Post-ERCP Acute Pancreatitis
Conditions
Keywords
Indomethacin, pancreatitis, ERCP
Brief summary
Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a standard method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.
Interventions
DRUGPre-ERCP rectal Indomethacin
Rectal Indomethacin was administrated within 30min before ERCP in all patients.
DRUGPost-operational Rectal Indomethacin
Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing diagnostic or therapeutic ERCP.
Exclusion criteria
* Unwillingness or inability to consent for the study; * Age \< 18 years old; * Intrauterine pregnancy; * Breastfeeding mother; * Standard contraindications to ERCP; * Allergy to NSAIDs; * Received NSAIDs in prior 7 days; * Renal failure (Cr \>1.4mg/dl=120umol/l); * Active or recurrent (within 4 weeks) gastrointestinal hemorrhage; * Acute pancreatitis within 72 hours; * Known pancreatic head mass; * Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram; * ERCP for biliary stent removal or exchange without anticipated pancreatogram; * Known active cardiovascular or cerebrovascular disease. * Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-ERCP Pancreatitis | 30 days | Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Moderate-to-severe Pancreatitis | 30 days | Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery). |
Countries
China
Participant flow
Recruitment details
From Dec 15, 2013 to Sep 21, 2015, 5325 consecutive patients undergoing ERCP in six centers in China were considered for the study.
Pre-assignment details
After screening, 2725 patients were excluded: 193 did not meet inclusion criteria, 2304 met exclusion criteria and 228 patients declined to participate.
Participants by arm
| Arm | Count |
|---|---|
| Pre-ERCP Group Pre-ERCP rectal Indomethacin in all patients.
Pre-operational rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients. | 1,297 |
| Post-ERCP Group Post-ERCP rectal Indomethacin in high-risk patients.
Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not. | 1,303 |
| Total | 2,600 |
Baseline characteristics
| Characteristic | Pre-ERCP Group | Post-ERCP Group | Total |
|---|---|---|---|
| Age, Continuous | 62 years | 63 years | 62 years |
| High-risk patients | 305 participants | 281 participants | 586 participants |
| Sex: Female, Male Female | 688 Participants | 693 Participants | 1381 Participants |
| Sex: Female, Male Male | 609 Participants | 610 Participants | 1219 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 1,297 | 33 / 1,303 |
| serious Total, serious adverse events | 15 / 1,297 | 15 / 1,303 |
Outcome results
Primary
Post-ERCP Pancreatitis
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-ERCP Group | Post-ERCP Pancreatitis | 47 participants |
| Post-ERCP Group | Post-ERCP Pancreatitis | 100 participants |
Secondary
Moderate-to-severe Pancreatitis
Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-ERCP Group | Moderate-to-severe Pancreatitis | 11 participants |
| Post-ERCP Group | Moderate-to-severe Pancreatitis | 23 participants |