UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058742 |
|---|---|
| Receipt number | R000067165 |
| Scientific Title | A multicenter randomized controlled trial of post-ESD coagulation syndrome after colorectal endoscopic submucosal dissection |
| Date of disclosure of the study information | 2025/08/20 |
| Last modified on | 2025/08/08 16:32:31 |
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Basic information
Public title
A multicenter randomized controlled trial of post-ESD coagulation syndrome after colorectal endoscopic submucosal dissection
Acronym
RCT of PECS after colorectal ESD
Scientific Title
A multicenter randomized controlled trial of post-ESD coagulation syndrome after colorectal endoscopic submucosal dissection
Scientific Title:Acronym
RCT of PECS after colorectal ESD
Region
| Japan |
Condition
Condition
Colorectal tumors 20mm - 50mm in diameter
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of early initiation of diet with that of normal initiation of diet after colorectal ESD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of post-ESD coagulation syndrome
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Group A: normal initiation group
Interventions/Control_2
Group B: early initiation group
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients
1. with colorectal tumors measuring 20 - 50 mm in diameter considered difficult to remove en bloc with endoscopic mucosal resection,
2. aged 20 - 90 years at the time of obtaining informed consent,
3. with Eastern Cooperative Oncology Group performance status of 0 - 2,
4. with antithrombotic drug management according to the Japanese Guidelines for Gastroenterological Endoscopy,
5. who provided written informed consent to participate in the study.
Key exclusion criteria
Patients with
1. colorectal tumors diagnosed as T1b cancer endospically,
2. colorectal tumors with local recurrence after endoscopic resection,
3. inflammatory bowel disease or familial adenomatous polyposis
4. a history of thrombocytopenia, coagulation system abnormalities, or bleeding tendency,
5. confirmed or possible pregnancy,
6. who have already enrolled in this study
7. unsuitable for clinical trial judged by clinicians
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | Shigeto |
| Middle name | |
| Last name | Yoshida |
Organization
NHO Kure Medical Center and Chugoku Cancer Center
Division name
Department of Endoscopy
Zip code
737-0023
Address
3-1 Aoyama-cho, Kure, Japan
TEL
+81-823-22-3111
yoshida.shigeto.tp@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Yuzuru |
| Middle name | |
| Last name | Tamaru |
Organization
NHO Kure Medical Center and Chugoku Cancer Center
Division name
Department of Endoscopy
Zip code
737-0023
Address
3-1 Aoyama-cho, Kure, Japan
TEL
+81-823-22-3111
Homepage URL
tamaru.yuzuru.vh@mail.hosp.go.jp
Sponsor or person
Institute
Department of Endoscopy, NHO Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
none
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
NHO Kure Medical Center and Chugoku Cancer Center
Address
3-1 Aoyama-cho, Kure, Japan
Tel
+81-823-22-3111
tamaru.yuzuru.vh@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
| 2025 | Year | 08 | Month | 20 | 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
| 2025 | Year | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 08 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067165
