UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Study of laser lithotripsy for pancreatic stone using peroral pancreatoscopy
Title of the study (Brief title)	Efficacy of laser lithotripsy for pancreatic stone using peroral pancreatoscopy
Region	Japan

Condition
Condition	Patients with pancreatic stone
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examined the efficacy of laser lithotripsy for pancreatic stone using pancreatoscopy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Safety and efficacy
Key secondary outcomes	Comparison with Historical control using extracorporeal shock wave litotripsy

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)Patients with symptoms caused by pancreatic stone 2)Main pancreatic duct stones in head/body of the pancreas
Key exclusion criteria	1)Patients considered ineligible for this study 2)Patients without written informed consent
Target sample size	30

Research contact person
Name of lead principal investigator	Rintaro Mikata
Organization	Chiba University Hospital
Division name	Department of Gastroenterology
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-226-2083
Email	ishihara@faculty.chiba-u.jp

Public contact
Name of contact person	Hiroshi Ohyama
Organization	Chiba University Hospital
Division name	Department of Gastroenterology
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-226-2083
Homepage URL
Email	ohyama-cib@umin.ac.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

Funding Source
Organization	Chiba University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 12 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 09 Month 26 Day
Anticipated trial start date	2012 Year 12 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective study

Management information
Registered date	2012 Year 11 Month 29 Day
Last modified on	2018 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011083