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The aim of this study is to compare the diagnostic yield of intermittent versus continuous suction in the diagnosis of pancreatic solid lesions.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent aspiration | Experimental | Empty syringe of 10cc and intermittent aspiration during puncture |
|
| Continous/standard aspiration | No Intervention | Empty syringe of 10cc and continous aspiration during puncture |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent aspiration | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in diagnostic yield of pancreatic solid lesions | Percentage of increase in positive smears between intermittent and continous suction | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Sample cellularity | Number of malignant clusters of cells on each endoscopic pass | Baseline |
| Blood contamination | Percentage of blood contamination of the slides |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herranz Pérez, MD | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de la Princesa | Madrid | 28006 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2019 | Feb 4, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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|
| Baseline |
| Number of passes to reach diagnosis | Number of passes needed to achieve a positive cytological diagnosis | Baseline |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |