Clincosm LogoSign in Get a demo

Comparison of EUS-FNB Biopsy Techniques of Solid Pancreatic Lesions

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez (Other)
Overall Status
Recruiting
CT.gov ID
NCT04843956
Collaborator
(none)
41
Enrollment
1
Location
1
Arm
15.7
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Endoscopic ultrasound-guided biopsy
 N/A

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.

  1. Capillary with suction (puncture with gradual withdrawal of the stylet, applying dry suction with a 10 ml air vacuum syringe after removing the stylet)

  2. Capillary without suction (puncture with removal of the stylet gradually, without suction after removing the stylet)

  3. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
41 participants
Allocation:
N/A
Intervention 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.
Primary Purpose:
Diagnostic
Official Title:
Comparación de Tres técnicas de Biopsia Guiada Por Endosonografia de Lesiones sólidas pancreáticas
Actual Study Start Date :
Jan 8, 2020
Anticipated Primary Completion Date :
Apr 30, 2021
Anticipated Study Completion Date :
Apr 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with solid pancreatic lesions

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)

Diagnostic Test: Endoscopic ultrasound-guided biopsy
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)
Other Names:
  • Pancreatic biopsy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quality of the sample in relation to the technique [18 months]

      Establish if there is a difference in the quality of the sample in relation to the technique used to obtain it

    Secondary Outcome Measures

    1. Sample contamination relative to technique [18 months]

      Establish if there is a difference in the contamination of the sample, in relation to the technique used to obtain it

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Héctor Miguel Delgado Cortes Monterrey Nuevo León Mexico 64460

    Sponsors and Collaborators

    • Hospital Universitario Dr. Jose E. Gonzalez

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. med. Hector Eloy Tamez Perez, Clinical profesor, Hospital Universitario Dr. Jose E. Gonzalez
    ClinicalTrials.gov Identifier:
    NCT04843956
    Other Study ID Numbers:
    • GA19-00014
    First Posted:
    Apr 14, 2021
    Last Update Posted:
    Apr 14, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Pancreatic Neoplasms

    Study Results

    No Results Posted as of Apr 14, 2021