UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility and efficacy of EUSguided drainage and endoscopic necrosectomy using a novel lumen-apposing metal stent
Title of the study (Brief title)	Efficacy of a novel lumen-apposing metal stent
Region	Japan

Condition
Condition	walled-off necrosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clinical treatment rate for WON
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical treatment rate for WON
Key secondary outcomes

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	Device,equipment Maneuver
Interventions/Control_1	EUS-guided drainage and direct endoscopic necrosectomy using a novel metal stent
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	18 years-old <=
Age-upper limit	99 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients with symptomatic sterile or infected walled-off necrosis, which can be punctured safely from stomach or duodenum under endoscopic ultrasound. 2)Patients consent to be included in the study based on his/her own free will after sufficient informing and understanding of the study.
Key exclusion criteria	1)Cases with sever complication in other organs except original disease 2)Cases having impossibility of cessation of anticoagulant 3)Cases with pregnancy or suspect of pregnancy 4)Cases with malignant cancer not having more than a half year prognosis 5)Cases that the size of lesion is less than 3 cm 6)Cases having difficulty in endoscopic approach 7)Cases having difficulty in visualization of lesion on EUS 8)Cases judged by principal investigator to be inadequate as subjects
Target sample size	20

Research contact person
Name of lead principal investigator	Takao Itoi
Organization	Tokyo Medical University
Division name	Department of Gastroenterology and Hepatology
Address	6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL	03-3342-6111
Email	itoi@tokyo-med.ac.jp

Public contact
Name of contact person	Shuntaro Mukai
Organization	Tokyo Medical University
Division name	Department of Gastroenterology and Hepatology
Address	6-7-1 Nishishijuku, Shinjuku-ku, Tokyo
TEL	03-3342-6111
Homepage URL
Email	s-mukai@tokyo-med.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Tokyo Medical University
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Tokyo Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 19 Day
Anticipated trial start date	2015 Year 10 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 03 Month 04 Day
Last modified on	2019 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024615