UMIN-ICDS Clinical Trial

Public title

Consideration of Treatment Options for Esophageal Varices

Acronym

Consideration of Treatment Options for Esophageal Varices

Scientific Title

Inter-group Comparative Trial on the Efficacy and Safety of EIS (L) Monotherapy, Transvascular Embolization, and Mucosal Fibrosing Method by APC for Esophageal Varices

Scientific Title:Acronym

Inter-group Comparative Trial of Conservative Treatments for Esophageal Varices

Region

Japan

Condition

Esophageal Varices

Classification by specialty

Gastroenterology

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim is to demonstrate that the prognosis is improved by the Mucosal Fibrosing Method by investigating and examining whether the selected treatment is associated with the rates of bleeding recurrence and non-bleeding recurrence.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Recurrence rate of bleeding in esophageal varices

Key secondary outcomes

Morphological recurrence rate of esophageal varices, Survival time, Occurrence rate of adverse events and safety profile

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

34

years-old

<=

Age-upper limit

89

years-old

>=

Gender

Male and Female

Key inclusion criteria

From past medical records preserved at Dokkyo Medical University Hospital from 1 April 2010 through 31 July 2022, we extracted the data of 226 patients diagnosed with esophagogastric varices, including those who had completed treatment.

Key exclusion criteria

Based on the records, cases with gastric varices alone, those in which treatment was not completed by December 31, 2021, those treated with EVL alone, and those with bleeding were excluded.

Target sample size

98

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

880 Kitakobayashi, Mibu town, Shimotsuga gun, Tochigi pref.

TEL

0282-87-2147

Email

yuka-t@dokkyomed.ac.jp

Name of contact person

1st name	Yuka
Middle name
Last name	Suzuki

Organization

Dokkyo Medical University School of Medicine

Division name

Department of Gastroenterology

Zip code

321-0293

Address

880 Kitakobayashi, Mibu town, Shimotsuga gun, Tochigi pref.

TEL

0282-87-2147

Homepage URL

Email

yuka-t@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

880 Kitakobayashi, Mibu town, Shimotsuga gun, Tochigi pref.

Tel

0282-87-2147

Email

yuka-t@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

Date of disclosure of the study information

2024

Year

04

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

98

Results

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

Recruitment status

Completed

Date of protocol fixation

2023

Year

08

Month

23

Day

Date of IRB

2023

Year

08

Month

31

Day

Anticipated trial start date

2023

Year

09

Month

05

Day

Last follow-up date

2025

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a retrospective study approved by the Ethics Committee of Dokkyo Medical University Hospital. This study will be conducted in accordance with the ethical principles based on the Declaration of Helsinki. The Ethics Committee of Dokkyo Medical University Hospital determined that since this is a retrospective study, written informed consent can be substituted with the obligation to provide information to the participants and the right to opt out to the participants. Statistical analyses were performed using software (SPSS v.28.0; IBM SPSS Inc.) Kaplan-Meier curves and Log Rank tests were used for time from end of treatment to morphologic recurrence and time from end of treatment to bleeding recurrence. Statistical significance was set at P<0.05. Statistical experts evaluated the statistics calculated for this study.

Registered date

2024

Year

04

Month

15

Day

Last modified on

2024

Year

04

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061826