NCT04843956

Comparison of EUS-FNB Biopsy Techniques of Solid Pancreatic Lesions

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Pancreatic Neoplasm

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2020-01-08
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2021-04-14
• Last updated: 2021-04-14

Locations

1 site across 1 country: Mexico