UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009027
Receipt number R000010596
Scientific Title Nafamostat Mesilate for prophylaxis of post-ERCP pancreatitis -A prospective, randomized, controlled, multicenter study -
Date of disclosure of the study information 2012/10/03
Last modified on 2021/02/11 17:45:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Nafamostat Mesilate for prophylaxis of post-ERCP pancreatitis
-A prospective, randomized, controlled, multicenter study -

Acronym

NM for prophylaxis of post-ERCP pancreatitis

Scientific Title

Nafamostat Mesilate for prophylaxis of post-ERCP pancreatitis
-A prospective, randomized, controlled, multicenter study -

Scientific Title:Acronym

NM for prophylaxis of post-ERCP pancreatitis

Region

Japan


Condition

Condition

Post-ERCP pancreatitis

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the efficacy of Nafamostat Mesilate for prophylaxis of post-ERCP pancreatitis. This study is a prospective, randomized, controlled, multicenter study.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The incidence and severity of post-ERCP pancreatitis in the non-administration and the administration of Nafamostat Mesilate group.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Non-administration of Nafamostat Mesilate group

Interventions/Control_2

Nafamostat Mesilate administered before ERCP group.

Interventions/Control_3

Nafamostat Mesilate administered after ERCP group.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who are planned ERCP with hospitalization.
1) Patients with agreement of this clinical study.
2) Aged 20 or over.

Key exclusion criteria

1) Patients without informed consent.
2) Patients who are not possible to communicate by mental disorder or disturbance of consciousness.
3) Patients who are pregnant or during pregnancy can not be ruled out.
4) Acute pancreatitis cases.
5) Patients with severe cardiopulmonary disease.
6) Patients who are received protease inhibitor within a week.
7) Patients with a history of allergy to iodine-based contrast agent and Nafamostat Mesilate.
8) Patients who are expected to be difficult to observe duodenal papilla endoscopically.
9) Endoscopic papillectomy cases.
10) Patients with Billroth-II and total gastrectomy.
11) Patients after treatment duodenal papilla EST, such as EPBD.
12) Patients who are judged inappropriate by medical examiner.

Target sample size

800


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuhiro Kida

Organization

Kitasato University East Hospital

Division name

Dept. of Gastroenterology

Zip code


Address

2-1-1,Asamizodai,Minami-Ku

TEL

042-748-9111

Email

m-kida@kitasato-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Imaizumi

Organization

Kitasato University Hospital

Division name

Dept. of Gastroenterology

Zip code


Address

1-15-1,Kitasato,Minami-Ku,Sagamihara, Kanagawa

TEL

042-778-8111

Homepage URL


Email

imaizumi@yhc.att.ne.jp


Sponsor or person

Institute

Dept. of Gastroenterology, Kitasato University East Hospital

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

北里大学東病院(神奈川県)
Kitasato University East hospital (Kanagawa)


Other administrative information

Date of disclosure of the study information

2012 Year 10 Month 03 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

Completed

Date of protocol fixation

2012 Year 09 Month 12 Day

Date of IRB

2012 Year 09 Month 12 Day

Anticipated trial start date

2012 Year 10 Month 03 Day

Last follow-up date

2021 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 10 Month 02 Day

Last modified on

2021 Year 02 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010596


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name