UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of traction assisted endoscopic submucosal dissection using clip and line for colorectal neoplasms: a randomized controlled trial
Title of the study (Brief title)	TAC STUDY
Region	Japan

Condition
Condition	colorectal neoplasm
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the utility of traction assisted endoscopic submucosal dissection using clip and line for colorectal neoplasms
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	ESD procedure time which is measured from the start of the submucosal injection until removal of the lesion
Key secondary outcomes	Self-completion rate, R0 resection rate, adverse events

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
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Conventional ESD group
Interventions/Control_2	Traction assisted ESD group
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 Colorectal neoplasms larger than 20 mm that were difficult to remove en bloc with conventional EMR 2 Colorectal neoplasms predicted to be non-invasive tumors and cancers with minute (less than 1000um) submucosal invasion
Key exclusion criteria	1 residual lesions after EMR 2 patients with IBD or FAP 3 patients with hematological abnormality 4 patients with severe organ failure 5 patients who have been judged as in appropriate for this study
Target sample size	84

Research contact person
Name of lead principal investigator	Yoji Takeuchi
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gastrointestinal Oncology
Address	1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL	+81-6-6972-1181
Email	takeuti-yo@mc.pref.osaka.jp

Public contact
Name of contact person	Yasushi Yamasaki
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Gastrointestinal Oncology
Address	1-3-3, Higashinari-ku, Osaka 537-8511, Japan
TEL	+81-6-6972-1181
Homepage URL
Email	yasshifive@yahoo.co.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases
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	大阪府立成人病センター(大阪府)

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 05 Day
Anticipated trial start date	2015 Year 08 Month 10 Day
Last follow-up date	2017 Year 01 Month 10 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 01 Month 10 Day
Date analysis concluded	2017 Year 01 Month 10 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 09 Day
Last modified on	2017 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021541