Pancreatic CancerNCT03829748
Intermittent Suction Technique in the Diagnosis of Pancreatic Solid Lesions
A study testing Intermittent aspiration in people with Pancreatic Cancer and Pancreatic Neoplasms, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
Trial summary
The aim of this study is to compare the diagnostic yield of intermittent versus continuous suction in the diagnosis of pancreatic solid lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Neoplasms
- What is being tested?
- Intermittent aspiration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 16 Jan 2019to 1 Mar 2020
- 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
- Pancreatic solid lesion
- Patients over 18 years old
- Suitable for endoscopy
Who cannot join
- Contraindication for endoscopy
- Active anticoagulant therapy
- Thrombocytopenia or coagulopathy in the absence of its correction prior to the procedure
- Absence of informed consent
- Pregnancy
- Not accessible lesion for endoscopic ultrasound puncture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Versus Continuous Suction Technique in the Diagnosis of Pancreatic Solid Lesions. A Pilot Study.
The aim of this study is to compare the diagnostic yield of intermittent versus continuous suction in the diagnosis of pancreatic solid lesions.
Read the detailed description
Solid lesions of the pancreas can be neoplastic or non neoplastic and it is important to accurately differentiate between them because of the poor prognosis related to pancreatic neoplasm. There are many types of solid pancreatic lesions: pancreatic adenocarcinoma, neuroendocrine tumor, lymphoma, solid pseudopapillary neoplasm and pancreatic metastasis.
There are several diagnostic methods for the study of pancreatic solid lesions. The different imaging test allow detection and characterization of those lesions, but most times an anatomopathological diagnosis is needed before stablishing the most appropriate treatment.
Endoscopic Ultrasound guided fine needle aspiration (EUS-FNA) is the diagnostic method of choice for the diagnosis of these lesions as it detects small lesions that sometimes cannot be found in radiological imaging test, evaluates vascular invasion and the presence of liver metastasis, and allows pancreatic puncture for a cytological diagnosis. EUS-FNA is the safest technique for pancreatic puncture and the least related to needle track seeding.
In order to gather as much material as possible different techniques have been proposed:
- Fanning technique and multiple pass technique: to guide the needle into different regions of the target lesions with or without removing the needle out of the lesion depending on wether the lesion is hard or soft.
- Use of stylet: there are no data clearly demonstrating that the use of suction increases the yield of EUS-FNA. Some authors do slow withdrawal of the stylet.
- Size of the needle: 19 gauge, 22 gauge, 25 gauge, depending on the localization, size and vascularization. There is increasing evidence that smaller needles offer at least similar results in diagnostic yield compared to larger needles and are also easier to manipulate.
- Use of suction: there is conflicting evidence in this point. Several studies have evaluated the use of high volume aspiration vs low volume aspiration, continous aspiration vs no aspiration and suction with empty syringe vs water-filled syringe but none is clearly better than other.
The investigators aim is to evaluate if the use of intermittent suction improves the diagnostic yield of pancreatic lesions compared to standard (continuous) suction. Up to our knowledge this method has not been yet evaluated.
- Conditions
- Pancreatic Cancer, Pancreatic Neoplasms
- Being tested
- Intermittent aspiration
- Keywords
- Pancreatic adenocarcinoma, Endoscopic ultrasound, Fine-needle aspiration
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent aspirationProcedure or surgery
Endoscopic ultrasound is done for the localization of the lesion and to localize the site of puncture.Prior to the puncture of the lesion the stylet is removed and a vacuum syringe is prepared with 10 cc of vacuum allowing the generation of continous pressure inside and connected to the end of the needle. Once the lesion is punctured 15 movements in and out of the lesions will be made while the syringe is opened and closed on and off for a total of 3 times each pass. A total of 4 passes will be done in each lesion.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent aspiration | Experimental | Empty syringe of 10cc and intermittent aspiration during puncture Receives: Procedure: Intermittent aspiration |
| Continous/standard aspiration | No intervention | Empty syringe of 10cc and continous aspiration during puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in diagnostic yield of pancreatic solid lesions
Percentage of increase in positive smears between intermittent and continous suction
Measured: Baseline
Secondary outcomes (3)
Sample cellularity
Number of malignant clusters of cells on each endoscopic pass
Measured: Baseline
Blood contamination
Percentage of blood contamination of the slides
Measured: Baseline
Number of passes to reach diagnosis
Number of passes needed to achieve a positive cytological diagnosis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start16 Jan 2019
- Primary completion16 Jan 2020
- Study completion1 Mar 2020
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herranz Pérez, MD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829748
- Sponsor's protocol ID
- RHerranz3638
- Status last verified
- May 2020
- First submitted
- 22 Jan 2019
- Last updated
- 22 May 2020
- 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 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Versus Continuous Suction Technique in the Diagnosis of Pancreatic Solid Lesions. A Pilot Study.
- ClinicalTrials.gov ID
- NCT03829748
- Acronym / sponsor ID
- RHerranz3638
- Conditions
- Pancreatic Cancer, Pancreatic Neoplasms
- Keywords
- Pancreatic adenocarcinoma, Endoscopic ultrasound, Fine-needle aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 4 Feb 2019 (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.
The aim of this study is to compare the diagnostic yield of intermittent versus continuous suction in the diagnosis of pancreatic solid lesions.
Detailed description
Solid lesions of the pancreas can be neoplastic or non neoplastic and it is important to accurately differentiate between them because of the poor prognosis related to pancreatic neoplasm. There are many types of solid pancreatic lesions: pancreatic adenocarcinoma, neuroendocrine tumor, lymphoma, solid pseudopapillary neoplasm and pancreatic metastasis.
There are several diagnostic methods for the study of pancreatic solid lesions. The different imaging test allow detection and characterization of those lesions, but most times an anatomopathological diagnosis is needed before stablishing the most appropriate treatment.
Endoscopic Ultrasound guided fine needle aspiration (EUS-FNA) is the diagnostic method of choice for the diagnosis of these lesions as it detects small lesions that sometimes cannot be found in radiological imaging test, evaluates vascular invasion and the presence of liver metastasis, and allows pancreatic puncture for a cytological diagnosis. EUS-FNA is the safest technique for pancreatic puncture and the least related to needle track seeding.
In order to gather as much material as possible different techniques have been proposed:
- Fanning technique and multiple pass technique: to guide the needle into different regions of the target lesions with or without removing the needle out of the lesion depending on wether the lesion is hard or soft.
- Use of stylet: there are no data clearly demonstrating that the use of suction increases the yield of EUS-FNA. Some authors do slow withdrawal of the stylet.
- Size of the needle: 19 gauge, 22 gauge, 25 gauge, depending on the localization, size and vascularization. There is increasing evidence that smaller needles offer at least similar results in diagnostic yield compared to larger needles and are also easier to manipulate.
- Use of suction: there is conflicting evidence in this point. Several studies have evaluated the use of high volume aspiration vs low volume aspiration, continous aspiration vs no aspiration and suction with empty syringe vs water-filled syringe but none is clearly better than other.
The investigators aim is to evaluate if the use of intermittent suction improves the diagnostic yield of pancreatic lesions compared to standard (continuous) suction. Up to our knowledge this method has not been yet evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent aspiration | Experimental | Procedure: Intermittent aspirationEmpty syringe of 10cc and intermittent aspiration during puncture |
| Continous/standard aspiration | No intervention | –Empty syringe of 10cc and continous aspiration during puncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pancreatic solid lesion
- Patients over 18 years old
- Suitable for endoscopy
Key exclusion criteria (6 listed)
- Contraindication for endoscopy
- Active anticoagulant therapy
- Thrombocytopenia or coagulopathy in the absence of its correction prior to the procedure
- Absence of informed consent
- Pregnancy
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 |
|---|---|---|
| Intermittent aspirationEndoscopic ultrasound is done for the localization of the lesion and to localize the site of puncture.Prior to the puncture of the lesion the stylet is removed and a vacuum syringe is prepared with 10 cc of vacuum allowing the generation of continous pressure inside and connected to the end of the needle. Once the lesion is punctured 15 movements in and out of the lesions will be made while the syringe is opened and closed on and off for a total of 3 times each pass. A total of 4 passes will be done in each lesion. | Procedure or surgery | Intermittent aspiration |
Primary outcome
Increase in diagnostic yield of pancreatic solid lesions
Time frame: Baseline
Percentage of increase in positive smears between intermittent and continous suction
3 secondary outcomes
Sample cellularity
Time frame: Baseline
Blood contamination
Time frame: Baseline
Number of passes to reach diagnosis
Time frame: Baseline
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 22 May 2020.
- Individual participant dataSharing planned: No
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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.
Herranz Pérez, MD principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent aspiration in people with Pancreatic Cancer and Pancreatic Neoplasms, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 22 May 2020. 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 Spain. 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?
Increase in diagnostic yield of pancreatic solid lesions (time frame: Baseline). 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 22 May 2020.