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2020-01-08
2021-04-30
2021-04-30
41
NCT04843956
Hospital Universitario Dr. Jose E. Gonzalez
Hospital Universitario Dr. Jose E. Gonzalez
INTERVENTIONAL
Comparison of EUS-FNB Biopsy Techniques of Solid Pancreatic Lesions
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-04-08 | N/A | 2021-04-11 |
2021-04-11 | N/A | 2021-04-14 |
2021-04-14 | N/A | 2021-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | 18 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | 18 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Hector Miguel Delgado Cortes, M.D Phone Number: +524423395099 Email: hectorm.delgado@gmail.com |
Study Contact Backup Name: Joel Omar Jaquez Quintana Phone Number: +528114183484 Email: jomjaqui@hotmail.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
