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

Pancreatic Solid Lesions Clinical Trial

Official title:

National Taiwan University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04924725
• Other study ID #: 201810024RINC
• Status: Completed
• Phase: N/A
• Start date: February 18, 2019
• Est. completion date: January 27, 2021

Study information

• Verified date: January 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

According to the study result by Katana et al., fanning technique in SPLs with avascular areas had a negative impact on diagnostic accuracy of FNA. Because of the retrospective basis of their study, a prospective study is warranted to answer whether 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 FNA/B passes than the conventional EUS-guided FNA/B with fanning needle throughout the mass is targeted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 27, 2021
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients aged more than 20years

• Referred for EUS-guided tissue acquisition for solid pancreatic lesions

• The size of the lesion greater than 1cm in the largest diameter

Exclusion Criteria:

• Patients with coagulopathy or altered anatomy

• Contraindications for conscious sedation

• Pregnancy

• Patients cannot provide informed consent

Related Conditions & MeSH terms

• Pancreatic Solid Lesions

Intervention

Procedure:
• Endoscopic ultrasound-guided fine needle biopsy
Endoscopic ultrasound-guided 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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of passes required to establish a diagnosis	The samples in each group will be sent for ROSE and pathology evaluation. If diagnosis could be made after ROSE, the procedure will be stopped. Otherwise, the FNB with be repeated for at most six times in each group.	1 day
Secondary	Diagnostic accuracy rate		3 months
Secondary	Overall complication rate		3 months