Complications of Endoscopic Retrograde Cholangio-Pancreatography (ERCP) - an Indian Perspective
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 929
- 试验地点
- 1
- 主要终点
- To evaluate incidence of complications of diagnostic and therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP)
研究概览
简要总结
Endoscopic retrograde cholangiopancreatography (ERCP) is a form of endoscopy where a Side-viewing endoscope is introduced into the duodenum, following which instruments are passed into bile or pancreatic ducts, to allow their radiological visualisation by injecting contrast medium and/or perform various therapeutic procedures, e.g., removal of bile duct stone. It is a complex endoscopic procedure with long learning curve and has number of complications which can even be life-threatening. Since its introduction in 1968, ERCP has become a widely used endoscopic procedure for a variety of disorders. Endoscopic biliary sphincterotomy was first reported in 1974. ERCP at its inception was predominantly a diagnostic procedure, however over the past decade its predominantly carried out for therapeutic indications because of the availability of other imaging techniques, such as abdominal Ultrasound (US), Computed Tomography (CT), Magnetic resonance cholangiopancreatography (MRCP), Endoscopic Ultrasound (EUS) that provide detailed diagnostic information and thus allowing appropriate selection of patients for therapeutic ERCP. Complications are expected to occur in a proportion of patients undergoing ERCP, even when performed by endoscopists with significant expertise in the procedure. A number of patient-related and technique-related factors are known to increase the risk of complication. ERCP requires sedation and therefore has in addition a risk of anaesthesia related adverse events. Most of the complications post-ERCP are apparent during the first 6 hours after the procedure. There are no large scale study evaluating the complications of ERCP in Indian or even Asian population. In an attempt to address this deficit we will be conducting a dual centre prospective study to look at the incidence of various ERCP-related complications. Proposed study will be done in both a tertiary care public academic centre and a tertiarycare private hospital. Both have specialised and well equipped department to carry out ERCP procedures and evaluate and manage complications if any.
详细描述
INTRODUCTION:
Endoscopic retrograde cholangiopancreatography (ERCP) is a form of endoscopy where a Side-viewing endoscope is introduced into the duodenum, following which instruments are passed into bile or pancreatic ducts, to allow their radiological visualisation by injecting contrast medium and/or perform various therapeutic procedures, e.g., removal of bile duct stone. It is a complex endoscopic procedure with long learning curve and has number of complications which can even be life-threatening.(1) . Since its introduction in 1968, ERCP has become a widely used endoscopic procedure for a variety of disorders (2).
Endoscopic biliary sphincterotomy was first reported in 1974(3). ERCP at its inception was predominantly a diagnostic procedure, however over the past decade its predominantly carried out for therapeutic indications (4-5) because of the availability of other imaging techniques, such as abdominal Ultrasound (US), Computed Tomography (CT), Magnetic resonance cholangiopancreatography (MRCP), Endoscopic Ultrasound (EUS) that provide detailed diagnostic information and thus allowing appropriate selection of patients for therapeutic ERCP. Complications are expected to occur in a proportion of patients undergoing ERCP, even when performed by endoscopists with significant expertise in the procedure. A number of patient-related and technique-related factors are known to increase the risk of complication (6). ERCP requires sedation and therefore has in addition a risk of anaesthesia related adverse events (7). Most of the complications post-ERCP are apparent during the first 6 hours after the procedure (8). Thus patients require careful monitoring during this phase to detect symptoms or signs suggesting adverse events. Table 1 below sums up the complications related to ERCP that has been reported in various studies. (9,10,11,12,13- 21) . Table 1: Complications of ERCP Related to pancreaticobiliary instrumentation Pancreatitis Bleeding Infection
Related to technical issue with endoscopy Electrosurgical hazards:
Thermal injury: perforation Inadequate cautery: Bleeding Air insufflation: Post ERCP pain Contrast allergy Perforation
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those more than or equal to 12 years of age undergoing diagnostic or therapeutic ERCP between 1st August 2018 to 31st July 2019 either for the first time or after a previous failed cannulation attempt
排除标准
- •Surgically altered anatomy of Upper GI tract
- •Failure of endoscopist to reach second part of duodenum due to pyloroduodenal obstruction despite endoscopic attempts to relieve the obstruction (e.g., balloon dilatation of stricture).
- •Those undergoing side-viewing endoscopy only with or without ampullary biopsy
- •Those undergoing stent removal without any biliary/pancreatic endotherapy
- •Repeat biliary endotherapy (e.g., stent exchange, second attempt at difficult stone removal) without pancreatic endotherapy
- •Repeat pancreatic endotherapy without biliary endotherapy
- •Immunodeficiency (primary or secondary)
- •Pregnancy
结局指标
主要结局
To evaluate incidence of complications of diagnostic and therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP)
时间窗: 30 days
An unplanned event attributable to the ERCP procedure that requires the patient to be admitted to hospital, or to stay longer than expected, or to undergo other interventions: * Within 30 days of procedure * We do not count in complication statistics any deviation that occurs during a procedure that is not obvious to the patient afterwards, and does not require unplanned admission.
次要结局
- To identify possible risk factors for these complications(30 days)
研究者
Kshaunish Das
Professor, Division of Gastroenterology, School of Digestive and Liver Disease
Post Graduate Institute of Medical Education and Research, Chandigarh