Intermittent Suction Technique in the Diagnosis of Pancreatic Solid Lesions
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|ClinicalTrials.gov Identifier: NCT03829748|
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Pancreatic Neoplasms||Procedure: Intermittent aspiration||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Intermittent Versus Continuous Suction Technique in the Diagnosis of Pancreatic Solid Lesions. A Pilot Study.|
|Actual Study Start Date :||January 16, 2019|
|Estimated Primary Completion Date :||January 16, 2020|
|Estimated Study Completion Date :||April 15, 2020|
Experimental: Intermittent aspiration
Empty syringe of 10cc and intermittent aspiration during puncture
Procedure: Intermittent aspiration
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.
No Intervention: Continous/standard aspiration
Empty syringe of 10cc and continous aspiration during puncture
- Increase in diagnostic yield of pancreatic solid lesions [ Time Frame: Baseline ]Percentage of increase in positive smears between intermittent and continous suction
- Sample cellularity [ Time Frame: Baseline ]Number of malignant clusters of cells on each endoscopic pass
- Blood contamination [ Time Frame: Baseline ]Percentage of blood contamination of the slides
- Number of passes to reach diagnosis [ Time Frame: Baseline ]Number of passes needed to achieve a positive cytological diagnosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829748
|Contact: Herranz Pérez, MDfirstname.lastname@example.org|
|Hospital Universitario de la Princesa||Recruiting|
|Madrid, Spain, 28006|
|Contact: Raquel Herranz Pérez 675124482 email@example.com|
|Sub-Investigator: Felipe de la Morena|
|Sub-Investigator: Cecilio Santander|
|Principal Investigator: Raquel Herranz|
|Principal Investigator:||Herranz Pérez, MD||Fundación de Investigación Biomédica - Hospital Universitario de La Princesa|