UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040098
Receipt number R000045718
Scientific Title Prospective evaluation of radiofrequency ablation for refractory benign pancreatic duct strictures
Date of disclosure of the study information 2020/04/07
Last modified on 2020/04/07 19:46:56

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Basic information

Public title

Prospective evaluation of radiofrequency ablation for refractory benign pancreatic duct strictures

Acronym

Prospective evaluation of radiofrequency ablation for refractory benign pancreatic duct strictures

Scientific Title

Prospective evaluation of radiofrequency ablation for refractory benign pancreatic duct strictures

Scientific Title:Acronym

Prospective evaluation of radiofrequency ablation for refractory benign pancreatic duct strictures

Region

Japan


Condition

Condition

refractory benign pancreatic duct stricture

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the feasibility and efficacy of RFA for refractory benign pancreatic duct strictures

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Technical and clinical success

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) chronic pancreatitis
2) refractory symptomatic benign pancreatic duct stricture

Key exclusion criteria

1) Patients having difficulty in transpapillary approach
2) Patients with surgically altered anatomy
3) Malignant strictures
4) Pancreatic tail stricture
5) Short length stricture
6) Contraindication of RFA
7) Performance status 4
8) Patients without informed consent
9) Inappropriate patients for entry on this study in the judgement of their research investigator

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Tadahisa
Middle name
Last name Inoue

Organization

Aichi Medical University

Division name

Department of Gastroenterology

Zip code

480-1195

Address

1-1 Yazakokarimata, Nagakute, Aichi, Japan

TEL

0561623311

Email

tinoue-tag@umin.ac.jp


Public contact

Name of contact person

1st name Tadahisa
Middle name
Last name Inoue

Organization

Aichi Medical University

Division name

Department of Gastroenterology

Zip code

480-1195

Address

1-1 Yazakokarimata, Nagakute, Aichi, Japan

TEL

0561623311

Homepage URL


Email

tinoue-tag@umin.ac.jp


Sponsor or person

Institute

Aichi Medical University

Institute

Department

Personal name



Funding Source

Organization

Aichi Medical University

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

Aichi Medical University

Address

1-1 Yazakokarimata, Nagakute, Aichi, Japan

Tel

0561623311

Email

kanrika@aichi-med-u.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

2020 Year 04 Month 07 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

2020 Year 03 Month 10 Day

Date of IRB

2020 Year 03 Month 27 Day

Anticipated trial start date

2020 Year 04 Month 07 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To evaluate the effeicacy and safety of RFA for refractory benign pancreatic duct strictures


Management information

Registered date

2020 Year 04 Month 07 Day

Last modified on

2020 Year 04 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045718


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name