- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01795066
Endoscopic Ultrasound-guided Fine Needle Biopsy With 25-gauge Biopsy Needles for Solid Pancreatic Masses
27 mars 2019 uppdaterad av: Yonsei University
For 12 months after approvement by the University of Yonsei institutional review board, of the 59 patients older than 20 years referred to our medical center for EUS-FNA or FNB, all consecutive pancreatic lesions were evaluated for inclusion in our prospective study.
The inclusion criteria for this study were the following: diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies with need of histologic tissue confirmation by EUS-FNA or EUS-FNB.
The exclusion criteria were the following: cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study.
Patients undergoing anticoagulant or anti- platelet therapy for non-critical problems discontinued treatment at least 5 days before the endoscopic procedure.
Written informed consent was obtained from all patients for the procedures performed and participation in the study, and the study protocol was approved by the University of Yonsei institutional review board.
All patients were underwent the procedure under conscious sedation with propofol and midazolam according to the current guidelines.8
After procedure, the patients were monitored for at least six hours in order to immediately detect post-procedural complications and were followed for up to 7 days in order to detect late complications.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
56
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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Seoul, Korea, Republiken av, 120-752
- Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Patients older than 20 years referred to our medical center for EUS-FNA or FNB with diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies
Exclusion Criteria:
- cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: EUS-FNB with 25-gauge
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Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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accessing the rate for procurement of the histologic core
Tidsram: up to 5 minuites after endoscopic ultrasound-guided fine needle biopsy
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The tissue samples were immediately fixed in formalin.
The histologic cassette was processed, embedded in paraffin, and then prepared in hematoxylin and eosin to be evaluated by one pathologist (K.H.K) for the presence of a histologic core.
If the histologic core was present, the specimen was graded as optimal or suboptimal.
Optimal specimens were those in which the procured material enabled satisfactory assessment of histologic architecture that either did not change the original diagnosis or yielded additional findings.
Suboptimal specimens were those in which the quality of the histologic core was unsatisfactory for assessment of histologic architecture.
When required, immunohistochemical or special staining was performed for differentiation of morphologically challenging lesions.10
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up to 5 minuites after endoscopic ultrasound-guided fine needle biopsy
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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the percentage of cases in which pathologists classified the sample quality as optimal for histological evaluation of 25-gauge biopsy needle
Tidsram: up to 5 minuites after after endoscopic ultrasound-guided fine needle biopsy
|
The tissue samples were immediately fixed in formalin.
The histologic cassette was processed, embedded in paraffin, and then prepared in hematoxylin and eosin to be evaluated by one pathologist (K.H.K) for the presence of a histologic core.
If the histologic core was present, the specimen was graded as optimal or suboptimal.
Optimal specimens were those in which the procured material enabled satisfactory assessment of histologic architecture that either did not change the original diagnosis or yielded additional findings.
Suboptimal specimens were those in which the quality of the histologic core was unsatisfactory for assessment of histologic architecture.
When required, immunohistochemical or special staining was performed for differentiation of morphologically challenging lesions.10
|
up to 5 minuites after after endoscopic ultrasound-guided fine needle biopsy
|
Samarbetspartners och utredare
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Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2013
Primärt slutförande (Faktisk)
22 januari 2015
Avslutad studie (Faktisk)
22 januari 2015
Studieregistreringsdatum
Först inskickad
12 februari 2013
Först inskickad som uppfyllde QC-kriterierna
16 februari 2013
Första postat (Uppskatta)
20 februari 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 mars 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 mars 2019
Senast verifierad
1 december 2015
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 4-2012-0856
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .