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Clinical Trials/NCT04707560
NCT04707560UnknownNot Applicable

Comparison of Heparin-based Wet Suction Method With Dry Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass

National Cheng-Kung University Hospital2 sites in 1 country50 target enrollmentStarted: January 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
2
Primary Endpoint
Quantification of tissue quality

Study Overview

Brief Summary

The objective of this randomized cross-over trial is to evaluate whether Heparin based wet suction technique, compared with dry suction technique, shall present a higher quality tissue core by using quantitative macroscopic and microscopic scale.

Detailed Description

Background & aim Endoscopic ultrasound guided fine needle biopsy (EUS-FNB) is the main tool for tissue acquisition and pathological diagnosis of pancreatic solid mass because of its superior accuracy and lower complication rate compared to CT-guided biopsy. However, the tissue adequacy and diagnostic yield remained unsatisfactory for 2 reasons. First, the conventional dry suction technique (DST) often get small tissue and 3 or more needle passes (i.e. biopsies) are required to obtain enough specimen. Second, blood contamination of the acquired tissue interfered with microscopic examination. Investigator aim to develop a novel technique to improve tissue acquisition within a fewer needle passes and avoid blood contamination by using heparin-based modified wet suction (H-MWST).

Methods This study will be a randomized crossover clinical trial. Patients with pancreatic solid mass indicated for EUS FNB will be enrolled. EUS FNB will be done by one experienced endoscopists in National Cheng Kung University Hospital. Patients will be randomized in a 1:1 ratio to receive EUS FNB with either dry suction technique (DST) or H-MWST first for the initial 2 needle passes, and then crossover to another suction technique for a total of 4 needle passes. The obtained tissue of each needle pass will be sent separately and examined by a pathologist who is unaware of the procedure order. Procedure related complications will be recorded. The primary outcome will be the acquired tissue quality quantified comparison. The secondary outcome will be the overall diagnostic yield, the specimen adequacy, and complication rate by each suction technique.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Diagnostic
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients had pancreatic solid mass on CT scan or abdominal echo image

Exclusion Criteria

  • Anti-platelet and anticoagulant user who cannot stop the medication
  • Recent acute pancreatitis episode (within 2 weeks)
  • Patient with severe cardio-pulmonary dysfunction
  • Pregnant women and adolescent < 20 years old

Outcomes

Primary Outcomes

Quantification of tissue quality

Time Frame: 48 weeks

White tissue core length will be assessed immediately after procedure. The acquired tumor tissue area and contaminant blood clot percentage will be assessed after total recruitment by single pathologist

Secondary Outcomes

  • Needle pass number needed to establish diagnosis(48 weeks)
  • Diagnostic performance between different suction method(48 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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