Physical Address
304 North Cardinal St.
Dorchester Center, MA 02124
In the 1970s and 1980s, endoscopic retrograde cholangiopancreatography (ERCP) transformed the diagnostic approach to suspected biliary disease and jaundice (see Chapters 20 and 30 ). Similarly, in the years since it was first performed in humans, , endoscopic sphincterotomy (ES) has had a dramatic impact on the management of biliary disease, specifically in the treatment of common bile duct (CBD) stones. The widespread availability of ES has made endoscopic stone extraction the primary modality for the management of choledocholithiasis. Interest in ERCP and endoscopic sphincterotomy as definitive therapy for CBD stones grew in the 1990s after the introduction of laparoscopic cholecystectomy (see Chapter 36 ). Patient-related factors, clinical judgment, availability of expertise, and current evidence from clinical trials must be combined to decide on an endoscopic, percutaneous, or surgical approach. Although ERCP as a diagnostic modality has been replaced by noninvasive imaging modalities such as magnetic resonance cholangiopancreatography (MRCP) (see Chapter 13 ), it remains the major nonoperative tool for the management of biliary diseases such as choledocholithiasis and obstructive jaundice.
Patients with choledocholithiasis may present with asymptomatic stones on noninvasive imaging or direct cholangiography or with a variety of clinical symptoms (see Chapter 33 ), such as cholestasis, pain, cholangitis (see Chapter 43 ), and pancreatitis (see Chapter 55 ). In the early days of ES—at a time when few endoscopy centers could offer the technique and criticisms by surgical experts were common—it was considered justifiable only in elderly postcholecystectomy patients with recurrent or retained bile duct stones who were at high risk of serious complications from open surgical CBD exploration or reexploration. The impressive success of ES in this group, combined with expanded availability, a low rate of complications, and strong patient preference, has led to ERCP becoming the primary modality for the management of CBD stones.
The endoscopist now must consider several clearly defined conditions for which endoscopic management may be indicated in patients with definite or suspected bile duct stones , :
Acute cholangitis
Visualized CBD stone on abdominal ultrasound, endoscopic ultrasound (EUS), computed tomography (CT), MRCP, or intraoperative cholangiogram
High suspicion of CBD stones: cholelithiasis, dilated CBD, and abnormal liver biochemical tests
Worsening gallstone pancreatitis
Recurrent CBD stones or gallstone pancreatitis, nonsurgical candidate for cholecystectomy
An endoscopy service that treats CBD stones must have access to an appropriate endoscopy facility and high-quality fluoroscopy. The endoscopy team must be fully cognizant of all basic ERCP maneuvers, less frequently used techniques, and potential complications and their management. It is essential to explain the nature of the procedure to the patient and to outline the purpose, benefits, advantages, alternatives, and potential hazards (see Chapters 20 and 30 ).
On successful deep biliary cannulation with a sphinctertome, a cholangiogram is initially performed, which defines the ductal anatomy and the extent of the stone burden. ES is usually the first therapeutic step in stone extraction. Balloon dilation of the biliary sphincter is an alternative to ES, but this has fallen out of favor due to increased risks of severe post-ERCP pancreatitis. Standard pull-type sphincterotomes allow a vertical incision to be made from the papillary orifice in a cephalad direction along the intramural course of the CBD for a variable length (average, 10 to 15 mm), depending on local anatomy, the degree of CBD dilation, and the size of the stone to be removed ( Fig. 37C.1 ). The incision is produced by the controlled application of monopolar electrocautery delivered by a generator specifically designed for endoscopic use. It is fundamental to ES technique that complete control of wire tension and electrocautery be maintained at all times. “Smart” generators incorporate a pulsed generator (Erbe, Tubingen, Germany; ConMed Endoscopic Technologies, Billerica, MA) with feedback-controlled power output, thus avoiding a “zipper effect” and reducing pancreatitis and bleeding.
Occasionally, a precut sphincterotomy, also referred to as an access papillotomy, is needed to initiate ES when the standard instrument cannot be inserted deeply. This incision is often needed when cannulation has been prevented by an impacted stone. The needle-knife is more useful in this situation because the intramural CBD is usually grossly distended and easily incised, starting from the papilla and extending cephalad. Needle-knife fistulotomy is a variant of this technique; the incision is begun above the papilla to form a choledochoduodenal fistulotomy. This technique is similar in efficacy to precut sphincterotomy, but more often it requires mechanical lithotripsy (ML) and may have a lower rate of pancreatitis. Patients with Billroth II partial gastrectomy ( Fig. 37C.2 ) and Roux-en-Y bypass operations present special problems to the endoscopist, and numerous methods have been described to obtain successful cannulation , and removal of CBD stones (see Chapter 37B ).
It is standard practice to attempt stone extraction from the CBD immediately after ES. The two accessory instruments used most commonly for this are the Dormia-type basket ( Fig. 37C.3 ) and the Fogarty-type balloon ( Figs. 37C.4 and 37C.5 ), which are greater than 90% successful in clearing the CBD. Occlusion cholangiography is performed after stone extraction to confirm complete ductal clearance.
Difficulties in extraction of CBD stones are either related to anatomic factors affecting the ability to perform an adequate ES or related to complex morphology of the stones themselves (see Chapters 30 and 37B ). An inaccessible papilla may be related to aberrant anatomy or unfavorable duodenal or papillary structures, such as a periampullary diverticulum, or prior surgery, such as Billroth II or Roux-en-Y reconstruction. Techniques have been described for the unique challenge of selective bile duct cannulation in a patient with a Billroth II partial gastrectomy. The performance of ES in Billroth II or Roux-en-Y anatomy is also a challenge because the visualized anatomy is inverted. In especially difficult cases, needle-knife sphincterotomy with a stentor guidewire used as a guide may be an option, or specially designed reverse-direction accessories. Roux-en-Y gastric bypass patients pose an extra challenge for the endoscopist due to the long pancreaticobiliary limb. ERCP using overtube-assisted enteroscopy has been performed successfully in patients with Roux-en-Y gastric bypass, with a recent meta-analysis demonstrating a 75% technical success rate and an 8% adverse event rate.
When ES has been successfully performed, extraction may be hindered by a variety of stone factors, including size, number, consistency, shape, and location of stones, as well as ductal factors such as contour and diameter at the level of and distal to the stones, and the presence of coexisting pathology (e.g., stricture or tumor). Stones that are likely to be more difficult to extract and may require adjuvant techniques to remove them are those that appear larger than the endoscope on radiographic imaging (usually >15 mm); stones that are numerous or hard in consistency; stones that are square, piston shaped, or faceted that tightly fit the bile duct or that are packed against each other; intrahepatic stones; or stones located proximal to a stricture or narrowed distal bile duct or in a sigmoid-shaped duct.
Methods that have been developed to dilate the papillary orifice, reduce stone size, and facilitate endoscopic removal include endoscopic papillary large balloon dilation (EPLBD), ML, intracorporeal lithotripsy with laser or electrohydraulic probes, extracorporeal shockwave lithotripsy (ESWL), and chemical contact dissolution therapy. Treatment options must be discussed jointly by the endoscopist, surgeon, and interventional radiologist when difficulties are encountered ( Fig. 37C.6 ).
ESWL with a variety of lithotripsy machines is now an alternative to endoscopic management of difficult bile duct stones. In contrast to intracorporeal techniques, direct contact with the stone is unnecessary. Most centers localize stones with fluoroscopic focusing during contrast perfusion of the bile duct through an endoscopically placed nasobiliary catheter or percutaneous drain. , Ponchon et al. reported ESWL success with an ultrasound localization system, although it was less effective when multiple stones were present. Several large series indicated success rates for ESWL stone fragmentation of 53% to 91% and duct clearance in 58% to 90%. Minor complications are common and include biliary pain, hemobilia, transient liver function test elevations, and cutaneous petechiae. Overall, with the use of endoscopic techniques such as ML, EHL, laser lithotripsy, and ESWL, one report showed successful stone removal in 98% of 217 patients, with only 5 patients requiring surgery. However, given the high efficacy of newer endoscopic techniques, ESWL is currently rarely used for bile duct stones.
Removal of large CBD stones is a challenge for the most skilled endoscopists (see Chapter 30 ). , ML remains an excellent option for stones that cannot be removed by conventional techniques because it can be used safely and effectively during the initial endoscopic procedure. Mechanical lithotripters are modifications of standard Dormia baskets and possess great tensile strength ( Fig. 37C.7 ). The reinforced basket is opened in the CBD, and the stone is entrapped within the braided wires. This procedure can be performed through the endoscope instrumentation channel, or it can be done after the endoscope has been removed from the patient and a metal sheath has been extended over the inner Teflon catheter. The end of the metal sheath is attached to a winding mechanism, which retracts the basket when cranked and impales the stone against the rigid distal end of the metal sheath leading to stone fracturing. The stone fragments can be removed with the same basket or a standard retrieval basket or balloon. In experienced centers, this technique allows removal of more than 90% of difficult bile stones that are refractory to standard extraction techniques, but multiple procedures may be required to achieve complete ductal clearance.
EPLBD in conjunction with ES has greatly improved the rates of ductal clearance of difficult stones without the need for advanced ERCP lithotripsy techniques. The first report of EPLBD (12–20 mm) with ES was described in 2003, when a retrospective review demonstrated that 38 out of 40 patients with large stones previously unable to be removed with standard techniques had successful ductal clearance with acceptable complication rates. Further research has shown that endoscopic sphincterotomy with EPLBD can obviate the need for ML. A review of seven studies included 902 patients and compared ES with EPBLD versus ES with standard techniques. The authors found no differences in ductal clearance between the EPLBD and standard-techniques groups (98% vs. 95%, P = .6), but patients in the EPLBD group needed less ML. The use of EPLBD had a relative risk reduction of 0.58 (0.32–0.74) in terms of adverse events. For large bile duct stones (>13 mm), EPLBD results in improved ductal clearance (96% vs. 74%, P < 0.001) with reduced need for ML (3.9% vs. 35.6%, P < 0.001) compared with ES alone.
Although the studies mentioned in the previous sections demonstrate the safety of EPLBD, there has been concern for the rare but serious complications, such as bleeding, perforation, and pancreatitis related to stretching the ampullary orifice to such a large size. A review of 33 publications including 2924 total procedures compared the complication rates of EPLBD with a large ES, with limited ES, and without ES. The rate of adverse events was less than 10% in each group and not significantly different. The rates of severe complications such as pancreatitis (all <4%) and perforation (all <0.5%) were acceptable and also not significantly different among the three groups. The rate of bleeding, however, was highest in the large ES group, at 4.1%, which was significantly higher than the limited-ES and no-ES groups (1.3% vs. 1.9%, respectively).
A multicenter retrospective study that included 946 patients who underwent EPBLD for CBD stones greater than 10 mm in size sought to determine the predictive factors of adverse events in EPLBD. Based on their findings, the authors made the following recommendations: (1) Indication should be patients with a dilated CBD without distal CBD strictures. (2) Avoid full-ES immediately before LBD to prevent perforation and bleeding. (3) Inflate the balloon gradually to recognize an occult stricture. (4) Discontinue balloon inflation if resistance is met in the presence of a persistent balloon waist. (5) Do not inflate the balloon beyond the maximal size of the upstream dilated CBD. (6) Do not hesitate to convert into alternative stone removal methods, such as ML or electrohydraulic lithotripsy (EHL), if there is difficulty in removing stones.
If performed correctly (with an incomplete ES and then EPLBD to the size of the CBD), ES with EPLBD is a safe and effective method for removal of multiple or large stones in the CBD, which leads to shorter procedure times with decreased use of lithotripsy techniques.
Since its development during the 1950s in the former Soviet Union as a method to fragment rocks during mining, EHL has been adapted for medical use in the treatment of nephrolithiasis and biliary tract calculi. The electrohydraulic probe consists of two coaxially isolated electrodes at the tip of a flexible catheter, which is capable of delivering electric sparks in short, rapid pulses leading to sudden expansion of the surrounding liquid environment and generating pressure waves that result in stone fragmentation. Direct cholangioscopy with either mother-daughter cholangioscopes or single-operator cholangioscopy (SOC) systems, such as the SpyGlass DS (Boston Scientific, Natick, MA), are used to directly target stones for fragmentation while avoiding ductal trauma or perforation. , Continuous saline irrigation is used with the bipolar electrode placed near the surface of the stone to provide a medium for shockwave energy transmission, to flush away debris, and to maintain adequate visualization. Reports document complete stone clearance after multiple sessions in 86% of patients, , and in a prospective nonrandomized trial, EHL was comparable to ESWL in stone clearance.
The largest study of EHL performed to date is a retrospective review of 407 patients with difficult biliary stones who underwent ERCP with SOC, using either EHL (75.2%) or laser lithotripsy (24.8%). On subgroup analysis, 74.5% of patients who underwent EHL achieved complete stone fragmentation and ductal clearance in a single procedure. Adverse events across the entire study population occurred in 15 patients (3.7%), including 6 with cholangitis and 1 with pancreatitis. The adverse events were classified as mild in 10 of 15 patients (66.7%).
Become a Clinical Tree membership for Full access and enjoy Unlimited articles
If you are a member. Log in here