UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006140 |
|---|---|
| Receipt number | R000007249 |
| Scientific Title | 1600 Endoscopic submucosal dissection cases in the esophagus, stomach, and colorectum: Complication rates, learning curve and long-term outcomes |
| Date of disclosure of the study information | 2011/08/09 |
| Last modified on | 2011/08/09 21:48:17 |
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Basic information
Public title
1600 Endoscopic submucosal dissection cases in the esophagus, stomach, and colorectum: Complication rates, learning curve and long-term outcomes
Acronym
ESD in gastrointestinal tract: short-term and long-term outcomes
Scientific Title
1600 Endoscopic submucosal dissection cases in the esophagus, stomach, and colorectum: Complication rates, learning curve and long-term outcomes
Scientific Title:Acronym
ESD in gastrointestinal tract: short-term and long-term outcomes
Region
| Japan |
Condition
Condition
early gastrointestinal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess short and long term treatment outcomes for 1633 early gastrointestinal neoplasms (Stomach 1136 Esophagus 136 Colorectum 361) by single operator focusing on pre-procedure characteristics to contribute ESD difficulty, and learning curve
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
En-block resection rate, en-bloc R0 resection rate, rates of cases under the guideline criteria and expanded criteria, intra-criteria resection rate, tumor diameter, resected specimen diameter , macroscopic type, location, postoperative bleeding rate, perforation rate, and also the learning curve of complication rate and En bloc R0 resection rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Intramucosal or slightly-invaded submucosal gastrointestinal neoplasms were considered eligible
Key exclusion criteria
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
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Toyonaga |
Organization
Kobe University Hospital
Division name
Department of Endoscopy
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6305
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Toyonaga |
Organization
Kobe University Hospital
Division name
Department of Endoscopy
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6305
Homepage URL
toyonaga@med.kobe-u.ac.jp
Sponsor or person
Institute
Kishiwada Tokushukai Hospital
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
岸和田徳州会病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 09 | 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
| 2002 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 07 | Month | 01 | Day |
Other
Other related information
Study design: Retrospective cohort study
Purpose: To assess our short-time and long-term treatment outcomes for a large number ESDs for early gastrointestinal neoplasms in the esophagus, stomach, and colorectum by single operator. We particularly focus on aspects that are likely to be relevant to clinicians who may need to advise patients of the risks and benefits of an ESD approach which may vary depending on the pre-procedure characteristics of the lesion. We also assess learning curves for important outcomes and complications.
Management information
Registered date
| 2011 | Year | 08 | Month | 09 | Day |
Last modified on
| 2011 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007249
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
