UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Cold Snare Polypectomy for Superficial Non-Ampullary Duodenal Epithelial Tumor
Title of the study (Brief title)	Phase II study of Cold Snare Polypectomy for Superficial Non-Ampullary Duodenal Epithelial Tumor (D-CSP)
Region	Japan

Condition
Condition	Superficial Non-Ampullary Duodenal Epithelial Tumor (SNADET) <= 10mm
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety of cold snare polypectomy (CSP)
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Delayed perforation and bleeding
Key secondary outcomes	The rate of spurting bleeding just after CSP, en-block resection, R0 resection, residual tumor 3 months after CSP, adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Cold Snare Polypectomy (CSP)
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) superficial non-ampullary duodenal epithelial tumor <= 10mm 2) bulbs~3rd part of deudenum 3) one lesion 4) elevated lesion expected to remove en-block using snare 5) 20 years old and more 6) can be followed for 3 months 7) Written informed consent
Key exclusion criteria	1) Impossible to suspend anticoagulant or antiplatelet medications (except low-dose aspirin) 2) Infectious disease with systemic therapy indicated 3) Women during pregnancy or breast-feeding 4) Psychosis 5) Systemic steroids medication 6) History of myocardial infarction within 6 months or unstable angina pectoris within 3 weeks 7) Severe respiratory disease requiring continuous oxygen therapy 8) Uncontrollable hypertension 9) Uncontrollable diabetes millutus 10) others
Target sample size	19

Research contact person
Name of lead principal investigator	Hiroyuki Ono
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
Address	Shimonagakubo1007, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL	055-989-5222
Email	h.ono@scchr.jp

Public contact
Name of contact person	Kohei Takizawa
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
Address	Shimonagakubo1007, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL	055-989-5222
Homepage URL
Email	k.takizawa@scchr.jp

Sponsor
Institute	Division of Endoscopy, Shizuoka Cancer Center
Institute
Department

Funding Source
Organization	None
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	静岡県立静岡がんセンター（静岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 25 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2017 Year 06 Month 06 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

Management information
Registered date	2015 Year 09 Month 29 Day
Last modified on	2017 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022149