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 |
Low dose Rectal diclofenac for prevention of Post-ESD Coagulation Syndrome(LOWER PECS): a randomized controlled trial
Low dose rectal diclofenac for prevention of Post-ESD Coagulation Syndrome(LOWER PECS): a randomized controlled trial
Low dose rectal diclofenac for prevention of Post-ESD Coagulation Syndrome(LOWER PECS): a randomized controlled trial
Low dose rectal diclofenac for prevention of Post-ESD Coagulation Syndrome(LOWER PECS): a randomized controlled trial
Japan |
Post-ESD coagulation syndrome
Gastroenterology |
Others
NO
To clarify the prevention effect of low dose rectal diclofenac for post-ESD coagulation syndrome(PECS).
Efficacy
The incident rate of PECS.
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
No treatment
YES
YES
Central registration
2
Prevention
Medicine |
Add a diclofenac sodium sup. (50mg) immediately after colorectal ESD once.
Perform a rectal examination immediately after colorectal ESD.
20 | years-old | <= |
85 | years-old | >= |
Male and Female
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.
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.
160
1st name | Naoya |
Middle name | |
Last name | Okada |
Omori Red Cross Hospital
Department of gastroenterology
143-8527
4-30-1, Chuo, Ota ward, Tokyo, JAPAN
08065720512
okdnya@gmail.com
1st name | Naoya |
Middle name | |
Last name | Okada |
Omori Red Cross Hospital
Department of gastroenterology
143-8527
4-30-1, Chuo, Ota ward, Tokyo, JAPAN
08065720512
okdnya@gmail.com
Omori Red Cross Hospital, Department of Gastroenterology
None
Other
Omori Red Cross Hospital
4-30-1, Chuo, Ota ward, Tokyo, 143-8527 JAPAN
03-3775-3111
okdnya@gmail.com
NO
2021 | Year | 07 | Month | 02 | Day |
Unpublished
Enrolling by invitation
2021 | Year | 06 | Month | 02 | Day |
2021 | Year | 05 | Month | 07 | Day |
2021 | Year | 06 | Month | 10 | Day |
2024 | Year | 03 | Month | 31 | Day |
2024 | Year | 03 | Month | 31 | Day |
2025 | Year | 12 | Month | 31 | Day |
2026 | Year | 12 | Month | 31 | Day |
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.
2021 | Year | 07 | Month | 02 | Day |
2024 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050701