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Clinical trial

Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis-A Randomized Controlled Trial

ID
Name
LYBWWG2023
Description
The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.
Trial arms
Trial start
2023-02-01
Estimated PCD
2023-12-31
Trial end
2024-02-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Indomethacin suppository
100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia
Arms:
Group A
Standard Medical Treatment
Standard Medical Treatment
Arms:
Group A, Group B
Size
200
Primary endpoint
Post-pancreatectomy Acute Pancreatitis
2 weeks after pancreatectomy
Eligibility criteria
Inclusion Criteria: \*All patients planned to undergo pancreatectomy. Exclusion Criteria: * asthma * allergic reactions to NSAIDs * CKD * internal hemorrhoids * anti-platelet medications
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}
Updated at
2023-02-10

1 organization

1 product

1 indication

Organization
Shanghai Jiao Tong University School of Medicine
Product
Indomethacin
Indication
Pancreatectomy