UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061375 |
|---|---|
| Receipt number | R000069941 |
| Scientific Title | A Prospective Comparative Study of Total Underwater Colonoscopy and CO2 Insufflation by Tandem Colonoscopy |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/26 12:30:38 |
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Basic information
Public title
A study comparing total underwater colonoscopy and CO2 insufflation colonoscopy
Acronym
Underwater vs CO2 Colonoscopy Study
Scientific Title
A Prospective Comparative Study of Total Underwater Colonoscopy and CO2 Insufflation by Tandem Colonoscopy
Scientific Title:Acronym
TUC-CO2 Study
Region
| Japan |
Condition
Condition
Colorectal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Total underwater colonoscopy (TUC) is a technique in which insertion is performed using water-assisted colonoscopy (WAC), and during withdrawal, the lumen is filled with water without gas insufflation for observation. By achieving moderate luminal distension and improving visibility through the optical properties of water, TUC is theoretically expected to reduce the polyp miss rate. In this study, we compare TUC with CO2 insufflation during colonoscope withdrawal to evaluate withdrawal time, polyp miss rate, and the characteristics of polyps missed by each method. In addition, patient pain scores are assessed to comprehensively examine the usefulness and safety of TUC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
polyp miss rate and adenoma miss rate
Key secondary outcomes
polyp detection rate and adenoma detection rate, withdrawal time, procedural pain assessment, sedative dosage
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
First perform withdrawal under water immersion, then perform withdrawal using CO2 insufflation. The intervention period is defined as the time from obtaining informed consent to two weeks after the examination and treatment.
Interventions/Control_2
First perform withdrawal using CO2 insufflation, followed by withdrawal under water immersion. The intervention period is defined as the time from obtaining informed consent to two weeks after the examination and treatment.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing inpatient treatment for colorectal tumors
2. Patients aged 18 years or older at the time of obtaining informed consent
3. No restriction on sex
4. Patients who have received sufficient explanation regarding participation in this study and have provided written informed consent of their own free will with adequate understanding
Key exclusion criteria
1. Patients with a history of colorectal surgery(excluding appendectomy)
2. Patients with inflammatory bowel disease
3. Patients with polyposis
4. Patients with heart failure(NYHA class III or IV)
5. Patients with severe hepatic dysfunction (Child Pugh class B or C)
6. Patients with chronic renal failure undergoing hemodialysis or peritoneal dialysis
7. Pregnant patients
8. Patients deemed ineligible for this study by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | koichi |
| Middle name | |
| Last name | Hamabe |
Organization
Yamaguchi University
Division name
Department of Gastroenterology and Hepatology
Zip code
755-8505
Address
1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2241
khamabe@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | koichi |
| Middle name | |
| Last name | Hamabe |
Organization
Yamaguchi University
Division name
Department of Gastroenterology and Hepatology
Zip code
755-8505
Address
1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2241
Homepage URL
khamabe@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University
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
Clinical Research Center, Yamaguchi University Hospital
Address
1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
Tel
0836-22-2428
me223@yamaguchi-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
| 2026 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 04 | Month | 26 | Day |
Last modified on
| 2026 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069941
