UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study for comparing newly designed 21-gauge and standard 22-gauge aspiration needles for the diagnosis of solid pancreatic masses
Title of the study (Brief title)	Prospective study comparing 21-gaude and 22-gauge needles for EUS-FNA of pancreatic masses
Region	Japan

Condition
Condition	solid pancreatic masses
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the performance characteristics and safety of newly designed 21-gauge needle versus standard 22-gauge aspiration needle for the diagnosis of solid pancreatic masses.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of diagnostic yield (sample cellularity and bloodiness) of the FNA samples between newly designed 21-gauge and standard 22-gauge needles for solid pancreatic masses
Key secondary outcomes	Comparison of technical success, diagnostic performance for malignancy, the number of needle passes required to obtain a diagnosis, needle angle during puncture, and complications

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	EUS-FNA is performed with a novel 21-gauge needle (EUS Sonopsy CY, Hakko Medical).
Interventions/Control_2	EUS-FNA is performed with a standard 22-gauge needle (SonoTip ProControl, Medi-Globe GmbH)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with a solid pancreatic mass who are planned to EUS-FNA
Key exclusion criteria	1. Patients with ECOG Performance status 4 2. Patients with bleeding tendency (prothrombin time international normalized ratio >1.5, platelets <50000) 3. Patients with pancreatic mass which cannot be visualized on EUS 4. Patients younger than 20 years old 5. Patients who do not agree to participate in this study
Target sample size	100

Research contact person
Name of lead principal investigator	Yukitaka Yamashita
Organization	Japanese Red Cross Wakayama Medical Center
Division name	Department of Gastroenterology and Hepatology
Address	4-20, Komatsubara-dori, Wakayama, 640-8558, Japan
TEL	073-422-4171
Email	y-yamashita@kankyo.ne.jp

Public contact
Name of contact person	Kosuke Minaga
Organization	Japanese Red Cross Wakayama Medical Center
Division name	Department of Gastroenterology and Hepatology
Address	4-20, Komatsubara-dori, Wakayama, 640-8558, Japan
TEL	073-422-4171
Homepage URL
Email	kousukeminaga@yahoo.co.jp

Sponsor
Institute	Japanese Red Cross Wakayama Medical Center
Institute
Department

Funding Source
Organization	No Funding Source
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 15 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 01 Month 31 Day
Date analysis concluded	2018 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	A total of 93 patients (40.9 % female; mean age 70.1 years) underwent EUS-FNA with the novel 21-gauge needle (n = 47) or the standard 22-gauge needle (n = 46). Baseline characteristics did not differ between the groups. The technical success rate was 100% in both groups, and the overall diagnostic accuracy for malignancy was similar between the groups (100 % in the 21-gauge group vs. 95.7% in the 22-gauge group, P = 0.242). Nevertheless, the 21-gauge needle resulted in significantly higher scores for cellularity (P = 0.010), and lower scores for blood contamination (P < 0.001). The median number of needle passes using the 21-gauge needle was less as compared to the 22-gauge needle (2 and 3, respectively, P = 0.003). The needle angle during puncture was more restricted in the 21-gauge needle (P < 0.001). Procedure-related complication rate was not different between the groups (P = 0.148).
Other related information

Management information
Registered date	2018 Year 05 Month 15 Day
Last modified on	2018 Year 09 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037150