UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of the electricity method for endoscopic papillectomy.
Acronym	Comparison of the electricity method for endoscopic papillectomy.
Scientific Title	Comparison of the electricity method for endoscopic papillectomy.
Scientific Title:Acronym	Comparison of the electricity method for endoscopic papillectomy.
Region	Japan

Condition
Condition	Ampullary of vater tumor
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare of frequency of complications for endoscopic papillectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency of delayed bleeding after endoscopic papillectomy.
Key secondary outcomes	Frequency of immediate bleeding, pancreatitis, etc after endoscopic papillectomy.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	We use auto-cut mode for endoscopic papillectomy.
Interventions/Control_2	We use end-cut mode for endoscopic papillectomy.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Ampullary of vater tumor patients who is planned endoscopic papillectomy in our hospital and related facilities.
Key exclusion criteria	Patients who refused the entry of this study.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Eisuke Iwasaki
Organization	Keio University School of Medicine
Division name	Division of Gastroenterology and Hepatology,Department of Internal Medicine
Zip code
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-3353-1211
Email	e-iwa@sunny.ocn.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuhiro Minami
Organization	Keio University School of Medicine
Division name	Division of Gastroenterology and Hepatology,Department of Internal Medicine
Zip code
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	e-iwa@sunny.ocn.ne.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	None
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
Address
Tel
Email

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 03 Month 08 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	Completed
Date of protocol fixation	2016 Year 02 Month 02 Day
Date of IRB	2016 Year 02 Month 22 Day
Anticipated trial start date	2016 Year 03 Month 08 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

Other
Other related information

Management information
Registered date	2016 Year 03 Month 07 Day
Last modified on	2019 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024659