Pancreatic Solid LesionsNCT04924751
Contrast-Enhanced Harmonic vs Conventional EUS-guided Fine Needle Biopsy for Solid Pancreatic Lesions: Randomized Controlled Trial
A study testing Endoscopic ultrasound-guided fine needle biopsy in people with Pancreatic Solid Lesions, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In the previous studies, EUS-guided fine needle aspiration (FNA) with fanning technique in solid pancreatic lesions (SPLs) with avascular areas had a negative impact on diagnostic accuracy of FNA. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Solid Lesions
- What is being tested?
- Endoscopic ultrasound-guided fine needle biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Mar 2020to 17 Mar 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged more than 20years, referred for EUS-guided tissue acquisition for solid pancreatic lesions greater than 1cm in the largest diameter will be recruited.
Who cannot join
- Patients with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy and those who cannot provide informed consent would be excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Yu-Ting Kuo, MD, MSc, +886-972652398, sfstruck@gmail.com
About this study
Official title: National Taiwan University Hospital
In the previous studies, EUS-guided fine needle aspiration (FNA) with fanning technique in solid pancreatic lesions (SPLs) with avascular areas had a negative impact on diagnostic accuracy of FNA. Because of the retrospective basis of previous studies, a prospective study is warranted to answer whether contrast-enhanced harmonic(CEH) EUS-guided FNA/B is superior to conventional EUS-guided FNA/B with fanning technique in SPLs. The main objective of this randomized trial therefore was to determine whether CEH-EUS-guided sampling to avoid non-enhanced areas within a mass lesion result in more rapid diagnosis requiring fewer FNB passes than the conventional EUS-guided FNB with fanning needle throughout the mass is targeted.
Read the detailed description
A prospective randomized controlled study was undertaken of patients with solid pancreatic mass lesions who were referred for EUS. Total 120 patients were randomized with 1:1 ratio into undergo CEH-EUS-guided FNB or conventional EUS-guided FNB with fanning technique. At the time of the procedure, the endoscopy nurse opened an envelope containing computer-generated randomization assignments for the study patients. All procedures were performed by a linear array echoendoscope (Olympus UCT260; Olympus, Tokyo, Japan). Procedures were performed under conscious sedation with patients in the left lateral decubitus position.
In CEH-EUS-guided FNB group, needle puncture directly to the enhancing area 15-20 times without passing to the non-enhancing area was performed. In conventional-EUS-guided FNB with fanning technique group, the needle was positioned at four different areas within the mass and then moved back and forth four times in each area to procure tissue (4 × 4). After each pass, the needle is removed and the stylet will be introduced into the needle to extrude any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). The total length of the MVC will be measured before placement into a formalin bottle. EUS-FNB is completed if the obtained MVC is longer than 4mm and deemed adequate by endoscopist. If the obtained MVC is < 4mm, the procedure is repeated until a MVC of ≥ 4mm is obtained and deemed adequate by endoscopist. A maximum of 7 passes is allowed.
- Conditions
- Pancreatic Solid Lesions
- Being tested
- Endoscopic ultrasound-guided fine needle biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound-guided fine needle biopsyDiagnostic test
Under endoscopic ultrasound guidance, fine-needle biopsy is used to collect biopsy samples from solid pancreatic lesions throughout the digestive tract and is useful in diagnosing solid pancreatic lesions.
| Study group | Role | What they receive |
|---|---|---|
| CEH-EUS-guided FNB group | Experimental | In CEH-EUS-guided FNB group, needle puncture directly to the enhancing area 15-20 times without passing to the non-enhancing area was performed. After each pass, the needle is removed and the stylet will be introduced into the needle to extrude any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). The total length of the MVC will be measured before placement into a formalin bottle. EUS-FNB is completed if the obtained MVC is longer than 4mm and deemed adequate by endoscopist. If the obtained MVC is < 4mm, the procedure is repeated until a MVC of ≥ 4mm is obtained and deemed adequate by endoscopist. A maximum of 7 passes is allowed. Receives: Diagnostic Test: Endoscopic ultrasound-guided fine needle biopsy |
| Conventional-EUS-guided FNB with fanning technique group | Active comparator | In conventional-EUS-guided FNB with fanning technique group, the needle was positioned at four different areas within the mass and then moved back and forth four times in each area to procure tissue (4 × 4). After each pass, the needle is removed and the stylet will be introduced into the needle to extrude any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). The total length of the MVC will be measured before placement into a formalin bottle. EUS-FNB is completed if the obtained MVC is longer than 4mm and deemed adequate by endoscopist. If the obtained MVC is < 4mm, the procedure is repeated until a MVC of ≥ 4mm is obtained and deemed adequate by endoscopist. A maximum of 7 passes is allowed. Receives: Diagnostic Test: Endoscopic ultrasound-guided fine needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the median number of passes required to establish a diagnosis
EUS-FNB is completed if the obtained macroscopic visible core (MVC) is longer than 4mm and deemed adequate by endoscopist
Measured: 1 day
Secondary outcomes (2)
diagnostic accuracy rate
Diagnostic accuracy was defined as the proportion of patients in whom successful diagnosis was reached within the procedure
Measured: 3 months
overall complication rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start17 Mar 2020
- Primary completion10 May 2021
- Study completion17 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Solid LesionsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924751
- Sponsor's protocol ID
- 201905065RIND
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taiwan University Hospital
- ClinicalTrials.gov ID
- NCT04924751
- Acronym / sponsor ID
- 201905065RIND
- Conditions
- Pancreatic Solid Lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 17 Mar 2022 (estimated)
- First posted
- 14 Jun 2021 (actual)
- 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.
In the previous studies, EUS-guided fine needle aspiration (FNA) with fanning technique in solid pancreatic lesions (SPLs) with avascular areas had a negative impact on diagnostic accuracy of FNA. Because of the retrospective basis of previous studies, a prospective study is warranted to answer whether contrast-enhanced harmonic(CEH) EUS-guided FNA/B is superior to conventional EUS-guided FNA/B with fanning technique in SPLs. The main objective of this randomized trial therefore was to determine whether CEH-EUS-guided sampling to avoid non-enhanced areas within a mass lesion result in more rapid diagnosis requiring fewer FNB passes than the conventional EUS-guided FNB with fanning needle throughout the mass is targeted.
Detailed description
A prospective randomized controlled study was undertaken of patients with solid pancreatic mass lesions who were referred for EUS. Total 120 patients were randomized with 1:1 ratio into undergo CEH-EUS-guided FNB or conventional EUS-guided FNB with fanning technique. At the time of the procedure, the endoscopy nurse opened an envelope containing computer-generated randomization assignments for the study patients. All procedures were performed by a linear array echoendoscope (Olympus UCT260; Olympus, Tokyo, Japan). Procedures were performed under conscious sedation with patients in the left lateral decubitus position.
In CEH-EUS-guided FNB group, needle puncture directly to the enhancing area 15-20 times without passing to the non-enhancing area was performed. In conventional-EUS-guided FNB with fanning technique group, the needle was positioned at four different areas within the mass and then moved back and forth four times in each area to procure tissue (4 × 4). After each pass, the needle is removed and the stylet will be introduced into the needle to extrude any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). The total length of the MVC will be measured before placement into a formalin bottle. EUS-FNB is completed if the obtained MVC is longer than 4mm and deemed adequate by endoscopist. If the obtained MVC is < 4mm, the procedure is repeated until a MVC of ≥ 4mm is obtained and deemed adequate by endoscopist. A maximum of 7 passes is allowed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEH-EUS-guided FNB group | Experimental | Diagnostic Test: Endoscopic ultrasound-guided fine needle biopsyIn CEH-EUS-guided FNB group, needle puncture directly to the enhancing area 15-20 times without passing to the non-enhancing area was performed. After each pass, the needle is removed and the stylet will be introduced into the needle to extrude any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). The total length of the MVC will be measured before placement into a formalin bottle. EUS-FNB is completed if the obtained MVC is longer than 4mm and deemed adequate by endoscopist. If the obtained MVC is < 4mm, the procedure is repeated until a MVC of ≥ 4mm is obtained and deemed adequate by endoscopist. A maximum of 7 passes is allowed. |
| Conventional-EUS-guided FNB with fanning technique group | Active comparator | Diagnostic Test: Endoscopic ultrasound-guided fine needle biopsyIn conventional-EUS-guided FNB with fanning technique group, the needle was positioned at four different areas within the mass and then moved back and forth four times in each area to procure tissue (4 × 4). After each pass, the needle is removed and the stylet will be introduced into the needle to extrude any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). The total length of the MVC will be measured before placement into a formalin bottle. EUS-FNB is completed if the obtained MVC is longer than 4mm and deemed adequate by endoscopist. If the obtained MVC is < 4mm, the procedure is repeated until a MVC of ≥ 4mm is obtained and deemed adequate by endoscopist. A maximum of 7 passes is allowed. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged more than 20years, referred for EUS-guided tissue acquisition for solid pancreatic lesions greater than 1cm in the largest diameter will be recruited.
Key exclusion criteria (1 listed)
- Patients with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy and those who cannot provide informed consent would be excluded.
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 |
|---|---|---|
| Endoscopic ultrasound-guided fine needle biopsyUnder endoscopic ultrasound guidance, fine-needle biopsy is used to collect biopsy samples from solid pancreatic lesions throughout the digestive tract and is useful in diagnosing solid pancreatic lesions. | Diagnostic test | CEH-EUS-guided FNB group, Conventional-EUS-guided FNB with fanning technique group |
Primary outcome
the median number of passes required to establish a diagnosis
Time frame: 1 day
EUS-FNB is completed if the obtained macroscopic visible core (MVC) is longer than 4mm and deemed adequate by endoscopist
2 secondary outcomes
diagnostic accuracy rate
Time frame: 3 months
overall complication rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound-guided fine needle biopsy in people with Pancreatic Solid Lesions, run by National Taiwan University Hospital at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 14 Jun 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Ting Kuo, MD, MSc (+886-972652398, sfstruck@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the median number of passes required to establish a diagnosis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2021.