UMIN-CTR Clinical Trial

Basic information
Public title	Chemically assisted ESD in the esophagus and the colon
Acronym	CA-ESD in the esophagus and the colon
Scientific Title	Chemically assisted ESD in the esophagus and the colon
Scientific Title:Acronym	CA-ESD in the esophagus and the colon
Region	Japan

Condition
Condition	Early stage esophageal cancer, esophageal dysplasia, early stage colonic cancer, and colonic adenoma with an indication of ESD
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	ESD has enabled us to radically excise superficial gastrointestinal (GI) tumors at any level of the GI tract regardless of lesion size. However, ESD is technically challenging and may carries a higher risks of complications especially in the esophagus and the colon with thinner mural thickness. Preceding animal and pilot clinical studies demonstrated that the submucosal injection of one of mucolytic agents, so called mesna chemically soften the submucosal tissue plane and facilitate submucosal dissection process in ESD in the stomach. In this study, we will evaluate this chemical effect of mesna for ESD in the esophagus and the colon.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Procedural success rate
Key secondary outcomes	En bloc resection rate Complication and side effect rate The healing process of post-therapeutic ulcerations Histological analysis of sampled specimens

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Using mesna as a submucosal injection solution.
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	Superficial lesions in the esophagus and the colon with indication of ESD removal.
Key exclusion criteria	History of hypersensitivity to mesna and women who were pregnant, lactating, or hoping to become pregnant during this study period
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuki Sumiyama
Organization	The Jikei University School of Medicine
Division name	Department of Endoscopy
Zip code
Address	3-25-8 Nishi Shinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	The Jikei University School of Medicine
Division name	Department of Endoscop
Zip code
Address
TEL
Homepage URL
Email	kaz_sum@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	Research fund of The Jikei University School of Medicine, Department of Endoscopy.
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	2010 Year 06 Month 21 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	2010 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date	2010 Year 06 Month 01 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	2010 Year 06 Month 19 Day
Last modified on	2012 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004581

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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