RÉSUMÉ
Background: Endoscopic retrograde cholangiopancreatography (ERCP) is now widely accepted as a therapeutic modality for benign and malignant diseases of the pancreaticobiliary tree. Acute pancreatitis is the most common and feared complication of ERCP, associated with substantial morbidity and mortality. This study aimed to compare the incidence of post-ERCP pancreatitis in combined rectal indomethacin and sublingual nitroglycerin with that of rectal indomethacin alone. Methods: This was a randomized controlled trial conducted in the Department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh during the period from July, 2019 to September, 2020. In this study, 100 hospitalized patients of >18 years age undergoing ERCP based on clinical indication and proper investigation were included. The study population was randomly divided into two groups - group A (patients who were given indomethacin suppository plus sublingual glyceryl trinitrate) and group B (patients who were given indomethacin alone). Results: In this study, we found that PEP developed in 11 out of 100 patients (11%). Post-ERCP pancreatitis developed in 2 (4%) in group A and 9 (18%) in group B (p=0.025), which was statistically significant. Mild PEP developed in none in group A and 4 (8%) in group B whereas moderate in 2 (4%) in group A and 3 (6%) in group B. Severe pancreatitis occurred in none in group A and 2 (4%) in group B (p=0.231) which was not statistically significant. Conclusions: This study showed that the combination of indomethacin suppository and sublingual GTN is superior to indomethacin suppository alone in preventing post-ERCP pancreatitis.
RÉSUMÉ
ABSTRACT Background This multicenter multinational RCT designed to compare the efficacy of suppository indomethacin and NAC for prevention of PEP. Methods: During a 6-month period, all of the ERCP cases in seven referral centers were randomly assigned to receive either 1200 mg oral NAC, indomethacin suppository 100 mg, 1200 mg oral NAC plus indomethacin suppository 100 mg or placebo 2 hours before ERCP. The primary outcomes were the rate and severity of any PEP. Results: A total of 432 patients included (41.4% male). They were originally citizens of 6 countries (60.87% Caucasian). They were randomly allocated to receive either NAC (group A, 84 cases), rectal indomethacin (group B, 138 cases), NAC + rectal indomethacin (group C, 115 cases) or placebo (group D, 95 cases). The rate of PEP in groups A, B and C in comparison with placebo were 10.7%, 17.4%, 7.8% vs 20% (P=0.08, 0.614 & 0.01 respectively). The NNT for NAC, indomethacin and NAC + indomethacin was 11, 38 and 8 respectively. Conclusion: Oral NAC is more effective than rectal indomethacin when compared to placebo for prevention of PEP and the combination of NAC and Indomethacin had the lowest incidence of PEP and may have synergistic effect in preventing of PEP (IRCT20201222049798N1; 29/12/2020).
RESUMO Contexto: Este estudo randomizado, controlado multicêntrico e multinacional foi projetado para comparar a eficácia da indometacina supositório e N-acetil cisteína (NAC) para prevenção de pancreatite pós colangiografia endoscópica. Métodos: Durante um período de 6 meses, todos os pacientes submetidos à CPRE em sete centros de referência foram aleatoriamente atribuídos para receber 1200 mg de NAC oral, supositório de indometacina 100 mg, 1200 mg de NAC oral mais supositório de indometacina 100 mg ou placebo 2 horas antes do procedimento. Os resultados primários foram a taxa e a gravidade de qualquer pancreatite pós procedimento (PPP). Resultados: Um total de 432 pacientes foram incluídos (41,4% do sexo masculino). Eram originalmente cidadãos de seis países (60,87% caucasianos). Foram alocados aleatoriamente para receber NAC (grupo A, 84 casos), indometacina retal (grupo B, 138 casos), NAC + indometacina retal (grupo C, 115 casos) ou placebo (grupo D, 95 casos). A taxa de PPP nos grupos A, B e C em comparação com o placebo foi de 10,7%, 17,4%, 7,8% vs 20% (P=0,08, 0,614 e 0,01, respectivamente). Conclusão A NAC oral é mais eficaz do que a indometacina retal quando comparado ao placebo para prevenção de PPP e a combinação de NAC e indometacina teve a menor incidência de PPP e pode ter efeito sinérgico na sua prevenção de PPP. (IRCT20201222049798N1; 29/12/2020).