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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
Sponsor:
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Brief Summary:
The aim of this study is to compare the diagnostic yield of intermittent versus continuous suction in the diagnosis of pancreatic solid lesions.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Pancreatic Neoplasms Procedure: Intermittent aspiration Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Increase in diagnostic yield of pancreatic solid lesions [ Time Frame: Baseline ]
    Percentage of increase in positive smears between intermittent and continous suction


Secondary Outcome Measures :
  1. Sample cellularity [ Time Frame: Baseline ]
    Number of malignant clusters of cells on each endoscopic pass

  2. Blood contamination [ Time Frame: Baseline ]
    Percentage of blood contamination of the slides

  3. Number of passes to reach diagnosis [ Time Frame: Baseline ]
    Number of passes needed to achieve a positive cytological diagnosis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Herranz Pérez, MD 675124482 raquelherranzperez@gmail.com

Locations
Spain
Hospital Universitario de la Princesa Recruiting
Madrid, Spain, 28006
Contact: Raquel Herranz Pérez    675124482    raquelherranzperez@gmail.com   
Sub-Investigator: Felipe de la Morena         
Sub-Investigator: Cecilio Santander         
Principal Investigator: Raquel Herranz         
Sponsors and Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Investigators
Principal Investigator: Herranz Pérez, MD Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
  Study Documents (Full-Text)

Documents provided by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:

Responsible Party: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT03829748     History of Changes
Other Study ID Numbers: RHerranz3638
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:
Pancreatic adenocarcinoma
Endoscopic ultrasound
Fine-needle aspiration

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases