Comparison of EUS-FNB Biopsy Techniques of Solid Pancreatic Lesions
Primary Purpose
Pancreatic Neoplasm
Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Endoscopic ultrasound-guided biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Over 18 years old
- Any gender.
- Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis.
Exclusion Criteria:
- That no lesion in the pancreas is identified by EUS.
- Pancreatic lesions with a cystic component.
- Alteration of coagulation parameters (INR> 1.5, Platelets <50,000 / mm3) or having taken antiplatelet agents or oral anticoagulants one week prior to the biopsy.
- History of acute pancreatitis in the last 4 weeks.
- Pregnant
- Refusal or inability to sign informed consent
Sites / Locations
- Héctor Miguel Delgado CortesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with solid pancreatic lesions
Arm Description
Patients who will undergo endoscopic ultrasound biopsy. Samples of at least 3 passes will be obtained, each pass obtained with a different technique (capillary with suction, capillary without suction and wet suction)
Outcomes
Primary Outcome Measures
Quality of the sample in relation to the technique
Establish if there is a difference in the quality of the sample in relation to the technique used to obtain it
Secondary Outcome Measures
Sample contamination relative to technique
Establish if there is a difference in the contamination of the sample, in relation to the technique used to obtain it
Full Information
NCT ID
NCT04843956
First Posted
April 8, 2021
Last Updated
April 11, 2021
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
1. Study Identification
Unique Protocol Identification Number
NCT04843956
Brief Title
Comparison of EUS-FNB Biopsy Techniques of Solid Pancreatic Lesions
Official Title
Comparación de Tres técnicas de Biopsia Guiada Por Endosonografia de Lesiones sólidas pancreáticas
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with a diagnosis of solid pancreatic lesions evidenced by imaging studies (CT, MRI) and who undergo endoscopic ultrasound-guided biopsy will be selected. Biopsies will be taken using modified tip needles (FNB) three different methods (capillary by suction, capillary without suction and wet suction).
From the results obtained from the pathology service, 3 variables will be assessed; Cellularity, blood contamination and suitability for a diagnosis.
Detailed Description
EUS-BAAF procedure The procedure will be performed with a linear echoendoscope (PENTAX 3.8 EG-3870 UTK) and a HITACHI HI VISION Avius ultrasound processor, after deep sedation by the anesthesiology service. BAF Acquire # 22 needles (Boston Scientific, Malborough, MA) will be used. 3 passes will be made to the tumor, each pass will consist of 10-15 movements of the needle back and forth in a fan within the solid lesion, under complete ultrasound control (ESGE 2017- Gastrointest Endoscopy Clin N Am 22 (2012) 155 -167). Doppler will be used to avoid any vascular structure in the path of the needle.
The passes will be in three different ways to compare.
Capillary with suction (puncture with gradual withdrawal of the stylet, applying dry suction with a 10 ml air vacuum syringe after removing the stylet)
Capillary without suction (puncture with removal of the stylet gradually, without suction after removing the stylet)
Moist suction (Before the puncture, the stylet is removed from the needle and irrigated with 1-2 ml saline solution to replace the air column with liquid, then the solid lesion is punctured and suction is placed with a vacuum syringe of 10 ml of air)
The quality of the biopsy will be evaluated by the pathologist independently and without knowing how the sample was obtained.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The samples will be analyzed independently by the pathology service, not knowing the order and the technique in which the samples were obtained. The histopathological result will be immediately available for patient care, however, the score obtained regarding the quality of the sample will correlate with the technique and the number of passes until the n of the study is completed.
Allocation
N/A
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with solid pancreatic lesions
Arm Type
Experimental
Arm Description
Patients who will undergo endoscopic ultrasound biopsy. Samples of at least 3 passes will be obtained, each pass obtained with a different technique (capillary with suction, capillary without suction and wet suction)
Intervention Type
Diagnostic Test
Intervention Name(s)
Endoscopic ultrasound-guided biopsy
Other Intervention Name(s)
Pancreatic biopsy
Intervention Description
Capillary with suction (puncture with gradual withdrawal of the stylet, applying dry suction with a 10 ml air vacuum syringe after removing the stylet)
Capillary without suction (puncture with removal of the stylet gradually, without suction after removing the stylet)
wet suction (Prior to puncture, the stylet is removed from the needle and irrigated with 1-2 ml saline solution to replace the air column with liquid, then the solid lesion is punctured and suction is placed with a 10 ml vacuum syringe of air)
Primary Outcome Measure Information:
Title
Quality of the sample in relation to the technique
Description
Establish if there is a difference in the quality of the sample in relation to the technique used to obtain it
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Sample contamination relative to technique
Description
Establish if there is a difference in the contamination of the sample, in relation to the technique used to obtain it
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 18 years old
Any gender.
Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis.
Exclusion Criteria:
That no lesion in the pancreas is identified by EUS.
Pancreatic lesions with a cystic component.
Alteration of coagulation parameters (INR> 1.5, Platelets <50,000 / mm3) or having taken antiplatelet agents or oral anticoagulants one week prior to the biopsy.
History of acute pancreatitis in the last 4 weeks.
Pregnant
Refusal or inability to sign informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hector Miguel Delgado Cortes, M.D
Phone
+524423395099
Email
hectorm.delgado@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Joel Omar Jaquez Quintana
Phone
+528114183484
Email
jomjaqui@hotmail.com
Facility Information:
Facility Name
Héctor Miguel Delgado Cortes
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Héctor Miguel Delgado Cortés
Phone
4423395099
Email
hectorm.delgado@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual data sharing plan
Citations:
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Comparison of EUS-FNB Biopsy Techniques of Solid Pancreatic Lesions
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