The Use of FNA and FNB in the Optimization of EUS-assisted Tissue Sampling
NCT ID: NCT02360839
Last Updated: 2023-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1000 participants
INTERVENTIONAL
2009-07-31
2022-12-31
Brief Summary
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This study is a part observational (early study phase) and part interventional study (late study phase) on the diagnostic accuracy of EUS-assisted tissue sampling by FNA or FNB during a 10-year period on a tertiary endoscopy centre.
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Detailed Description
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Each study case is reviewed post-EUS (according to the schedule precised below) regarding further diagnostic work-up, neoadjuvant treatment, surgery result, clinical follow-up, (neo)adjuvant treatment, and survival. Non-parametrical tests will be applied as the main statistical method.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Early
Study subjects (patients) undergoing endoscopic ultrasound (with or without FNA/TCB) for clinical reasons during 2005-2011.
No interventions assigned to this group
Late
Study subjects (patients) undergoing endoscopic ultrasound with EUS-guided sampling of various lesions for clinical reasons during 20012-2015.
Subjects sampled with both EUS-FNA and EUS-FNB on the same lesion. Randomization on first needle order.
EUS-guided fine needle biopsy sampling (EUS-FNB)
Dual sampling with EUS-FNA and EUS-FNB in a randomized order.
Interventions
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EUS-guided fine needle biopsy sampling (EUS-FNB)
Dual sampling with EUS-FNA and EUS-FNB in a randomized order.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Per Hedenström
OTHER
Responsible Party
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Per Hedenström
Dr
Principal Investigators
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Riadh Sadik, Prof
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital, Gothenburg
Locations
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Dr Per Hedenström
Gothenburg, , Sweden
Countries
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References
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Hedenstrom P, Demir A, Khodakaram K, Nilsson O, Sadik R. EUS-guided reverse bevel fine-needle biopsy sampling and open tip fine-needle aspiration in solid pancreatic lesions - a prospective, comparative study. Scand J Gastroenterol. 2018 Feb;53(2):231-237. doi: 10.1080/00365521.2017.1421704. Epub 2018 Jan 4.
Other Identifiers
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Dnr 1092-11
Identifier Type: -
Identifier Source: org_study_id
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