7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients: a Multicentre, Single-blinded, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Post-ERCP Pancreatitis
研究概览
简要总结
Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis (PEP) is estimated to be 10% to 15% in high-risk patients. Current guidelines recommend using pancreatic duct stent (PDS) for PEP prevention in high-risk patients, but it is not clear whether stent length will affect the effect of PEP prevention. The longer PDS will remain in the pancreatic duct for a longer period of time, thereby ensuring prolonged decompression with subsequent lowering of the risk for PEP. Findings from two retrospective studies showed that longer PDS was more effective in reducing the risk of post-ERCP hyperamylasemia and the frequency of PEP compared with the shorter PDS. We conducted this trial to test whether 7cm PDS was superior to 5cm PDS in PEP prevention in high-risk patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Un-intentional pancreatic duct cannulation:
- •2 or more times;
- •1 time with more than 10 minutes cannulation.
- •Double-wire technique;
- •High-risk patients:
- •met at least 1 of the major criteria
- •Clinical suspicion of sphincter of Oddi dysfunction;
- •Pancreatic sphincterotomy
- •Delayed precut sphincterotomy
- •≥ 8 cannulation attempts
- •Pneumatic dilatation of an intact biliary sphincter
- •Ampullectomy
- •or met at least 2 or more of the minor criteria
- •Age < 50;
- •Normal TBIL;
- •≥ 3 injections of contrast into the pancreatic duct with ≥ 1 injection to the tail of the pancreas;
排除标准
- •Therapeutic PDS;
- •Acute pancreatitis within 3 days;
- •With a history of pancreatic surgery or biliary-enteric anastomosis;
- •Pregnant or breastfeeding women;
- •unwilling or inability to provide consent.
研究组 & 干预措施
5cm PDS group
All patients in this group receive 5cm 5-Fr PDS.
干预措施: 5cm 5-Fr PDS (Device)
5cm PDS group
All patients in this group receive 5cm 5-Fr PDS.
干预措施: Indomethacin (Drug)
7cm PDS group
All patients in this group receive 7cm 5-Fr PDS.
干预措施: 7cm 5-Fr PDS (Device)
7cm PDS group
All patients in this group receive 7cm 5-Fr PDS.
干预措施: Indomethacin (Drug)
结局指标
主要结局
Post-ERCP Pancreatitis
时间窗: 14 days
The diagnosis of PEP was established if there was new onset of upper abdominal pain associated with an increased serum amylase level of at least 3 times the upper limit of normal range at 24 hours after the procedure, and hospitalization for at least 2 nights.
次要结局
- Moderate to severe PEP(14 days)
- Other complications of ERCP(14 days)
研究者
Yanglin Pan
Associated professor
Air Force Military Medical University, China