Pharmacological prophylaxis versus pancreatic duct stenting plus pharmacological prophylaxis for prevention of post-ERCP pancreatitis: results are as yet inconclusive

10.1055/a-0977-3119

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common and major complication following ERCP. Rectal nonsteroidal anti-inflammatory drugs (NSAIDs) are easy to administer and are generally recommended for PEP prophylaxis. Whether the addition of pancreatic duct (PD) stenting to rectal NSAIDs provides additional benefit has not previously been shown.

Sotoudehmanesh et al. recently published a randomized, controlled, double-blind, noninferiority trial to evaluate the effectiveness of PD stenting plus pharmacological prophylaxis (Group A) vs. pharmacological prophylaxis alone (Group B) for PEP prevention in high risk patients in this journal [1]. Among the total of 414 patients enrolled, PEP occurred in 12.6 % of patients (95 % confidence interval [CI] 8.6 % – 17.6 %) in group A and 15.9 % (95 %CI 11.4 % – 21.4 %) in group B. The authors concluded that the study failed to demonstrate noninferiority or inferiority of pharmacological prophylaxis alone compared with the combined intervention.

There are however a few points worth considering. First, the authors had a high PEP rate in both of their groups as the risk of PEP in high risk patients receiving any prophylaxis has been reported to be around 5 % [2] [3] [4]. The authors implicated the involvement of fellows in training as being one of the possible reasons for this. However, a previous trial by the group [5], done in similar settings, reported a 6.7 % risk of PEP in high risk patients receiving a combination of pharmacological prophylaxis. The higher rate of PEP in either group could have decreased the power of the study.

Another major concern is regarding noninferiority. The actual difference in the rates of PEP between the two interventions was 3.3 %. The upper boundary of the 95 %CI of the difference turns out to be 10.2 %, which is greater than the prespecified noninferiority margin of 5 %. Therefore, the study results failed to show noninferiority of pharmacological prophylaxis alone compared with combined intervention. The authors should not have concluded “the study failed to demonstrate noninferiority or inferiority of pharmacological prophylaxis alone compared with PD stenting plus pharmacological prophylaxis in the prevention of PEP in high risk patients.”

Therefore, the question as to whether the addition of PD stenting to rectal NSAID prophylaxis can further reduce the rate of PEP remains yet to be answered.

Publication History

Article published online:
25 March 2020

• References

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