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Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis (PuSH)

2026年8月18日 更新者：Nicholas Burgess、Westmead Hospital

Preventing Post ERCP Pancreatitis by Short Stay Aggressive Hydration (PuSH) -a Prospective Randomized Trial.

Post-ERCP pancreatitis (PEP) is the most common serious adverse event after endoscopic retrograde cholangiopancreatography (ERCP), occurring in roughly 7-15% of patients. Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and peri-procedural aggressive intravenous hydration each reduce PEP, but published hydration regimens are delivered over 8-24 hours and require an overnight hospital stay, which is impractical where ERCP is increasingly performed as a same-day procedure.

This multicentre, prospective, randomised controlled trial tests whether a short (under 4 hours) aggressive hydration regimen with Lactated Ringer's solution, combined with rectal indomethacin, is superior to standard care (rectal indomethacin plus low-volume hydration) for preventing PEP, while supporting same-day discharge. Adults undergoing ERCP are randomised 1:1. The primary outcome is the incidence of PEP defined by consensus (Cotton) criteria. A total of 1300 participants (650 per arm) will be enrolled.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Design: multicentre, parallel-group, superiority RCT with 1:1 allocation, conducted in high-volume tertiary academic endoscopy units.

Interventions: All participants receive 100 mg indomethacin per rectum within 30 minutes before or after ERCP. Participants randomised to aggressive hydration receive a peri-procedural bolus of Lactated Ringer's 20 mL/kg over ~1 hour, then 3 mL/kg/hour for 3 hours (post-procedure infusion capped at 1000 mL). Participants randomised to standard care receive low-volume Lactated Ringer's at the discretion of the endoscopist/anaesthetist (up to 1.5 mL/kg/hour, max 500 mL over 3 hours). For BMI > 40 kg/m2, infusion rates are capped assuming a BMI of 40. Pancreatic duct stenting is permitted in both arms at the proceduralist's discretion per guidelines. Aggressive hydration is discontinued if signs of fluid overload develop.

Follow-up: pre-discharge assessment (fluid-overload exam, pain), a 24-hour telephone follow-up (bloods if symptomatic), and a 30-day telephone follow-up for delayed events and hospitalisation.

Analysis: primary analysis by intention-to-treat; per-protocol analysis also performed. Statistical analysis is conducted blinded to allocation.

研究类型

介入性

注册 (估计的)

1300

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age over 18 years
  • Undergoing ERCP
  • Able to provide informed consent

Exclusion Criteria:

  • Unable to give consent
  • Clinical signs/symptoms of congestive cardiac failure (pitting oedema, NYHA class ≥ 2, or oxygen saturation ≤ 90%)
  • Respiratory failure (pre-procedure SpO2 < 90% on room air, or requirement for non-invasive/mechanical ventilation)
  • Contraindication to rectal NSAIDs (allergy; active gastrointestinal bleeding)
  • Estimated GFR (MDRD) ≤ 30 mL/min
  • Altered biliary or duodenal anatomy (e.g. prior biliary/pancreatic surgery, Roux-en-Y reconstruction)
  • Known hypo- or hypernatraemia (serum sodium < 130 or > 150 mmol/L)
  • Pregnancy
  • Severe liver disease (cirrhosis with ascites)
  • Previous sphincterotomy (unless undergoing pancreatic duct intervention)
  • Acute pancreatitis
  • Chronic pancreatitis (unless undergoing a pancreatic duct intervention)
  • Sphincter of Oddi dysfunction
  • Pancreatic mass causing biliary obstruction

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Aggressive Hydration
Rectal indomethacin 100 mg plus short-stay aggressive hydration: Lactated Ringer's bolus 20 mL/kg over ~1 hour, then 3 mL/kg/hour for 3 hours (post-procedure infusion capped at 1000 mL).
其他：Short-Stay Aggressive Hydration
Lactated Ringer's bolus 20 mL/kg over ~1 hour then 3 mL/kg/hour x 3 hours (cap 1000 mL post-procedure); rate capped at BMI 40 if BMI > 40.
药品：Rectal Indomethacin
Indomethacin 100 mg per rectum within 30 minutes before, during or after ERCP.
有源比较器：Standard Care
Rectal indomethacin 100 mg plus standard low-volume hydration at proceduralist/anaesthetist discretion (Lactated Ringer's up to 1.5 mL/kg/hour, max 500 mL over 3 hours).
药品：Rectal Indomethacin
Indomethacin 100 mg per rectum within 30 minutes before, during or after ERCP.
其他：Standard Peri-procedural Hydration
Low-volume Lactated Ringer's at operator discretion, up to 1.5 mL/kg/hour, max 500 mL over 3 hours.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of post-ERCP pancreatitis (PEP)
大体时间：Within 72 hours after ERCP (onset within 24 hours)
PEP defined by consensus (Cotton) criteria, requiring ALL of: new or worsened upper abdominal pain; serum amylase or lipase at least 3x the upper limit of normal; pain and enzyme elevation persisting for at least 24 hours; and hospitalisation (or prolongation) of at least 2 days attributable to pancreatitis.
Within 72 hours after ERCP (onset within 24 hours)

次要结果测量

结果测量
措施说明
大体时间
PEP not fulfilling full Cotton criteria
大体时间：Within 72 hours after ERCP (onset within 24 hours)
Post-ERCP pancreatitis not meeting full Cotton criteria.
Within 72 hours after ERCP (onset within 24 hours)
Delayed PEP
大体时间：24 hours to 30 days after ERCP
Post-ERCP pancreatitis (by Cotton criteria) with onset more than 24 hours after ERCP, identified after initial discharge.
24 hours to 30 days after ERCP
Severity of PEP
大体时间：Within 30 days after ERCP
Severity graded by Cotton criteria and the Revised Atlanta Classification
Within 30 days after ERCP
ERCP associated adverse events
大体时间：Within 30 days after ERCP
ERCP-associated adverse events graded by consensus (Cotton) criteria as mild, moderate, or severe: bleeding, perforation, and infection (cholangitis).
Within 30 days after ERCP
Signs of fluid overload
大体时间：Peri-procedural to 24 hours after ERCP
Pulmonary oedema, peripheral (pitting) oedema, or exacerbation of congestive cardiac failure.
Peri-procedural to 24 hours after ERCP
Hospitalization for any reason within 30 days
大体时间：Within 30 days after ERCP
Proportion of participants hospitalised (including unplanned admission or readmission) for any reason within 30 days of ERCP. Ascertained from medical records and the 30-day follow-up call.
Within 30 days after ERCP
Cost effectiveness
大体时间：Within 30 days after ERCP
Cost-effectiveness of short-stay aggressive hydration versus standard care, comparing total cost of healthcare resource use (intravenous fluids and consumables, procedure/recovery time, length of stay, and PEP-related admissions or readmissions) in relation to PEP cases avoided. Reported as incremental cost effectiveness ratio (ICER) for post-ERCP pancreatitis cases avoided.
Within 30 days after ERCP
Hospitalization Length of Stay
大体时间：Within 30 days of ERCP
In participants hospitalised (including unplanned admission or readmission) for any reason within 30 days of ERCP, the length of hospital stay measured in days. Ascertained from medical records and the 30-day follow-up call.
Within 30 days of ERCP
Hospitalization for PEP Length of Stay
大体时间：Within 30 days of ERCP
In participants hospitalised (including unplanned admission or readmission) for PEP within 30 days of ERCP, the length of hospital stay measured in days. Ascertained from medical records and the 30-day follow-up call.
Within 30 days of ERCP

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Westmead Hospital

调查人员

  • 首席研究员：Nicholas Burgess、Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, Australia

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2029年6月1日

研究注册日期

首次提交

2026年8月5日

首先提交符合 QC 标准的

2026年8月18日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月18日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2019/ETH13255

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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