JPRN-jRCTs031200202招募中2 期
Examination of post-ERCP pancreatitis preventive effect of load infusion therapy with lactated Ringer's solutionRandomized controlled trial
Kurita Yusuke0 个研究点目标入组 950 人开始时间: 2020年11月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 950
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •(1) Patients aged 20 to 85 at the time of consent acquisition
- •(2) Gender: Any
- •(3) Patients who are clinically indicated for ERCP and undergo ERCP (malignant biliary stricture, pancreatic cancer, acute cholangitis, common bile duct stone, IgG4 sclerosing cholangitis, primary sclerosing cholangitis, etc.)
- •(4) Post-ERCP pancreatitis risk (moderate or higher)
- •(5) PS is 2 or less
- •(6) Patients who can take oral drugs, meals and beverages
- •(7) Patients expected to have stable primary disease (including cancer) 6 months after registration during the observation period
- •(8) Patients who have written informed consent to participate in this study, who comply with the compliance items during this study participation, who can receive the medical examination prescribed in this study plan and report symptoms etc.
排除标准
- •(1) Patients with low risk of post-ERCP pancreatitis (confirmed cases of chronic pancreatitis, pancreatic head tumor, periodic biliary stent replacement)
- •(2) Patients with acute pancreatitis
- •(3) Patients with hypotension including sepsis
- •(4) Heart failure patients (NYHA Class II or above)
- •(5) Patients with renal failure (creatinine clearance <30 mL/min)
- •(6) Patients with liver failure (patients with cirrhosis and ascites)
- •(7) Patients with respiratory failure (defined as oxygen saturation <90%)
- •(8) Hyponatremia (Na+ levels <130mEq/L)
- •(9) Hypernatremia (Na+ levels> 150mEq/L)
- •(10) Hypokalemia (K+ levels <3.0mEq/L)
- •(11) Patients who are pregnant or breastfeeding, patients who wish to become pregnant during the study period, patients who wish to become pregnant of a partner during the study period.
- •(12) In addition, patients who are judged to be unsuitable for study participation by the investigator or investigator based on combination therapy and medical findings.
- •(13) Patients in other clinical studies or clinical trials
研究者
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