UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035344 |
|---|---|
| Receipt number | R000040268 |
| Scientific Title | Establishment of Endoscopic Duodenal Observational Protocol on Duodenal Lesion Detection During Screening Esophagogastroduodenoscopy |
| Date of disclosure of the study information | 2019/01/04 |
| Last modified on | 2022/12/26 15:57:00 |
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Basic information
Public title
Establishment of Endoscopic Duodenal Observational Protocol on Duodenal Lesion Detection During Screening Esophagogastroduodenoscopy
Acronym
Endoscopic Duodenal Observational Protocol
Scientific Title
Establishment of Endoscopic Duodenal Observational Protocol on Duodenal Lesion Detection During Screening Esophagogastroduodenoscopy
Scientific Title:Acronym
Endoscopic Duodenal Observational Protocol
Region
| Japan |
Condition
Condition
Duodenal Lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To propose endoscopic duodenal observational protocol on duodenal lesion detection
Basic objectives2
Others
Basic objectives -Others
To investigate the incidental rate of duodenal lesion by the observational protocol
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
The completion rate of established observational protocol
Key secondary outcomes
1.The incidental rate of duodenal lesion
2.The incidental rate of duodenal meoplasms which need treatment
3.The examination time of duodenum
4.Total examination time
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
Patients who undergo screening esophagogastroduodenoscopy
Key exclusion criteria
1)without informed consent
2)already detected duodenal neoplasm
3)past history of upper GI surgery
4)severe mental status
5)inproper indication judged by doctor
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Kobara |
Organization
Faculty of Medicine, Kagawa University
Division name
Gastroenterology and Neurology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
0878985111
kobara@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Masae |
| Middle name | |
| Last name | Miyoshi |
Organization
Faculty of Medicine, Kagawa University
Division name
Investigator
Zip code
761-0793
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
0878985111
Homepage URL
chosa@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Gastroenterology and Neurology, Faculty of Medicine, Kagawa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
KKR hospital Mitsugu Yasuda
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa University
Address
1750-1 Ikenobe, Miki, Kita
Tel
0878912156
kobara@med.kagawa-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | 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
1549
Results
There were 1549 participants. The 7PR completion rate was 81.1% and the detection rate of overall neoplasms, adenomas, and carcinomas were 0.84, 0.71, and 0.06%, respectively. The area in which most neoplasms was detected was contralateral to the ampulla (69.2%), and the fewest the transverse duodenum (0%). 7PR is acceptable for duodenal examination and a potential quality indicator.
Results date posted
| 2022 | Year | 12 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This prospective observational study was conducted at two facilities and enrolled consecutive participants who had undergone screening EGD between April 2019 and August 2021. The inclusion criteria were age >20 years and screening EGD examination. The exclusion criteria were duplicated participants, previous diagnosis of UGI malignant neoplasms and duodenal tumors, history of resection of part of the UGI tract, and presence of psychosis or psychiatric symptoms.
Participant flow
Enrolled patients underwent our developed-comprehensive duodenal examination protocol, called the Seven Pictures Rule (7PR)
Adverse events
7PR procedure-associated complications
Outcome measures
The primary outcome was the 7PR completion rate. Completion of 7PR was defined as capture of the required seven photos in any sequence. Secondary outcomes were total rates of detection of lesions or neoplasms (adenomas, carcinomas, and others) requiring treatment overall and for each location, duodenal and total examination time, rates of completion of 7PR for S and U scopes, and 7PR procedure-associated complications. The total examination time was the duration between insertion of the scope into the mouth and its retrieval. Duodenal examination time was the duration between the first and seventh photo-documentation.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 12 | Month | 22 | Day |
Last modified on
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040268
