Intermittent Suction Technique in the Diagnosis of Pancreatic Solid Lesions
Primary Purpose
Pancreatic Cancer, Pancreatic Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intermittent aspiration
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring Pancreatic adenocarcinoma, Endoscopic ultrasound, Fine-needle aspiration
Eligibility 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
Sites / Locations
- Hospital Universitario de la Princesa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intermittent aspiration
Continous/standard aspiration
Arm Description
Empty syringe of 10cc and intermittent aspiration during puncture
Empty syringe of 10cc and continous aspiration during puncture
Outcomes
Primary Outcome Measures
Increase in diagnostic yield of pancreatic solid lesions
Percentage of increase in positive smears between intermittent and continous suction
Secondary Outcome Measures
Sample cellularity
Number of malignant clusters of cells on each endoscopic pass
Blood contamination
Percentage of blood contamination of the slides
Number of passes to reach diagnosis
Number of passes needed to achieve a positive cytological diagnosis
Full Information
NCT ID
NCT03829748
First Posted
January 22, 2019
Last Updated
May 21, 2020
Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
1. Study Identification
Unique Protocol Identification Number
NCT03829748
Brief Title
Intermittent Suction Technique in the Diagnosis of Pancreatic Solid Lesions
Official Title
Intermittent Versus Continuous Suction Technique in the Diagnosis of Pancreatic Solid Lesions. A Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
January 16, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Pancreatic Neoplasms
Keywords
Pancreatic adenocarcinoma, Endoscopic ultrasound, Fine-needle aspiration
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intermittent aspiration
Arm Type
Experimental
Arm Description
Empty syringe of 10cc and intermittent aspiration during puncture
Arm Title
Continous/standard aspiration
Arm Type
No Intervention
Arm Description
Empty syringe of 10cc and continous aspiration during puncture
Intervention Type
Procedure
Intervention Name(s)
Intermittent aspiration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Increase in diagnostic yield of pancreatic solid lesions
Description
Percentage of increase in positive smears between intermittent and continous suction
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Sample cellularity
Description
Number of malignant clusters of cells on each endoscopic pass
Time Frame
Baseline
Title
Blood contamination
Description
Percentage of blood contamination of the slides
Time Frame
Baseline
Title
Number of passes to reach diagnosis
Description
Number of passes needed to achieve a positive cytological diagnosis
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herranz Pérez, MD
Organizational Affiliation
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intermittent Suction Technique in the Diagnosis of Pancreatic Solid Lesions
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