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2019-01-16
2020-01-16
2020-03-01
33
NCT03829748
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
INTERVENTIONAL
Intermittent Suction Technique in the Diagnosis of Pancreatic Solid Lesions
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: * 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-01-22 | N/A | 2020-05-21 |
2019-02-01 | N/A | 2020-05-22 |
2019-02-04 | N/A | 2020-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Intermittent aspiration Empty syringe of 10cc and intermittent aspiration during puncture | PROCEDURE: Intermittent aspiration
|
| NO_INTERVENTION: Continous/standard aspiration Empty syringe of 10cc and continous aspiration during puncture |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Increase in diagnostic yield of pancreatic solid lesions | Percentage of increase in positive smears between intermittent and continous suction | Baseline |
| Secondary Outcome Measures | 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 | Baseline |
| Number of passes to reach diagnosis | Number of passes needed to achieve a positive cytological diagnosis | Baseline |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
