UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055093 |
|---|---|
| Receipt number | R000062937 |
| Scientific Title | Endocuff Vision-Assisted Colonoscopy Significantly Improves Adenoma Detection In A Shorter Withdrawal Time Compared With Standard Colonoscopy: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/07/28 |
| Last modified on | 2024/07/28 20:22:27 |
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Basic information
Public title
Endocuff Vision-Assisted Colonoscopy Significantly Improves Adenoma Detection In A Shorter Withdrawal Time Compared With Standard Colonoscopy: A Randomized Controlled Trial
Acronym
Endocuff Vision-assisted Colonoscopy
Scientific Title
Endocuff Vision-Assisted Colonoscopy Significantly Improves Adenoma Detection In A Shorter Withdrawal Time Compared With Standard Colonoscopy: A Randomized Controlled Trial
Scientific Title:Acronym
Endocuff Vision-assisted Colonoscopy
Region
| Asia(except Japan) |
Condition
Condition
Colonoscopy is considered the most effective method for detecting and removing colorectal adenomas and is recommended as the primary screening modality for CRC, and missing these lesions is related to interval CRC. The colon has angulated segments and haustral bends, which create blind areas and potentially lead to missed adenomas. Therefore, the development of devices attached to the distal end of a colonoscope that helps to flatten such areas and expose the mucosa is potentially useful. Endocuff Vision (Olympus Co., Ltd., Tokyo, Japan) is a device made of a plastic barrel with a row of flexible and soft arms [6]. This device is attached to the tip of the colonoscope, helping to flatten the mucosal folds during the withdrawal phase Although several studies in Western countries have shown that Endocuff Vision-assisted colonoscopy (EC) can improve the colorectal adenoma detection rate (ADR), such evidence in Asia is still scarce.
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the performance of Endocuff Vission-assisted colonoscopy (EC) in terms of ADR compared with that of standard colonoscopy (SC) for detecting colorectal adenomas in Vietnamese patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
colorectal adenoma detection rate (ADR)
Key secondary outcomes
1. the ADR and polyp detection rate (PDR), the advanced adenoma detection rate (AADR) and the serrated sessile lesion detection rate (SSLDR)
2. the mean number of adenomas per procedure (MAP) and the mean number of polyps per procedure (MPP)
3. the cecal intubation time and the withdrawal time
4. the difficulty of scope insertion assessed by endoscopists
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Endocuff Vission-assisted colonoscopy
Interventions/Control_2
Standard colonoscopy
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects aged >= 40 years who were referred for colonoscopy due to clinical symptoms or for CRC screening
Key exclusion criteria
Individuals who met any of the following criteria were excluded: (i) history of colorectal surgery or polypectomy, (ii) preendoscopic suspicion of colorectal obstruction, (iii) known colonic stricture or severe diverticulosis, (iv) uncorrected coagulation disorders or ongoing anticoagulant therapy that had not been appropriately discontinued, (v) inadequate bowel preparation, or (vi) incomplete colonoscopy.
Target sample size
228
Research contact person
Name of lead principal investigator
| 1st name | Duc |
| Middle name | Trong |
| Last name | Quach |
Organization
University of Medicine and Pharmacy at Ho Chi Minh City
Division name
Department of Internal Medicine
Zip code
700000
Address
217 Hong Bang Street, Ward 11, District 5, Ho Chi Minh City, Vietnam
TEL
84918080225
drquachtd@gmail.com
Public contact
Name of contact person
| 1st name | Duc |
| Middle name | Trong |
| Last name | Quach |
Organization
University of Medicine and Pharmacy at Ho Chi Minh City
Division name
Department of Internal Medicine
Zip code
700000
Address
217 Hong Bang Street, Ward 11, District 5, Ho Chi Minh City, Vietnam
TEL
84918080225
Homepage URL
drquachtd@gmail.com
Sponsor or person
Institute
University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam
Institute
Department
Personal name
Ngo Quoc Dat
Funding Source
Organization
Olympus Vietnam Co., Ltd
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japanese
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Board of Ethics in Biomedical Research of the University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam
Address
217 Hong Bang Street, Ward 11, District 5, Ho Chi Minh City, Vietnam
Tel
842838558411
nghiencuukhoahoc@ump.edu.vn
Secondary IDs
Secondary IDs
NO
Study ID_1
831/HDDD-DHYD
Org. issuing International ID_1
Board of Ethics in Biomedical Research of the University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
University Medical Center Ho Chi Minh City, Vietnam
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
497
Results
Compared with the SC group, the EV group had significantly higher ADRs (0.357 vs. 0.226, p = 0.002) and MAPs (0.68 vs. 0.39, p = 0.004). The intubation durations were comparable between the two groups. The withdrawal time in the EC group was shorter than that in the SC group (median [seconds]: 266 [IR: 224, 314] vs. 360 [IR: 310, 390], p < 0.001).
Results date posted
| 2024 | Year | 07 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were 476 participants (241 in the EC group, 235 in the SC group) with a median age of 52 (interquartile range [IR]: 46, 58) years. There were no significant differences between the two groups regarding age, sex, smoking status, family history of colorectal cancer or indications for colonoscopy.
Participant flow
A total of 497 subjects were randomly assigned to the EC or SC group and underwent colonoscopy. One subject in the EC group required removal of the Endocuff Vision device due to severe diverticulosis. After excluding additional subjects who had inadequate bowel preparation and/or incomplete colonoscopy, 476 participants (241 in the EC group and 235 in the SC group) were included
Adverse events
No adverse events were observed.
Outcome measures
There were no significant differences between the two groups regarding age, sex, smoking status, family history of colorectal cancer or indications for colonoscopy. Compared with the SC group, the EV group had significantly higher ADRs (35.7% vs. 22.6%, p = 0.002) and MAPs (0.68 vs. 0.39, p = 0.004). The intubation durations were comparable between the two groups. The withdrawal time in the EC group was shorter than that in the SC group (median [seconds]: 266 [IR: 224, 314] vs. 360 [IR: 310, 390], p < 0.001).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 28 | Day |
Last modified on
| 2024 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062937
