UMIN-CTR Clinical Trial

Public title

A study on the usefulness of sound velocity correction mode in ultrasonography endoscopy for chronic pancreatitis

Acronym

Comparison of ultrasound velocity in different stages of chronic pancreatitis

Scientific Title

A study on the usefulness of sound velocity correction mode in ultrasonography endoscopy for chronic pancreatitis

Scientific Title:Acronym

Comparison of ultrasound velocity in different stages of chronic pancreatitis

Region

Japan

Condition

Chronic pancreatitis

Classification by specialty

Medicine in general

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate whether differences in ultrasound velocity occur with the progression of chronic pancreatitis.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To evaluate the relevance of the optimal ultrasound speed (USS)for each degree of chronic pancreatitis (CP)according the Japanese diagnostic criterion for CP in 2019 (JDCCP2019) and to investigate whether the analysis of USS contributes to the diagnosis of CP.

Key secondary outcomes

calculation of cutoff value for early-stage CP on JDCCP2019.

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

SU-1 ultrasound processor (FUJIFILM Medical Co., Ltd, Tokyo, Japan) with linear/radial arrayed EUS scope (EG580UR, EG-580UT; FUJIFILM Medical Co., Ltd, Tokyo, Japan)
Patients who were deemed to require pancreatic evaluation were included in the study; the time period of inclusion was set from December 2018 to September 2021.

Interventions/Control_2

SU-1 ultrasound processor (FUJIFILM Medical Co., Ltd, Tokyo, Japan) with linear/radial arrayed EUS scope (EG580UR, EG-580UT; FUJIFILM Medical Co., Ltd, Tokyo, Japan)
Patients who were deemed to require pancreatic evaluation were included in the study; the time period of inclusion was set from December 2018 to September 2021.

Interventions/Control_3

SU-1 ultrasound processor (FUJIFILM Medical Co., Ltd, Tokyo, Japan) with linear/radial arrayed EUS scope (EG580UR, EG-580UT; FUJIFILM Medical Co., Ltd, Tokyo, Japan)
Patients who were deemed to require pancreatic evaluation were included in the study; the time period of inclusion was set from December 2018 to September 2021.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients requiring EUS for pancreatic scrutiny.
Patients who have been fully informed about the research and have given written consent of their own free will with full understanding.

Key exclusion criteria

Patients deemed inappropriate by the principal investigator or sub-investigator

Target sample size

300

Name of lead principal investigator

1st name	Atsushi
Middle name
Last name	Irisawa

Organization

Dokkyo Medical University School of medicine

Division name

Department of Gastroenterology

Zip code

321-0293

Address

Tochigi, Japan

TEL

0282-86-1111

Email

irisawa@dokkyomed.ac.jp

Name of contact person

1st name	Takahito
Middle name
Last name	Minaguchi

Organization

Dokkyo Medical University School of medicine

Division name

Department of Gastroenterology

Zip code

321-0293

Address

Tochigi, Japan

TEL

0282-86-1111

Homepage URL

Email

takahito@dokkyomed.ac.jp

Institute

Dokkyo Medical University School of medicine

Institute

Department

Personal name

Organization

Dokkyo Medical University School of medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Dokkyo Medical University School of medicine

Address

Tochigi,Japan

Tel

0282861111

Email

takahito@dokkyomed.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

獨協医科大学病院（栃木県）

Date of disclosure of the study information

2021

Year

06

Month

10

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/35108413/

Publication of results

Partially published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35108413/

Number of participants that the trial has enrolled

113

Results

The Spearman's correlation coefficient for the number of EUS findings and USS was 0.759, indicating a strong correlation. ICC was calculated for the three measurements of USS and showed high reproducibility with ICC (2.3) =0.975 (0.965-0.982). The Spearman correlation coefficient between USS and CP stage was 0.747 (P<0.001). ROC curves were analyzed for normal pancreas. Using USS of 1535 m/s as the cutoff value, an area of 0.957, specificity of 95.9%, and sensitivity of 87.5% were obtained.

Results date posted

2023

Year

06

Month

09

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The median age of 113 patients was 68 years (range: 23-85 years). The patients were diagnosed as normal (n=64), definite CP (n=5), probable CP (n=3), or ECP (n=41; definite ECP in 18, probable ECP in 23) using JDCCP2019. Alcohol consumption was the cause of CP found in 8 cases (100%). Other than that, the clear cause was unknown (idiopathic). No patients had hereditary pancreatitis. 15 patients had a history of pancreatitis, 35 patients had abdominal pain or back pain, and 15 patients had elevated pancreatic enzymes. 3 cases of abnormal exocrine function were judged by decreased albumin level, and N-benzoyl-L-tyrosal-p-aminobenzoic acid test was not performed. No patients had histopathology performed. CT and magnetic resonance imaging examinations were performed on 103 and 101 patients.

Participant flow

EUS was performed on 1226 patients with suspected pancreaticobiliary disease between December 2018 and March 2021. Of these, 119 patients were selected if they met the following criteria: patient age was at least 18 years, consent for the examination was obtained, transgastric delineation of the pancreatic parenchyma was possible, and a region of interest (ROI) could be established within the parenchyma. Patients with substantial or cystic masses in the pancreas were excluded from the study.

Adverse events

No adverse events were observed.

Outcome measures

Primary endpoint: Evaluation of differences in optimal USS according to the degree of CP

Secondary endpoints: Correlation between USS in chronic and non-chronic pancreatitis, including early-stage pancreatitis correlation between cutoff value, number of EUS findings and USS.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2018

Year

12

Month

01

Day

Date of IRB

2020

Year

07

Month

20

Day

Anticipated trial start date

2018

Year

12

Month

01

Day

Last follow-up date

2021

Year

09

Month

09

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

06

Month

07

Day

Last modified on

2023

Year

06

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050793