UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015322
Receipt number R000017814
Scientific Title Endoscopic treatment for walled-off necrosis after acute pancreatitis using plastic stents vs. nobel dedicated biflanged metal stent, prospective randomized controlled trial
Date of disclosure of the study information 2014/10/02
Last modified on 2017/10/04 15:09:13

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Basic information

Public title

Endoscopic treatment for walled-off necrosis after acute pancreatitis using plastic stents vs. nobel dedicated biflanged metal stent, prospective randomized controlled trial

Acronym

Endoscopic treatment for walled-off necrosis using plastic stents vs. biflanged metal stent, prospective randomized controlled trial

Scientific Title

Endoscopic treatment for walled-off necrosis after acute pancreatitis using plastic stents vs. nobel dedicated biflanged metal stent, prospective randomized controlled trial

Scientific Title:Acronym

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

1st name
Middle name
Last name Itoi Takao

Organization

Tokyo Medical University

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

6-7-1 Nishishijuku, Shinjuku-ku, Tokyo

TEL

03-3342-6111

Email

itoitakao@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Shuntaro Mukai

Organization

Tokyo Medical University

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

6-7-1 Nishishijuku, Shinjuku-ku, Tokyo

TEL

03-3342-6111

Homepage URL


Email

maezora1031@yahoo.co.jp


Sponsor or person

Institute

Tokyo Medical University Hospital Department of Gastroenterology and Hepatology

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Terminated

Date of protocol fixation

2014 Year 10 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017814


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name