UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of Tip-in endoscopic mucosal resection for large flat colorectal Adenomas: a Randomized control trial
Acronym	STAR trial
Scientific Title	Safety and efficacy of Tip-in endoscopic mucosal resection for large flat colorectal Adenomas: a Randomized control trial
Scientific Title:Acronym	STAR trial
Region	Japan

Condition
Condition	large flat colorectal adenomas
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and efficacy of the Tip-in EMR technique for large flat colorectal adenomas (15-25 mm in diameter) in randomized comparison with conventional EMR method.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	En bloc resection rate in intention-to-treat analysis
Key secondary outcomes	1.En bloc resection rate in per-protocol analysis 2. Complete R0 resection rate 3. One-year accumulate recurrence rate 4. En bloc resection rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter) 5. One-year accumulate recurrence rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter) 6. Complete R0 resection rate in group A (15-19 mm in diameter) and group B (20-24 mm in diameter) 7. En bloc resection rate by lesion location 8. One-year accumulate recurrence rate in en bloc resection group and piecemeal resection group 9. One-year accumulate recurrence rate in R0 resection group and R1resection group 10. One-year accumulate recurrence rate in cases of RX resection 11. Rate of exclusion by poor lesion lifting in cases with previous biopsies 12. Complication rate 13. Accuracy of endoscopic diagnosis for residual adenomas during surveillance tests

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	YES
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	Maneuver
Interventions/Control_1	conventional EMR
Interventions/Control_2	Tip-in EMR technique
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 a large flat adenoma (15-25 mm in size) 2. Patients aged over 20 years old when consents to the participation is obtained 3. Ptients consented after full understanding of this study
Key exclusion criteria	1. Cases with clinical diagnosis of T1 cancer 2. Cases with difficulties to interrupt intake of anticoagulant drugs 3. Inappropriate cases by investigators
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kenichiro Imai
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
Zip code
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL	055-989-5222
Email	k.imai1977@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Kenichiro Imai
Organization	Shizuoka Cancer Center
Division name	Division of Endoscopy
Zip code
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
TEL	055-989-5222
Homepage URL
Email	k.imai1977@gmail.com

Sponsor
Institute	Division of Endoscopy, Shizuoka Cancer Center
Institute
Department

Funding Source
Organization	Division of Endoscopy, Shizuoka Cancer Center
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
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	2017 Year 02 Month 14 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	2017 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date	2017 Year 01 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 20 Day
Last modified on	2017 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026835

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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