UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of pre-clipping fixation endoscopic mucosal resection to achieve sufficient bulging and surgical margin-negative resection
Title of the study (Brief title)	Pre-clipping fixation EMR
Region	Japan

Condition
Condition	Colon polyps
Classification by specialty	Medicine in general Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In performing endoscopic mucosal resection (EMR), accurate snaring and surgical margin-negative resection pathologically while maintaining an ample safety margin is very important in determining the post-resection treatment strategy. However, snare strangulation of an inadequate safety margin sometimes occurs with thermal denaturation, which makes it difficult to determine the surgical margins pathologically; furthermore, local recurrence sometimes occurs. The aim of this study is to evaluate the efficacy of pre-clipping EMR by which sufficient bulging, accurate snaring and surgical margin-negative resection are obtained.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of pathologically negative surgical margin of EMR between conventional EMR group and pre-clipping EMR group.
Key secondary outcomes	1. L/W ratio during EMR by EUS between conventional EMR group and pre-clipping EMR group. 2. The number of re-snaring between conventional EMR group and pre-clipping EMR group. 3. The procedure time of EMR between conventional EMR group and pre-clipping EMR group. 4. The procedure time of closing post-EMR site between conventional EMR group and pre-clipping EMR group.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
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	Three-point pre-clipping EMR to colorectal polyp
Interventions/Control_2	Conventional EMR to colorectal polyp
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	95 years-old >
Gender	Male and Female
Key inclusion criteria	Colorectal polyps those size are over 5 mm in diameter under 20mm in diameter
Key exclusion criteria	Colorectal polyps those size are under 5 mm in diameter. Patients who are not obtained informed and consent by written and verbal form.
Target sample size	70

Research contact person
Name of lead principal investigator	Hirohito Mori
Organization	Kagawa university
Division name	Department of Gastroenterology and Neurology
Address	1750-1, Miki, Kida, Kagawa, Japan
TEL	+81-87-891-2156
Email	hiro4884@med.kagawa-u.ac.jp

Public contact
Name of contact person	kazunori Yamashita
Organization	Ehime Rousai Hospital
Division name	Medical Affairs Division
Address	13-27 Minamikomatsubara, Niihama, Ehime 792-8550, Japan
TEL	+81-897-33-6191
Homepage URL
Email	ijikachou@ehimerosai.jp

Sponsor
Institute	Ehime Rousai Hospital Kagawa university
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)

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	香川大学医学部　Kagawa university 愛媛労災病院　Ehime Rousai Hospital

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 04 Day
Anticipated trial start date	2014 Year 09 Month 13 Day
Last follow-up date	2016 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 09 Month 13 Day
Last modified on	2016 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017619