NeoplasmsNCT02360839
The Use of FNA and FNB in the Optimization of EUS-assisted Tissue Sampling
A study testing EUS-guided fine needle biopsy sampling (EUS-FNB) in people with Neoplasms, run by Per Hedenström at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- EUS-guided fine needle biopsy sampling (EUS-FNB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSweden
- Study dates
- Jul 2009to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral for a diagnostic EUS
Who cannot join
- Referral for an interventional EUS
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Neoplasms
- Being tested
- EUS-guided fine needle biopsy sampling (EUS-FNB)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided fine needle biopsy sampling (EUS-FNB)Device
Dual sampling with EUS-FNA and EUS-FNB in a randomized order.
| Study group | Role | What they receive |
|---|---|---|
| Early | No intervention | Study subjects (patients) undergoing endoscopic ultrasound (with or without FNA/TCB) for clinical reasons during 2005-2011. |
| Late | Other | 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. Receives: Device: EUS-guided fine needle biopsy sampling (EUS-FNB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Follow up is by time of surgery (in average 2 months after EUS-FNB)
Secondary outcomes (1)
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).
Measured: Follow up is by time of surgery (in average 2 months after EUS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startJul 2009
- Primary completion31 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Hedenström
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Per Hedenström, Sahlgrenska University Hospital
- Investigators
- Riadh Sadik, Prof, Principal investigator, Sahlgrenska University Hospital, Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360839
- Sponsor's protocol ID
- Dnr 1092-11
- Status last verified
- Jun 2023
- First submitted
- 26 Jan 2015
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29301477
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of FNA and FNB in the Optimization of EUS-assisted Tissue Sampling
- ClinicalTrials.gov ID
- NCT02360839
- Acronym / sponsor ID
- Dnr 1092-11
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Per HedenströmUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early | No intervention | –Study subjects (patients) undergoing endoscopic ultrasound (with or without FNA/TCB) for clinical reasons during 2005-2011. |
| Late | Other | Device: EUS-guided fine needle biopsy sampling (EUS-FNB)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referral for a diagnostic EUS
Key exclusion criteria (1 listed)
- Referral for an interventional EUS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-guided fine needle biopsy sampling (EUS-FNB)Dual sampling with EUS-FNA and EUS-FNB in a randomized order. | Device | Late |
Primary outcome
The cellular quality of the EUS-FNA specimens (categorical variable).
Time frame: Follow up is by time of surgery (in average 2 months after EUS-FNA)
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.
The histological quality of the EUS-FNB specimens (categorical variable).
Time frame: Follow up is by time of surgery (in average 2 months after EUS-FNB)
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.
1 secondary outcome
Immunohistochemistry profiling of EUS
Time frame: Follow up is by time of surgery (in average 2 months after EUS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Derived from this study: PubMed 29301477Hedenstrom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riadh Sadik, Prof principal investigator
Sahlgrenska University Hospital, Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided fine needle biopsy sampling (EUS-FNB) in people with Neoplasms, run by Per Hedenström at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cellular quality of the EUS-FNA specimens (categorical variable). (time frame: Follow up is by time of surgery (in average 2 months after EUS-FNA)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02360839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.