UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021403
Receipt number R000024537
Scientific Title A multicenter prospective study to compare outcomes of endoscopic and surgical interventions for chronic pancreatitis-induced pain
Date of disclosure of the study information 2016/04/01
Last modified on 2023/03/19 22:45:00

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Basic information

Public title

A multicenter prospective study to compare outcomes of endoscopic and surgical interventions for chronic pancreatitis-induced pain

Acronym

A multicenter prospective study to compare outcomes of endoscopic and surgical interventions for chronic pancreatitis-induced pain

Scientific Title

A multicenter prospective study to compare outcomes of endoscopic and surgical interventions for chronic pancreatitis-induced pain

Scientific Title:Acronym

A multicenter prospective study to compare outcomes of endoscopic and surgical interventions for chronic pancreatitis-induced pain

Region

Japan


Condition

Condition

chronic pancreatitis

Classification by specialty

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

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This multicenter prospective study aims to compare endoscopic and surgical interventions for pain relief in patients with chronic pancreatitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clinical outcomes one year after endoscopic or surgical intervention for pain relief

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. definite diagnosis of chronic pancreatitis
2. patients who are going to undergo endoscopic and/or surgical interventions.
3. written informed consent

Key exclusion criteria

1. patients who are going to undergo only psueudocyst drainage
2. patients who had undergone pancreatic resection.
3. patients diagnosed with pancreatic cancer or suspected of having pancreatic cancer.
4. patients who had undergone endoscopic interventions within one year

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Masayuki
Middle name
Last name Kitano

Organization

Wakayama Medical University School of Medicine

Division name

Second Department of Internal Medicine

Zip code

641-0012

Address

811-1 Kimiidera, Wakayama, JAPAN

TEL

073-447-2300

Email

kitano@wakayama-med.ac.jp


Public contact

Name of contact person

1st name Kosuke
Middle name
Last name Minaga

Organization

Kindai University Faculty of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

589-8511

Address

377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN

TEL

072-366-0221

Homepage URL


Email

cpstudy@med.kindai.ac.jp


Sponsor or person

Institute

english

Institute

Department

Personal name



Funding Source

Organization

english

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

Institutional Review Board of Kindai University Hospital

Address

377-2 Ohno-higashi, Osaka-sayama, Osaka, Japan

Tel

072-366-0221

Email

zizen@med.kindai.ac.jp


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 04 Month 01 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

Open public recruiting

Date of protocol fixation

2016 Year 03 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 04 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

ee


Management information

Registered date

2016 Year 03 Month 09 Day

Last modified on

2023 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024537


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name