UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044741 |
|---|---|
| Receipt number | R000050701 |
| Scientific Title | Low dose rectal diclofenac for prevention of Post-ESD Coagulation Syndrome(LOWER PECS): a randomized controlled trial |
| Date of disclosure of the study information | 2021/07/02 |
| Last modified on | 2024/01/30 00:58:40 |
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Basic information
Public title
Low dose Rectal diclofenac for prevention of Post-ESD Coagulation Syndrome(LOWER PECS): a randomized controlled trial
Acronym
Low dose rectal diclofenac for prevention of Post-ESD Coagulation Syndrome(LOWER PECS): a randomized controlled trial
Scientific Title
Low dose rectal diclofenac for prevention of Post-ESD Coagulation Syndrome(LOWER PECS): a randomized controlled trial
Scientific Title:Acronym
Low dose rectal diclofenac for prevention of Post-ESD Coagulation Syndrome(LOWER PECS): a randomized controlled trial
Region
| Japan |
Condition
Condition
Post-ESD coagulation syndrome
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the prevention effect of low dose rectal diclofenac for post-ESD coagulation syndrome(PECS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incident rate of PECS.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Add a diclofenac sodium sup. (50mg) immediately after colorectal ESD once.
Interventions/Control_2
Perform a rectal examination immediately after colorectal 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 who are going to receive colorectal ESD for the neoplasm 20 mm in size or larger, except for the tumor located in the Rb
(rectum below the peritoneal reflection).
2) Patients who are 20 years old or older and 85 years old or younger.
Key exclusion criteria
1) major organ failure (Liver disease; Child-Pugh classification C, Renal disease; stage 4 or higher, Heart failure; NYHA classification 3 or higher).
2) Performance Status(ECOG) 3 or 4.
3) Patients who use steroids or NSAIDs regularly.
4) Patients with Visual analog scale (VAS) >20mm, WBC > 10000, or body temperature > 37.0 at the time before ESD.
5) Patients who are contraindicant to NSAIDs use.
6) Patients who are going to have ESD or EMR for multiple lesions simultaneously.
7) The cases of intraoperative perforation.
8) The patients who are judged by attending doctors as not suitable for this trial. If systolic blood pressure is under 70 mmHg, diclofenac sodium cannot be given to the patient.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Okada |
Organization
Omori Red Cross Hospital
Division name
Department of gastroenterology
Zip code
143-8527
Address
4-30-1, Chuo, Ota ward, Tokyo, JAPAN
TEL
08065720512
okdnya@gmail.com
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Okada |
Organization
Omori Red Cross Hospital
Division name
Department of gastroenterology
Zip code
143-8527
Address
4-30-1, Chuo, Ota ward, Tokyo, JAPAN
TEL
08065720512
Homepage URL
okdnya@gmail.com
Sponsor or person
Institute
Omori Red Cross Hospital, Department of Gastroenterology
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
Omori Red Cross Hospital
Address
4-30-1, Chuo, Ota ward, Tokyo, 143-8527 JAPAN
Tel
03-3775-3111
okdnya@gmail.com
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 | 07 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Since patient recruitment was limited due to the pandemic of COVID-19, we decided to extend the interval of data entry and patient follow-up. This content has been approved by the IRB in our institution.
Management information
Registered date
| 2021 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050701
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
