Low-acid Contrast Media for Preventing Post ERCP Pancreatitis: a Multicenter, Retrospective, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,979
- 试验地点
- 2
- 主要终点
- The rate of Post-ERCP pancreatitis
研究概览
简要总结
Title： Low-acid contrast media for preventing post ERCP pancreatitis: a multicenter, retrospective, cohort study (LAMP-R) .
Objective:
Main objective: This study aims to determine whether low-acid contrast media can reduce the incidence of post-ERCP pancreatitis.
Secondary objective: To investigate the severity of post-ERCP pancreatitis, the incidence rate of other complications, and the risk factors associated with different pH values of contrast media.
Research Design：Multicenter, retrospective cohort study.
Research participants:
Inclusion criteria: Patients aged 18 to 90 years who underwent ERCP diagnostic and therapeutic procedures were included consecutively.
Exclusion criteria: Patients who did not use contrast medium during ERCP, failed ERCP papillary intubation, developed acute pancreatitis within 3 days before surgery, ERCP stent removal/replacement, had a history of pancreaticoduodenectomy or biliary-enteric anastomosis, and whose postoperative amylase/lipase levels could not be traced were excluded.
Outcomes:
1. The rate of post-ERCP pancreatitis and severity of PEP 2. The rate of infection 3. The rate of gastrointestinal bleeding 4. The rate of perforation.
Sample size calculation:
A total of approximately 3,881 eligible ERCP patients were included from five tertiary Grade A centers. Specifically, 2,305 patients were from Qilu Hospital of Shandong University, 463 from Linyi People's Hospital, 121 from Qilu Third Hospital of Shandong University, 106 from Dezhou Hospital of Qilu Hospital of Shandong University, and 886 from Shengli Oilfield Central Hospital.
Statistical analysis SPSS 27 is used for statistics and analysis, including descriptive analysis, single-factor and multi-factor logistic regression analysis, analysis of variance, t-test, propensity score matching (PSM), etc. Categorical data are presented as counts and proportions, while continuous data are presented as mean ± standard deviation, depending on the distribution. Categorical data are analyzed using χ2 and Fisher's exact test, and continuous data are analyzed using Student's t-test or Mann-Whitney U test. Primary and secondary outcomes are presented as relative risks (RRs) with 95% confidence intervals (CIs).
详细描述
Introduction
- The Clinical Burden of Post-ERCP Pancreatitis (PEP) Endoscopic Retrograde Cholangiopancreatography (ERCP) is a standard procedure for the diagnosis and treatment of pancreatobiliary diseases. However, it is associated with significant complications, among which post-ERCP pancreatitis (PEP) is the most frequent, occurring in 3-10% of all procedures and in 15-20% of high-risk patients. Despite continuous improvements in techniques and preventive strategies, PEP remains a major concern as it prolongs hospitalization, increases healthcare costs, and in severe cases, leads to substantial morbidity and mortality.
- Contrast Media as a Potential Etiological Factor in PEP. The pathogenesis of PEP is multifactorial and not fully understood, involving mechanical, thermal, enzymatic, and chemical insults. A key procedural step in ERCP is the injection of contrast media into the pancreaticobiliary ducts. The resultant increase in hydrostatic pressure and the potential chemical irritation of the pancreatic ductal epithelium are hypothesized to trigger the inflammatory cascade leading to PEP. Emerging preclinical evidence suggests that the physicochemical properties of contrast media, particularly acidity (pH), may be a critical modifiable risk factor. Basic science studies indicate that low-pH contrast agents can exacerbate pancreatic injury through TRPV1-dependent pathways and by inducing abnormal calcium signaling, activating NF-κB and calcineurin pathways in acinar cells. For instance, injecting a contrast medium at pH 6.9 caused significant pancreatic edema and damage in animal models, while a solution at pH 7.3 caused minimal injury. These findings highlight a compelling biological plausibility for investigating contrast media characteristics in clinical PEP, yet high-quality clinical evidence is currently lacking.
- Rationale and Focus of the Present Study. Building on the mechanistic hypothesis that acidity matters, we conducted preliminary measurements of three commonly used iso-osmolar non-ionic monomeric contrast agents (Iohexol, Iopromide, Ioversol). Notably, after 1:1 dilution with sterile water (a common practice in ERCP), the pH values differ: Iopromide (7.13~7.32), Ioversol (6.54~6.86), and Iohexol (7.25~7.46). This presents a natural experiment to evaluate whether these variations in acidity (pH) influence PEP risk in a real-world clinical setting.
Research method:
A multi-center, retrospective, cohort study.
Date collection:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 90 years who underwent ERCP diagnostic and therapeutic procedures were included consecutively.
排除标准
- •Patients who did not use contrast media during ERCP
- •Failed ERCP papillary intubation
- •Patients with acute pancreatitis within 3 days before ERCP
- •ERCP stent removal/replacement
- •Patients who had a history of pancreaticoduodenectomy or biliary-enteric anastomosis
- •Patients whose postoperative amylase/lipase levels could not be traced.
研究组 & 干预措施
Ioversol
Acidic contrast media, ioversol is used for radiography during ERCP procedure.
干预措施: Ioversol (Drug)
Iopromide
Neutral contrast media, iopromide is used for contrast during ERCP procedure.
干预措施: Iopromide (Drug)
Iohexol
Alkaline contrast media, iohexol is used for contrast during ERCP procedure.
干预措施: Iohexol (Drug)
结局指标
主要结局
The rate of Post-ERCP pancreatitis
时间窗: Assessed up to 3 days after ERCP procedure.
According to the Cotton criteria and consensus opinions, post-ERCP pancreatitis is defined as new-onset upper abdominal pain after surgery, with amylase or lipase levels elevated to three times the upper limit of normal, and an extended hospital stay of at least 2 nights.
次要结局
- The severity of post-ERCP pancreatitis(Assessed up to 10 days after ERCP procedure.)
- The rate of infection(Assessed up to 3 days after ERCP procedure.)
- The rate of gastrointestinal bleeding(Assessed up to 3 days after ERCP procedure.)
- Perforation(Assessed up to 3 days after ERCP procedure.)
研究者
Yanqing Li
Professor of Medicine
Shandong University