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

NCT04924751 | Unknown

• 1 other identifier: 201905065RIND
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 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 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

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). 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

Interventions

Endoscopic ultrasound-guided fine needle biopsy DIAGNOSTIC_TEST

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.

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 greater than 1cm in the largest diameter will be recruited.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Central Study Contacts

Yu-Ting Kuo, MD, MSc

CONTACT

+886-972652398; sfstruck@gmail.com

Hsiu-Po Wang, MD

CONTACT

+886-972651306; wanghp@ntu.eud.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: At the time of the procedure, the endoscopy nurse opened an envelope containing computer-generated randomization assignments for the study patients.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 14, 2021
• Study Start: March 17, 2020
• Primary Completion: May 10, 2021
• Study Completion: March 17, 2022
• Last Updated: June 14, 2021

Record last verified: 2021-06

Locations

TW (1)