Phase 3 N=192 Randomized Quadruple-blind Prevention

Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Post-ERCP Acute Pancreatitis

Bottom Line

View on ClinicalTrials.gov: NCT02641561 ↗

Enrolled (actual)

192

Serious AEs

0.0%

Results posted

Feb 2018

Primary outcome: Primary: The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Either Elevated Amylase or Lipase 3 x Upper Limit of Normal — 10; 6; 9; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Indomethacin (Drug); Lactated Ringer's Solution (Drug); Normal Saline (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Cooper Health System
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Either Elevated Amylase or Lipase 3 x Upper Limit of Normal	10; 6; 9; 3	—
PRIMARY The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Imaging Suggestive of Acute Pancreatitis	0; 1; 0; 1	—
SECONDARY The Number of Participants With Acute Respiratory Distress Syndrome (ARDS) After ERCP as Assessed by ARDSnet Criterion (Below)	1; 0; 0; 0	—
SECONDARY The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)	10; 6; 9; 3	—
SECONDARY The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)	10; 6; 9; 3	—
SECONDARY The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)	10; 6; 9; 3	—
SECONDARY The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)	10; 6; 9; 3	—
SECONDARY The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)	10; 6; 9; 3	—
SECONDARY The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)	10; 6; 9; 3	—
SECONDARY The Number of Participants With Sepsis After ERCP as Assessed by Infectious Source Defined by Positive Microbiology Culture	0; 0; 0; 0	—
SECONDARY The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated Creatinine Blood Test	0; 1; 0; 0	—
SECONDARY The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated International Normalized Ratio (INR)	0; 0; 0; 0	—
SECONDARY The Number of Participants With Pancreatic Pseudocyst After ERCP as Assessed by Abdominal Imaging Suggestive of Pseudocyst	0; 0; 0; 1	—
SECONDARY The Number of Participants With Pancreatic Abscess After ERCP as Assessed by Abdominal Imaging Suggestive of Pancreatic Abscess	0; 0; 0; 0	—
SECONDARY The Number of Participants With Perforation After ERCP as Assessed by Abdominal Imaging Suggestive of Perforation	0; 0; 0; 0	—
SECONDARY The Number of Participants Who Undergo Surgery After ERCP, as Assessed by Surgical Operative Report	0; 0; 0; 0	—
SECONDARY The Number of Participants With Mortality After ERCP as Assessed by Medical Record Reporting	1; 2; 2; 1	—
SECONDARY The Number of Participants With Post-procedural Medical Care (ED Visit, Urgent Care, Hospitalization) as Assessed by Medical Record and Patients Self-reporting	6; 2; 2; 1	—
SECONDARY The Length of Stay (LOS) of Participants After ERCP if Medical Care is Sought as Assessed in Days	2.3; 2.2; 1.9; 4.3	—
SECONDARY The Number of Participants Who Were Readmitted After ERCP as Assessed by Medical Record and Patients Self-reporting	6; 2; 2; 1	0.04 sig

Summary

Post-ERCP pancreatitis is a well-known and sometimes life-threatening complication of ERCP. Both LR and rectal indomethacin have shown benefit in preventing post-ERCP pancreatitis. Despite this, no study to date has evaluated both of these measures for preventing post-ERCP pancreatitis. It is our hope to evaluate the combination of these two modalities for preventing post-ERCP pancreatitis compared with either modality alone.

Eligibility Criteria

Inclusion Criteria

1 Subjects who are undergoing endoscopic retrograde cholangiopancreatography (ERCP)

Age > 18 years
Non-pregnant
Non-prisoners
Subjects who can sign informed consent
Serum Creatinine 1.2 milligrams/deciliter (mg/dL)
Subjects with renal failure (acute and chronic)
Subjects with congestive heart failure (ejection fraction < 40%)
Subjects with cirrhosis of the liver
Subjects with allergy to aspirin or non-steroidal anti-inflammatory drugs (NSAIDS)
Subjects with gastrointestinal hemorrhage
Subjects on chronic non-steroidal anti-inflammatory drugs NSAIDS
Subjects with acute pancreatitis the day of their procedure (CITE 1-3)(APPENDIX 1)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02641561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.