NCT04924725

Prospective Comparison of Diagnostic Accuracy Between Contrast-enhanced Harmonic and Conventional EUS-guided Fine-needle Biopsy in Solid Pancreatic Lesions

Completed NA Last updated 14 June 2021

What this trial tests

NA trial testing Endoscopic ultrasound-guided fine needle biopsy in Pancreatic Solid Lesions in 120 participants. Completed in 27 January 2021.

Timeline

18 February 2019

Primary endpoint
18 February 2019

27 January 2021

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	diagnostic
Enrollment	120
Start date	18 February 2019
Primary completion	18 February 2019
Estimated completion	27 January 2021
Sites	1 location across Taiwan

Drugs / interventions tested

• Endoscopic ultrasound-guided fine needle biopsy

Conditions studied

• Pancreatic Solid Lesions — all drugs for Pancreatic Solid Lesions →

Sponsor

National Taiwan University Hospital

Who can join

20 and older, any sex, with Pancreatic Solid Lesions. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Endoscopic ultrasonography (EUS)-guided fine-needle aspiration/biopsy (FNA/B) is used to collect biopsy samples from many organs throughout the digestive tract and is useful in diagnosing solid pancreatic lesions (SPLs). The reported diagnostic accuracy of EUS-FNA for SPLs is 85-89.4%, the sensitivity is 82-94.7%, and the specificity is 100%. One randomized controlled trial reported that the fanning technique of FNA was superior to the standard approach because fewer passes were required to establish the diagnosis. However, in many cases, like SPLs with the presence of fibrosis and necrosis background, four or more needle passes are still needed to obtain sufficient biopsy samples. There is a potential risk of tumor seeding associated with multiple needle punctures. Therefore, it is important to minimize the number of needle passes.

Contrast-enhanced harmonic EUS (CEH-EUS) using sonazoid (Daiichi-Sankyo, Tokyo, Japan) is useful to visualize parenchymal perfusion in the pancreas and characterize of SPLs. Because the necrotic or fibrotic area within the SPLs were appeared as non-enhanced area, CEH-EUS could help us to avoid puncture the non-enhancing area hence increased the diagnostic accuracy. Katana et al. reported that conventional EUS-FNA has lower sensitivity (72.9%) for pancreatic adenocarcinoma with non-enhanced areas compared to with enhanced areas (94.3%) on CEH-EUS. Therefore, it would be difficult to obtain sufficient biopsy samples through unenhanced areas of SPLs.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomized trial of contrast-enhanced harmonic guidance versus fanning technique for EUS-guided fine-needle biopsy sampling of solid pancreatic lesions.
   Kuo YT, Chu YL, Wong WF, Han ML, et al · · 2023 · cited 16× · PMID 36509113 · DOI 10.1016/j.gie.2022.12.004