UMIN-CTR Clinical Trial

Basic information
Public title	The effect of a passive bending colonoscope on ERCP for patients with surgical altered anatomy, multicenter comparative study
Acronym	PBCS-ERCP study
Scientific Title	The effect of a passive bending colonoscope on ERCP for patients with surgical altered anatomy, multicenter comparative study
Scientific Title:Acronym	PBCS-ERCP study
Region	Japan

Condition
Condition	Biliary stricture, Pancreatic duct stricture, Bile duct stone
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To retrospectively evaluate and compare the efficacy of passive bending colonoscope and balloon assisted enteroscope on ERCP for the patients with surgical altered anatomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Success rate to reach anastomotic site or ampulla of vater
Key secondary outcomes	1.Success rate to cannulate biliary/pancreatic duct, 2.Success rate to complete the procedure, 3. Procedure time (reaching to anastomotic site/ampulla, cannulation, over all procedure), 4. Adverse event

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 who underwent ERCP in the condition of surgical altered anatomy. 2. Patients who underwent ERCP by means of passive bending colonoscope or balloon assisted enteroscpe. 3. Patients who are 20 years of age or older
Key exclusion criteria	1. Patients without data and information regarding to procedure. 2. Patients who had Billroth-I reconstruction. 3. Patients that the physician in charge consider not suitable for inclusion
Target sample size	270

Research contact person
Name of lead principal investigator	1st name Shin Middle name Last name Kato
Organization	Sapporo City General Hospital
Division name	Department of Gastroenterology
Zip code	060-8604
Address	Kita 11, Nishi 13, Chuo-ku, Sapporo
TEL	0117262211
Email	shinchan1231@gmail.com

Public contact
Name of contact person	1st name Shin Middle name Last name Kato
Organization	Sapporo City General Hospital
Division name	Department of Gastroenterology
Zip code	0608604
Address	Kita 11, Nishi 13, Chuo-ku, Sapporo
TEL	0117262211
Homepage URL
Email	shin.kato@doc.city.sapporo.jp

Sponsor
Institute	Sapporo City General Hospital
Institute
Department

Funding Source
Organization	Self funding
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	Sapporo City General Hospital
Address	Kita 11, Nishi 13, Chuo-ku, Sapporo
Tel	0117262211
Email	shin.kato@doc.city.sapporo.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	2021 Year 10 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	Enrolling by invitation
Date of protocol fixation	2021 Year 06 Month 11 Day
Date of IRB	2021 Year 06 Month 23 Day
Anticipated trial start date	2021 Year 06 Month 23 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2021 Year 09 Month 22 Day
Last modified on	2021 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052001