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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044741
Enrollment
160
Registered
2021-07-02
Start date
2021-06-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-ESD coagulation syndrome

Interventions

Add a diclofenac sodium sup. (50mg) immediately after colorectal ESD once. Perform a rectal examination immediately after colorectal ESD.

Sponsors

Omori Red Cross Hospital, Department of Gastroenterology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The incident rate of PECS.

Countries

Japan

Contacts

Public ContactNaoya Okada

Omori Red Cross Hospital Department of gastroenterology

okdnya@gmail.com08065720512

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026