UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054735 |
|---|---|
| Receipt number | R000062537 |
| Scientific Title | A randomized controlled trial comparing conventional ESD versus underwater ESD for superficial colorectal epithelial tumors |
| Date of disclosure of the study information | 2024/06/24 |
| Last modified on | 2024/09/09 20:34:13 |
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Basic information
Public title
A randomized controlled trial comparing conventional and underwater endoscopic submucosal dissection for colorectal tumors
Acronym
Comparison of conventional vs underwater ESD of colorectal tumors
Scientific Title
A randomized controlled trial comparing conventional ESD versus underwater ESD for superficial colorectal epithelial tumors
Scientific Title:Acronym
RCT comparing conventional and underwater ESD for colorectal tumors
Region
| Japan |
Condition
Condition
Superficial colorectal epithelial tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of underwater ESD (UESD; underwater endoscopic submucosal dissection) for superficial colorectal epithelial tumors of 50 mm or less, comparing with conventional ESD (CESD; conventional endoscopic submucosal dissection) in a randomized controlled trial.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Procedure time
Key secondary outcomes
Time of making mucosal flap, number of patient'sposition changes during ESD, number of intraoperative bleeds requiring hemostatic forceps, incidence of intraoperative perforation, incidence of muscle layer injury, amount of sedation, dissection speed, procedure completion rate, en bloc resection rate, complete resection rate (R0 resection rate), presence of bowel fluid/air in case with intraoperative perforation, incidence of postoperative bleeding, incidence of delayed perforation, incidence of post-ESD coagulation syndrome (PECS; post-ESD coagulation syndrome), hospitalization period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Underwater ESD
Interventions/Control_2
Conventional ESD
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 20 years or older scheduled for ESD for colorectal epithelial tumors
2) The lesion endoscopically diagnosed to have a long diameter of 50 mm or less before treatment
3) Scheduled for endoscopic treatment of one lesion.
4) Patient age is between 20 and 85 years at enrollment of this study.
5) PS (ECOG) is 0, 1 or 2.
6) The patient has been fully informed about participation in the study and written consent has been obtained from the patient.
Key exclusion criteria
1) Remnant or recurrence after endoscopic resection
2) Critical organ failure (heart, lung, liver, kidney, bone marrow)
3) Patients with a history of colorectal surgery (excluding appendicectomy)
4) cT1b (clinical deep submucosal invasive cancer)
5) lesion with muscular layer retraction
6) the lesion extending into the appendix orifice, ileum, diverticulum or anal canal
7) Patients with ulcerative colitis
8) Patients with familial adenomatous polyposis
9) Pregnant and lactating women
10) Patients taking antithrombotic agents which are not able to be interrupted or replaced in accordance with the guidelines for Japanese Gastroenterological Endoscopy Society.
11) Other cases which an attending doctor judge inappropriate
Target sample size
686
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University School of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Akimoto |
Organization
Keio University School of Medicine
Division name
Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL
03-5363-3437
Homepage URL
t-akimoto@nms.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Motohiko Kato
Funding Source
Organization
Keio University School of Medicine
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, Keio University School of Medicine
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20241021
Org. issuing International ID_1
Research Ethics Committee, Keio University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2024 | Year | 06 | Month | 23 | Day |
Last modified on
| 2024 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062537
