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

April 5, 2021 updated by: National Cheng-Kung University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heparin Wet first group
Heparin based wet suction method of EUS FNB will go first for 2 passes and then shift to dry suction method for another 2 passes.
Procedure: EUS fine needle biopsy with heparin wet suction

EUS FNB with Heparin wet suction:

Investigator will remove stylet from the FNB device and then infuse Heparin 1ml (5000IU) into device before procedure. The syringe will pre-loaded with 10 ml negative pressure and attach to device upon needle tip insertion into mass lesion.

EUS FNB with Dry suction:

Investigator will remove stylet from the FNB device. Syringe will be pre-loaded with 10 ml negative pressure in syringe and attach to needle tail upon needle tip inserted into target lesion.

Other Names:
  • EUS fine needle biopsy with dry suction
Experimental: Dry suction first group
Dry suction method of EUS FNB will go first for 2 passes and then shift to heparin base wet suction method for another 2 passes.
Procedure: EUS fine needle biopsy with heparin wet suction

EUS FNB with Heparin wet suction:

Investigator will remove stylet from the FNB device and then infuse Heparin 1ml (5000IU) into device before procedure. The syringe will pre-loaded with 10 ml negative pressure and attach to device upon needle tip insertion into mass lesion.

EUS FNB with Dry suction:

Investigator will remove stylet from the FNB device. Syringe will be pre-loaded with 10 ml negative pressure in syringe and attach to needle tail upon needle tip inserted into target lesion.

Other Names:
  • EUS fine needle biopsy with dry suction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Needle pass number needed to establish diagnosis
Time Frame: 48 weeks
After 5 working days of histology slide preparation and pathologist interpretation. Investigator can get the result
48 weeks
Diagnostic performance between different suction method
Time Frame: 48 weeks
After 5 working days of histology slide preparation and pathologist interpretation. Investigator can get the result
48 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication
Time Frame: 54 weeks
Investigator will keep follow up patient during admission course and 3 months after procedure to determine if presented with complications
54 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Investigators

  • Study Director: Bor-Shyang Sheu, Professor, National Cheng-Kung University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 11, 2021

First Posted (Actual)

January 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NationalCheng-KungU (Registry Identifier: National Cheng-Kung University Hospital Clinical Trial Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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