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

NCT04924725 | Completed

• 1 other identifier: 201810024RINC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Solid Lesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Diagnostic accuracy rate

  3 months

• Overall complication rate

  3 months

Study Arms (2)

CEH-EUS-guided FNB group

EXPERIMENTAL

In CEH-EUS-guided FNB group, needle puncture directly to the enhancing area 15-20 times without passing to the non-enhancing area under CEH mode was performed.

Procedure: Endoscopic ultrasound-guided fine needle biopsy

Conventional-EUS-guided FNB with fanning technique group

ACTIVE COMPARATOR

In conventional-EUS-guided FNB with fanning technique group, the needle was positioned at four different areas within the mass and then moved back and forth four times in each area to procure tissue (4 × 4).

Procedure: Endoscopic ultrasound-guided fine needle biopsy

Interventions

Endoscopic ultrasound-guided fine needle biopsy PROCEDURE

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

CEH-EUS-guided FNB group; Conventional-EUS-guided FNB with fanning technique group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with coagulopathy or altered anatomy
• Contraindications for conscious sedation
• Pregnancy
• Patients cannot provide informed consent

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• Kuo YT, Chu YL, Wong WF, Han ML, Chen CC, Jan IS, Cheng WC, Shun CT, Tsai MC, Cheng TY, Wang HP. Randomized trial of contrast-enhanced harmonic guidance versus fanning technique for EUS-guided fine-needle biopsy sampling of solid pancreatic lesions. Gastrointest Endosc. 2023 Apr;97(4):732-740. doi: 10.1016/j.gie.2022.12.004. Epub 2022 Dec 9.

  PMID: 36509113 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The samples in each group will be sent for rapid onsite cytology evaluation (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. In conventional group, if the diagnosis could be made within three times of FNB, we will inject Sonazoid and record the enhance pattern of the pancreatic lesion. If the diagnosis still undetermined, the patient will receive CEH-EUS-guided FNB as cross-over test.

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 14, 2021
• Study Start: February 18, 2019
• Primary Completion: February 18, 2019
• Study Completion: January 27, 2021
• Last Updated: June 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)