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lack of funding
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Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique utilized to diagnose and treat pathologic conditions involving the ducts draining the liver and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and occurs in approximately 11% of children undergoing the procedure. By definition it leads to prolongation of hospital stay or delays in care and rarely can result in long-term morbidity or even death. Recent adult trials have demonstrated prevention of PEP with administration of rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed in children thus no "gold standard" or even commonly accepted method of preventing PEP in the pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages over rectally administered NSAIDs in the pediatric population in that it would allow for more consistent weight based dosing and would have more predictable absorption compared to suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical Center Dallas over a two-year period. The primary outcome measurement will be development of PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease rates of post-ERCP pancreatitis in pediatric patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Experimental | Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg). |
|
| Placebo | Placebo Comparator | Single dose IV normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Post-ERCP Pancreatitis | Number of patients who develop post-ERCP pancreatitis | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Post-ERCP Bleeding | Number of patients who develop post-ERCP bleeding | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Increased Pain Score | Number of patients with increased pain scores after the procedure | pre-procedural, 24 hours |
| 24-h Post-ERCP Pain Score | Pain score recorded 24-hrs after the ERCP was performed as recorded on a 10-point Likert pain scale (0= lowest value, no pain, 10=highest value, severe pain) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M Troendle, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Medical Center of Dallas | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31651801 | Derived | Troendle DM, Gurram B, Huang R, Barth BA. IV Ibuprofen for Prevention of Post-ERCP Pancreatitis in Children: A Randomized Placebo-controlled Feasibility Study. J Pediatr Gastroenterol Nutr. 2020 Jan;70(1):121-126. doi: 10.1097/MPG.0000000000002524. |
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10 patients excluded after enrollment. 5 did not undergo ERCP and thus did not receive a study drug. 3 did not have study drug available in time for procedure. 2 did not meet inclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen | Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg). Ibuprofen |
| FG001 | Placebo | Single dose IV normal saline placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen | Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg). Ibuprofen |
| BG001 | Placebo | Single dose IV normal saline placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-ERCP Pancreatitis | Number of patients who develop post-ERCP pancreatitis | Posted | Count of Participants | Participants | 2 weeks |
|
|
2 weeks
All adverse events were defined by the American Society of Gastroenterology (ASGE) lexicon for endoscopic adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibuprofen | Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg). Ibuprofen |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment | Post-ERCP Pancreatitis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Troendle | UT Southwestern | 214456-8000 | david.troendle@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2014 | Feb 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
|
|
| pre-procedural, 24 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Mean Pain Score | Baseline pain score on 10-point Likert scale | Mean | Inter-Quartile Range | units on a Likert scale |
|
|
|
| Secondary | Post-ERCP Bleeding | Number of patients who develop post-ERCP bleeding | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Other Pre-specified | Increased Pain Score | Number of patients with increased pain scores after the procedure | Posted | Count of Participants | Participants | pre-procedural, 24 hours |
|
|
|
| Other Pre-specified | 24-h Post-ERCP Pain Score | Pain score recorded 24-hrs after the ERCP was performed as recorded on a 10-point Likert pain scale (0= lowest value, no pain, 10=highest value, severe pain) | Posted | Mean | Inter-Quartile Range | score on a Likert pain scale | pre-procedural, 24 hours |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 3 |
| 29 |
| EG001 | Placebo | Single dose IV normal saline placebo | 0 | 29 | 0 | 29 | 9 | 29 |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment | Abdominal pain not related to post-ERCP pancreatitis |
|
| Bleeding | Gastrointestinal disorders | Systematic Assessment | post-ERCP bleeding |
|
| Cholangitis | Hepatobiliary disorders | Systematic Assessment | Post-ERCP cholangitis |
|
| Perforation | Gastrointestinal disorders | Systematic Assessment | ERCP related perforation |
|
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| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |