Intermittent Suction Technique in the Diagnosis of Pancreatic Solid Lesions
Intermittent Versus Continuous Suction Technique in the Diagnosis of Pancreatic Solid Lesions. A Pilot Study.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Madrid, Spain, 28006
- Hospital Universitario de la Princesa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pancreatic solid lesion
- Patients over 18 years old
- Suitable for endoscopy
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intermittent aspiration
Empty syringe of 10cc and intermittent aspiration during puncture
|
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.
|
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No Intervention: Continous/standard aspiration
Empty syringe of 10cc and continous aspiration during puncture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increase in diagnostic yield of pancreatic solid lesions
Time Frame: Baseline
|
Percentage of increase in positive smears between intermittent and continous suction
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sample cellularity
Time Frame: Baseline
|
Number of malignant clusters of cells on each endoscopic pass
|
Baseline
|
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Blood contamination
Time Frame: Baseline
|
Percentage of blood contamination of the slides
|
Baseline
|
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Number of passes to reach diagnosis
Time Frame: Baseline
|
Number of passes needed to achieve a positive cytological diagnosis
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Herranz Pérez, MD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHerranz3638
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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