Pancreas DiseaseNCT06298604
Motorized Fine Needle Biopsy vs Standard Needles
A study testing EUS-guided standard fine needle biopsy and EUS-guided motorized fine needle biopsy in people with Pancreas Disease and Liver Diseases, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
Trial summary
Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy. A newly developed motorized fine needle biopsy (mFNB), the Precision-GI (Limaca, Israel) promises intact tissue acquisition without sample damage, relying on controlled axial… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pancreas Disease, Liver Diseases
- What is being tested?
- EUS-guided standard fine needle biopsy and EUS-guided motorized fine needle biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEcuador
- Study dates
- 9 Dec 2023to 9 Dec 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18 and 99 years
- Patients referred to our center who require EUS-guided liver or pancreas biopsy.
- Male or female patients.
- Patients able to give consent
Who cannot join
- Pregnancy or nursing
- Patients with coagulation disorders (platelets <50.000/mm3, international normalised ratio (INR) >2)
- Any underlying medical condition that contraindicates EUS-guided fine needle biopsy such as anatomical alterations, significant gastric outlet obstruction, collateral intervening vessels.
Trial locations and contacts
1 site in 1 country.
Ecuador1 site, 1 recruiting
- Recruiting
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
Guayaquil, 090505
Carlos Robles-Medranda, MD FASGE, +593989158865, carlosoakm@yahoo.es
Carlos Robles-Medranda, MD FASGE
About this study
Official title: Comparison Between a Novel Motorized EUS Guided Fine Needle Biopsy (FNB) With Standard Needle for Pancreatic and Liver Biopsies
Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy. A newly developed motorized fine needle biopsy (mFNB), the Precision-GI (Limaca, Israel) promises intact tissue acquisition without sample damage, relying on controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition.
Given the advancement mentioned, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound (EUS)-guided pancreatic and liver specimens through a prospective, interventional, single-center trial. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy.
Read the detailed description
The development of Endoscopic ultrasound-guided tissue acquisition (EUS-TA) has been remarkable. Initially focused on obtaining samples from the pancreas, it has expanded significantly to include various organs adjacent to the gastrointestinal system (i.e., liver, lymph nodes, adrenal glands).
One of the key advancements in EUS-TA involves the shift from cytological analysis, with fine-needle aspiration (FNA), to histological and even genetic evaluations, with fine-needle biopsies (FNB). FNB addresses some limitations associated with FNA, such as low tumor cellularity and the inability to retain cellular architecture.
Recent improvements in puncture techniques and needles, allow for the collection of high-quality specimens, comparable to core needle biopsy, to achieve standards for specimen adequacy (i.e., intact liver cores of at least 15-20 mm with a complete portal triad count of 11). Some current available needle designs include the crown type, flanged type, 20 Gauge FNB needles with forward-faced core traps, and the fork-tip needles, demonstrating high diagnostic accuracy and a low rate of adverse events.
The Precision-GI is a new motorized fine needle (mFNB) developed by LIMACA Medical in Israel for EUS-guided FNB. It operates using a battery-powered motor that enables controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition. Moreover, a sharp stylet facilitates crossing through the gastrointestinal wall, allowing for the reach of target lesions. The rotational electromechanical cutting movement into the lesion promises intact motorized tissue acquisition without sample damage.
In the present study, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of EUS-guided pancreatic and liver specimens. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy.
- Conditions
- Pancreas Disease, Liver Diseases
- Being tested
- EUS-guided standard fine needle biopsy, EUS-guided motorized fine needle biopsy
- Keywords
- Fine-needle biopsy, Endosonography, liver, pancreas, pathology
- Medical subject headings
- Pancreatic Diseases, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided standard fine needle biopsyDevice
Using the echoendoscope, a pancreatic lesion or liver parenchyma will be identified, and a 19-gauge standard fine needle biopsy device (Boston Scientific, USA) is inserted on it to obtain the sample or specimen.
EUS-guided motorized fine needle biopsyDevice
Using the echoendoscope, a pancreatic lesion or liver parenchyma will be identified, and a 20-gauge motorized fine needle biopsy device (Limaca, Israel) is inserted on it to obtain the sample or specimen.
| Study group | Role | What they receive |
|---|---|---|
| Standard EUS-guided FNB | Active comparator | Patients scheduled for EUS-guided liver or pancreas biopsy will undergo the procedure using a standard 19-gauge needle Receives: Device: EUS-guided standard fine needle biopsy |
| Motorized EUS-guided FNB | Experimental | Patients scheduled for EUS-guided liver or pancreas biopsy will undergo the procedure using a motorized 20-gauge needle. Receives: Device: EUS-guided motorized fine needle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic ultrasound fine needle biopsy sample quality
Based on tissue "core"; Tissue core is defined as a architecturally intact piece of at least 550 micron in the greatest axis. The tissue core will be evaluated in both groups by the pathologist immediately after its acquisition.
Measured: Up to two hours after the procedures
Diagnostic accuracy according to histological analysis
Proportion of subjects with a definitive diagnosis based on the number of passes and throws for tissue acquisition.
Measured: Up to one week
Secondary outcomes (1)
Tissue blood contamination
Evaluation of tissue blood contamination will be based on a sample quality score:
- Only blood
- High (>50% of the surface of the slide)
- Moderate (25%-50% of the surface of the slide)
- Low (<25% of the surface of the slide)
Measured: Up to one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start9 Dec 2023
- Primary completion9 Oct 2024 (estimated)
- Study completion9 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreas DiseaseStudies 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
- Model description
- Prospective, diagnostic,, cross-sectional study
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Robles-Medranda, Instituto Ecuatoriano de Enfermedades Digestivas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298604
- Sponsor's protocol ID
- IECED-12112023
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mendoza Ladd A, Casner N, Cherukuri SV, Garcia C, Padilla O, Dwivedi A, Hakim N. Fine Needle Biopsies of Solid Pancreatic Lesions: Tissue Acquisition Technique and Needle Design Do Not Impact Specimen Adequacy. Dig Dis Sci. 2022 Sep;67(9):4549-4556. doi: 10.1007/s10620-021-07316-4. Epub 2021 Dec 2.
PubMed 34859313Di Mitri R, Mocciaro F, Antonini F, Scimeca D, Conte E, Bonaccorso A, Scibetta N, Unti E, Fornelli A, Giorgini S, Binda C, Macarri G, Larghi A, Fabbri C. Stylet slow-pull vs. standard suction technique for endoscopic ultrasound-guided fine needle biopsy in pancreatic solid lesions using 20 Gauge Procore needle: A multicenter randomized trial. Dig Liver Dis. 2020 Feb;52(2):178-184. doi: 10.1016/j.dld.2019.08.023. Epub 2019 Oct 7.
PubMed 31601535Fujita A, Ryozawa S, Tanisaka Y, Ogawa T, Saito Y, Katsuda H, Miyaguchi K, Yasuda M, Araki R, Mashimo Y, Tashima T, Nakano Y, Terada R, Jinushi R, Mizuide M. Comparison of Fork-tip and Franseen needles for endoscopic ultrasound-guided fine-needle biopsy in pancreatic solid lesions: A propensity-matched analysis. DEN Open. 2022 Jun 28;3(1):e147. doi: 10.1002/deo2.147. eCollection 2023 Apr.
PubMed 35898843
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between a Novel Motorized EUS Guided Fine Needle Biopsy (FNB) With Standard Needle for Pancreatic and Liver Biopsies
- ClinicalTrials.gov ID
- NCT06298604
- Acronym / sponsor ID
- IECED-12112023
- Conditions
- Pancreas Disease, Liver Diseases
- Keywords
- Fine-needle biopsy, Endosonography, liver, pancreas, pathology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades DigestivasUniversity, hospital or other
- Study start
- 9 Dec 2023 (actual)
- Primary completion
- 9 Oct 2024 (estimated)
- Study completion
- 9 Dec 2024 (estimated)
- First posted
- 7 Mar 2024 (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.
Recent improvements in punctures techniques and needles now allow for the collection of high-quality specimens comparable to core needle biopsy. A newly developed motorized fine needle biopsy (mFNB), the Precision-GI (Limaca, Israel) promises intact tissue acquisition without sample damage, relying on controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition.
Given the advancement mentioned, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of endoscopic ultrasound (EUS)-guided pancreatic and liver specimens through a prospective, interventional, single-center trial. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy.
Detailed description
The development of Endoscopic ultrasound-guided tissue acquisition (EUS-TA) has been remarkable. Initially focused on obtaining samples from the pancreas, it has expanded significantly to include various organs adjacent to the gastrointestinal system (i.e., liver, lymph nodes, adrenal glands).
One of the key advancements in EUS-TA involves the shift from cytological analysis, with fine-needle aspiration (FNA), to histological and even genetic evaluations, with fine-needle biopsies (FNB). FNB addresses some limitations associated with FNA, such as low tumor cellularity and the inability to retain cellular architecture.
Recent improvements in puncture techniques and needles, allow for the collection of high-quality specimens, comparable to core needle biopsy, to achieve standards for specimen adequacy (i.e., intact liver cores of at least 15-20 mm with a complete portal triad count of 11). Some current available needle designs include the crown type, flanged type, 20 Gauge FNB needles with forward-faced core traps, and the fork-tip needles, demonstrating high diagnostic accuracy and a low rate of adverse events.
The Precision-GI is a new motorized fine needle (mFNB) developed by LIMACA Medical in Israel for EUS-guided FNB. It operates using a battery-powered motor that enables controlled axial tissue cutting and high-speed rotational coring for optimized tissue acquisition. Moreover, a sharp stylet facilitates crossing through the gastrointestinal wall, allowing for the reach of target lesions. The rotational electromechanical cutting movement into the lesion promises intact motorized tissue acquisition without sample damage.
In the present study, the investigators aim to compare the performance of the mFNB with the standard needle during the acquisition of EUS-guided pancreatic and liver specimens. The study will consist of two groups of patients: one assigned to the standard fine needle biopsy (FNB) and the other to the mFNB. The primary study outcomes will include sample quality (core integrity), and diagnostic accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Prospective, diagnostic,, cross-sectional study
| Arm | Type | Receives |
|---|---|---|
| Standard EUS-guided FNB | Active comparator | Device: EUS-guided standard fine needle biopsyPatients scheduled for EUS-guided liver or pancreas biopsy will undergo the procedure using a standard 19-gauge needle |
| Motorized EUS-guided FNB | Experimental | Device: EUS-guided motorized fine needle biopsyPatients scheduled for EUS-guided liver or pancreas biopsy will undergo the procedure using a motorized 20-gauge needle. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between 18 and 99 years
- Patients referred to our center who require EUS-guided liver or pancreas biopsy.
- Male or female patients.
- Patients able to give consent
Key exclusion criteria (3 listed)
- Pregnancy or nursing
- Patients with coagulation disorders (platelets <50.000/mm3, international normalised ratio (INR) >2)
- Any underlying medical condition that contraindicates EUS-guided fine needle biopsy such as anatomical alterations, significant gastric outlet obstruction, collateral intervening vessels.
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 standard fine needle biopsyUsing the echoendoscope, a pancreatic lesion or liver parenchyma will be identified, and a 19-gauge standard fine needle biopsy device (Boston Scientific, USA) is inserted on it to obtain the sample or specimen. | Device | Standard EUS-guided FNB |
| EUS-guided motorized fine needle biopsyUsing the echoendoscope, a pancreatic lesion or liver parenchyma will be identified, and a 20-gauge motorized fine needle biopsy device (Limaca, Israel) is inserted on it to obtain the sample or specimen. | Device | Motorized EUS-guided FNB |
Primary outcome
Endoscopic ultrasound fine needle biopsy sample quality
Time frame: Up to two hours after the procedures
Based on tissue "core"; Tissue core is defined as a architecturally intact piece of at least 550 micron in the greatest axis. The tissue core will be evaluated in both groups by the pathologist immediately after its acquisition.
Diagnostic accuracy according to histological analysis
Time frame: Up to one week
Proportion of subjects with a definitive diagnosis based on the number of passes and throws for tissue acquisition.
1 secondary outcome
Tissue blood contamination
Time frame: Up to one hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Background: PubMed 34859313Mendoza Ladd A, Casner N, Cherukuri SV, Garcia C, Padilla O, Dwivedi A, Hakim N. Fine Needle Biopsies of Solid Pancreatic Lesions: Tissue Acquisition Technique and Needle Design Do Not Impact Specimen Adequacy. Dig Dis Sci. 2022 Sep;67(9):4549-4556. doi: 10.1007/s10620-021-07316-4. Epub 2021 Dec 2.
- Background: PubMed 31601535Di Mitri R, Mocciaro F, Antonini F, Scimeca D, Conte E, Bonaccorso A, Scibetta N, Unti E, Fornelli A, Giorgini S, Binda C, Macarri G, Larghi A, Fabbri C. Stylet slow-pull vs. standard suction technique for endoscopic ultrasound-guided fine needle biopsy in pancreatic solid lesions using 20 Gauge Procore needle: A multicenter randomized trial. Dig Liver Dis. 2020 Feb;52(2):178-184. doi: 10.1016/j.dld.2019.08.023. Epub 2019 Oct 7.
- Background: PubMed 35898843Fujita A, Ryozawa S, Tanisaka Y, Ogawa T, Saito Y, Katsuda H, Miyaguchi K, Yasuda M, Araki R, Mashimo Y, Tashima T, Nakano Y, Terada R, Jinushi R, Mizuide M. Comparison of Fork-tip and Franseen needles for endoscopic ultrasound-guided fine-needle biopsy in pancreatic solid lesions: A propensity-matched analysis. DEN Open. 2022 Jun 28;3(1):e147. doi: 10.1002/deo2.147. eCollection 2023 Apr.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreas Disease
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Active, not recruitingPhase 2
Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer
Pancreatic Cancer
RecruitingPhase 2/3
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
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.
Instituto Ecuatoriano de Enfermedades Digestivas (IECED)
Guayaquil, Ecuador
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 standard fine needle biopsy and EUS-guided motorized fine needle biopsy in people with Pancreas Disease and Liver Diseases, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
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 4 inclusion and 3 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 22 Mar 2024. 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 Ecuador. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopic ultrasound fine needle biopsy sample quality (time frame: Up to two hours after the procedures). 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 NCT06298604, which also lists 3 linked publications.
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 22 Mar 2024.