Post-ERCP Acute Pancreatitis
Conditions
Keywords
post-ERCP pancreatitis, pediatric, ibuprofen
Brief summary
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.
Interventions
DRUGIbuprofen
DRUGplacebo
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age\<=18 years * Undergoing ERCP (defined as cannulation of the major or minor papilla) for any indication
Exclusion criteria
* Age\>18 * Pancreatitis within the 72 hours preceding ERCP * Allergy or hypersensitivity to Aspirin or NSAID medications * Pregnancy or breastfeeding mother * Cr \>1.4 * Gastrointestinal hemorrhage in preceding 72 hours * Heart disease reliant upon a patient ductus arteriosis * History of sickle cell disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-ERCP Pancreatitis | 2 weeks | Number of patients who develop post-ERCP pancreatitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-ERCP Bleeding | 2 weeks | Number of patients who develop post-ERCP bleeding |
Other
| Measure | Time frame | Description |
|---|---|---|
| Increased Pain Score | pre-procedural, 24 hours | Number of patients with increased pain scores after the procedure |
| 24-h Post-ERCP Pain Score | pre-procedural, 24 hours | 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) |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Ibuprofen Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).
Ibuprofen | 29 |
| Placebo Single dose IV normal saline
placebo | 29 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Pump malfunction, drug not delivered | 1 | 0 |
Baseline characteristics
| Characteristic | Ibuprofen | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 29 Participants | 29 Participants | 58 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 14 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 15 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Mean Pain Score | 2.9 units on a Likert scale | 2.2 units on a Likert scale | 2.6 units on a Likert scale |
| Sex: Female, Male Female | 20 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 3 / 29 | 9 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
Post-ERCP Pancreatitis
Number of patients who develop post-ERCP pancreatitis
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibuprofen | Post-ERCP Pancreatitis | 2 Participants |
| Placebo | Post-ERCP Pancreatitis | 5 Participants |
Secondary
Post-ERCP Bleeding
Number of patients who develop post-ERCP bleeding
Time frame: 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibuprofen | Post-ERCP Bleeding | 2 Participants |
| Placebo | Post-ERCP Bleeding | 0 Participants |
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)
Time frame: pre-procedural, 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ibuprofen | 24-h Post-ERCP Pain Score | 1.1 score on a Likert pain scale |
| Placebo | 24-h Post-ERCP Pain Score | 3.1 score on a Likert pain scale |
Other Pre-specified
Increased Pain Score
Number of patients with increased pain scores after the procedure
Time frame: pre-procedural, 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ibuprofen | Increased Pain Score | 1 Participants |
| Placebo | Increased Pain Score | 11 Participants |