Pancreatitis, AcutePhase 2PRECISENCT06623513
Efficacy and Safety of Parecoxib vs. Indomethacin in Preventing Post-ERCP Pancreatitis
A Phase 2 study testing Parecoxib Sodium and Indomethacin suppository in people with Pancreatitis, Acute and Cholangiopancreatography, Endoscopic Retrograde, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatitis, Acute, Cholangiopancreatography, Endoscopic Retrograde
- What is being tested?
- Parecoxib Sodium and Indomethacin suppository
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years.
- Patients scheduled to undergo ERCP for conditions such as common bile duct stones, benign or malignant biliary strictures, cholangitis, suspected biliary tumors, unexplained jaundice, or pancreas divisum.
Who cannot join
- Previous papillectomy.
- Previous endoscopic sphincterotomy (EST) without planned pancreatic duct intervention.
- Simple biliary stent removal or replacement without planned pancreatic duct intervention.
- Biliary-duodenal fistula, post-biliary-duodenal anastomosis, or post-biliary-jejunal anastomosis.
- Malignant tumor of the pancreatic head.
- Currently or recently (within 1 week) suffering from acute pancreatitis.
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- Current or recent (within 1 week) use of NSAIDs.
- Recent (within 2 weeks) or within 4 weeks prior to surgery, gastrointestinal bleeding or peptic ulcers.
- History of significant adverse reactions to NSAIDs.
- Renal insufficiency (creatinine clearance \< 30 mL/min).
- Moderate to severe hepatic impairment (Child-Pugh score ≥ 7).
- Severe cardiovascular or cerebrovascular disease.
- Patients with psychiatric disorders.
- Pregnant or breastfeeding patients.
- Patients without a rectum.
- Patients unwilling or unable to provide informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-Center, Prospective, Randomized, Controlled, Exploratory Trial Comparing the Efficacy and Safety of Parecoxib vs. Indomethacin in Preventing Post-ERCP Pancreatitis: The PRECISE Trail
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.
- Being tested
- Parecoxib Sodium, Indomethacin suppository
- Keywords
- Parecoxib, Indomethacin, Post-ERCP Pancreatitis, Efficacy, Safety
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parecoxib SodiumDrug
Parecoxib Sodium 40 mg administered intravenously 30 minutes before the ERCP procedure.
Indomethacin suppositoryDrug
Indomethacin suppository 100 mg administered rectally 30 minutes before the ERCP procedure.
| Study group | Role | What they receive |
|---|---|---|
| Parecoxib Group | Experimental | Not described Receives: Drug: Parecoxib Sodium |
| Indomethacin Group | Active comparator | Not described Receives: Drug: Indomethacin suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours after ERCP procedure.
Secondary outcomes (4)
Incidence of Moderate to Severe PEP
The severity of PEP will be classified according to the Cotton consensus and the revised Atlanta classification.
Measured: At discharge (up to 30 days)
Incidence of Hyperamylasemia
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.
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, AcuteStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ge Yu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623513
- Sponsor's protocol ID
- CCTR-2023C01
- Acronym
- PRECISE
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Randomized, Controlled, Exploratory Trial Comparing the Efficacy and Safety of Parecoxib vs. Indomethacin in Preventing Post-ERCP Pancreatitis: The PRECISE Trail
- ClinicalTrials.gov ID
- NCT06623513
- Acronym / sponsor ID
- PRECISE / CCTR-2023C01
- Keywords
- Parecoxib, Indomethacin, Post-ERCP Pancreatitis, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parecoxib Group | Experimental | Drug: Parecoxib Sodium |
| Indomethacin Group | Active comparator | Drug: Indomethacin suppository |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 80 years.
- Patients scheduled to undergo ERCP for conditions such as common bile duct stones, benign or malignant biliary strictures, cholangitis, suspected biliary tumors, unexplained jaundice, or pancreas divisum.
Key exclusion criteria (16 listed)
- Previous papillectomy.
- Previous endoscopic sphincterotomy (EST) without planned pancreatic duct intervention.
- Simple biliary stent removal or replacement without planned pancreatic duct intervention.
- Biliary-duodenal fistula, post-biliary-duodenal anastomosis, or post-biliary-jejunal anastomosis.
- Malignant tumor of the pancreatic head.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parecoxib SodiumParecoxib Sodium 40 mg administered intravenously 30 minutes before the ERCP procedure. | Drug | Parecoxib Group |
| Indomethacin suppositoryIndomethacin suppository 100 mg administered rectally 30 minutes before the ERCP procedure. | Drug | Indomethacin Group |
Primary outcome
Incidence of Post-ERCP Pancreatitis (PEP)
Time frame: 24 hours after ERCP procedure.
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).
4 secondary outcomes
Incidence of Moderate to Severe PEP
Time frame: At discharge (up to 30 days)
Incidence of Hyperamylasemia
Time frame: 3 and 24 hours after ERCP procedure
Post-Procedure Discomfort Symptoms
Time frame: 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
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Parecoxib Sodium and Indomethacin suppository in people with Pancreatitis, Acute and Cholangiopancreatography, Endoscopic Retrograde, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ge Yu, MD (021-63240090-9185, ge.yu@shgh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-ERCP Pancreatitis (PEP) (time frame: 24 hours after ERCP procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.