Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059328) titled 'Additive Effect of Local Post-Procedural Cryoprevention on the Prevention of Post-ERCP Pancreatitis in Patients Receiving Rectal Diclofenac: A Multicenter Retrospective Study' on Oct. 8.
Study Type:
Observational
Primary Sponsor:
Institute - Kitasato University School of Medicine
Condition:
Condition - pancreaticobiliary disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the additive effect of local post-procedural cryoprevention on the prevention of post-ERCP pancreatitis in patients receiving rectal diclofenac alone.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who underwent ERCP
Key exclusion criteria - 1. Patients under 20 years of age
2. Patients without a naive papilla
3. Patients who received any prophylactic measure for PEP other than rectal diclofenac (25 mg)
4. Patients with acute pancreatitis
5. Patients with surgically altered gastrointestinal anatomy, excluding those with Billroth I reconstruction
6. Patients who withdrew consent through the opt-out process
Target Size - 1200
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 09 Month 04 Day
Date of IRB - 2025 Year 10 Month 07 Day
Anticipated trial start date - 2025 Year 10 Month 08 Day
Last follow-up date - 2027 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067045
Disclaimer: Curated by HT Syndication.
