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This study aims to evaluate the efficacy and safety of parecoxib versus indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). It is a single-center, prospective, randomized, controlled, exploratory trial. Participants will be randomly assigned to receive either parecoxib or indomethacin as a preventive treatment. The primary endpoint is to compare the efficacy of the two drugs in reducing the incidence of PEP. Secondary endpoints include the incidence of moderate to severe PEP and post-ERCP-related adverse events. This study will systematically assess the efficacy and safety of both drugs, providing preliminary data for future larger confirmatory trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parecoxib Group | Experimental |
| |
| Indomethacin Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parecoxib Sodium | Drug | Parecoxib Sodium 40 mg administered intravenously 30 minutes before the ERCP procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Post-ERCP Pancreatitis (PEP) | The primary outcome is the proportion of patients who develop post-ERCP pancreatitis. PEP is characterized by new or worsened abdominal pain, elevated serum amylase levels (≥3 times the upper normal limit). | 24 hours after ERCP procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Moderate to Severe PEP | The severity of PEP will be classified according to the Cotton consensus and the revised Atlanta classification. | At discharge (up to 30 days) |
| Incidence of Hyperamylasemia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ge Yu, MD | Contact | 021-63240090-9185 | ge.yu@shgh.cn |
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| Indomethacin suppository | Drug | Indomethacin suppository 100 mg administered rectally 30 minutes before the ERCP procedure. |
|
Hyperamylasemia is defined as a serum amylase level greater than three times the upper limit of normal, without the onset of new abdominal pain or worsening of existing pain.
| 3 and 24 hours after ERCP procedure |
| Post-Procedure Discomfort Symptoms | Definition: Post-ERCP discomfort symptoms primarily include abdominal pain, nausea, vomiting, sore throat, abdominal bloating, dizziness, and headache. To comprehensively assess the severity of these symptoms, the study will utilize the Symptom Severity Index (SSI) to quantify and analyze patient-reported symptoms. Assessment Method: Each symptom will be self-assessed by the patient using the Numeric Rating Scale (NRS), a self-assessment tool, and verified by the study staff. The score ranges from 0 to 10, where 0 represents no symptoms, and 10 represents the most severe symptoms. Scoring Weights: The final score for each symptom will be calculated by multiplying the symptom score by its respective weight. The total symptom score will be the sum of all weighted scores, with a maximum score of 100. | Baseline (pre-procedure), 3 hours post-procedure, 6 hours post-procedure, 12 hours post-procedure, 24 hours post-procedure, 48 hours post-procedure, 72 hours post-procedure, and at discharge (up to 30 days) |
| Bleeding, Perforation, Cholangitis, Cardiac Adverse Events, Renal Adverse Events | Symptom-driven detection methods will be used to evaluate adverse events. The severity of bleeding, perforation, and cholangitis will be assessed according to the Cotton criteria. | 3 hours post-procedure, 6 hours post-procedure, 12 hours post-procedure, 24 hours post-procedure, 48 hours post-procedure, 72 hours post-procedure, and at discharge (up to 30 days) |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C409945 | parecoxib |
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