Thoracoscopic Laser Speckle Contrast Imaging for Segment Resections

NCT05545085 | Unknown

• 1 other identifier: NL82338.099.22
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale Lung cancer remains to be the leading cause of cancer-related deaths worldwide1. The current standard-of-care for small lung cancer is a total lobectomy. Albeit effective with respect to the radical excision of the tumour, the substantial loss in lung tissue may be clinically relevant, especially in combination with frequently co-existing lung diseases. Thoracoscopic segmentectomy is a combination of adequate oncological resection with lung-tissue-sparing properties and is being increasingly used because of its several advantages compared with lobar resections. By defining the segment that has to be excised pre-operatively, the key to successful pulmonary segmentectomy is to subsequently intraoperatively recognize the intersegmental planes correctly. The conventional and most common method uses a ventilation method (inflation/deflation technique). With the increasing availability of endoscopic imaging systems, indocyanine green (ICG) fluorescence imaging is a more advanced method to determine intersegmental planes. The major limitation is the use of an exogenous contrast agent. After injection, the ICG only has very limited "imaging time window" (minutes) in which the images can be used to determine the intersegmental planes. Furthermore, the use of dye limits repeatability of measurements due to rest ICG, the extra operating room time required for the injection, wash-in and wash-out of the dye as well as change of camera settings. These limitations leave room for new technologies and improvements. The investigators hypothesized that an endoscopic laser speckle imaging device could overcome the limitations of ICG-fluorescence imaging and could thus be a very useful addition in intersegmental plane detection. PerfusiX-Imaging (LIMIS Development BV, Leeuwarden, The Netherlands) is such an endoscopic laser speckle contrast imager that has been developed in the Medical Centre Leeuwarden since 2014. LSCI has never been used to identify intersegmental planes, however, based on the similarities between LSCI and ICG-fluorescence, this novel imaging approach is thought to be effective and potentially could be used as a standard-of-care. Objectives In this trial the investigators will study the utility of PerfusiX-Imaging for the identification of intersegmental planes during thoracoscopic segmentectomy. Study design The current study is a prospective, observational single-centre study in the Medical Center Leeuwarden. Study population A total of 10 patients undergoing an upper left or right lobectomy. Patient related study procedures All patients will undergo the standard-of-care program which includes perfusion assessment by ICG-fluorescence imaging. In addition to this standard-of-care, 2D-perfusion maps will be generated from images taken with PerfusiX-Imaging (LIMIS Development BV, Leeuwarden, The Netherlands). Not related to the patient, the PerfusiX-Imaging images will be shown to the surgeon postoperatively and peroperative questionnaires will be filled regarding the standard-of-care perfusion assessment. Study parameters/endpoints Due to the explorative character of this study, there is no formal hierarchy in the respective endpoints of this study. In this, all endpoints will add to the overall assessment of the feasibility of the PerfusiX-imaging derived visual feedback for detecting interlobar and intersegmental planes in lung tissue. The investigators will register whether it was possible to detect the intersegmental plane. Subsequently, compare the difference in location of both the interlobar and intersegmental planes as derived from visual feedback from the PerfusiX-imaging system is compared, with images derived from ICG imaging and the surgical eye. During the procedure, the time needed to generate and acquire the visual feedback from the PerfusiX-imaging system will be determined. The investigators will also determine the interpretability of the visual feedback from the PerfusiX-imaging system by users (surgeons). In addition, the investigators will determine Laser Speckle Perfusion Unit (LSPU) cut-off values of PerfusiX-imaging in lung tissue with the best sensitivity and specificity for the indication of level of tissue perfusion. Burden, risk and benefit to participation Burden Not applicable. Risks Not applicable. Benefit Not applicable.

Conditions

Pulmonary Cancer

Outcome Measures

Primary Outcomes (6)

• The ability of PerfusiX-Imaging of detecting the interlobar and intersegmental planes.

  \- The total number of interlobar and intersegmental planes detected using PerfusiX-Imaging (yes/no, percentages, 95% Confidence Interval).

  1 day

• The ability of PerfusiX-Imaging of detecting the interlobar and intersegmental planes compared to ICG and surgical eye

  \- Comparison between total amount of detected planes using PerfusiX-Imaging, ICG and the surgical eye (yes/no per modality, percentages, 95% Confidence Interval).

  1 day

• Assessing the conformity of plane location between PerfusiX-Imaging and ICG-fluorescence/surgical eye.

  \- Difference in location of planes of LSCI, compared to ICG and the surgical eye (means with standard deviation, median with range)

  1 day

• Required time to capture images with PerfusiX-Imaging

  \- Time per measurement and total time per procedure in minutes (means with standard deviation, median with range)

  1 day

• Interpretability of visual feedback derived from PerfusiX-Imaging by the operating surgeon.

  \- Overlap in surface between modalities (means with standard deviation, median with range)

  1 day

• Determination of Laser Speckle Perfusion Unit (LSPU) cut-off value with the highest sensitivity and specificity

  \- ROC curve analysis (Laser Speckle values referenced to standard care (ICG)) and anatomical feature (interlobar fissure).

  during the total inclusion time, depending on the time needed to include all required patients.

Study Arms (1)

Group 1

All included patients meeting the eligibility criteria and scheduled to undergo a lobectomy in the Medical Centre Leeuwarden.

Device: Laser Speckle Contrast Imaging using the PerfusiX-Imaging Device

Interventions

Laser Speckle Contrast Imaging using the PerfusiX-Imaging Device DEVICE

Patient will undergo the standard of care lobectomy for pulmonary cancer. In addition, peroperative imaging using the Laser Speckle Contrast Imaging device will be performed.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All included patients meeting the eligibility criteria and scheduled to undergo a lobectomy in the Medical Centre Leeuwarden

You may qualify if:

• Scheduled to undergo upper left or right lobectomy
• Age 18 years or older
• Written informed consent

You may not qualify if:

• \- Medical or psychiatric conditions that compromise the patient's ability to give informed consent

Sponsors & Collaborators

• Frisius Medisch Centrum: lead
• University of Groningen: collaborator
• LIMIS Development: collaborator

Study Sites (1)

Medical Center Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

RECRUITING

Related Publications (12)

• Andolfi M, Potenza R, Seguin-Givelet A, Gossot D. Identification of the intersegmental plane during thoracoscopic segmentectomy: state of the art. Interact Cardiovasc Thorac Surg. 2020 Mar 1;30(3):329-336. doi: 10.1093/icvts/ivz278.

  PMID: 31773135 BACKGROUND

• Funai K, Kawase A, Shimizu K, Sekihara K, Yamashita T, Shiiya N. Fluorescence navigation with indocyanine green for identification of intersegmental planes using a photodynamic eye camera. J Thorac Dis. 2020 Sep;12(9):4817-4824. doi: 10.21037/jtd-20-1448.

  PMID: 33145054 BACKGROUND

• Zhang Z, Liao Y, Ai B, Liu C. Methylene blue staining: a new technique for identifying intersegmental planes in anatomic segmentectomy. Ann Thorac Surg. 2015 Jan;99(1):238-42. doi: 10.1016/j.athoracsur.2014.07.071. Epub 2014 Nov 14.

  PMID: 25440279 BACKGROUND

• Nex G, Schiavone M, De Palma A, Quercia R, Brascia D, De Iaco G, Signore F, Panza T, Marulli G. How to identify intersegmental planes in performing sublobar anatomical resections. J Thorac Dis. 2020 Jun;12(6):3369-3375. doi: 10.21037/jtd.2020.01.09.

  PMID: 32642262 BACKGROUND

• Oh S, Suzuki K, Miyasaka Y, Matsunaga T, Tsushima Y, Takamochi K. New technique for lung segmentectomy using indocyanine green injection. Ann Thorac Surg. 2013 Jun;95(6):2188-90. doi: 10.1016/j.athoracsur.2012.12.068.

  PMID: 23706452 BACKGROUND

• Pischik VG, Kovalenko A. The role of indocyanine green fluorescence for intersegmental plane identification during video-assisted thoracoscopic surgery segmentectomies. J Thorac Dis. 2018 Nov;10(Suppl 31):S3704-S3711. doi: 10.21037/jtd.2018.04.84.

  PMID: 30505555 BACKGROUND

• Briers JD, Fercher AF. Retinal blood-flow visualization by means of laser speckle photography. Invest Ophthalmol Vis Sci. 1982 Feb;22(2):255-9.

  PMID: 7056639 BACKGROUND

• Draijer M, Hondebrink E, van Leeuwen T, Steenbergen W. Review of laser speckle contrast techniques for visualizing tissue perfusion. Lasers Med Sci. 2009 Jul;24(4):639-51. doi: 10.1007/s10103-008-0626-3. Epub 2008 Dec 3.

  PMID: 19050826 BACKGROUND

• Boas DA, Dunn AK. Laser speckle contrast imaging in biomedical optics. J Biomed Opt. 2010 Jan-Feb;15(1):011109. doi: 10.1117/1.3285504.

  PMID: 20210435 BACKGROUND

• Heeman W, Dijkstra K, Hoff C, Koopal S, Pierie JP, Bouma H, Boerma EC. Application of laser speckle contrast imaging in laparoscopic surgery. Biomed Opt Express. 2019 Mar 25;10(4):2010-2019. doi: 10.1364/BOE.10.002010. eCollection 2019 Apr 1.

  PMID: 31086715 BACKGROUND

• Sun Y, Zhang Q, Wang Z, Shao F, Yang R. Is the near-infrared fluorescence imaging with intravenous indocyanine green method for identifying the intersegmental plane concordant with the modified inflation-deflation method in lung segmentectomy? Thorac Cancer. 2019 Oct;10(10):2013-2021. doi: 10.1111/1759-7714.13192. Epub 2019 Sep 3.

  PMID: 31482671 BACKGROUND

• Matsuura Y, Mun M, Ichinose J, Nakao M, Nakagawa K, Okumura S. Recent fluorescence-based optical imaging for video-assisted thoracoscopic surgery segmentectomy. Ann Transl Med. 2019 Jan;7(2):32. doi: 10.21037/atm.2019.01.23.

  PMID: 30854385 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• E.C. Boerma

  Frisius Medisch Centrum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

E.C. Boerma, MD/PhD

CONTACT

+31-58-2866738; christiaan.boerma@mcl.nl

F. Grimme, Md/PhD

CONTACT

frederike.grimme@mcl.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: November 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: September 1, 2023
• Last Updated: January 9, 2023

Record last verified: 2023-01

Locations

NL (1)