UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the efficacy and safety of underwater endoscopic submucosal dissection with pocket creation method for superficial colorectal neoplasms
Title of the study (Brief title)	Water-pocket ESD for colorectal neoplasms
Region	Japan

Condition
Condition	The indicated lesions for ESD in the colorectum
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the efficacy and safety of WP-ESD in the colorectum
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The dissection speed
Key secondary outcomes	The procedure time The rate of en bloc resection Adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are 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	The group with conventional ESD
Interventions/Control_2	The group with WP-ESD
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The size of lesion is larger than 2cm and less than 5cm It is possible to follow the clinical course more than 28 d after ESD
Key exclusion criteria	Patients who have hematological abnormality and/or undergoing hemodialysis Patients who have serious complications Patients who are considered to be inappropriate for this study by doctors Patients who have polypoid lesions and/or inflammatory bowel disease Women who have baby and are pregnant
Target sample size	100

Research contact person
Name of lead principal investigator	Hideaki Harada
Organization	New Tokyo Hospital
Division name	Gastroenterology
Address	1271 Wanagaya, Matsudo, Chiba 270-2232 Japan
TEL	047-711-8700
Email	nerimaendo@hotmail.co.jp

Public contact
Name of contact person	Kenji Hayasaka
Organization	New Tokyo Hospital
Division name	Gastroenterology
Address	1271 Wanagaya, Matsudo, Chiba 270-2232 Japan
TEL	047-711-8700
Homepage URL
Email	dr25027@gk2.so-net.ne.jp

Sponsor
Institute	New Tokyo Hospital
Institute
Department

Funding Source
Organization	New Tokyo Hospital
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

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 28 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date
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	2017 Year 02 Month 27 Day
Last modified on	2019 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030226