All procedure-related interventions were dictated by the performing endoscopist. Immediately after the procedure, if the endoscopist and research coordinator determined that inclusion criteria had been met, patients were randomly assigned to receive either two 50-mg indomethacin suppositories or two identical-appearing placebo suppositories. The randomization schedule, which was stratified according to study center, was generated centrally at the University of Michigan.
The suppositories were administered immediately after ERCP while the patient was still in the procedure room. The rectal route was selected on the basis of available pilot data suggesting that only rectal NSAIDs are effective in preventing post-ERCP pancreatitis, perhaps owing to more rapid and complete bioavailability than with oral administration.10 (link),18 (link) The indomethacin suppositories were purchased from two vendors: G&W Laboratories and Custom Med Apothecary. Formal potency testing confirmed that the vendors provided indomethacin suppositories that were pharmacodynamically equivalent (Analytic Research Laboratories).
The suppositories were administered immediately after ERCP while the patient was still in the procedure room. The rectal route was selected on the basis of available pilot data suggesting that only rectal NSAIDs are effective in preventing post-ERCP pancreatitis, perhaps owing to more rapid and complete bioavailability than with oral administration.10 (link),18 (link) The indomethacin suppositories were purchased from two vendors: G&W Laboratories and Custom Med Apothecary. Formal potency testing confirmed that the vendors provided indomethacin suppositories that were pharmacodynamically equivalent (Analytic Research Laboratories).
