A RCT of evaluating performance of puncture needles in EUS-TA for pancreatic tumors

JRCT ID: jRCT1032240067

Registered date:08/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic tumors
• Date of first enrollment: 08/05/2024
• Target sample size: 42
• Study type: Interventional

Intervention(s)

The order of puncture needles to be used will be randomly assigned in endoscopic ultrasound-guided tissue sampling (EUS-TA) of pancreatic mass lesions as follows:
(1) 1st: novel puncture needle (Century Medical, Trident), 2nd: conventional puncture needle (Boston Scientific, Acquire S)
(2) 1st: conventional puncture needle, 2nd: novel puncture needle

Outcome(s)

• Primary Outcome: Percentage of tissue scores of 5 for both conventional and novel puncture needle specimens, following a previous report that defined a tissue score of 5 as one of high quality and sufficient for histological assessment (total tissue sample > x10 power field in length)

Secondary Outcome

-Tissue area of each specimen obtained with the conventional and novel puncture needle
-Percentage of tumor cells in each of the conventional and novel puncture needles
-Blood contamination rate of conventional and novel puncture needles
-Puncture performance of the conventional and novel puncture needles
-Treatment time for the conventional and novel puncture needles
-Frequency of adverse events after testing with the conventional and novel puncture needles

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following conditions are eligible
1) Persons who are 20 years of age or older at the time of obtaining consent
2) Patients with pancreatic mass lesions eligible for EUS-TA
3) Patients who have been fully informed of the study and given written consent of their own free will based on a thorough understanding of the study.

Exclude criteria

Patients who meet any of the following conditions are not eligible
1) ECOG Performance Status 3 or higher
2) Bleeding risk with HAS-BLED score of 3 or higher or platelet count less than 50,000/mm2
3) Receiving two or more antithrombotic agents
4) Presence of a pancreatic mass undetectable by EUS
5) Pregnancy
6) Refusal to participate
7) Patients deemed by the study investigator or sub-investigator to be unsuitable for the safe conduct of this study.

Related Information

• Primary Sponsor: Hiroshi Ohyama
• Source(s) of Monetary Support: Chiba University Hospital