UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003995
Receipt number R000004806
Scientific Title A Prospective Randomized Trial of Pancreatic Spontaneous Dislodgement Stents to Prevent Acute Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Date of disclosure of the study information 2010/08/05
Last modified on 2010/08/04 12:42:19

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Basic information

Public title

A Prospective Randomized Trial of Pancreatic Spontaneous Dislodgement Stents to Prevent Acute Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Acronym

A Prospective Randomized Trial of Pancreatic Spontaneous Dislodgement Stents to Prevent Acute Post-ERCP Pancreatitis

Scientific Title

A Prospective Randomized Trial of Pancreatic Spontaneous Dislodgement Stents to Prevent Acute Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis

Scientific Title:Acronym

A Prospective Randomized Trial of Pancreatic Spontaneous Dislodgement Stents to Prevent Acute Post-ERCP Pancreatitis

Region

Japan


Condition

Condition

Post-ERCP Pancreatitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We are conducting a prospective trial to evaluate efficacy, spontaneous dislodgement and complication for spontaneous dislodgement stents (Geenen pancreatic stent, Cook) with 3cm length and 5Fr diameter in high-risk patients for post-ERCP pancreatitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary study endopoints were the frequency and severity of post-ERCP pancreatitis.

Key secondary outcomes

Further we evaluated hyperamylasemia, the success rate of stent placement, the duration of stent dislodgment and other complications in both groups.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

stent group

Interventions/Control_2

no stent group

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


Not applicable

Gender

Male and Female

Key inclusion criteria

The study group consisted of patients at high risk for post-ERCP pancreatitis because of previous post-ERCP pancreatitis, sphincter of Oddi dysfunction (SOD), a difficult cannulation, the performance of pre-cut, pancreatic duct biopsy or IDUS, and a case requiring greater than 30 minutes in total examination.

Key exclusion criteria

We excluded younger patients than 20 years old and patients with pancreatitis due to gall stone.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Mine

Organization

Tokai University School of Medicine

Division name

Gastroenterology

Zip code


Address

143 Shimokasuya, Isehara

TEL

0463-93-1121

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshiaki Kawaguchi

Organization

Tokai University School of Medicine

Division name

Gastroenterology

Zip code


Address

143 Shimokasuya, Isehara

TEL

0463-93-1121

Homepage URL


Email

y711kawa@is.icc.u-tokai.ac.jp


Sponsor or person

Institute

Tokai University School of Medicine, Department of Gastroenterology

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

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

2010 Year 08 Month 05 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

2007 Year 01 Month 22 Day

Date of IRB


Anticipated trial start date

2007 Year 01 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

2010 Year 08 Month 04 Day

Last modified on

2010 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004806


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name