Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04707560
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2021-01-11
Brief Title:
Heparin-based Wet Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
Comparison of Heparin-based Wet Suction Method With Dry Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None