UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endoscopic treatment for walled-off necrosis after acute pancreatitis using plastic stents vs. nobel dedicated biflanged metal stent, prospective randomized controlled trial
Title of the study (Brief title)	Endoscopic treatment for walled-off necrosis using plastic stents vs. biflanged metal stent, prospective randomized controlled trial
Region	Japan

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

Objectives
Narrative objectives1	To clarify the efficacy and safety of endoscopic treatment for walled-off necrosis using a novel biflanged metal stent.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	technical success rate, clinical success rate adverse event rate, mortality rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	In the patients of PS group, conventional EUS guided transmural drainage using plastic stents is performed. In the patients of BFMS group, EUS-guided transmural drainage using a novel dedicated biflanged metal stent is performed.
Interventions/Control_2	In the patients of BFMS group, EUS-guided transmural drainage using a novel dedicated biflanged metal stent is performed.
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	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	40

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

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	maezora1031@yahoo.co.jp

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

Funding Source
Organization	none
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	2014 Year 10 Month 02 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 10 Month 01 Day
Anticipated trial start date	2014 Year 10 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 10 Month 02 Day
Last modified on	2017 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017814