An interventional study of EUS-guided fine needle biopsy sampling (EUS-FNB) in Neoplasms, sponsored by Per Hedenström. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-28.
Sponsored by Per Hedenström · Not applicable, Interventional, and Diagnostic
Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology and/or fine needle biopsy (FNB) for histology may be used in the diagnostic work-up of intrathoracic and intrabdominal lesion of unknown origin. Certain lesions (such as pancreatic adenocarcinoma) are often well characterized by cytology assessment of FNA-samples while others are not (such as GIST-tumors).
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.
Variables affecting the diagnostic accuracy of EUS-FNA and EUS-FNB in different cases and tumor scenarios will be studied in detail such as the influence of medical equipment used (i.e the different types and sizes of puncture needles), the experience of the endosonographers, cytopathologists and pathologists and the use of rapid on-site evaluation of cytology samples.
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.
9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 1,000 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with Per Hedenström as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Study subjects (patients) undergoing endoscopic ultrasound (with or without FNA/TCB) for clinical reasons during 2005-2011.
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.
Device: EUS-guided fine needle biopsy sampling (EUS-FNB)
Dual sampling with EUS-FNA and EUS-FNB in a randomized order.
The cellular quality of the EUS-FNA specimens (categorical variable).
Specimens are measured on a standardized 5-grade categorical scale - from 1 (=poor, non-diagnostic yield) to 5 (excellent, completely diagnostic yield). There is no specific unit measured (the variable is not a continuous one). The results from cytology assessment of EUS-derived tissue are compared to the final diagnosis, that is based on the subsequent surgery report. Results from FNA and FNB are regarded equally important. That is why both are treated as Primary Outcomes.
Time frame: Follow up is by time of surgery (in average 2 months after EUS-FNA)
The histological quality of the EUS-FNB specimens (categorical variable).
Specimens are measured on a standardized 5-grade categorical scale - from 1 (=poor, non-diagnostic yield) to 5 (excellent, completely diagnostic yield). There is no specific unit measured (the variable is not a continuous one). The results from pathology assessment of EUS-derived tissue are compared to the final diagnosis, that is based on the subsequent surgery report. Results from FNA and FNB are regarded equally important. That is why both are treated as Primary Outcomes.
Time frame: Follow up is by time of surgery (in average 2 months after EUS-FNB)
Immunohistochemistry profiling of EUS
The immunohistochemical (IHC) profile of tumor material from EUS-samples will be compared to the immunohistochemical profile of tissue derived from surgery of the very same case (categorical variable, Yes (1) = correct IHC-profiling by EUS or No (2) = non-correct IHC-profiling by EUS).
Time frame: Follow up is by time of surgery (in average 2 months after EUS)
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.