UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044031 |
|---|---|
| Receipt number | R000050279 |
| Scientific Title | Evaluation of the impact of CAD EYE on the quality of colonoscopy and the learning curve of gastroenterology fellows |
| Date of disclosure of the study information | 2021/04/26 |
| Last modified on | 2023/04/27 14:52:31 |
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Basic information
Public title
Evaluation of the impact of CAD EYE on the quality of colonoscopy and the learning curve of gastroenterology fellows
Acronym
cad eye b study
Scientific Title
Evaluation of the impact of CAD EYE on the quality of colonoscopy and the learning curve of gastroenterology fellows
Scientific Title:Acronym
cad eye b study
Region
| Japan |
Condition
Condition
Patients who were referred and scheduled for total colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a randomized clinical trial of endoscopic observation using CAD EYE and normal endoscopic observation (WLI) to compare the adenoma detection and polyp miss rates.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adenoma Detection Rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Group A: Colonoscopy observation with CAD EYE
Interventions/Control_2
Group B: Colonoscopy observation with WLI
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
| 18 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 patients between 18 and 79 years of age (at the time of signing the consent form) undergoing lower gastrointestinal endoscopy.
2 patients who understand the contents of the consent document and can sign the consent form of their own free will (in the case of minors, their guardians).
3 patients who are required to undergo lower gastrointestinal endoscopy (patients who meet any of the following conditions)
patients with positive fecal occult blood
patients who have been previously diagnosed or treated for colorectal adenoma or colorectal cancer (not applicable for those who have undergone colorectal resection)
those with digestive symptoms such as abdominal pain, diarrhea, constipation, etc.
those who need to be screened for gastrointestinal cancer.
those who have a family history of colorectal cancer or colorectal adenoma.
those who have a family history of colorectal cancer or colorectal adenoma
other patients who are judged to need lower gastrointestinal endoscopy by the physician in charge
Key exclusion criteria
patients who have undergone bowel resection.
patients with a history of inflammatory bowel disease.
patients with a history of familial adenomatous polyposis
patients with a history of hereditary non-polyposis colorectal cancer
patients with a known history of severe intestinal adhesions
patients who are judged by their physician to be unable to participate in the study
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
Ureshino Medical Center
Division name
Gastroenterology
Zip code
8430393
Address
Shimojyukukou 4279-3, Ureshino city
TEL
0954431120
daisukehawks@gmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Yamaguchi |
Organization
Ureshino Medical Center
Division name
Gastroenterology
Zip code
8430393
Address
Shimojyukukou 4279-3, Ureshino city
TEL
0954431120
Homepage URL
daisukehawks@gmail.com
Sponsor or person
Institute
Ureshino Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Ureshino Medical Center
Address
Shimojyukukou 4279-3, Ureshino city
Tel
0954431120
honjo.yoko.vd@mail.hosp.go.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
| 2021 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/den.14573
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/den.14573
Number of participants that the trial has enrolled
231
Results
We analyzed data for 231 patients (Group A, n=113; Group B, n=118). The ADR was not significantly different between the two groups. Group A had a significantly lower AMR (25.6% vs. 38.6%, p=0.033) and number of missed adenomas per patient (0.5 vs. 0.9, p=0.004) than Group B.
Results date posted
| 2023 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients in this multicenter randomized controlled trial were divided into Group A (observation using CAD EYE) and Group B (standard observation). Six trainees performed colonoscopies using a back-to-back method in pairs with gastroenterology experts. The primary endpoint was the trainees' adenoma detection rate (ADR), and the secondary endpoints were the trainees' adenoma miss rate (AMR) and Assessment of Competency in Endoscopy (ACE) tool scores. Each trainee's learning curve was evaluated using a cumulative sum (CUSUM) control chart.
Participant flow
The study involved adults aged >20 years who were scheduled for outpatient colonoscopy from May 2021 to March 2022. The colonoscopy examinations were performed either because of a positive fecal immunochemical test or for surveillance after colonic polypectomy. We excluded patients with ileus, suspected bowel obstruction, or toxic megacolon; prior abdominal or pelvic surgery; inflammatory bowel disease; advanced malignancy; severe liver damage (Child-Pugh gradeC); dementia or other cognitive disorders; hypersensitivity to bowel preparation drugs for colonoscopy; and pregnancy or lactation.
Adverse events
No perioperative severe adverse events were observed in this study.
Outcome measures
We analyzed data for 231 patients (Group A, n=113; Group B, n=118). The ADR was not significantly different between the two groups. Group A had a significantly lower AMR (25.6% vs. 38.6%, p=0.033) and number of missed adenomas per patient (0.5 vs. 0.9, p=0.004) than Group B. Group A also had significantly higher ACE tool scores for pathology identification (2.26 vs. 2.07, p=0.030) and interpretation and identification of pathology location (2.18 vs. 2.00, p=0.038). For the CUSUM learning curve, Group A showed a trend toward a lower number of cases of missed multiple adenomas by the six trainees.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 25 | Day |
Last modified on
| 2023 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050279
