UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000759 |
|---|---|
| Receipt number | R000000854 |
| Scientific Title | Endoscopic resection for laterally spreading tumor (LST) -(endoscopic submucosal dissecion (ESD) vs. endoscopic mucosal resection)- |
| Date of disclosure of the study information | 2007/07/04 |
| Last modified on | 2014/03/12 17:49:57 |
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Basic information
Public title
Endoscopic resection for laterally spreading tumor (LST)
-(endoscopic submucosal dissecion (ESD) vs. endoscopic mucosal resection)-
Acronym
endoscopic resection for LST (ESD vs. EMR)
Scientific Title
Endoscopic resection for laterally spreading tumor (LST)
-(endoscopic submucosal dissecion (ESD) vs. endoscopic mucosal resection)-
Scientific Title:Acronym
endoscopic resection for LST (ESD vs. EMR)
Region
| Japan |
Condition
Condition
early colorectal cancer or adenoma
(laterally spreading tumor (LST))
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the appropriate method of endoscopic resection for laterally spreading tumor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of local recurrence after endoscopic resection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Group A. ESD group
1. The solution of a mixture of Glyceol and 1% 1900-KDa hyaluronic acid preparation is injected into the submucosal layer.
2. Mucosal incision is started with the knife for ESD.
3. The lesion is resected with submucosal dissection.
Interventions/Control_2
Group B. EMR group
1. The solution of normal saline is injected into the submucosal layer.
2. The lesion is resected with an electrosurgical snare.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients who were diagnosed as laterally spreading tumor (granular type:LST-G)
2.Patients who had preoperative diagnoses of mucosal or slight submucosally invasive neoplasms.
3.Patients whose lesion was diagnosed as 20-40mm in diameter.
4. Patients who provided written informed consent.
Key exclusion criteria
1.Patients with serious complication.
2.Patients who were judged inappropriate by their physicians.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Fujishiro |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyoku, Tokyo, 113-8655
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
TEL
03-3815-5411
Homepage URL
Sponsor or person
Institute
The University of Tokyo, Department of Gastroenterology
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2007 | Year | 07 | Month | 04 | 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
Completed
Date of protocol fixation
| 2007 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 07 | Month | 03 | Day |
Last modified on
| 2014 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000854
