The Use of FNA and FNB in the Optimization of EUS-assisted Tissue Sampling

Neoplasms Clinical Trial

Official title:

The Use of FNA and FNB in the Optimization of EUS-assisted Tissue Sampling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360839
• Other study ID #: Dnr 1092-11
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Referral for a diagnostic EUS

Exclusion Criteria:

• Referral for an interventional EUS

Related Conditions & MeSH terms

• Neoplasms

Intervention

Device:
• EUS-guided fine needle biopsy sampling (EUS-FNB)
Dual sampling with EUS-FNA and EUS-FNB in a randomized order.

Locations

Country	Name	City	State
Sweden	Dr Per Hedenström	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Per Hedenström

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Follow up is by time of surgery (in average 2 months after EUS-FNA)
Primary	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.	Follow up is by time of surgery (in average 2 months after EUS-FNB)
Secondary	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).	Follow up is by time of surgery (in average 2 months after EUS)