UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016842 |
|---|---|
| Receipt number | R000019557 |
| Scientific Title | Analysis of clinical and pathological features, and endoscopic therapy of nonampullary duodenal adenoma/carcinoma |
| Date of disclosure of the study information | 2015/03/19 |
| Last modified on | 2022/01/26 16:15:27 |
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Basic information
Public title
Analysis of clinical and pathological features, and endoscopic therapy of nonampullary duodenal adenoma/carcinoma
Acronym
Analysis of features and endoscopic therapy of duodenal adenoma/carcinoma
Scientific Title
Analysis of clinical and pathological features, and endoscopic therapy of nonampullary duodenal adenoma/carcinoma
Scientific Title:Acronym
Analysis of features and endoscopic therapy of duodenal adenoma/carcinoma
Region
| Japan |
Condition
Condition
Nonampullary duodenal adenoma/carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal clinical and pathological features, and appropriate method of endoscopic therapy of nonampullary duodenal adenoma/carcinoma, retrospectively
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of en bloc resection of lesions according to the method of endoscopic therapy
Key secondary outcomes
Relationship between patients background such as age, sex and comorbid disease, and lesions information such as localization, morphological findings, size and pathological findings
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent endoscopic resection for nonampullary duodenal lesions which were pathologically diagnosed as adenoma or carcinoma
Key exclusion criteria
Patients evaluated incompetent by doctors in attendance
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Arai |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
260-8670
Address
Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL
043-226-2083
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Maruoka |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL
043-226-2083
Homepage URL
maruoka-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Research Ethics Committee, Graduate School of Medicine, Chiba University
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, Japan
Tel
043-226-2501
igaku-rinri@office.chiba-u.jp
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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34284025/
Number of participants that the trial has enrolled
126
Results
Both UEMR and EMRC had a significantly higher R0 resection rate than EMR. UEMR had significantly lower multiple resection and postbleeding rates than EMR. Only 1 patient (2.1%) who underwent EMRC experienced intraoperative and postoperative perforation. EMR was involved in RX/1 and piecemeal resection. The recurrence rates of EMR, UEMR, and EMRC were 4.3%, 2.0%, and 6.3%, respectively.
Results date posted
| 2022 | Year | 01 | Month | 26 | Day |
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 | 01 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2015 | Year | 03 | Month | 19 | Day |
Last modified on
| 2022 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019557
