Mansour-Ghanaei Fariborz, Joukar Farahnaz, Khalesi Ali Akbar, Naghipour Mohammadreza, Sepehrimanesh Masood, Mojtahedi Kourosh, Yeganeh Sara, Saedi Hamid Saeidi, Asl Saba Fakhrieh
GI Cancer Screening and Prevention Research Center, Rasht, Iran.
Caspian Digestive Disease Research Center, Rasht, Iran.
Ann Hepatobiliary Pancreat Surg. 2020 Aug 31;24(3):259-268. doi: 10.14701/ahbps.2020.24.3.259.
BACKGROUNDS/AIMS: Acute pancreatitis is the most widespread complication of endoscopic retrograde cholangiopancreatography. Here, we investigated the efficacy of rectal suppository naproxen, sublingual isosorbide dinitrate and their co-administration in the prevention of post-ERCP pancreatitis.
This double-blind randomized clinical trial carried out from June 2015 to February 2016 at the Gastrointestinal and Liver Diseases Research Center in Rasht, Iran. A total of 585 patients were selected from candidates for diagnostic or therapeutic ERCP by using the simple sampling method. Patients divided into three groups. Group A received 500 mg naproxen, group B took 5 mg isosorbide dinitrate, and group C was co-administrated both agents before ERCP. The primary outcome measure was the development of pancreatitis onset of pain in the upper abdomen and increase of serum amylase activity more than 3 times over the upper normal limit (60-100 IU/L) within first the 24 h post-ERCP.
Totally, 80 patients developed PEP included 29 (4.9%), 24 (4.1%), and 27 (4.6%) patients in groups A, B, and C, respectively (=0.845). Longer ERCP time (=0.041), using diazepam (=0.033), a higher number of pancreatic ducts cannulation (＜0.001), pancreatic duct injection (=0.013), and using pancreatic stent (=0.004) were the predisposing factors for PEP.
Our findings indicated that prophylactic naproxen suppository or isosorbide dinitrate sublingually or co-administration had no significant difference in the prevention and severity of PEP, however, enhancing the endoscopist's skills can be effective. Departments and educational hospitals should develop their assessment and quality assurance measures for the training of fellows' not only technical training but also an understanding of the diagnostic and therapeutic roles of the procedure.
背景/目的：急性胰腺炎是内镜逆行胰胆管造影术最常见的并发症。在此，我们研究了直肠栓剂萘普生、舌下含服硝酸异山梨酯及其联合应用在预防内镜逆行胰胆管造影术后胰腺炎方面的疗效。
这项双盲随机临床试验于2015年6月至2016年2月在伊朗拉什特的胃肠和肝病研究中心进行。通过简单抽样法从诊断性或治疗性内镜逆行胰胆管造影术的候选患者中总共选取了585例患者。患者分为三组。A组接受500毫克萘普生，B组服用5毫克硝酸异山梨酯，C组在进行内镜逆行胰胆管造影术前联合使用这两种药物。主要观察指标是胰腺炎的发生，即上腹部疼痛发作，以及内镜逆行胰胆管造影术后24小时内血清淀粉酶活性升高超过正常上限（60 - 100国际单位/升）的3倍。
总共有80例患者发生了内镜逆行胰胆管造影术后胰腺炎，A组、B组和C组分别有29例（4.9%）、24例（4.1%）和27例（4.6%）患者（P = 0.845）。内镜逆行胰胆管造影时间较长（P = 0.041）、使用地西泮（P = 0.033）、胰管插管数量较多（＜0.001）、胰管注射（P = 0.013）以及使用胰管支架（P = 0.004）是内镜逆行胰胆管造影术后胰腺炎的诱发因素。
我们的研究结果表明，预防性使用萘普生栓剂或舌下含服硝酸异山梨酯或联合应用在预防内镜逆行胰胆管造影术后胰腺炎及其严重程度方面没有显著差异，然而，提高内镜医师的技能可能是有效的。各科室和教学医院不仅应制定针对住院医师技术培训的评估和质量保证措施，还应使其了解该操作的诊断和治疗作用。
