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. 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. 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

Table 1: Complications of ERCP 

Multiple studies have evaluated the incidence of post ERCP complications . Prospective surveys from single referral centres ensure the highest accuracy but are unlikely to be representative of the frequency and severity of unfavourable events in day-to-day practice. By comparison, prospective multi-centre studies involving centres with different volumes of activity and operators with various degrees of expertise more reliably reflect the general effectiveness and safety of ERCP in the community..

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 tertiary-care private hospital. Both have specialised and well equipped department to carry out ERCP procedures and evaluate and manage complications if any.

AIMS:

Primary Aim:

To evaluate incidence of complications of diagnostic and therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP)

Secondary Aim:

To identify possible risk factors for these complications.

DEFINITIONS: 

• ERCP Procedure: Defined as a procedure when the endoscopist has made contact, persistently or repeatedly, with the major (or minor) papilla with an intention to cannulate the bile duct and/or pancreatic duct for diagnostic or therapeutic purpose. Intended ERCP, where the endoscopist makes contact with papillae but fails to cannulate will be taken as an ERCP procedure.

• COMPLICATION: 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.

• INCIDENTS – Undesired events that do not qualify as complications.
• ADVERSE SEQUELAE – Adverse but inevitable results of the procedure, such as the loss of sphincter activity due to sphincterotomy.