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

National Taiwan University Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Solid Lesions
• Intervention / Treatment: Diagnostic test: Endoscopic ultrasound-guided fine needle biopsy

Detailed Description

A prospective randomized controlled study was undertaken of patients with solid pancreatic mass lesions who were referred for EUS. Total 120 patients were randomized with 1:1 ratio into undergo CEH-EUS-guided FNB or conventional EUS-guided FNB with fanning technique. At the time of the procedure, the endoscopy nurse opened an envelope containing computer-generated randomization assignments for the study patients. All procedures were performed by a linear array echoendoscope (Olympus UCT260; Olympus, Tokyo, Japan). Procedures were performed under conscious sedation with patients in the left lateral decubitus position.

In CEH-EUS-guided FNB group, needle puncture directly to the enhancing area 15-20 times without passing to the non-enhancing area was performed. 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). After each pass, the needle is removed and the stylet will be introduced into the needle to extrude any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). The total length of the MVC will be measured before placement into a formalin bottle. EUS-FNB is completed if the obtained MVC is longer than 4mm and deemed adequate by endoscopist. If the obtained MVC is < 4mm, the procedure is repeated until a MVC of ≥ 4mm is obtained and deemed adequate by endoscopist. A maximum of 7 passes is allowed.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Ting Kuo, MD, MSc; Phone Number: +886-972652398; Email: sfstruck@gmail.com
• Study Contact Backup: Name: Hsiu-Po Wang, MD; Phone Number: +886-972651306; Email: wanghp@ntu.eud.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yu-Ting Kuo, MD, MSc; Phone Number: +886-972652398; Email: sfstruck@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged more than 20years, referred for EUS-guided tissue acquisition for solid pancreatic lesions greater than 1cm in the largest diameter will be recruited.

Exclusion Criteria:

• Patients with coagulopathy, altered anatomy, contraindications for conscious sedation, pregnancy and those who cannot provide informed consent would be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CEH-EUS-guided FNB group; In CEH-EUS-guided FNB group, needle puncture directly to the enhancing area 15-20 times without passing to the non-enhancing area was performed. After each pass, the needle is removed and the stylet will be introduced into the needle to extrude any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). The total length of the MVC will be measured before placement into a formalin bottle. EUS-FNB is completed if the obtained MVC is longer than 4mm and deemed adequate by endoscopist. If the obtained MVC is < 4mm, the procedure is repeated until a MVC of ≥ 4mm is obtained and deemed adequate by endoscopist. A maximum of 7 passes is allowed.	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.
Active Comparator: Conventional-EUS-guided FNB with fanning technique group; 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). After each pass, the needle is removed and the stylet will be introduced into the needle to extrude any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). The total length of the MVC will be measured before placement into a formalin bottle. EUS-FNB is completed if the obtained MVC is longer than 4mm and deemed adequate by endoscopist. If the obtained MVC is < 4mm, the procedure is repeated until a MVC of ≥ 4mm is obtained and deemed adequate by endoscopist. A maximum of 7 passes is allowed.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the median number of passes required to establish a diagnosis	EUS-FNB is completed if the obtained macroscopic visible core (MVC) is longer than 4mm and deemed adequate by endoscopist	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic accuracy rate	Diagnostic accuracy was defined as the proportion of patients in whom successful diagnosis was reached within the procedure	3 months
overall complication rate		3 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2020
• Primary Completion (Actual): May 10, 2021
• Study Completion (Anticipated): March 17, 2022

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 201905065RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No