Comparison of EUS-FNB Biopsy Techniques of Solid Pancreatic Lesions

April 11, 2021 updated by: Dr. med. Hector Eloy Tamez Perez, Hospital Universitario Dr. Jose E. Gonzalez

Comparación de Tres técnicas de Biopsia Guiada Por Endosonografia de Lesiones sólidas pancreáticas

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Héctor Miguel Delgado Cortes
        • Contact:

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of the sample in relation to the technique
Time Frame: 18 months
Establish if there is a difference in the quality of the sample in relation to the technique used to obtain it
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sample contamination relative to technique
Time Frame: 18 months
Establish if there is a difference in the contamination of the sample, in relation to the technique used to obtain it
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (ACTUAL)

January 8, 2020

Primary Completion (ANTICIPATED)

April 30, 2021

Study Completion (ANTICIPATED)

April 30, 2021

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 11, 2021

First Posted (ACTUAL)

April 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 11, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA19-00014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual data sharing plan

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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