UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032598
Receipt number 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 22:50:41

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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 or person

Institute

Japanese Red Cross Wakayama Medical Center

Institute

Department

Personal name



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

Value
https://center6.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