jRCTs031200202招募中不适用
Examination of post-ERCP pancreatitis preventive effect of load infusion therapy with lactated Ringer's solution Randomized controlled trial
未提供0 个研究点目标入组 950 人开始时间: 2021年3月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 950
- 主要终点
- Post-ERCP pancreatitis incidence
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 85age old under（—）
- 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
结局指标
主要结局
Post-ERCP pancreatitis incidence
时间窗: within 24 hours after ERCP
This study examines the post-ERCP pancreatitis preventive effect of fluid loading. Therefore, the primary evaluation item this time is the post-ERCP pancreatitis incidence rate as a direct evaluation item. **Diagnostic criteria for post-ERCP pancreatitis** (1) Newly developed upper abdominal pain (2) Pancreatic enzymes (amylase and/or lipase) increased more than 3 times the institutional upper limit of normal (3) (1) and (2) within 24 hours after ERCP (4) Hospitalization extension of 2 nights or more Post-ERCP pancreatitis if all of the above are met
次要结局
- Severity evaluation by Cotton classification
- Severity evaluation based on pancreatitis clinical practice guidelines
- Post-ERCP pancreatitis CT Grade
- Severity assessment by Atlanta classification(at least 30 days after ERCP)
研究者
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