Know Cancer

or
forgot password

Prospective Comparative Study on Endoscopic Ultrasonography (EUS) - Guided Fine-Needle Aspiration (FNA) Using the 22G Conventional Needles or Procore Needles Without Immediate On-site Cytopathologic Examination


Phase 3
18 Years
80 Years
Open (Enrolling)
Both
Self Efficacy

Thank you

Trial Information

Prospective Comparative Study on Endoscopic Ultrasonography (EUS) - Guided Fine-Needle Aspiration (FNA) Using the 22G Conventional Needles or Procore Needles Without Immediate On-site Cytopathologic Examination


Endoscopic ultrasound (EUS) - guided fine needle aspiration (FNA) is a well-established
technique for tissue sampling of intestinal and extra-intestinal mass lesions. The accuracy
of EUS-guided FNA varies from 60% - 100% with a complication rate of 0% - 3%. The diagnostic
accuracy of the procedure can be improved by the use immunohistochemical studies and genetic
analyses.It may also be improved by obtaining a larger biopsy specimen with a core biopsy
needle. However, puncturing with a core-biopsy needle may not be always feasible due to the
technical difficulty of inserting the larger needle through the bended endoscope. As a
result, the advantage of a core-biopsy needle on providing a larger amount of cellular
material is offset by a higher rate of technical failures, especially in the setting of a
transduodenal puncture. Recently, a new 22G FNA needle with a reverse bevel at the tip has
become available (ECHO-HD-22-C, Cook Endoscopy, USA.). The design of the device promotes the
collection of core samples by shearing material from target lesion during retrograde
movement of the needle in the lesion. Hence, the aim of this study is to compare the
tissue-sampling rate and the diagnostic accuracy rate of EUS-FNA using 22G conventional and
Procore needles.


Inclusion Criteria:



- Ages of 18-80 undergoing EUS-guided tissue acquisition

- Informed consent available

Exclusion Criteria:

- Coagulopathy

- Previous history of upper gastrointestinal surgery

- Contraindications for conscious sedation

- Pregnancy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with cyto-histopathology confirmed neoplasms diagnosed by EUS-guided FNA

Outcome Description:

A positive diagnosis of malignancy by an EUS biopsy specimen is accepted as a true positive. A benign diagnosis is conīŦrmed by surgical tissue samples when available or clinical follow-up after 1 year.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

CHARING CHONG, MBChB

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, CUHK

Authority:

Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:

ChineseUHK

NCT ID:

NCT01581762

Start Date:

April 2012

Completion Date:

October 2014

Related Keywords:

  • Self Efficacy
  • EUS, FNA

Name

Location