Lactated Ringer's solution in combination with rectal indomethacin for prevention of post-ERCP pancreatitis and readmission: a prospective randomized, double-blinded, placebo-controlled trial.
OBJECTIVE
Prospective data have shown the benefit of rectal indomethacin (IND) for preventing post-ERCP pancreatitis (PEP). A recent pilot study demonstrated a lower incidence of PEP after an 8-hour lactated Ringer's solution (LR) infusion. The aim of this study was to evaluate the efficacy of IND with or without bolus LR in patients at high-risk for PEP.


METHODS
In this randomized, double-blinded, placebo-controlled trial we assigned patients to standard normal saline solution (NS) + placebo, NS + IND, LR + placebo, or LR + IND. Each liter of fluid infusion was completed within 30 minutes. Patients were determined high-risk based established criterion and excluded if they had pancreatitis, contraindications to IND, or signs of volume overload. Our primary outcome was PEP, defined by standardized criterion. Our secondary outcomes were severe acute pancreatitis, localized adverse events, death, length of stay, and readmission.


RESULTS
Our sample consisted of 192 patients (48 per group) who completed follow-up at 24 hours and at 30 days post-ERCP. All patients had at least 1 high-risk criterion for PEP, and 56% had >1. PEP occurred in 3 patients (6%) in the LR + IND versus 10 (21%) in the NS + placebo group (P = .04). Readmission rates were lower in the LR + IND group (1 [2%]) versus the NS + placebo group (6 [13%]; P = .03). No differences were found between the other study groups. There was 1 case of severe pancreatitis (NS + IND) and 1 case of pseudocyst (LR + IND).


CONCLUSIONS
In patients at high risk for PEP, LR + IND reduced the incidence of PEP and readmission rates compared with NS + placebo. (Clinical trial registration number: NCT02641561.).
Cooper Medical School of Rowan University, MD Anderson Cancer Center at Cooper, Department of Medicine, Division of Gastroenterology and Liver Diseases, Mount Laurel, New Jersey, USA.
Shaffer R S
SRS
Mok
Cooper Medical School of Rowan University, MD Anderson Cancer Center at Cooper, Department of Medicine, Division of Gastroenterology and Liver Diseases, Mount Laurel, New Jersey, USA.
Henry C
HC
Ho
Cooper Medical School of Rowan University, MD Anderson Cancer Center at Cooper, Department of Medicine, Division of Gastroenterology and Liver Diseases, Mount Laurel, New Jersey, USA.
Paurush
P
Shah
Cooper Medical School of Rowan University, MD Anderson Cancer Center at Cooper, Department of Medicine, Division of Gastroenterology and Liver Diseases, Mount Laurel, New Jersey, USA.
Milan
M
Patel
Cooper Medical School of Rowan University, MD Anderson Cancer Center at Cooper, Department of Medicine, Division of Gastroenterology and Liver Diseases, Mount Laurel, New Jersey, USA.
John P
JP
Gaughan
Cooper Medical School of Rowan University, MD Anderson Cancer Center at Cooper, Department of Medicine, Division of Gastroenterology and Liver Diseases, Mount Laurel, New Jersey, USA.
Adam B
AB
Elfant
D000285:Administration, Rectal; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D006801:Humans; D007213:Indomethacin / Q000627:therapeutic use*; D007552:Isotonic Solutions / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000209:etiology / Q000517:prevention & control*; D010359:Patient Readmission; D000077325:Ringer's Lactate
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007552:Isotonic Solutions; D000077325:Ringer's Lactate; D007213:Indomethacin