Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Tlalpan, Mexico.
Hospital Bernardette, Guadalajara, Mexico.
BMJ Open Gastroenterol. 2021 Feb;8(1). doi: 10.1136/bmjgast-2020-000562.
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is a complication associated with important morbidity, occasional mortality and high costs. Preventive strategies are suboptimal as PEP continues to affect 4% to 9% of patients. Spraying epinephrine on the papilla may decrease oedema and prevent PEP. This study aimed to compare rectal indomethacin plus epinephrine (EI) versus rectal indomethacin plus sterile water (WI) for the prevention of PEP.
This multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 mL of sterile water or a 1:10 000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure. The trial was stopped half way through after a new publication reported an increased incidence of PEP among patients receiving epinephrine.
Of the 3602 patients deemed eligible, 3054 were excluded after screening. The remaining 548 patients were randomised to EI group (n=275) or WI group (n=273). The EI and WI groups had similar baseline characteristics. Patients in the EI group had a similar incidence of PEP to those in the WI group (3.6% (10/275) vs 5.12% (14/273), p=0.41). Pancreatic duct guidewire insertion was identified as a risk factor for PEP (OR 4.38, 95% CI (1.44 to 13.29), p=0.009).
Spraying epinephrine on the papilla was no more effective than rectal indomethacin alone for the prevention of PEP.
This study was registered with ClinicalTrials.gov (NCT02959112).
内镜逆行胰胆管造影（ERCP）后胰腺炎（PEP）是一种与重要发病率、偶发性死亡率和高成本相关的并发症。尽管预防性策略并不理想，但 PEP 仍会影响 4%至 9%的患者。在乳头喷洒肾上腺素可减轻水肿并预防 PEP。本研究旨在比较直肠吲哚美辛加肾上腺素（EI）与直肠吲哚美辛加无菌水（WI）预防 PEP 的效果。
这项多中心随机对照试验纳入了年龄>18 岁、有 ERCP 适应证且主乳头未接受过治疗的患者。所有患者均接受 100mg 直肠吲哚美辛和 10mL 无菌水或 1:10000 肾上腺素稀释液。术后 24 小时和 7 天，通过电话询问患者 PEP 症状。在一项新发表的报告显示接受肾上腺素治疗的患者 PEP 发生率增加后，试验进行到一半时停止。
在符合条件的 3602 名患者中，经过筛选后有 3054 名被排除。其余 548 名患者被随机分为 EI 组（n=275）或 WI 组（n=273）。EI 组和 WI 组的基线特征相似。EI 组的 PEP 发生率与 WI 组相似（3.6%（10/275）与 5.12%（14/273），p=0.41）。胰管导丝插入被确定为 PEP 的危险因素（OR 4.38，95%CI（1.44 至 13.29），p=0.009）。
在乳头喷洒肾上腺素并不比单独使用直肠吲哚美辛更能预防 PEP。
本研究在 ClinicalTrials.gov 注册（NCT02959112）。
