UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013393
Receipt number R000014929
Scientific Title A prospective, randomised study of "back light system" for picking up specimens in EUS-FNA
Date of disclosure of the study information 2014/03/12
Last modified on 2022/07/09 22:00:34

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Basic information

Public title

A prospective, randomised study of "back light system" for picking up specimens in EUS-FNA

Acronym

A prospective, randomised study of "back light system" for picking up specimens in EUS-FNA

Scientific Title

A prospective, randomised study of "back light system" for picking up specimens in EUS-FNA

Scientific Title:Acronym

A prospective, randomised study of "back light system" for picking up specimens in EUS-FNA

Region

Japan


Condition

Condition

pancreatic mass

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is evaluating the efficacy of back light system "BIOEVALUATOR" for picking up specimens in EUS-FNA by endosonographers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

The adequacy rate in each group.

Key secondary outcomes

Gross visual assessment of specimen adequacy, accuracy rate of EUS-FNA and adequacy rates of each time in each endosonographer.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

In EUS-FNA, 1st puncture picking up specimen with BIOEVALUATOR and 2nd puncture without it.

Interventions/Control_2

In EUS-FNA, 1st puncture picking up specimen without BIOEVALUATOR and 2nd puncture with it.

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 pancreatic mass who are refered to EUS-FNA

Key exclusion criteria

Patients with pancreatic mass which we cannot detect by EUS
Patients with severe ascites
Patients with other fatal disease
Patients who have risk of bleeding
Patients who do not agree to participate in this study

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Hironari
Middle name
Last name Kato

Organization

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences

Division name

Department of Gastroenterology and Hepatology

Zip code

700-8558

Address

2-5-1 Shikata-cho, Okayama, 700-8558, Japan

TEL

086-235-7219

Email

drkatocha@yahoo.co.jp


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Harada

Organization

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences

Division name

Department of Gastroenterology and Hepatology

Zip code

700-8558

Address

2-5-1 Shikata-cho, Okayama, 700-8558, Japan

TEL

086-235-7219

Homepage URL


Email

rharada927@yahoo.co.jp


Sponsor or person

Institute

Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences

Institute

Department

Personal name



Funding Source

Organization

None

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

Okayama University

Address

2-5-1 Shikata-cho, Okayama, 700-8558, Japan

Tel

086-223-7151

Email

MAE6605@adm.okayama-u.ac.jp


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

岡山大学病院(岡山県)


Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 12 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000014929

Publication of results

Published


Result

URL related to results and publications

https://www.e-ce.org/journal/view.php?doi=10.5946/ce.2019.004

Number of participants that the trial has enrolled

80

Results

A total of 80 consecutive patients were eligible during the study period. Adequacy was observed for 52 specimens (65%) with the BLS and 54 (68%) without the BLS (p=0.88). In assessment of specimen adequacy on gross examination, only fair agreement was observed both with and without BLS (kappa score 0.40 and 0.29, respectively).

Results date posted

2019 Year 05 Month 30 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 05 Month 16 Day

Baseline Characteristics

Median age was 67 years; there were 30 females and 50 males. In terms of location, 38 of tumors were found in the pancreatic head, 25 in the pancreatic body, and 17 in the pancreatic tail. The median size of lesions was 27 mm in the long axis and 20 mm in the short axis. All 80 patients underwent EUS-FNA. A median of 3 FNA passes per patient was performed on the pancreatic mass. EUS-FNA was performed via the stomach in 45 patients and via the duodenum in 35.

Participant flow

To control the variables that could influence study results, we randomized the patients using a crossover design for BLS use or non-use in the first and second passes. Randomization was performed immediately after the endosonographer detected the pancreatic mass. An individual other than the endosonographer performing the EUS-FNA used biased-coin randomization to allocate cases to the groups. Randomization was performed in a 1:1 ratio.

Adverse events

There was no bleeding or perforation with EUS-FNA in this series. Mild pancreatitis occurred in 1 patient with pancreatic head cancer; however, this resolved with conservative therapy and prolonged the hospital stay by only 1 night.

Outcome measures

1)Adequacy rate in the BLS and non-BLS groups
2)Gross visual assessments of specimen adequacy

Plan to share IPD

none

IPD sharing Plan description

none


Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 02 Month 18 Day

Date of IRB

2014 Year 06 Month 17 Day

Anticipated trial start date

2014 Year 03 Month 12 Day

Last follow-up date

2015 Year 04 Month 01 Day

Date of closure to data entry

2015 Year 04 Month 01 Day

Date trial data considered complete

2015 Year 04 Month 01 Day

Date analysis concluded

2015 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2014 Year 03 Month 11 Day

Last modified on

2022 Year 07 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014929


Research Plan
Registered date File name
2019/05/30 ④臨床試験計画書第3版.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name