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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032598
Receipt No. R000037150
Scientific Title A prospective study for comparing newly designed 21-gauge and standard 22-gauge aspiration needles for the diagnosis of solid pancreatic masses
Date of disclosure of the study information 2018/05/25
Last modified on 2018/09/29

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Basic information
Public title A prospective study for comparing newly designed 21-gauge and standard 22-gauge aspiration needles for the diagnosis of solid pancreatic masses
Acronym Prospective study comparing 21-gaude and 22-gauge needles for EUS-FNA of pancreatic masses
Scientific Title A prospective study for comparing newly designed 21-gauge and standard 22-gauge aspiration needles for the diagnosis of solid pancreatic masses
Scientific Title:Acronym 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
1st name
Middle name
Last name Yukitaka Yamashita
Organization Japanese Red Cross Wakayama Medical Center
Division name Department of Gastroenterology and Hepatology
Zip code
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
1st name
Middle name
Last name Kosuke Minaga
Organization Japanese Red Cross Wakayama Medical Center
Division name Department of Gastroenterology and Hepatology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 05 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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