Effect of 3°C Saline Irrigation Toward the Duodenal Papilla to Prevent Post-ERCP Pancreatitis: Protocol for a Multicenter, Controlled, Randomized, Patient-Blinded Trial in Bogotá, Colombia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- Incidence of post-ERCP pancreatitis (PEP) at 24 hours
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) is an endoscopic procedure used to diagnose and treat problems in the bile ducts and pancreas. One of its most common complications is **post-ERCP pancreatitis**. This multicenter randomized clinical trial will evaluate whether **cooling the duodenal papilla** with **sterile saline at 3°C** immediately after ERCP can reduce the risk of post-ERCP pancreatitis compared with standard ERCP care.
Adults **≥18 years** with a **native papilla** scheduled for diagnostic or therapeutic ERCP at **three high-complexity university hospitals in Bogotá/Cundinamarca (Colombia)** will be randomized **1:1** to: (1) **intervention**-instillation of **250 mL** of **3°C sterile saline** in **five 50-mL aliquots** directed to the papilla through the endoscope working channel at the end of ERCP, with aspiration between aliquots; or (2) **control**-standard ERCP with no additional instillation. The saline temperature will be verified immediately before administration. Standard preventive measures (e.g., rectal NSAIDs, lactated Ringer's hydration, prophylactic pancreatic stent when clinically indicated) may be used per usual care and will be recorded.
The **primary outcome** is post-ERCP pancreatitis at **24 hours**, defined using Cotton criteria (new/worsening abdominal pain plus serum amylase or lipase ≥3× the upper limit of normal). Secondary outcomes include pancreatitis severity, other ERCP-related complications, and safety through day 7 (including a telephone follow-up). Participants will be screened and consented before sedation; randomization occurs at the end of the ERCP; clinical assessment and labs are performed at 24 hours; follow-up continues through day 7.
Safety monitoring will include systematic assessment for potential effects related to local cooling (e.g., chills, duodenal spasm, mucosal bleeding at the instillation site, or clinically relevant hypothermia) at 2 and 24 hours, with surveillance for serious adverse events through day 7.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •**Inclusion Criteria:**
- •Adults **18 years of age or older**
- •**Native (unmodified) duodenal papilla**
- •Scheduled for **diagnostic or therapeutic ERCP**
排除标准
- •**Inaccessible papilla** or papilla **surgically altered/modified**
- •**Ongoing acute or chronic pancreatitis**
- •**Pregnancy**
- •**Ethical or medical contraindications to ERCP**
- •**Lack of informed consent**
研究组 & 干预措施
Cold Saline Papillary Irrigation (3°C)
At the end of ERCP, 250 mL of sterile saline at 3°C is instilled onto the duodenal papilla in five 50-mL aliquots through the endoscope working channel, with aspiration between aliquots to enhance the local effect.
干预措施: Topical Cold Sterile Saline Irrigation of the Duodenal Papilla (3°C) (Procedure)
Standard ERCP (Usual Care)
Standard ERCP performed with no additional saline instillation. Usual prophylaxis may be used when clinically indicated (e.g., rectal NSAIDs, lactated Ringer's hydration, prophylactic pancreatic stent in high-risk cases) and is recorded.
干预措施: Standard ERCP (Usual Care) (Other)
结局指标
主要结局
Incidence of post-ERCP pancreatitis (PEP) at 24 hours
时间窗: 24 hours after ERCP
Proportion of participants with PEP defined by Cotton criteria: compatible abdominal pain plus serum amylase or lipase ≥3× upper limit of normal at 24 hours
次要结局
- Incidence of moderate-to-severe post-ERCP pancreatitis(Up to Day 7 after ERCP)
- Abdominal pain assessment(24 hours after ERCP)
研究者
Juan Pablo Alzate
Clinical research institute investigator
Universidad Nacional de Colombia