surgery; Intestinal perfusion; Anastomosis; Safety; Feasibility; Bowel ischemia

Outcome Measures

Primary Outcomes (6)

• Feasibility of ICG-FA for intraoperative assessment of intestinal perfusion

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

  10 minutes intraoperatively (recording)

• Feasibility of ICG-FA for intraoperative assessment of intestinal perfusion

  b. 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);

  10 minutes intraoperatively (recording)

• Feasibility of ICG-FA for intraoperative assessment of intestinal perfusion

  c. 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);

  10 minutes intraoperatively (recording)

• Feasibility of ICG-FA for intraoperative assessment of intestinal perfusion

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

  10 minutes intraoperatively (recording)

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

  a. 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;

  24 hours

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

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

  24 hours

Secondary Outcomes (1)

• Comparison of conventional and ICG-FA mediated assessment

  Through study completion, on average within 4 weeks

Study Arms (1)

Intraoperative perfusion assessment using ICG-FA

EXPERIMENTAL

Surgical 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.

Device: Perfusion assessment by means of the SPY-PHI camera

Interventions

Perfusion assessment by means of the SPY-PHI camera DEVICE

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.

Intraoperative perfusion assessment using ICG-FA

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• UMC Utrecht: collaborator
• Stryker Endoscopy: collaborator

Related Publications (17)

• 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.

  PMID: 22098511 BACKGROUND

• 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.

  PMID: 25451666 BACKGROUND

• 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.

  PMID: 29663330 BACKGROUND

• 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.

  PMID: 32944782 BACKGROUND

• 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.

  PMID: 32886195 BACKGROUND

• 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.

  PMID: 32845390 BACKGROUND

• 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.

  PMID: 29106320 BACKGROUND

• 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.

  PMID: 32189424 BACKGROUND

• 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.

  PMID: 15937809 BACKGROUND

• 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.

  PMID: 36404183 BACKGROUND

• 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.

  PMID: 26439370 BACKGROUND

• 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.

  PMID: 31858494 BACKGROUND

• 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.

  PMID: 27132541 BACKGROUND

• 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.

  PMID: 33485614 BACKGROUND

• 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.

  PMID: 23701792 BACKGROUND

• Kamran A, Zendejas B, Meisner J, Choi SS, Munoz-San Julian C, Ngo P, Manfredi M, Yasuda JL, Smithers CJ, Hamilton TE, Jennings RW. Effect of Posterior Tracheopexy on Risk of Recurrence in Children after Recurrent Tracheo-Esophageal Fistula Repair. J Am Coll Surg. 2021 May;232(5):690-698. doi: 10.1016/j.jamcollsurg.2021.01.011. Epub 2021 Feb 5.

  PMID: 33556502 BACKGROUND

• Meira J, Marques ML, Falcao-Reis F, Rebelo Gomes E, Carneiro A. Immediate Reactions to Fluorescein and Indocyanine Green in Retinal Angiography: Review of Literature and Proposal for Patient's Evaluation. Clin Ophthalmol. 2020 Jan 20;14:171-178. doi: 10.2147/OPTH.S234858. eCollection 2020.

  PMID: 32021082 BACKGROUND

Related Links

• Verdye Indocyanine Green description (Dutch)

MeSH Terms

Conditions

Volvulus Of Midgut; Intestinal Perforation

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jan Hulscher, MD, PhD

  UMC Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eline Breuking, MB, LLB

CONTACT

0887554070; e.a.breuking2@students.uu.nl

Otis van Varsseveld, MD

CONTACT

0503614796; o.c.van.varsseveld@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: February 17, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share