UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study investigating the efficacy and safety of hybeid endoscopic submucosal dissection
Title of the study (Brief title)	Efficacy and safety of Hybrid-ESD
Region	Japan

Condition
Condition	Colorectal adenoma/intramucosal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and efficacy of Hybrid-ESD for the treatment of colorectal adenoma/cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Complication rate assessed after endoscopic treatment
Key secondary outcomes	Procedure time, The rate of adverse events (perforation, delayed bleeding) These autcomes were assessed one Month after the treatment

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Patients with 20-30mm colorectal adenoma/intramucosal cancer were considered eligible. Hybrid ESD was performed using newly-developed device which enable scircumferential incision and submucosal dissection.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with 20-30mm colorectal adenoma/intramucosal cancer were consequentially enrolled in the present study.
Key exclusion criteria	We exclude patients with colorectal adenoma/intramucosalcancer larger than 30mm. Patients whose lesions were found to be outside the guideline or expanded criteria for ESD by the endoscopic characteristics and histological findings of biopsy specimens. Patients in disagreement with informed consent
Target sample size	10

Research contact person
Name of lead principal investigator	Ken Ohata
Organization	NTT Medical Center Tokyo
Division name	Department of Gastroenterology
Address	5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL	+81-3-3448-6111
Email	ken.ohata1974@gmail.com

Public contact
Name of contact person	Eiji Sakai
Organization	NTT Medical Center Tokyo
Division name	Department of Gastroenterology
Address	5-9-22 Higashi-gotanda Shinagawa-ku, Tokyo 141-8625, Japan
TEL	+81-3-3448-6111
Homepage URL
Email	eiji525@yokohama-cu.ac.jp

Sponsor
Institute	NTT Medical Center Tokyo Department of Gastroenterology
Institute
Department

Funding Source
Organization	This study do not need financial support
Organization
Division
Category of Funding Organization	Profit organization
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	2016 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 30 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2017 Year 05 Month 30 Day
Date of closure to data entry	2017 Year 05 Month 30 Day
Date trial data considered complete	2017 Year 05 Month 30 Day
Date analysis concluded	2017 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 30 Day
Last modified on	2019 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025980