UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Initial use of Rotatable sphincterotome facilitates selective bile duct cannulation compared with use of conventional sphincterotome: a prospective randomized controlled trial of papillotome.
Title of the study (Brief title)	Cannulation Study
Region	Japan

Condition
Condition	Of all diseases needed to perform ERC.
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Initial use of rotatable sphincterotome facilitate common bile duct cannulation and reduce risk of post ERCP pancreatitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	The primary endpoint is successful selective bile duct cannulation within 10 miniutes and 10 times after randomization.
Key secondary outcomes	The secondary endpoints are successful final selective bile duct cannulation rates, procedure success rate, selective bile duct cannulation time, number of attempts at bile duct cannulation, number of accidental pancreatic duct insertions, procedure time, radiation exposure time, use of precutting for selective bile duct cannulation, and complications including PEP rates in the randomized patients and also in the initially enrolled cohort.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rotatable shincterotome
Interventions/Control_2	Conventional sphincterotome
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. In patients with native papilla.
Key exclusion criteria	1. In patients with ECOG Perfoemance Status Grade 4. 2. In patients with impaired consciousness. 3. In patients with suspected pancreatobiliary maljunction. 4. In patients with previous gastrectomy with Billroth II or Roux-en-Y reconstruction. 5. In patients with acute pancreatitis 6. In patients with impacted stone or tumor of ampulla of Vater. 7. In patients with bilioduodenal fistula opening around the papilla
Target sample size	200

Research contact person
Name of lead principal investigator	Akira Kurita
Organization	Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name	Division of Gastroenterology and Hepatology, Digestive Disease Center
Address	2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
TEL	06-6312-8831
Email	kuritaaki1976@gmail.com

Public contact
Name of contact person	Akira Kurita
Organization	Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name	Division of Gastroenterology and Hepatology, Digestive Disease Center
Address	2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
TEL	06-6312-8831
Homepage URL
Email	kuritaaki1976@gmail.com

Sponsor
Institute	Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	田附興風会医学研究所北野病院(大阪府)

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 15 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2018 Year 12 Month 20 Day
Date of closure to data entry	2018 Year 12 Month 20 Day
Date trial data considered complete	2018 Year 12 Month 20 Day
Date analysis concluded	2018 Year 12 Month 31 Day

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

Management information
Registered date	2015 Year 06 Month 22 Day
Last modified on	2018 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020629