Qian Yang-Yang, Chen Hui, Tang Xin-Ying, Jiang Xi, Qian Wei, Zou Wen-Bin, Xin Lei, Li Bo, Qi Yan-Fen, Hu Liang-Hao, Zou Duo-Wu, Jin Zhen-Dong, Wang Dong, Du Yi-Qi, Wang Luo-Wei, Liu Feng, Li Zhao-Shen, Liao Zhuan
Department of Gastroenterology, Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, 168 Changhai Road, Shanghai, 200433, China.
Digestive Endoscopy Center, Changhai Hospital, the Second Military Medical University, Shanghai, China.
Trials. 2017 Nov 2;18(1):513. doi: 10.1186/s13063-017-2250-7.
Pancreatic extracorporeal shock wave lithotripsy (P-ESWL) is the first-line therapy for large pancreatic duct stones. Although it is a highly effective and safe procedure for the fragmentation of pancreatic stones, it is still not complication-free. Just like endoscopic retrograde cholangiopancreatography (ERCP), pancreatitis is the most common complication. To date, nonsteroidal anti-inflammatory drugs (NSAIDs) have proven to be the only effective prophylactic medication for post-ERCP pancreatitis and the European, American and Japanese Society for Gastrointestinal Endoscopy guidelines have recommended prophylactic rectally administered indomethacin for all patients undergoing ERCP. Given the little research about effective prevention for post P-ESWL pancreatitis, we aim to determine whether rectally administered indomethacin can reduce post-ESWL-pancreatitis.
METHODS/DESIGN: The RIPEP study is a prospective, randomized, double-blinded, placebo-controlled trial. One thousand three hundred and seventy patients with chronic pancreatitis and pancreatic stones (>5 mm in diameter) treated with P-ESWL at Changhai Hospital will be randomly allocated to rectally administered indomethacin or placebo therapy before the procedure. The primary endpoint is the incidence of post-ESWL pancreatitis. Secondary endpoints include the severity of pancreatitis, occurrence rate of asymptomatic hyperamylasemia and other complications.
The RIPEP trial is designed to show that rectally administered indomethacin reduces the development and severity of post-ESWL pancreatitis and benefits patients treated with P-ESWL.
ClinicalTrials.gov, ID: NCT02797067 . Registered on 17 November 2016.
胰体外冲击波碎石术（P-ESWL）是治疗大型胰管结石的一线疗法。尽管它在胰石碎裂方面是一种高效且安全的手术，但仍并非毫无并发症。与内镜逆行胰胆管造影术（ERCP）一样，胰腺炎是最常见的并发症。迄今为止，非甾体类抗炎药（NSAIDs）已被证明是预防ERCP术后胰腺炎的唯一有效药物，欧美及日本胃肠内镜学会指南已推荐对所有接受ERCP的患者预防性直肠给予吲哚美辛。鉴于对P-ESWL术后胰腺炎有效预防的研究较少，我们旨在确定直肠给予吲哚美辛是否能降低ESWL术后胰腺炎的发生率。
方法/设计：RIPEP研究是一项前瞻性、随机、双盲、安慰剂对照试验。在长海医院接受P-ESWL治疗的1370例慢性胰腺炎和胰石（直径>5毫米）患者将在手术前被随机分配接受直肠给予吲哚美辛或安慰剂治疗。主要终点是ESWL术后胰腺炎的发生率。次要终点包括胰腺炎的严重程度、无症状高淀粉酶血症的发生率及其他并发症。
RIPEP试验旨在表明直肠给予吲哚美辛可降低ESWL术后胰腺炎的发生及严重程度，并使接受P-ESWL治疗的患者受益。
ClinicalTrials.gov，标识符：NCT02797067。于2016年11月17日注册。
