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Contrast-Enhanced Harmonic vs Conventional EUS-guided Fine Needle Biopsy for Solid Pancreatic Lesions: Randomized Controlled Trial

NCT04924751 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-06-14

No results posted yet for this study

Summary

In the previous studies, EUS-guided fine needle aspiration (FNA) with fanning technique in solid pancreatic lesions (SPLs) with avascular areas had a negative impact on diagnostic accuracy of FNA. Because of the retrospective basis of previous studies, a prospective study is warranted to answer whether contrast-enhanced harmonic(CEH) EUS-guided FNA/B is superior to conventional EUS-guided FNA/B with fanning technique in SPLs. The main objective of this randomized trial therefore was to determine whether CEH-EUS-guided sampling to avoid non-enhanced areas within a mass lesion result in more rapid diagnosis requiring fewer FNB passes than the conventional EUS-guided FNB with fanning needle throughout the mass is targeted.

Conditions

  • Pancreatic Solid Lesions

Interventions

DIAGNOSTIC_TEST

Endoscopic ultrasound-guided fine needle biopsy

Under endoscopic ultrasound guidance, fine-needle biopsy is used to collect biopsy samples from solid pancreatic lesions throughout the digestive tract and is useful in diagnosing solid pancreatic lesions.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-17
Primary Completion
2021-05-10
Completion
2022-03-17

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04924751 on ClinicalTrials.gov