Rectal Indomethacin Decreases the Incidence of Pancreatitis Following Endoscopic Retrograde Cholangiopancreatography in High-risk Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Post ERCP Acute Pancreatitis
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) is now a widely accepted therapy for treating benign and malignant diseases of the pancreatobiliary tree. Acute pancreatitis represents the most common and feared complication following ERCP. The reported incidence of this complication is from 1% to 40% according to the presence of high-risk factors for this complication or the presence dysfunction in the sphincter of Oddi (SOD). In most prospective series, the incidence has ranged between 3.5% and 20% for nonselected and high-risk patients, respectively. Independent risk factors for post-ERCP pancreatitis are either patient- or procedure-related.
详细描述
Design This is a randomized clinical trial carried out in patients scheduled for ERCP at the Department of Gastrointestinal Endoscopy and Department of Gastroenterology of the Specialties Hospital of the Western Medical Center, in Guadalajara, Jalisco, Mexico. The investigators include patients with an elevated baseline risk of post-ERCP pancreatitis based on prospectively validated patient- and procedure-related independent risk factors.
The ERCP procedures are performed with the patient under topical pharyngeal anesthesia with 2% lidocaine and after administration of sedation (midazolam) and analgesia (fentanyl) intravenously, with dosages at the discretion of the endoscopist. Patients receive complementary oxygen through an external nasal device at 3 to 5 L/min and infusion of 200 to 500 mL of 0.9% sterile saline solution.
The equipment and protocol that are being used to perform ERCP consist of a video duodenoscope (Olympus, Tokyo, Japan), sphincterotome traction for selective cannulation of the bile duct, a needle scalpel to perform precut sphincterotomy, a hydrophilic guide wire via the bile duct, a Dormia basket and/or balloon catheter for stone extraction, and nonionic water-soluble contrast medium at 300 mg/mL (Optira 300™; ioversol injection 64%; Mallinckrodt Pharmaceuticals, Dublin, Ireland) for opacification of the biliary and pancreatic ducts.
Pancreatic stents are being used only to treat pancreatic fistulas and to prevent pancreatitis. All patients are monitored continuously during the procedure, with determinations of blood pressure, heart rate, respiratory rate, and arterial blood oxygen saturation.
Eligible patients who provide written informed consent undergo the randomization at conclusion of the ERCP procedure because patients without risk factors could be included in the study based on procedure-related factors alone. If patients met the inclusion criteria, they are randomly assigned to receive a 100 mg suppository of indomethacin or 2.4 g of glycerin suppository immediately afterwards while still under sedation. All patients are observed to prevent spontaneous expulsion of the suppository until they became completely awake. All patients, staff endoscopists, residents, and researchers are blinded to the treatment assigned to each of them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If they met one or more of the following criteria:
- •a clinical suspicion of SOD dysfunction;
- •or a history of post-ERCP pancreatitis, pancreatic
- •or precut sphincterotomy,
- •more than eight cannulation attempts,
- •pneumatic dilatation of an intact biliary sphincter,
- •or ampullectomy
- •Patients were also eligible for inclusion if they met two of the following criteria:
- •aged 50 years or younger and female gender
- •or a history of recurrent pancreatitis (>2 episodes),
- •three or more injections of contrast agent into the pancreatic duct with at least one injection to the tail of the pancreas,
- •excessive injection of contrast agent into the pancreatic duct resulting in opacification of pancreatic acini,
- •or the need for acquisition of a cytology specimen from the pancreatic duct with the use of a tissue-sampling brush.
排除标准
- •unwillingness or inability to consent for the study
- •pregnancy
- •breast feeding
- •standard contraindications for ERCP
- •hypersensitivity to aspirin or NSAIDs
- •previous use of NSAIDs within 1 week
- •renal failure (creatinine clearance rate >1.4 mg/dL)
- •active or recent (< 4 weeks) gastrointestinal hemorrhage
- •chronic calcified pancreatitis
- •pancreatic head malignancy
- •any procedure performed on the major papilla/ventral pancreatic duct in patients with a pancreatic divisum
- •previous ERCP for biliary stent removal or exchange without an anticipated pancreatogram
- •subjects with prior biliary sphincterotomy and scheduled for repeat biliary therapy without an anticipated pancreatogram
- •or anticipated inability to follow our protocol
研究组 & 干预措施
Indomethacin
100 mg of Indomethacin suppository immediately afterwards while still under sedation
干预措施: Indomethacin (Drug)
2.6-g suppository of glycerin
suppository of 2.4 g of glycerin immediately afterwards while still under sedation
干预措施: 2.6-g suppository of glycerin (Drug)
结局指标
主要结局
Post ERCP Acute Pancreatitis
时间窗: 48 hours after the procedure.
Defined as the development of new or increased abdominal pain consistent with pancreatitis, and elevated blood amylase or lipase \>3 times the upper limit of normal until 24 h after the procedure, and hospitalization (or prolongation of existing hospitalization) for at least 2 nights.
次要结局
- Routine laboratory examinations(2 hours after procedure and daily until hospital discharge, an expected average of 10 days.)
- Severity of post-ERCP pancreatitis(48 hours after procedure.)
- Measurement of serum amylase(2 hours post-ERCP)
- Acute Pancreatitis(During 30 days after hospital discharge.)
- Asymptomatic hyperamylasemia(48 hours after procedue.)
研究者
Alejandro Gonzalez-Ojeda
PhD. MD
Instituto Mexicano del Seguro Social