Diagnostic and therapeutic strategies for choledocholithiasis. A systematic review of endoscopy and general surgery

 

 

Nº de DOI: 10.34896/RSI.2026.15.38.002

 

 

AUTHORS

1. Jennifer Dayanara Tiban Changoluisa. General Practitioner. Affiliated with Clínica Pazmiño Narváez. Graduate of Universidad UTE. Based in Quito, Ecuador. https://orcid.org/0009-0006-3849-1492
2. Leslie Mandina Acosta Vasquez. General Practitioner. Affiliated with private healthcare institutions in Ecuador. Graduate of Pontificia Universidad Católica del Ecuador. Based in Quito, Ecuador. https://orcid.org/0009-0002-8016-6731
3. Stefano Sigifredo Zambrano Pacheco. General Practitioner. Affiliated with Hospital General Dr. Gustavo Domínguez Zambrano. Graduate of Universidad Laica Eloy Alfaro de Manabí. Based in Santo Domingo, Ecuador. https://orcid.org/0009-0001-0814-5699
4. Evelyn Kiabeth Ledesma Peña. General Practitioner with a Master’s Degree in Occupational Health and Safety. Affiliated with the Gobierno Autónomo Descentralizado San Jacinto de Buena Fe. Graduate of Universidad Católica de Santiago de Guayaquil. Based in Quevedo, Ecuador. https://orcid.org/0009-0008-3095-9518
5. Ginela Rocío Rengel Pinzón. General Practitioner. Affiliated with private healthcare institutions in Ecuador. Graduate of Universidad Católica de Cuenca. Based in Loja, Ecuador. https://orcid.org/0000-0003-0497-2563

ABSTRACT

The authors emphasize the importance of a tailored-approach using the algorithm specified above, balancing stone characteristics, the patient comorbidities, and local institutional capacities to deliver effective and safe care. As we look to the future, the proposal of artificial intelligence (AI) as planning methodology for strategies in preparing for eventual procedures, and the opportunity for a «hybrid» laparo-endoscopic rendezous procedures in an effort to advance clinical treatment⁴.

KEY WORDS

Choledocholithiasis, common bile duct stones, endoscopic retrograde cholangiopancreatography, laparoscopic common bile duct exploration, and cholecystectomy.

RESUMEN

Los autores destacan la importancia de un enfoque personalizado basado en el algoritmo anteriormente descrito, que equilibre las características del cálculo, las comorbilidades del paciente y las capacidades institucionales locales para brindar una atención eficaz y segura. De cara al futuro, se plantea el uso de la inteligencia artificial (IA) como metodología de planificación estratégica para la preparación de procedimientos, así como la oportunidad de realizar procedimientos híbridos de tipo *rendezvous* (encuentro) laparoscópico-endoscópico con el fin de avanzar en el tratamiento clínico.

PALABRAS CLAVE

Coledocolitiasis, cálculos en el conducto biliar común, colangiopancreatografía retrógrada endoscópica, exploración laparoscópica del conducto biliar común y colecistectomía.

INTRODUCTION

The prevalence of choledocholithiasis (stones of the common bile duct (CBD) presents a considerable problem for both patients and healthcare systems due to the resulting high morbidity and costs associated with treatment. Traditionally, choledocholithiasis was managed with open surgical exploration; however, the treatment paradigm has shifted in favor of minimally invasive approaches, now divided largely into an endoscopic gastroenterology strategy or a laparoscopic surgical strategy. We conducted a systematic review to compare efficacy, safety, and clinical outcomes of these two main modalities of treatment. A comprehensive search of PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, and similar databases was performed to identify randomized controlled trials and high-quality observational studies comparing single-stage laparoscopic common bile duct exploration (LCBDE) with the two-stage treatment approach of endoscopic retrograde cholangiopancreatography (ERCP) then laparoscopic cholecystectomy (LC). Data were synthesized demonstrating a significantly higher stone clearance rate and shorter total length of stay in hospital in the single-stage laparoscopic setting compared with the two-stage endoscopic-surgical pathway¹. While ERCP is still the standard answer to decompress the CBD rapidly in the high-risk population, risks associated with ERCP such as post-ERCP pancreatitis (PEP) and long-term sphincter of Oddi dysfunction². In contrast, LCBDE entails direct visualization of the biliary tree and a hormonal-sphincterio path of the sphincter, but this requires additional expertise and equipment³. Diagnostic methods have also changed, with some methods, primarily non-invasive, such as magnetic resonance cholangiopancreatography (MRCP) and endoscopic ultrasound (EUS) largely replacing ERCP for diagnosing CBD stones to minimize procedural risks².

OBJECTIVE

To compare the efficacy, safety, clinical outcomes, and economic impact of endoscopic and laparoscopic surgical strategies for the diagnosis and treatment of choledocholithiasis.

METHODOLOGY

To ensure a complete and transparent review of the literature, a systematic search was undertaken of multiple electronic databases including PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL). The search strategy employed the use of Medical Subject Headings (MeSH) terms and keywords associated with “choledocholithiasis,” “common bile duct stones,” “endoscopic retrograde cholangiopancreatography,” “laparoscopic common bile duct exploration” and “cholecystectomy” as it pertains to various clinical studies. The search was limited to studies published in English and focused on the past two decades in order to reflect a contemporary clinical context and technological advances¹. Apart from the database searches that were conducted, the relevant reference lists in review articles and meta-analyses also underwent manual search for additional studies that might have been missed.

The inclusion criteria were guided by the need for high-quality evidence comparing different management strategies for concomitant cholelithiasis and choledocholithiasis. The selection of studies for inclusion in the review was limited to:

1. Randomized controlled trials or prospective or retrospective observational studies.
2. Studies comparing single-stage management (LCBDE + LC) versus two-stage management (ERCP + LC).
3. Studies reporting on primary outcomes such as stone clearance rates, total hospital length of stay, and procedural complications, provided they report on adult patient populations (≥18 years) with confirmed common bile duct stones.

Exclusion criteria included:

1. Only intrahepatic stones or malignant biliary obstructions were included.
2. Case reports, editorials, and small case series (n < 10).
3. Studies where the primary outcomes of interest cannot be extracted or confounded by unrelated pathologies.

Data extraction was carried out by two reviewers independently through a predefined standardized data collection form. The following variables were extracted and collected: study design, sample size, patient demographics (age, sex), stone characteristics (size, number), surgical techniques (EST versus EPBD, transcystic versus transcholedochal), and clinical outcomes (success rate, morbidity, mortality, and costs). When there was disagreement between reviewers, a third senior reviewer was used to resolve the disagreement. The quality of included studies was evaluated using established quality assessment tools: the Cochrane Risk of Bias tool for randomized controlled trials (RCTs) and the Newcastle-Ottawa Scale for observational studies. The inherent aim of the assessment was to evaluate bias due to selection, performance, detection, and attrition to determine the reliability of synthesized data.

The data synthesis was primarily aimed to compare the effectiveness and safety of one-stage and two-stage interventions. Qualitative and quantitative synthesis was utilized where appropriate to use random-effects meta-analytical techniques to address study heterogeneity. Dichotomous outcomes, such as stone clearance and complications, were expressed as odds ratio (OR) and 95% confidence interval (CI) of the dichotomous outcome. Continuous outcomes such as length of stay and costs were expressed as mean difference (MD). Heterogeneity was evaluated as >50% using the I² statistic as a guide. Qualitative synthesis was used for themes with insufficient quantifiable quality data for reliability, such as long-term functional outcomes and the influences of artificial intelligence in surgical planning.

RESULTS

Choledocholithiasis is a common manifestation of gallstone disease, and a significant portion of patients with cholelithiasis will have gallstones in the CBD. Although it is widely accepted the overall incidence of cholelithiasis is between 5 – 15% in the adult population, the incidence of CBD stones is approximately 5% to 30% in the context of a cholelithiasis diagnosis⁵. The presentation of choledocholithiasis is broad can present as an asymptomatic patient found to have choledocholithiasis incidentally, to life-threatening complications such as acute obstructive jaundice, ascending cholangitis, and gallstone pancreatitis⁶. Managing these patients is challenging given the need for biliary tree clearance, including definitive intervention for the stone-forming gallbladder.

Historically, common bile duct stones (CBDS) were managed with open cholecystectomy and common bile duct exploration, but ERCP was introduced in the 1970s and laparoscopic cholecystectomy was introduced in the late 1980s. In recent decades, routine approaches of a «two-stage» approach of pre-operative ERCP for ductal clearance then laparoscopic cholecystectomy became the standard of care at many institutions. These guidelines were largely due to early laparoscopic surgical limitations, while therapeutic options and opportunities developed rapidly with ERCP, such as endoscopic sphincterotomy (EST), balloon dilation, and other techniques².

Despite the prevalence of the two-stage approach, the advent of laparoscopic common bile duct exploration (LCBDE) represents a challenge to this paradigm. Specifically, LCBDE offers a “single-stage” approach for both cholelithiasis and choledocholithiasis all in one anesthetic episode. Recent studies suggest that LCBDE might not only be equally effective as ERCP, but also achieve improved stone clearance and length of hospital stay¹. Moreover, the endoscopic approach is not without harm; EST induces the irreversible destruction to the sphincter of Oddi, which can incur adverse long-term effects such as duodenobiliary reflux, recurrent stone formation, and chronic cholangitis⁷.

The engagement in an endoscopic-first or surgical-first approach is an active point of discussion between gastroenterologists and general surgeons. Variables contributing to this decision include the surgical risk to the patient, size and quantity of the stone burden, diameter of the common bile duct, and availability of resources and expertise⁸. What is additionally recognized, as we shift to value-based care, are the cost-effectiveness and resource utilization of alternative approaches.

The aim of this systematic review is to provide a rigorous comparative analysis of current diagnostic and therapeutic strategies for choledocholithiasis. By synthesizing the most contemporary clinical evidence, we present an overview of the success of diagnostic and treatment modalities and the economic impact of endoscopic management versus surgery. We will also discuss modern diagnostic innovations in terms of their utility for multi-modality or multi-disciplinary «hybrid» approaches to care in the gastroenterology and surgery spaces.

Pathophysiology and Clinical Presentation:

Mechanism of Stone Formation and Migration:

The pathophysiology associated with choledocholithiasis is ultimately linked with bile composition and the anatomy of the biliary tree. There are two main types of common bile duct stones: primary and secondary. Primary common bile duct stones occur de novo in the bile ducts most commonly due to bile stasis, a chronic bacterial infection, and congenital anatomical abnormalities, such as Caroli’s disease. Primary stones are typically brown pigment stones that contain calcium bilirubinate, and are often associated with the presence of bacteria in the bile⁵. Secondary common bile duct stones, which account for most cases of choledocholithiasis in Western populations, develop in the gallbladder before migrating through the cystic duct and into the common bile duct. The majority of these stones are comprised of cholesterol or mixed stones.

The movement of stones is an active process, depending on the size of stone and diameter of the cystic duct. Once a stone has traversed the CBD it may either pass spontaneously into the duodenum, remain asymptomatic, or obstruct at the narrowest point of the biliary system (the ampulla of Vater). Depending on the presence and location of these stones biochemical pathways are activated that produce physiological responses, such as increased intraductal pressure and decreased outflow of bile, which ultimately leads to bacterial translocation and clinical cholangitis. The recurrence rate of CBD stones following initial removal is concerning, reportedly between 4%-25%⁵. For example, any dilated common bile duct (>15mm), the presence of periampullary diverticula, and the angle of the CBD that promotes stasis all increase the risk of recurrence⁵.

Clinical Presentation and Risk Stratification:

The clinical presentation of choledocholithiasis is variable. Many patients are asymptomatic with stones identified on imaging or at the time of cholecystectomy for symptomatic cholelithiasis. When there is a presentation, it is usually biliary colic, characterized by acute, episodic pain either in the right upper quadrant or epigastrium radiating into the back or shoulder. With significant obstruction symptoms may also include jaundice, characterized as yellowing of the sclerae and skin, dark urine, and pale stools.

The most serious presentations are acute cholangitis that may be described by Charcot’s triad or Reynolds’ pentad, which adds hypotension and mental state changes. These are considered surgical and endoscopic emergencies as the patients require biliary decompression⁶. Clinical guidelines from organizations such as the ASGE and ESGE offer risk stratification tools that allow physicians to categorize patients into high, intermediate, or low risk for having CBD stones based on clinical predictors, biochemical markers and ultrasound findings initially. Patients identified as high risk (e.g., CBD stone seen on ultrasound or total bilirubin >4 mg/dL) may be taken straight to a therapeutic intervention, whereas the intermediate patients may have a follow-up diagnostic non-invasive imaging study².

Biochemical Markers and Predictive Scoring Systems

Biochemical markers frequently play a role in the initial assessment and stratification of patients suspected of choledocholithiasis. Elevation in liver function tests (LFTs), particularly cholestatic markers, such as alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT) and conjugated bilirubin are highly suggestive of obstruction of the duct. These histological markers are not completely specific to choledocholithiasis, as they may be elevated due to cholecystitis, hepatic parenchymal disease, or exertional compression of the bile duct.
Studies demonstrate that the elevation pattern and degree of LFTs may help predict the risk of finding a CBD stone. For example, a total bilirubin level above 4 mg/dL is highly predictive of choledocholithiasis. However, variable LFTs or trends of LFT improvement may represent passage of the stone to the duodenum. Although LFTs provide useful clinical information, they are insufficient as a standalone diagnostic marker. Scoring systems have been developed to assist in refining the evaluation of more high-risk patients requiring procedures, which have included factors such as age, LFTs, and ultrasound findings (e.g., CBD diameter). For example, CBD diameter >6 mm ultrasound of a patient with an intact gallbladder is considered a substantial predictor of ductal stones. The purpose of the scoring system was to mitigate the incidence of «negative» ERCP procedures, which can present risks for complications, like pancreatitis.

Diagnostic Modality in Practice:

Non-invasive imaging: US, CT, and MRCP:

For a patient with suspected choledocholithiasis, the first step in evaluation is non-invasive imaging. Transabdominal ultrasound (US) is the most widely used first-line imaging modality due to cost, ease of availability, and absence of ionizing radiation. Although the US is very helpful when considering the presence of cholelithiasis (gallstones within the gallbladder), its sensitivity for visualization of CBD stones is limited (20-50%). Instead, US can indirectly suggest the possibility of choledocholithiasis by showing a dilated common bile duct. Computed Tomography (CT) is also frequently performed in the emergent setting to evaluate abdominal pain. CT may have improved sensitivity to demonstrate ductal dilation and may identify some calcified stones; however, it is not sensitive to radiolucent cholesterol stones and is not an ideal primary diagnostic for choledocholithiasis.

Magnetic Resonance Cholangiopancreatography (MRCP) has emerged as the gold standard non-invasive diagnostic modality. MRCP uses T2-weighted MRI sequences to provide a three-dimensional, high-resolution image of the biliary tree with or without the use of contrast and without any invasive intervention. Its sensitivity and specificity are >90% in the detection of CBD stones. MRCP can exclude CBD stones and avoid unnecessary ERCP in intermediate risk patients. MRCP is limited, however, as a «static» diagnostic test with no therapeutics. In addition, it may lack sensitivity for very small stones (<3mm) and in the setting of severe biliary sludge.

Endoscopic Ultrasound (EUS) as a Diagnostic Imaging:

Endoscopic Ultrasound (EUS) is also considered a highly accurate technological, minimally invasive diagnostic modality that connects endoscopy and imaging. EUS involves placing a high-frequency ultrasound transducer within the duodenum, close to the biliary tree, allowing for <> imaging than is possible with MRCP, especially with small stones or microlithiasis. EUS is another good tool to play a «gatekeeper» role for intermediate risk patients. Clinical protocols have utilized EUS to confirm whether stones are present before progression to ERCP, improving accuracy and significantly decreasing unnecessary invasive procedures and complications.

The greatest benefit of EUS is its substantial negative predictive value — nearly 100% in many series. This allows clinicians to safely exclude choledocholithiasis and proceed with laparoscopic cholecystectomy without further ductal evaluation. EUS is more invasive than MRCP (it requires sedation and an endoscopic procedure), but it is safer than ERCP because it does not involve cannulating the biliary or pancreatic ducts and therefore carries no risk of post-ERCP pancreatitis (PEP) ². Sometimes the decision to perform EUS versus MRCP is dictated by local availability, cost, and the unique clinical situation of the patient (eg, MRI incompatible implants).

Invasive Diagnostics: ERCP and Intraoperative Cholangiography:

In this modern era, ERCP has moved from diagnostic to primarily therapeutic. Although diagnostic ERCP was once a gold standard because it offered direct fluoroscopic visualization of the biliary tree, it is now discouraged because of its complication risks. Post-ERCP pancreatitis occurs in approximately 5% to 10% of patients, which is not appropriate for the first-line diagnosis when non-invasive options are available (these being MRCP and EUS) ². ERCP is now limited to patients with a high clinical suspicion of stones, and in whom therapeutic intervention (eg, stone extraction) is planned.

In the surgical setting, intraoperative cholangiography (IOC) continues to be an important diagnostic and protective maneuver. IOC is performed during laparoscopic cholecystectomy by injecting radiopaque contrast through the cystic duct to visualize the biliary anatomy (and any possible obturation). IOC provides dynamic real-time information, allows the operating surgeon to recognize and avoid anatomical variations and potential bile duct injuries, and to detect the presence or absence of common bile duct (CBD) stones⁹. If a stone were found on IOC, the surgeon can then directly progress to laparoscopic common bile duct exploration (LCBDE), thus facilitating a single-stage approach³. In addition, the IOC is valuable in detecting «silent» CBD stones that may be missed on preoperative imaging. That said, there is controversy regarding the routine use of IOC – some surgeons promote selective IOC on known or anticipated preoperative risk factors while others advocate for IOC for routine «road mapping» of anatomy⁸.
To summarize, the diagnostic approach for choledocholithiasis has moved toward more conservative, imaging-first approach. The use of high-sensitivity tests like MRCP and EUS has led to improved patient selection and ensured that invasive therapies like ERCP are performed only on patients having or requiring true therapeutic interventions. Intraoperative modalities like IOC continue to prove essential for safety and definitive surgical treatment. This diagnostic rigor provides the basis for effective decisions about therapy, whether endoscopic or surgical.

Endoscopic Therapeutic Approaches:

The therapeutic landscape for choledocholithiasis has undergone a paradigm shift with the evolution of endoscopic techniques where Endoscopic Retrograde Cholangiopancreatography (ERCP) is the primary means of clearing the duct. While ERCP was initially developed for diagnostic purposes, non-invasive imaging has become reliable and sensitive enough that it has fundamentally changed the role of ERCP to a purely therapeutic one. The success of endoscopic management is predicated on successful cannulation of the papilla and either the use of mechanical energy or heat energy to assist with stone removal.

Endoscopic Retrograde Cholangiopancreatography (ERCP) Techniques:

Standard ERCP techniques consist of selective cannulation of the common bile duct (CBD) with a sphincterotome and wire under fluoroscopic guidance. This procedure is the cornerstone of modern biliary management, especially in the context of the «sequential approach», where ERCP is performed early in the management, prior to laparoscopic cholecystectomy. Recent literature demonstrates successful ductal clearance with endoscopic management in the high 90% range in specialized centres. In one paper comparing two groups of 70 patients who were treated using a sequential approach, ERCP was successful in 93% of cases¹⁰.

However, when a patient has altered gastrointestinal anatomy such as having had Roux-en-Y gastric bypass (RYGB) operation, the technical aspect of performing the ERCP becomes significantly more complicated. In these patients, the bypass has created a longer and more complex route to reach the bypassed biliary-enteric limb using ERCP, and they will require advanced techniques. Enteroscopy assisted ERCP (EA-ERCP) has historically been used in these cases, but with a, even lower technical success rate of around 77%¹¹. A next-generation procedure, Endoscopic Ultrasound-direct transgastric ERCP (EDGE) has developed to bypass some of these limitations. EDGE works by creating a gastro-gastric or gastro-jejunal fistula using a lumen-apposing metal stent (LAMS), allowing a standard duodenoscope to reach the bypassed stomach. Clinical data suggests that EDGE and Laparoscopy-assisted ERCP (LA-ERCP) are significantly better than EA-ERCP with technical success rates of 96% and 93%, respectively¹¹. A regional service evaluation from EDGE in the United Kingdom found the technical success rate at the first attempt was 92.8% and 100% clinical success rate¹².

Endoscopic Sphincterotomy and Balloon Dilation

In most cases, ductal clearance is accented by enlarging the biliary orifice. Endoscopic sphincterotomy (EST) is the electrosurgical incision of the biliary sphincter and remains the standard of care for most CBD stones. It provides the ability to remove larger stones and allows for the introduction of other extraction tools (baskets and balloons, etc). While it is a successful procedure, there exists a risk of immediate complications, notably bleeding and perforation, and longer-term concerns about permanent loss of sphincter of Oddi function, subsequently putting the patient at risk for duodenobiliary reflux and recurrent stone formation.

Endoscopic papillary balloon dilation (EPBD) is an alternative or adjunct to EST. EPBD preserves the integrity of the sphincter more than EST and is often used in patients who have coagulopathy or are at risk for bleeding. In patients with large or multiple stones, a combination of limited EST and large-diameter balloon dilation (ESPLBD) is often used to create a larger exit pathway for stones, with a decreased need for mechanical lithotripsy.

Management of Complex and Impacted Stones:

Complex choledocholithiasis—established by large stones (>15 mm) as impacted stones or in difficult positions—requires advanced endoscopic interventions. When standard extraction techniques fail, mechanical lithotripsy is first-line adjunctive therapy but may be limited based on not being able to open the basket around a large stone. If this occurs, cholangioscopy guided lithotripsy with electrohydraulic or laser energy is a targeted approach to fragment the stone while under direct visualization.

Management of these difficult cases typically requires a multidisciplinary perspective. If endoscopic clearance is not achieved, biliary stenting (plastic or metal) can be used as a temporizing option to achieve biliary drainage and prevent cholangitis, while planning a definitive surgical intervention or repeat endoscopic procedure. The transition from «therapeutic-first» to a «diagnostic confirmed» approach is paramount. If an intermediate-risk patient is managed with ERCP without definitive evidence of stone, they are subjected to the procedural risks without any anticipated benefit. In research studies of patients directed to ERCP after a positive intraoperative cholangiogram (IOC), stones persistently remained on ERCP after IOC in only 50.6% of cases; suggesting the initial diagnosis of stones was not verified, or stones passed spontaneously¹³.

General Surgery Management Strategies:

Surgical management of choledocholithiasis has evolved from open exploration to minimally invasive approaches, allowing for definitive treatment of both gallbladder and bile duct stones at the same operative time. Laparoscopic common bile duct exploration (LCBDE) is now a recognized and reasonable alternative to ERCP, especially when performed by surgeons with specific biliary training.

Laparoscopic Common Bile Duct Exploration (LCBDE):

LCBDE can be performed through two main routes: the transcystic approach or through the transcholedochal approach (choledochotomy). The preferred route is determined by the anatomy of the cystic duct, the size of stones, the number of stones, and the diameter of the CBD.

The transcystic approach, whenever possible, is often preferred since it will not create an incision in the CBD, with less risk of biliary stricture and leak. This option is usually most appropriate for stones that are below the cystic-CBD junction and are smaller than the diameter of the cystic duct. The transcystic approach has been greatly expanded by the use of adjuncts like holmium laser lithotripsy (LABEL). Label fragments stones that would be too large for the cystic duct and has been shown to improve the success rate of transcystic extraction from 66.5% to 82.7%¹⁴.

The transcholedochal technique entails a direct incision into the CBD and is generally reserved for larger stones, multiple stones, or stones that are in the proximal ducts. This suggests the frequent use of a choledochoscope to visualize the ductal system to ensure complete clearance. In one study comparing LCBDE and open surgery, the laparoscopic technique had a clearance rate of 98% with an average hospital stay of three days¹⁵.

Open Exploration with T-tube:

While laparoscopic techniques represent the gold standard, and open common bile duct exploration remains a skill necessary in complicated cases or if the laparoscopic approach does not work. Open surgery is also associated with an increased morbidity and lengthier recovery compared to LCBDE. For example, open surgery has been shown to be associated with a 15% morbidity rate, wound infections and ileus being two complications, compared to LCBDE which is roughly 5%¹⁵.

Historically, a cornerstone of CBD exploration was the placement of a T-tube to provide external drainage and a tract for postoperative extraction of stones if necessary. However, the trend in modern surgery is towards primary closure of the CBD or the placement of an internal biliary stent since T-tubes are uncomfortable for patients and could result in complications during removal for both patients and surgeons. Even with these issues, open surgery is still effective for stone clearance, and success rates are in the 96.6% range¹⁵.

Cholecystectomy Timing Relative to Bile Duct Clearance:

The timing of cholecystectomy plays an essential role in managing patients with cholecysto-choledocholithiasis. In the two-stage (sequential) approach, ERCP is performed, followed by laparoscopic cholecystectomy (LC). However, when this two-stage process occurs over time, it may certainly lead to an increase of inflammatory adhesions in Calot’s triangle making the subsequent surgery more difficult and increasing the rate of conversion to open surgery.

Single-stage management, when a LC and LCBDE is performed together, is a possible solution to this problem and it also offers definitive treatment at one anesthetic experience. This one-and-done approach also means patients do not have to endure the physiological stress associated with going under anesthetic multiple times or have a «vulnerable period,» in between the two procedures which the patient might become symptomatic for recurrent biliary symptoms. Clinical pathways designed with emphasis on single-stage LCBDE have shown advantages such as decreased length of stay and overall less anesthesia¹⁶. Single-stage cases in a regional cohort reported a length of stay 3.6 days, however multi-stage cases 8.1 days¹⁷.

Comparative Analysis of Outcomes and Complications:

The choice between endoscopic and surgical approaches is driven by comparison of efficacy of stone clearance, safety of the procedure and use of healthcare resources.

Rates of success and efficacy of stone clearance:

Both ERCP and LCBDE resulted in high rates of ductal clearance. In a large cohort, the laparoendoscopic rendezvous (LERV) technique, a single-stage hybrid approach that involves the surgeon passing a guidewire antegrade to assist the endoscopist, provided a 97% ductal clearance rate, which was slightly better than the 93% success rate in the sequential ERCP group¹⁰. Similarly, LCBDE has demonstrated ductal clearance rates as high as 98.4%. These results suggest that surgical exploration is at least as effective as endoscopy if performed by experienced teams¹⁵.

The success of these techniques also depends on the characteristics of the stones. Although ERCP is highly successful in the majority of stones, LCBDE with adjuncts such as laser (LABEL) has been especially useful for transcystic clearance of larger stones, which would otherwise require choledochotomy¹⁴. Robotic-assisted common bile duct exploration (RACBDE) is an emerging modality. Its pooled stone clearance rate is approximately 95%, suggesting that robotic platforms are at least as effective as laparoscopic procedures, while offering superior visualization and dexterity¹⁸.

Post-procedural complications: pancreatitis versus bile leaks:

The complication profiles of an endoscopic versus surgical approach differ considerably. Pancreatitis (i.e., post-ERCP pancreatitis, PEP) is the most common and most worrisome complication of the endoscopic approach. One comparative analysis demonstrated a PEP rate of 27% in the sequential ERCP group, while the uncomplicated group (LERV) had an operative plan that avoided the trauma related to repeated cannulation attempts using the guidewire and thus had a considerably lower risk of clinically relevant pancreatitis¹⁰.

In contrast, the complications associated with surgical exploration are bile leaks and surgical site infections. The morbidity of LCBDE is reported to be 5% and has primarily been associated with minor bile leaks and missed stones¹⁵. Open surgery is effective at clearing stones, but associated morbidity is higher than LCBDE and reported to be as high as 15%, most often as a result of wounds and pulmonary complications¹⁵. RacBDE (i.e., robotic surgery) decreases some associated risks and has a 34% lower risk of complications compared with open surgery but has a greater operative time¹⁸.

Length of stay, cost-effectiveness, and recovery:

One of the most compelling arguments for single-stage management is the ability to reduce the overall length of hospital stay (LoS). Multi-stage management (ERCP followed by LC) lengthens LoS due to the actual waiting time between each procedure and the total recovery time needed after procedures. Data demonstrates that the average LoS of multi-stage procedures is 8.1 days, while 3.6 days was reported for a single-stage procedure¹⁷. Another paper confirmed this, in which LCBDE had an average length of stay of 3 days versus 8 days for open surgery¹⁵.

The economic consequences are just as meaningful. Although the upfront expense for a single-stage LCBDE or LERV may be relatively greater due to time and equipment utilization, the resultant reduction in total hospital days and avoidance of a second admission or anesthetic event is often reimbursed as a collective result. Consistent with the above, study findings show that LERV is associated with shorter length of stay (p < 0.001) and lower cumulative morbidity (15% vs 30%, p < 0.001) as compared to the sequential approach, which will ultimately contribute to lower total costs for hospital-care delivery when stacked up against the sequential approach¹⁰.

DISCUSSION

The management of choledocholithiasis is evolving toward a personalized medicine model where procedure selection is individualized based on a patient’s clinical status, complexity of stone burden, and medical expertise available at the institution.

The single-stage versus two-stage management discussion remains centered on the duality between procedural specialization and systemic efficiency. The «Two-Hit» model (ERCP then surgical intervention) relies on gastroenterology proceduralists having a high technical success rate but is ultimately a two-system event for the patient, which can be over taxing to elderly and medically complex patients. The single-stage LCBDE or LERV offers a more system-efficient and patient-favorable option while inherently decreasing LoS and number of anesthetic exposures¹⁶.

Though the advantages of single-stage management are evident, it is often underutilized. This is frequently perceived as a result of «learning curve constraints» by general applicable and surgeons with no formal or specialized training. Over the last decade, surgical trainees are ostensibly decreasing in familiarity with LCBDE^16. Implementing a known push toward LCBDE on all choledocholithiasis patients requires a pre-defined stepwise algorithm for decision-making, and evoking further access to an operative theatre’s reprollection of choledochoscopes and laser lithotripsy tools of armor for available to the general surgeon and/or generalizable staff.

Standardization of care delivery in complex biliary disease has the best opportunity for optimal outcomes in complex biliary disease by stratified roles among each respective discipline. An example of an MDT comprised of a surgeon, an endoscopist, and a radiologist, can allow for «truly personalized surgery»¹⁹. In a patient with RYGB, the MDT might come to a decision to arranged EDGE, LA-ERCP, or the most complete surgical exploration based on the patient’s anatomy and the surgeon’s comfort with laparoscopic CBD access^{11, 12}.

The hybrid LERV method epitomizes the ideal merger. The LERV technique brings together the benefits of laparoscopy (gallbladder removal and antegrade wire placement) and endoscopy (retrograde stone extraction) to dilate the risks of both procedures; examples include failed cannulation and difficult CBD incisions¹⁰. This is an apparent movement from competitive paradigms to the collaborative paradigm of the most efficient/safest clearance of the biliary tree.

Though evidence favoring single-stage management is increasing, there are still a number of gaps. Most current literature remains turned towards retrospective studies or non-randomized cohorts and thus open to selection bias. For example, the more complicated cases may be diverted to open surgery or targeted ERCP management, while the simpler cases may be subjected to LCBDE; either of these conditions or combinations could contribute to skewed outcomes.

Still poorly understood is the natural history of incidental CBD stones that are identified intraoperatively. Some evidence suggests that smaller, asymptomatic stones, while they may be in the CBD, have potential to pass spontaneously without intervention¹³. In clinical context where intervention is associated with high risk for biliary intervention, a conservative approach of observation would be reasonable. Still, existing guidelines recommend routine removal. To fully evaluate the lifetime value of one treatment modality over another, we still lack long-term data of stone recurrence and the data and implications of sphincterotomy of the biliary microbiome and future stone formation. The ongoing CREST Choles study (China) aims to contribute to some of these issues by producing real-world, real-time data on adverse outcomes and economic burden associated with different treatment modalities²⁰.

CONCLUSIONS

There has been a movement of managing choledocholithiasis from a one-size-fits-all approach to a developed, sophisticated list of endoscopic and surgical treatment options. Endoscopic treatment, especially ERCP, still represents the overwhelming majority of intervention, but advanced modalities, like EDGE, provide management for patients with complex anatomy. Despite these developments in endoscopic management, the implications of post-procedural pancreatitis are significant and the need for several procedures when taking the sequential approach, is an obvious and undesirable component of the model.

Laparoscopic common bile duct exploration and the hybrid laparoendoscopic rendezvous provide compelling merits as single-stage options. Both modalities have consistently demonstrated higher, or equivalent, stone clearance rates, significantly decreased length of stay and host of overall morbidity, if compared to the sequential two-stage approach. Moreover, the inclusion of technology, such as holmium laser lithotripsy or a robotic platform has only strengthened surgical management.

In the end, the decision on the strategy of management should rest with a multidisciplinary team, and when local expertise is available, to utilize single-stage options where feasible, to optimize patient safety and resource use. Future research should include with care of further risk score stratification for incidental stones and the safety to be found in the surgical CBD exploration expertise gap to expand greater access to hi value, single-stage pathways.

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