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New through-the-needle brush for pancreatic cysts assessment: a randomized control trial
KTH, School of Electrical Engineering and Computer Science (EECS), Intelligent systems, Micro and Nanosystems.ORCID iD: 0000-0001-5677-0096
Pathology and Cytology Department, Karolinska University Hospital Stockholm, Sweden.
KTH, School of Electrical Engineering and Computer Science (EECS), Intelligent systems, Micro and Nanosystems.ORCID iD: 0000-0001-8248-6670
Department of Surgical and Perioperative Sciences/Surgery, Umeå University, Umeå, Sweden; Division of Surgery, CLINTEC, Karolinska Institute, Stockholm, Sweden.ORCID iD: 0000-0002-1843-5673
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2023 (English)In: iGIE, ISSN 2949-7086, Vol. 2, no 4, p. 481-488Article in journal (Refereed) Published
Abstract [en]

AbstractObjectiveCurrent endoscopic ultrasound technologies (EUS) are suboptimal in the assessment of pancreatic cystic lesions (PCLs). We developed a new through-the- needle brush, the "loop brush", to improve the cellular yield, and thereby sensitivity,of EUS fine needle aspiration (EUS-FNA) of pancreatic cysts. In this study, we aim to evaluate its safety and efficacy.DesignWe performed an in-vivo randomized controlled trial in pigs using artificial cysts. In one group, the loop brush was deployed through a 22G EUS-FNA needle into the cysts. In the control group, cystic punction was performed with standard EUS- FNA. Loop brushes were visually inspected post-procedure. Cytological assessment, cell counting, and hemoglobin analysis were performed in samples from both groups.ResultsArtificial cysts (n=114) were punctured in six pigs, 57 in each group. Neither adverse events nor significant device malfunction occurred during loop brushing. Samples collected with the brush had non-detectable concentrations of hemoglobin in 72% (41/57) of cases, and 26% (16/57) had less than 0.6 g/dL, with no significant difference to the controls (p=0.32). Brushing cell counts were associated with significantly increased cell counts (11.7× median difference, p<.0001). Cytological smears were diagnostic in 77% of cases in the brushing group, while 54% in the control group (p=0.01, Fisher’s exact test; p=0.006, Chi-square test).ConclusionsThe new loop brush procedure appears to be safe, causing neither significant bleeding nor device malfunction. Samples obtained with the loop brush were suitable for cytological analysis and showed significantly higher cell yield than controls. Further clinical studies are warranted.

Place, publisher, year, edition, pages
Elsevier BV , 2023. Vol. 2, no 4, p. 481-488
National Category
Cancer and Oncology Gastroenterology and Hepatology Medical Instrumentation
Research subject
Medical Technology
Identifiers
URN: urn:nbn:se:kth:diva-335212DOI: 10.1016/j.igie.2023.08.006Scopus ID: 2-s2.0-85202981853OAI: oai:DiVA.org:kth-335212DiVA, id: diva2:1793687
Note

QC 20240919

Available from: 2023-09-01 Created: 2023-09-01 Last updated: 2025-02-11Bibliographically approved
In thesis
1. Overcoming the Barriers of Fine-Needle Aspiration
Open this publication in new window or tab >>Overcoming the Barriers of Fine-Needle Aspiration
2023 (English)Doctoral thesis, comprehensive summary (Other academic)
Alternative title[sv]
Att Överkomma Barriärer för Finnålsaspiration
Abstract [en]

Cysts, closed sac-like structures filled with fluid or air, can form anywhere in the body. In the majority of cases, cysts are benign (not cancerous). However, these structures can also be precursors of cancer, pointing to the location where cancer can originate. This makes cysts a prime location for examination, especially when they occur in the pancreas. Pancreatic cancer has the lowest survival rate after five years in 2023 (12%) due to the late diagnosis, limiting treatment options. Fine-Needle Aspiration (FNA) is a diagnostic technique used to aspirate the liquid content of cysts. The liquid may possess cells used to determine cyst malignancy, yet up to 66% of samples have little to no cells.

Firstly, we introduce a new concept of brush: the loop brush. Unlike traditional brushes with a handle and a block of bristles, the loop brush consists of a handle and a loop-shaped wire. The loop of loop brushes can be compressed within the inner diameter of an FNA needle and autonomously expanded to the size of cysts. Loops can be made of nitinol or commercially available absorbable sutures such as Monocryl, PDS II, and Catgut. Loop brushes increase the cell yield of modeled cysts by an order of magnitude and are, apparently, as safe as standard FNA (FNA without a loop brush). Such brushes could present a promising solution to the lack of cells in liquid samples of cysts, increasing treatment options and producing better, cost-effective care for patients.

Secondly, we present a hand-sized microfluidic device to prepare rapid on-site evaluation(ROSE) of FNA samples. During ROSE, FNA samples are prepared by cytopathologists in the operating room for further inspection with a microscope. However, cytopathologists are often time-limited, preventing the dissemination of ROSE. Our device allows sample preparation with minimum chemical quantities and the potential to be implemented by all healthcare providers. This microfluidic device would allow the dissemination of ROSE, preventing the need for patients to return to the OR and accelerating diagnosis.

Abstract [sv]

Cystor, stängda säckliknande strukturer fyllda med vätska eller luft, kan bildas överallt i kroppen. I majoriteten av fall så är cystor godartade, dvs icke cancer-bildande. Cystor kan dock utgöra förstadier till cancer, och indikera var cancer kan börja bildas. Detta gör cystor till utmärkta kandidater för undersökning, särskilt om de uppstår i pankreas. Pankreascancer har lägst grad av överlevande av alla cancertyper efter 5 år i 2023 (12%) pga sen diagnostik och begränsade behandlingsmetoder. Finnålsaspiration (FNA) är en diagnostisk Teknik som används för att aspirera vätska ur cystor. Den här vätskan kan innehålla celler som kan analyseras för att avgöra om cystan är god- eller elakartad, men upp till 66% av prover som tas har lite eller inga celler.

I första hand introducerar vi ett nytt borstkoncept; loop-borsten. Till skillnad från traditionella borstar med ett handtag som har borsthår på slutet, så består denna borste av ett handtag och en loop-formad tråd. Loopen kan komprimeras inuti en FNA-nål och självmant expanderas för att fylla cystvolymer. Dessa loopar kan göras av nitinol eller kommersiellt tillgängliga resorberbara suturer så som Monocryl, PDS II och Catgut. Loop-borsten ökar den mängd celler i cystmodeller som provtas med en storleksordning och är lika säker som den standardiserade FNA-tekniken utan loopen. Denna loop kan utgöra en lovande lösning för den brist på celler som tas i vätskeprover från cystor, vilket kan öka behandlingsalternativen och producera bättre  och mer kostnadseffektiva behandlingar för patienter. 

Senare, presenterar vi en mikrofluidisk device, ungefär lika stor som en hand, som skall användas för rapid on-site evaluation (ROSE) av FNA-prover. Under en ROSE-procedur så förbereds FNA-prover av en cytopatolog i operationsrummet för att vidareundersökas i mikroskop. Cytopatologer är dock ofta tidsbegränsade, vilket förhindrar spridningen av ROSE. Vår device tillåter förberedning av provet med minimal användning av kemiska tillsatser och kan potentiellt implementeras av alla sjukvårdsaktörer. Denna mikrofluidiska device skulle möjliggöra spridning av ROSE-metoden och förminska behovet för patienter att återvända till operationssalen och göra den diagnostiska proceduren snabbare. 

Place, publisher, year, edition, pages
Stockholm: KTH Royal Institute of Technology, 2023. p. xi, 86
Series
TRITA-EECS-AVL ; 2023:77
Keywords
Cysts, Cystic fluid, Pancreatic Cancer, Fine-needle Aspiration, Early diagnosis, Surgical instruments, Nitinol, Absorbable sutures, Loop brush, Cythopathology, Rapid on-site evaluation, Microfluidics
National Category
Gastroenterology and Hepatology Cancer and Oncology Medical Instrumentation
Research subject
Electrical Engineering
Identifiers
urn:nbn:se:kth:diva-338969 (URN)978-91-8040-745-8 (ISBN)
Public defence
2023-11-24, Kollegiesalen, Brinellvägen 6, Stockholm, 10:00 (English)
Opponent
Supervisors
Funder
Swedish Cancer Society, 19 0513 Fk 01 HRegion Stockholm, HMT project #20180849
Note

QC 20231103

Available from: 2023-11-03 Created: 2023-11-02 Last updated: 2025-02-11Bibliographically approved

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Marques, Filipevan der Wijngaart, WouterRoxhed, Niclas

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