- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04607720
Clinical Research on a Novel Deep-learning Based System in Pancreatic Mass Diagnosis
23. oktober 2020 oppdatert av: The Third Xiangya Hospital of Central South University
Clinical Research on a Noval Deep-learning Based System in Benign and Malignant Pancreatic Masses Diagnosing Under Harmonic Contrast-enhanced Endoscopic Ultrasound
In this study, a single-center, prospective, self-control, and blind design was adopted.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
It is planned to enroll 100 patients with solid pancreatic masses who are to be diagnosed with contrast-enhanced harmonic endoscopy ultrasonography (CH-EUS) follow by EUS-guided fine-needle aspiration (EUS-FNA).
First, all patients will be diagnosed both by the AI-assisted diagnosis system and the endoscopists under CH-EUS; Second, to compare the EUS-FNA under the guidance of the AI-assisted ultrasound diagnosis system and the EUS-FNA under manual identification, patients were randomly assigned to undergo EUS-FNA with or without the guidance of AI-assisted diagnosis system for the first two passes.
Studietype
Intervensjonell
Registrering (Forventet)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Hunan
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Changsha, Hunan, Kina, 410013
- Rekruttering
- The Third XIANGYA Hospital of Central South University
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Ta kontakt med:
- Wang Xiaoyan, MD
- Telefonnummer: +8613974889301
- E-post: wxy20011@163.com
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 90 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 1. Age ≥18 years old, <90 years old 2.The patient is confirmed to be a solid pancreatic mass in imaging examinations (MRI, CT or ultrasound), and CH-EUS is required for auxiliary diagnosis 3. Agree to participate in this study and sign the CH-EUS informed consent form
Exclusion Criteria:
- Subjects who meet any of the following criteria cannot be selected for this trial:
First. The patient's physical condition does not meet the requirements of conventional ultrasound endoscopic puncture:
- Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc.
- Blood coagulation dysfunction (platelet count <50×1012, international standardized ratio> 1.5) or taking oral anticoagulants such as aspirin or warfarin within a week
- Anesthesia assessment failed
- Had acute pancreatitis within 2 weeks
- Pregnancy or breastfeeding
- Known history of allergy to sulfur hexafluoride or other components
- Recent acute coronary syndrome or clinically unstable ischemic heart attack
- Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure> 90mmHg), patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome.
Second. Disagree to participate in this study
Third. There are other problems that do not meet the requirements of this research or that affect the results of the research:
- Pancreatic disease has undergone surgery or chemotherapy beforehand
- The patient was diagnosed with pancreatic cystic disease or duodenal stenosis
- Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: the artificial-EUS-FNA group
the first two passes were made without the AI-assisted diagnosis system guidance during EUS-FNA, and then two passes were made under guidance from the AI-assisted diagnosis system
|
The ultrasound endoscopists manually determined the region of interest (ROI) according to CH-EUS, and punctured 2 needles in the tumor area with a 22G needle, and each needle moved 15-20 times back and forth in the lesion.
After puncture, insert the needle core, rinse the needle with 0.1ml sterile saline, and further apply air flushing to ensure that each tissue is sent to the slide.
In the AI-assisted diagnosis system, the assisted targeting EUS-FNA unit is applied, and the ultrasound endoscopist selects the region of interest (ROI) according to the thermogram to perform targeted EUS-FNA puncture(2 needles in the same way).
|
|
Eksperimentell: the AI-EUS-FNA group
the first two passes were made with the AI-assisted diagnosis system guidance and then another two manual passes without the AI-assisted diagnosis system guidance.
|
The ultrasound endoscopists manually determined the region of interest (ROI) according to CH-EUS, and punctured 2 needles in the tumor area with a 22G needle, and each needle moved 15-20 times back and forth in the lesion.
After puncture, insert the needle core, rinse the needle with 0.1ml sterile saline, and further apply air flushing to ensure that each tissue is sent to the slide.
In the AI-assisted diagnosis system, the assisted targeting EUS-FNA unit is applied, and the ultrasound endoscopist selects the region of interest (ROI) according to the thermogram to perform targeted EUS-FNA puncture(2 needles in the same way).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
accuracy
Tidsramme: 1 year
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compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
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1 year
|
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sensitivity
Tidsramme: 1 year
|
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
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1 year
|
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specificity
Tidsramme: 1 year
|
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
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1 year
|
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positive predictive value
Tidsramme: 1 year
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compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
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1 year
|
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negative predictive value
Tidsramme: 1 year
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compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
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1 year
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the diagnosis rate of first needle aspiration
Tidsramme: 1 year
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compared the diagnosis rate of AI-EUS-FNA and artificial-EUS-FNA first needle aspiration for benign and malignant pancreatic masses
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1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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core tissue length
Tidsramme: 1 year
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To evaluate the specimen quality through core tissue length of AI-EUS-FNA and artificial-EUS-FNA
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1 year
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Li Tian, MD, The Third XIANGYA Hospital of Central South University
- Hovedetterforsker: Anliu Tang, MD, The Third XIANGYA Hospital of Central South University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2020
Primær fullføring (Forventet)
31. desember 2021
Studiet fullført (Forventet)
30. juni 2022
Datoer for studieregistrering
Først innsendt
18. oktober 2020
Først innsendt som oppfylte QC-kriteriene
23. oktober 2020
Først lagt ut (Faktiske)
29. oktober 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. oktober 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. oktober 2020
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2020-CH-EUS-AI
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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