Pancreatic CancerONE PASSNCT05436704
Is One Pass Enough for the Diagnosis of the Pancreatic Masses During EUS-FNB?
An observational study of Pancreatic Cancer, run by Istituto Clinico Humanitas Mater Domini at 1 site in Italy.
Trial summary
Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Major complications after EUS-TA of solid masses are rare. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- EUS-FNB
- Type of treatment
- Surgery or procedure
- How many people
- 79 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jun 2022to 30 Jun 2024
- Phase
- Observational
- 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
Study population: 79 patients with solid pancreatic masses underwent EUS-FNB will be included.
Who may be able to join
- Age greater than 18, both genders.
- Both in-patient and out-patients.
- Presence of a solid lesion. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
- FNB performed by a 22G needle Acquire® (Boston Scientific).
- Tissue acquisition with fanning technique.
- Able to obtained informed consent.
Who cannot join
- Patients underwent EUS-FNA with or without ROSE
- Patients underwent EUS-FNB plus ROSE.
- Previous biopsy of the lesion with diagnosis of malignancy
- Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
- Pregnancy or breast-feeding.
- Patients unable to understand and/or read the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is One Pass Enough for the Diagnosis of the Pancreatic Masses During EUS-FNB? A Prospective Study
Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Major complications after EUS-TA of solid masses are rare. Several studies have been published in the last recent years aimed to identify factors related to a non-diagnostic or false-negative EUS-FNA, and to improve its diagnostic yield using different needle gauge and different tissue acquisition technique as fanning technique, slow-pull stylet extraction or suction technique.
To overcome this problem, new EUS-TA needles entered in clinical practice to obtain histological specimens increasing the accuracy of the EUS-TA. Preliminary result with these new needles, called EUS-fine needle biopsy (FNB) are promising with an accuracy rate more than 90%.
Read more
Recently, Leungh et al. conducted an observational study to evaluate the role of macroscopic on-site evaluation (MOSE) on the diagnostic accuracy of 22G Franseen-tip needle. The study demonstrated that MOSE using the 22G Franseen tip needle could limit needle passes by accurately estimating histologic core fragments. However, the study limitations such as the small sample size and the lack of control group, hampered the value of the conclusions.
So, nowadays, no definitive data regarding how many needle passes need to be performed with FNB needles, neither regarding the use of MOSE to evaluate the specimens obtained with FNB needle. The MOSE technique of the acquired tissue was proposed for the first time by Iwashita et al, using a 19G needle and is nowadays a well-established technique with high accuracy in the final diagnosis.
The aim of our study is to evaluate if during EUS-FNB of pancreatic masses only one needle pass with MOSE evaluation can be satisfactory to obtain a correct diagnosis.
- Conditions
- Pancreatic Cancer
- Being tested
- EUS-FNB
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-FNBProcedure or surgery
EUS-FNB
| Study group | Role | What they receive |
|---|---|---|
| EUS-FNB | Not described Receives: Procedure: EUS-FNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic accuracy of one pass EUS-FNB.
EUS-FNB only one needle pass inside the target lesions with MOSE evaluation can be satisfactory to obtain a correct diagnosis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start21 Jun 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas Mater Domini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benedetto Mangiavillano, MD, Principal investigator, benedetto.mangiavillano@mc.humanitas.it
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436704
- Sponsor's protocol ID
- 07-2022
- Acronym
- ONE PASS
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is One Pass Enough for the Diagnosis of the Pancreatic Masses During EUS-FNB? A Prospective Study
- ClinicalTrials.gov ID
- NCT05436704
- Acronym / sponsor ID
- ONE PASS / 07-2022
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Istituto Clinico Humanitas Mater DominiUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 29 Jun 2022 (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.
Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Major complications after EUS-TA of solid masses are rare. Several studies have been published in the last recent years aimed to identify factors related to a non-diagnostic or false-negative EUS-FNA, and to improve its diagnostic yield using different needle gauge and different tissue acquisition technique as fanning technique, slow-pull stylet extraction or suction technique.
To overcome this problem, new EUS-TA needles entered in clinical practice to obtain histological specimens increasing the accuracy of the EUS-TA. Preliminary result with these new needles, called EUS-fine needle biopsy (FNB) are promising with an accuracy rate more than 90%.
Recently, Leungh et al. conducted an observational study to evaluate the role of macroscopic on-site evaluation (MOSE) on the diagnostic accuracy of 22G Franseen-tip needle. The study demonstrated that MOSE using the 22G Franseen tip needle could limit needle passes by accurately estimating histologic core fragments. However, the study limitations such as the small sample size and the lack of control group, hampered the value of the conclusions.
So, nowadays, no definitive data regarding how many needle passes need to be performed with FNB needles, neither regarding the use of MOSE to evaluate the specimens obtained with FNB needle. The MOSE technique of the acquired tissue was proposed for the first time by Iwashita et al, using a 19G needle and is nowadays a well-established technique with high accuracy in the final diagnosis.
The aim of our study is to evaluate if during EUS-FNB of pancreatic masses only one needle pass with MOSE evaluation can be satisfactory to obtain a correct diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-FNB | – | Procedure: EUS-FNB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 79 patients with solid pancreatic masses underwent EUS-FNB will be included.
Key inclusion criteria (6 listed)
- Age greater than 18, both genders.
- Both in-patient and out-patients.
- Presence of a solid lesion. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
- FNB performed by a 22G needle Acquire® (Boston Scientific).
- Tissue acquisition with fanning technique.
Key exclusion criteria (6 listed)
- Patients underwent EUS-FNA with or without ROSE
- Patients underwent EUS-FNB plus ROSE.
- Previous biopsy of the lesion with diagnosis of malignancy
- Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
- Pregnancy or breast-feeding.
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-FNBEUS-FNB | Procedure or surgery | EUS-FNB |
Primary outcome
The diagnostic accuracy of one pass EUS-FNB.
Time frame: 24 months
EUS-FNB only one needle pass inside the target lesions with MOSE evaluation can be satisfactory to obtain a correct diagnosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Benedetto Mangiavillano, MD principal investigator
benedetto.mangiavillano@mc.humanitas.it
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Istituto Clinico Humanitas Mater Domini at 1 site in Italy.
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 6 inclusion and 6 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 29 Jun 2022. 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 Italy. 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?
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 diagnostic accuracy of one pass EUS-FNB. (time frame: 24 months). 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 29 Jun 2022.