Advanced Image Guidance Utilized in Liver Surgery
20. april 2022 opdateret af: Wake Forest University Health Sciences
Advanced Image Guidance for Ablation Probe Placement in Laparoscopic Liver Surgery: A Pilot Study
Advanced Image Guidance for this study was used during laparoscopic microwave ablation surgery to help the surgeon accurately place the ablation needle into the tumor of patients diagnosed with liver cancer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Hepatocellular carcinoma (HCC) is diagnosed in over 19,000 Americans annually and responsible for 17,000 deaths.
Worldwide, (HCC) is the third leading cause of cancer death.
Hepatocellular carcinoma recurs frequently due to its multi-centric nature, which requires repeated treatments and often results in progressively fewer treatment options because of severe underlying liver dysfunction.
While surgery offers the best prognosis for such tumors and lesions, only 10-15% of all patients are candidates for removal by surgical means, necessitating the exploration of other treatment options.
InnerOptic's AIM Guidance System is designed to alleviate the difficulty in using ultrasound to place a needle.
AIM shows the needle and the ultrasound slice in their locations in 3D on a stereo monitor, making the spatial relationship between them obvious.
AIM also displays the needle trajectory and where the needle will intersect with the ultrasound image, providing the surgeon with an indication of where the needle will go, if inserted along the needle shaft.
AIM can also render an ablation volume guide, providing the surgeon with further confirmation that the needle is placed accurately and providing a volumetric guide regarding the power settings of the ablation.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
14
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204
- Carolinas Health System
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Individuals who have hepatocellular carcinoma.
- Individuals who are candidates for microwave ablation surgery.
Exclusion Criteria:
- Individuals who do not have hepatocellular carcinoma.
- Individuals who are not a candidate for laparoscopic microwave ablation surgery.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intraoperative Imaging
Laparoscopic microwave ablation surgery utilizing the Advanced Image Guidance system for needle placement.
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Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Successful Insertion of Ablation Antenna Into Target Lesion
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
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Once the ablation antenna has been placed into the target lesion, the success or failure of the attempt will be confirmed with conventional ultrasound alone, in two planes.
If the placement is deemed successful, the surgeon will commence the ablation of the tumor.
If the placement is deemed insufficient, the probe will be removed and another placement will be attempted using conventional guidance.
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Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM)
Tidsramme: Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
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A subjective grading scale from which the surgeon will provide the relative ease of lesion targeting using Advanced Image Guidance (AIM) and the guidance system; the scale will be numbered 1-5 with one being significantly difficult and five being significantly easy.
The percentage of participants with a score of 5 is reported below.
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Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2012
Primær færdiggørelse (Faktiske)
1. september 2013
Studieafslutning (Faktiske)
1. februar 2014
Datoer for studieregistrering
Først indsendt
7. maj 2012
Først indsendt, der opfyldte QC-kriterier
14. august 2012
Først opslået (Skøn)
16. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. april 2022
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12-11-13B
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