Post-ERCP Acute Pancreatitis
Conditions
Keywords
Post ERCP acute pancreatitis, Post Fine Needle Aspiration (FNA) acute pancreatitis, Indomethacin, Rectal Non Steroidal Anti-Inflammatory Drugs (NSAIDs)
Brief summary
The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.
Interventions
DRUGIndomethacin
100 mg Indomethacin PR x 1
DRUGPlacebo
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Scheduled for an ERCP at Dartmouth-Hitchcock 2. Age greater than 18 years old 3. Ability to provide written informed consent
Exclusion criteria
1. Inability to provide written informed consent 2. ERCP being performed for diagnosis and/or treatment of acute pancreatitis 3. Current ongoing acute pancreatitis 4. Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 5. Contra-indication to NSAID therapy (creatinine level \>1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection) 6. Pregnant or nursing mothers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Developed Acute Pancreatitis | From randomization to 30 days after ERCP | Number of patients who developed pancreatitis following ERCP based on Atlanta Classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Developed Moderately Severe Pancreatitis | From randomization to 30 days after ERCP | Number of patients with moderately severe pancreatitis based on Atlanta Classification |
| Number of Patients Who Developed Mild Pancreatitis | From randomization to 30 days after ERCP | Number of patient who developed mild acute pancreatitis based on the Atlanta Classification |
| Number of Patients Who Developed Severe Pancreatitis | From randomization to 30 days after ERCP | Number of patients with severe acute pancreatitis based on the Atlanta Classification |
| Number of Patient Deaths | From randomization to 30 days after ERCP | Number of patients who died from any cause from the time of ERCP until 30 days post-procedure |
| Number of Patients With 30 Days Hospital Re-admission | From randomization until 30 days after ERCP | Number of patients admitted to the hospital for any cause following ERCP |
| Number of Patients Who Developed Gastrointestinal Bleeding | From randomization to 30 days after ERCP | Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure |
Countries
United States
Participant flow
Recruitment details
All patients who presented to Dartmouth-Hitchcock Medical Center for Endoscopic Retrograde Cholangiopancreatography (ERCP) for any reason between March 2013 and December 2014
Participants by arm
| Arm | Count |
|---|---|
| Indomethacin Indomethacin 100 mg PR x 1 in peri-procedural period
Indomethacin: 100 mg Indomethacin PR x 1 | 223 |
| Placebo Placebo suppositories (#2)
Placebo | 226 |
| Total | 449 |
Baseline characteristics
| Characteristic | Placebo | Indomethacin | Total |
|---|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 15.1 | 64.9 years STANDARD_DEVIATION 23.7 | 64.6 years STANDARD_DEVIATION 19.9 |
| Balloon Dilation of Biliary Sphincter No | 206 participants | 202 participants | 408 participants |
| Balloon Dilation of Biliary Sphincter Yes | 20 participants | 21 participants | 41 participants |
| Biliary Strent Placement No | 142 participants | 134 participants | 276 participants |
| Biliary Strent Placement Yes | 84 participants | 89 participants | 173 participants |
| Concomitant Endoscopic Ultrasound with Fine Needle Aspiration (EUS/FNA) No | 186 participants | 182 participants | 368 participants |
| Concomitant Endoscopic Ultrasound with Fine Needle Aspiration (EUS/FNA) Yes | 40 participants | 41 participants | 81 participants |
| Difficult Cannulation No | 184 participants | 177 participants | 361 participants |
| Difficult Cannulation Yes | 42 participants | 46 participants | 88 participants |
| History of post-ERCP Pancreatitis No | 217 participants | 214 participants | 431 participants |
| History of post-ERCP Pancreatitis Yes | 9 participants | 9 participants | 18 participants |
| History of Previous Sphincterotomy No | 155 participants | 151 participants | 306 participants |
| History of Previous Sphincterotomy Yes | 71 participants | 72 participants | 143 participants |
| Indication Acute Cholangitis | 13 participants | 12 participants | 25 participants |
| Indication Ampullectomy | 5 participants | 6 participants | 11 participants |
| Indication Biliary Leak | 12 participants | 11 participants | 23 participants |
| Indication Biliary Stent Change | 25 participants | 25 participants | 50 participants |
| Indication Choledocholithiasis | 52 participants | 59 participants | 111 participants |
| Indication Increased Liver Tests/Jaundice | 9 participants | 13 participants | 22 participants |
| Indication Malignant Biliary Obstruction | 50 participants | 53 participants | 103 participants |
| Indication Other | 31 participants | 16 participants | 47 participants |
| Indication Pancreatic Duct Stone | 2 participants | 3 participants | 5 participants |
| Indication Pancreatic Leak/Disruption | 12 participants | 11 participants | 23 participants |
| Indication Pancreatic Stricture | 5 participants | 3 participants | 8 participants |
| Indication Recurrent Acute Pancreatitis | 2 participants | 5 participants | 7 participants |
| Indication Suspected Sphincter of Oddi Dysfunction (SOD) | 8 participants | 6 participants | 14 participants |
| Minor Duct Sphincterotomy No | 222 participants | 218 participants | 440 participants |
| Minor Duct Sphincterotomy Yes | 4 participants | 5 participants | 9 participants |
| Pancreatic Acinarization No | 222 participants | 218 participants | 440 participants |
| Pancreatic Acinarization Yes | 4 participants | 5 participants | 9 participants |
| Pancreatic Stent Placement No | 191 participants | 187 participants | 378 participants |
| Pancreatic Stent Placement Yes | 35 participants | 36 participants | 71 participants |
| Pancreatography No | 177 participants | 173 participants | 350 participants |
| Pancreatography Yes | 49 participants | 50 participants | 99 participants |
| Periprocedural Fluid Volume | 703 Milliliters STANDARD_DEVIATION 355 | 705 Milliliters STANDARD_DEVIATION 335 | 704 Milliliters STANDARD_DEVIATION 345 |
| Precut Biliary Sphincterotomy No | 210 participants | 212 participants | 422 participants |
| Precut Biliary Sphincterotomy Yes | 16 participants | 11 participants | 27 participants |
| Previous ERCP No | 147 participants | 142 participants | 289 participants |
| Previous ERCP Yes | 79 participants | 81 participants | 160 participants |
| Sex: Female, Male Female | 118 Participants | 118 Participants | 236 Participants |
| Sex: Female, Male Male | 108 Participants | 105 Participants | 213 Participants |
| Therapeutic Biliary Sphincterotomy No | 112 participants | 117 participants | 229 participants |
| Therapeutic Biliary Sphincterotomy Yes | 114 participants | 106 participants | 220 participants |
| Therapeutic Pancreatic Sphincterotomy No | 221 participants | 211 participants | 432 participants |
| Therapeutic Pancreatic Sphincterotomy Yes | 5 participants | 12 participants | 17 participants |
| Trainee Involvement No | 58 participants | 71 participants | 129 participants |
| Trainee Involvement Yes | 168 participants | 152 participants | 320 participants |
| Wire Cannulation of Pancreatic Duct No | 137 participants | 133 participants | 270 participants |
| Wire Cannulation of Pancreatic Duct Yes | 89 participants | 90 participants | 179 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 223 | 6 / 226 |
| serious Total, serious adverse events | 0 / 223 | 3 / 226 |
Outcome results
Primary
Number of Patients Who Developed Acute Pancreatitis
Number of patients who developed pancreatitis following ERCP based on Atlanta Classification
Time frame: From randomization to 30 days after ERCP
Population: Patient who randomized into the study and received either rectal indomethacin or placebo
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Indomethacin | Number of Patients Who Developed Acute Pancreatitis | 16 participants |
| Placebo | Number of Patients Who Developed Acute Pancreatitis | 11 participants |
p-value: 0.33Fisher Exact
Secondary
Number of Patient Deaths
Number of patients who died from any cause from the time of ERCP until 30 days post-procedure
Time frame: From randomization to 30 days after ERCP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Indomethacin | Number of Patient Deaths | 0 participants |
| Placebo | Number of Patient Deaths | 3 participants |
p-value: 0.25Fisher Exact
Secondary
Number of Patients Who Developed Gastrointestinal Bleeding
Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure
Time frame: From randomization to 30 days after ERCP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Indomethacin | Number of Patients Who Developed Gastrointestinal Bleeding | 4 participants |
| Placebo | Number of Patients Who Developed Gastrointestinal Bleeding | 6 participants |
p-value: 0.75Fisher Exact
Secondary
Number of Patients Who Developed Mild Pancreatitis
Number of patient who developed mild acute pancreatitis based on the Atlanta Classification
Time frame: From randomization to 30 days after ERCP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Indomethacin | Number of Patients Who Developed Mild Pancreatitis | 16 participants |
| Placebo | Number of Patients Who Developed Mild Pancreatitis | 9 participants |
p-value: 0.15Fisher Exact
Secondary
Number of Patients Who Developed Moderately Severe Pancreatitis
Number of patients with moderately severe pancreatitis based on Atlanta Classification
Time frame: From randomization to 30 days after ERCP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Indomethacin | Number of Patients Who Developed Moderately Severe Pancreatitis | 0 participants |
| Placebo | Number of Patients Who Developed Moderately Severe Pancreatitis | 1 participants |
p-value: 1Fisher Exact
Secondary
Number of Patients Who Developed Severe Pancreatitis
Number of patients with severe acute pancreatitis based on the Atlanta Classification
Time frame: From randomization to 30 days after ERCP
Population: Assess the number of patients who developed severe acute pancreatitis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Indomethacin | Number of Patients Who Developed Severe Pancreatitis | 0 participants |
| Placebo | Number of Patients Who Developed Severe Pancreatitis | 1 participants |
p-value: 1Fisher Exact
Secondary
Number of Patients With 30 Days Hospital Re-admission
Number of patients admitted to the hospital for any cause following ERCP
Time frame: From randomization until 30 days after ERCP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Indomethacin | Number of Patients With 30 Days Hospital Re-admission | 31 participants |
| Placebo | Number of Patients With 30 Days Hospital Re-admission | 20 participants |
p-value: 0.1Fisher Exact