A COMBINATION OF RECTAL INDOMETHACIN AND COLD WATER EXPOSURE OF THE AMPULLA AFTER ERCP IS SUPERIOR TO RECTAL INDOMETHACIN ALONE IN REDUCING THE INCIDENCE OF PEP
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Categorisation of Post ERCP Pancreatitis
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) has emerged as the primary modality in the management of biliary and pancreatic disease. The complications occurring from ERCP can range from mild to fatal. Procedure related complications are Pancreatitis , Bleeding , Infections- Cholangitis, Cholecystitis , Perforations of which Post-ERCP pancreatitis (PEP) is the most common serious adverse event. Reported incidence of PEP is 8.6-10.7% according to studies(overall RCTs).In India it is 6.6% (2020 study). Prevention as well as early detection and management of PEP results in a satisfactory outcome. Multiple RCTs and meta-analyses show rectal indomethacin/diclofenac significantly reduce PEP in average- and high-risk patients; now recommended by ASGE/ESGE for nearly all ERCPs. Other measures for prevention of PEP are prophylactic pancreatic duct stents in high-risk anatomy/instrumentation; wire-guided cannulation; minimizing PD contrast; periprocedural aggressive lactated Ringer's hydration. Cryoprevention effect was shown to reduce postprocedure papillary edema and thus lower the risk of PEP
- Rectal NSAIDs reduce but do not eliminate PEP.
- Cold-water ampullary cooling is biologically plausible but under-studied.
- First study to demonstrate if combination of rectal indomethacin and cold-water irrigation may have a synergistic effect.
- First study in Indian population.
详细描述
• Assess whether combination therapy reduces PEP compared to NSAIDS alone.
Secondary Aims:
- Compare PEP severity (Cotton grading and revised Atlanta criteria).
- Adverse effects
- Length of hospital stay and/or intensive care unit stay
- Assess feasibility and adherence and fidelity of cooling protocol.
- Explore effect modification by baseline PEP risk (average vs high-risk), type of intervention (diagnostic vs therapeutic ERCP), and prophylactic pancreatic stenting use
DESIGN AND DURATION OF THE STUDY: Single centre pilot randomised control superiority trail over 12 months with 30 days followup
INCLUSION / EXCLUSION CRITERIA:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Standard ERCP indication
- •Consent given
排除标准
- •Pregnancy and lactation
- •Chronic calcific pancreatitis / pancreatic divisum / pancreatic head
- •malignancy / acute pancreatitis within 14 days of ERCP
- •ERCP for biliary/pancreatic stent exchange or removal or prior biliary sphincterotomy
- •Chronic kidney disease with GFR <30 or acute kidney injury.
- •Presence of rectal anomaly
- •Active GI bleeding or high bleeding risk precluding NSAIDs;platelet <50000/L;INR >1.5 not correctable
- •NSAID allergy
- •Cirrhosis Child-Pugh C
- •Temp instability or severe cardiopulmonary disease precluding cooling/shock risk.
- •Sphincter of Oddi dysfunction (Type 3)
研究组 & 干预措施
Rectal Indomethacin plus Papilary spay of Cold saline
Intervention group: Rectal indomethacin( 100 mg suppository administered 30-60 minutes pre ERCP + cold saline irrigation (4 - 10°C, 250 mL, 2 min)
Rectal Indomethacin alone
Rectal indomethacin should be administered to the patient before 30 minutes ERCP procedure
结局指标
主要结局
Categorisation of Post ERCP Pancreatitis
时间窗: 10 Days
Incidence of Post ERCP Pancreatitis by Cotton criteria: severity graded as mild/ moderate/ severe per consensus
次要结局
- Abdomen pain score assessment(24 hours)
- Adverse events detection : GI bleeding, perforation, cholangitis, aspiration, hypoxemia(24 hours)
- Serum amylase and lipase 24 hours post ERCP.(24 hours)
研究者
Mohan Ramchandani
Director
Asian Institute of Gastroenterology, India