UMIN-CTR Clinical Trial

Public title

Prospective Cohort Study on efficacy and safety of transcutaneous minocycline (MINO) injection therapy for patients of simple giant hepatic cysts.

Acronym

Prospective Cohort Study on efficacy and safety of transcutaneous minocycline (MINO) injection therapy for patients of simple giant hepatic cysts.

Scientific Title

Prospective Cohort Study on efficacy and safety of transcutaneous minocycline (MINO) injection therapy for patients of simple giant hepatic cysts.

Scientific Title:Acronym

Prospective Cohort Study on efficacy and safety of transcutaneous minocycline (MINO) injection therapy for patients of simple giant hepatic cysts.

Region

Japan

Condition

Simple giant hepatic cysts

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We will explore efficacy and safety of transcutaneous MINO injection therapy following puncture and drainage for patients of simple giant hepatic cyst.

Basic objectives2

Others

Basic objectives -Others

We will explore efficacy and safety of transcutaneous MINO injection therapy following puncture and drainage for patients of simple giant hepatic cysts.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

The primary outcome is to research the recurrence rate of simple giant hepatic cysts. The recurrence case is defined as follows;
-Patients who have abdominal distension
-Patients who have prominent tendency to large in cyst size
-Patients who have liver dysfunction
-Patients who have bleeding and infection in hepatic cysts
-Patients who have risk of hepatic cyst rupture
-Patients who have acute abdomen due to torsion
-Patients who have dilatation of bile ducts
The recurrence rate will be calculated as accumulated recurrence rate for 3 years.

Key secondary outcomes

The secondary outcome is reduction rate of cysts at each evaluation period. The reduction rate will be calculated by cyst volume based on CT results comparing at the time of pre-treatment to post- treatment. We will evaluate the changes in symptoms between pre-treatment and post-treatment.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine	Device,equipment	Maneuver

Interventions/Control_1

We will perform puncture, drainage and MINO injection therapy for patients of hepatic cysts.

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

20

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

-Patients who have never received this treatment before
-Patients who satisfy at least one of the following conditions;
a. Patients who have abdominal distension
b. Patients who have prominent tendency to large in cyst size
c. Patients who have liver dysfunction
d. Patients who have bleeding and infection in hepatic cysts
e. Patients who have risk of hepatic cyst rupture
f. Patients who have acute abdomen due to torsion
g. Patients who have dilatation of bile ducts
-Patients who require this treatment instead of the alternative treatment such as surgery
-Patients from whom consent has been obtained to participate in this study, which has been approved by the ethics committee

Key exclusion criteria

a. Patients who have malignant tumors.
b. Patients who have multiple hepatic cysts congenitally such as polycystic kidney disease.
c. Patients whose cysts are connected to vessels and bile ducts
d. Patients who have more serious disease compared to simple giant hepatic cysts.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Yuichi Nozaki

Organization

National Center for Global Health and Medicine

Division name

Department of Gastroenterology

Zip code

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo

TEL

03-3202-7181

Email

ynozaki@hosp.ncgm.go.jp

Name of contact person

1st name
Middle name
Last name	Yuichi Nozaki

Organization

National Center for Global Health and Medicine

Division name

Department of Gastroenterology

Zip code

Address

1-21-1 Toyama, Shinjuku-ku, Tokyo

TEL

03-3202-7181

Homepage URL

Email

ynozaki@hosp.ncgm.go.jp

Institute

National Center for Global Health and Medicine,
Department of Gastroenterology

Institute

Department

Personal name

Organization

National Center for Global Health and Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

National Center for Global Health and Medicine, Kohnodai Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立国際医療研究センター(東京都)

Date of disclosure of the study information

2013

Year

10

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Terminated

Date of protocol fixation

2013

Year

10

Month

16

Day

Date of IRB

Anticipated trial start date

2013

Year

10

Month

16

Day

Last follow-up date

2020

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

10

Month

15

Day

Last modified on

2018

Year

10

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014078