UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Cohort Study on efficacy and safety of transcutaneous minocycline (MINO) injection therapy for patients of simple giant hepatic cysts.
Title of the study (Brief title)	Prospective Cohort Study on efficacy and safety of transcutaneous minocycline (MINO) injection therapy for patients of simple giant hepatic cysts.
Region	Japan

Condition
Condition	Simple giant hepatic cysts
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Yuichi Nozaki
Organization	National Center for Global Health and Medicine
Division name	Department of Gastroenterology
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Email	ynozaki@hosp.ncgm.go.jp

Public contact
Name of contact person	Yuichi Nozaki
Organization	National Center for Global Health and Medicine
Division name	Department of Gastroenterology
Address	1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL	03-3202-7181
Homepage URL
Email	ynozaki@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine, Department of Gastroenterology
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Center for Global Health and Medicine, Kohnodai Hospital
Name of secondary funｄer(s)

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	国立国際医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 16 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 10 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 15 Day
Last modified on	2018 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014078