ERCP: Indications, Technique and Biliary Devices

Clinical Indications for ERCP

ERCP is indicated in both diagnostic and therapeutic settings, although the advent of non-invasive imaging modalities — magnetic resonance cholangiopancreatography (MRCP) and endoscopic ultrasound (EUS) — has substantially reduced its purely diagnostic role.

Primary therapeutic indications:
Choledocholithiasis. The presence of stones within the common bile duct is the most common indication for ERCP. The procedure enables endoscopic sphincterotomy (division of the sphincter of Oddi) followed by stone extraction using a balloon extraction catheter or Dormia basket.

Biliary strictures. In the setting of benign strictures (post-surgical, chronic pancreatitis-related) or malignant obstruction (cholangiocarcinoma, pancreatic head carcinoma), ERCP allows the placement of plastic biliary stents or self-expanding metal stents (SEMS) to restore biliary drainage.

Acute biliary pancreatitis with cholangitis. In patients presenting with acute cholangitis secondary to biliary obstruction, international guidelines recommend urgent ERCP within 24–72 hours of symptom onset.

Pancreatic duct pathology. ERCP is employed in the management of pancreatic duct strictures, pancreatic fistulae, and intraductal stones in the context of chronic pancreatitis.

Procedure Overview: From Patient Preparation to Technique

Patient Preparation

The patient must be fasted for a minimum of six hours prior to the procedure. Pre-procedural coagulation screening (INR, platelet count) is required, and anticoagulant or antiplatelet therapy must be managed according to ESGE-recommended bridging protocols.

ERCP is performed on an inpatient or day-case basis in an endoscopy suite equipped with a fluoroscopy unit and a radiolucent table. The patient is typically positioned in the prone or left lateral decubitus position.

Endoscopic Technique

A side-viewing duodenoscope — specifically designed to reach the major duodenal papilla (the ampulla of Vater, where the common bile duct and pancreatic duct drain into the duodenum) — is used. The instrument channel of the duodenoscope accommodates the accessory devices required throughout the procedure.

The key steps of therapeutic ERCP include:

• Selective biliary cannulation. Using a sphincterotome or a standard catheter over a hydrophilic guidewire, the endoscopist selectively cannulates the common bile duct or pancreatic duct. Iodinated contrast medium is injected to fluoroscopically delineate the biliary and pancreatic ductal anatomy, identifying stones, strictures, or other abnormalities.
• Endoscopic sphincterotomy. Incision of the sphincter of Oddi using a cutting current is the key step that provides access to the biliary tree for subsequent therapeutic manoeuvres.
• Stone extraction. Common bile duct stones are extracted using a balloon catheter or Dormia basket. For large stones (>15 mm), mechanical lithotripsy — fragmentation of the stone with a dedicated crushing basket — is the first-line technique. In specialised centres, intraductal laser lithotripsy or electrohydraulic lithotripsy (EHL) under direct choledochoscopic vision may be employed.
• Stent placement. In the setting of biliary strictures, plastic stents (requiring exchange every three months) or SEMS are deployed. SEMS are preferred for malignant strictures due to their significantly longer patency duration.

Biliary Lithotripsy: Managing Difficult Common Bile Duct Stones

Mechanical lithotripsy is the first-line technique for difficult choledochal stones — defined as large (>15 mm), multiple, barrel-shaped, or impacted stones that cannot be extracted by standard balloon or basket techniques.

The lithotripter basket is deployed around the stone and progressively tightened until fragmentation occurs, after which the resulting fragments are retrieved using a balloon catheter.

In cases where mechanical lithotripsy proves insufficient, intraductal laser lithotripsy (using holmium or pulsed-dye laser systems under choledochoscopic guidance via SpyGlass DS or equivalent platforms) or extracorporeal shock wave lithotripsy (ESWL) are available as second-line options at tertiary referral centres.

The Role of Medical Devices in ERCP

The technical success of an ERCP procedure is critically dependent on the quality and reliability of the accessory devices employed. The ERCP kits and single-use accessories distributed by Meditalia S.r.l. — including sphincterotomes, selective cannulation catheters, extraction balloons, Dormia baskets, hydrophilic guidewires, and biliary stents — are selected to ensure precise manoeuvrability, compatibility with the leading duodenoscopes on the market, and full compliance with EU MDR Regulation 2017/745.

The use of certified single-use accessories is strongly supported by regulatory guidance from both the FDA and European competent authorities, particularly following documented outbreaks of multidrug-resistant organism transmission associated with inadequately reprocessed reusable duodenoscopes. Single-use design eliminates this risk category entirely, offering an additional layer of patient safety in a high-complexity procedural setting.

ERCP and Choledochoscopy: The Frontier of Direct Visualisation

Choledochoscopy — direct intraluminal visualisation of the common bile duct using a miniaturised probe introduced through the working channel of the duodenoscope — represents the most advanced frontier of ERCP-based intervention. Systems such as SpyGlass DS II enable targeted biopsy of indeterminate biliary strictures and laser lithotripsy under direct vision, delivering a substantial improvement in diagnostic yield and therapeutic success rates compared to conventional fluoroscopy-guided techniques alone.