Efficacy and safety of endoscopic retrograde cholangiopancreatography in the treatment of bile duct stones

Abstract

BACKGROUND

The current surgical treatments for bile duct stones (BDSs) demonstrate suboptimal efficacy, warranting further exploration of superior therapies or improvement of existing surgical protocols.

AIM

To assess the therapeutic efficacy and safety profiles of endoscopic retrograde cholangiopancreatography (ERCP) vs common bile duct exploration (CBDE) in BDS treatment.

METHODS

This study enrolled 103 consecutive patients with BDSs treated at the First People’s Hospital of Changde from January 2024 to January 2025, with 53 patients undergoing ERCP (ERCP group) and 50 receiving conventional CBDE (CBDE group). Comprehensive comparative analyses were conducted across multiple parameters, including clinical efficacy, surgical success rate, safety (bile leakage incidence, surgical site infection, acute pancreatitis, and acute cholangitis), postoperative biochemical markers (total bilirubin and serum amylase), surgery-related metrics (stone removal time, procedure duration, intraoperative blood loss, and hospitalization time), and postoperative recovery indicators (time to intestinal recovery, jaundice resolution, biliary drainage removal, and postoperative activity recovery).

RESULTS

The ERCP group demonstrated markedly superior overall efficacy than the CBDE group, with similar surgical success rates and comparable stone removal durations. Importantly, patients undergoing ERCP experienced fewer complications overall, required less operative time, had minimal intraoperative blood loss, and needed shorter hospitalization periods. Recovery parameters such as bowel function recovery, jaundice resolution, biliary stent removal, and normal activity resumption, were significantly improved in the ERCP group. Both groups demonstrated substantial postoperative reductions in total bilirubin and amylase, with no significant intergroup differences.

CONCLUSION

ERCP demonstrates effectiveness and safety in managing BDSs, thereby providing notable clinical benefits that support its broader implementation in medical practice.

Key Words: Bile duct stones; Endoscopic retrograde cholangiopancreatography; Common bile duct exploration; Efficacy; Safety; Clinical outcomes

Core Tip: The current research assessed the effectiveness and safety of endoscopic retrograde cholangiopancreatography (ERCP) in treating bile duct stones and provided valuable evidence to guide clinical decision-making. We conducted a comprehensive analysis, including therapeutic effectiveness, procedural success rates, patient safety, postoperative biochemical parameters, surgery-related metrics, and recovery outcomes, to compare ERCP with conventional common bile duct exploration, thereby confirming ERCP’s clinical advantages in enhancing clinical outcomes, improving safety and procedural efficiency, and speeding up patient recovery.

INTRODUCTION

Cholelithiasis is a prevalent and high-risk gastrointestinal disorder that correlates with substantial healthcare expenditures, thereby imposing substantial health and financial challenges for patients and healthcare systems[1,2]. This condition includes gallstones and bile duct stones (BDSs), with an estimated global prevalence of 10.0%-15.0% among adults[3]. Based on epidemiological trends, the occurrence of BDSs, especially in older and middle-aged demographics, is increasing[4]. Clinically classified as intrahepatic or extrahepatic, BDSs frequently manifest as aggregated or dispersed calcifications, causing biliary strictures[5]. Without intervention, these stones can induce biliary blockages, repeated cholangitis episodes, and bacterial overgrowth in the biliary ducts, which significantly increases the likelihood of infections[6]. BDSs are challenging to effectively treat because stones often persist, symptoms tend to reappear, and patients predominantly require repeat surgeries[7].

Therapeutic outcomes for BDSs remain suboptimal with current surgical methods, driving the need for continued innovation in clinical management to optimize efficacy and patient safety[8]. Among these, common bile duct exploration (CBDE) is a gold-standard intervention, where surgeons perform an anterior wall incision (open or laparoscopic incision) on the common bile duct to facilitate stone extraction under direct visualization with choledochoscopy or forceps assistance. This method is especially effective for treating challenging intrahepatic and extrahepatic BDSs, circumventing duodenal anatomical barriers[9]. The procedure’s invasiveness and longer recovery period restrict its widespread adoption despite its higher success rate in stone clearance and decreased recurrence[10]. Evidence from a systematic review and meta-analysis revealed that CBDE carries greater risks of retained stones and bile duct leakage postoperatively compared with laparoscopic transcystic techniques[11]. Alternatively, endoscopic retrograde cholangiopancreatography (ERCP) has appeared as a minimally invasive option, utilizing duodenoscopic cannulation of the papilla with contrast-assisted stone localization. After papillary dilation (performed via balloon techniques or endoscopic sphincterotomy), stones are removed using retrieval baskets or balloons, with mechanical lithotripsy applied for larger stones[12]. The procedure’s success in complete stone clearance is operator-dependent and associated with potential adverse events, including infections, bleeding episodes, and pancreatic inflammation, in addition to a significant recurrence rate, despite being less invasive and enabling speedier recovery[13]. Evidence confirms ERCP’s clinical effectiveness and safety for choledocholithiasis while optimizing recovery through reductions in total hospitalization period, preoperative stay duration, and operative time[14]. This study compares CBDE and ERCP in terms of efficacy, surgical success rates, safety, biochemical markers, surgical metrics, and recovery outcomes. The comparative data generated will serve as an important reference for BDS intervention selection.

MATERIALS AND METHODS

Case selection

We retrospectively reviewed data from 103 patients with BDS treated from January 2024 to January 2025, categorized based on treatment approach into CBDE (n = 50) or ERCP (n = 53) groups. A qualified surgical team (minimum 5 years of specialized experience) performed all interventions. Under the Declaration of Helsinki guidelines, all patient data were de-identified to ensure confidentiality. Baseline demographic and clinical parameters demonstrated no significant inter-group differences (P > 0.05), thereby confirming group comparability.

Inclusion and exclusion criteria

Inclusion criteria were BDSs confirmed based on relevant examinations[15]; characteristic clinical manifestations (upper abdominal pain, dyspepsia, or obstructive jaundice); no previous stone interventions; procedure (CBDE or ERCP) eligibility; no outcome-affecting medications (90-day preclusion); complete and reliable clinical records. Exclusion criteria were recurrent biliary stones or biliary malignancies; acute biliary inflammation; chronic peritonitis history; previous major abdominal surgery or significant intra-abdominal adhesions; comorbid cardiopulmonary dysfunction or hematologic diseases; current pregnancy or breastfeeding; psychiatric conditions; complex biliary anatomy (refractory stones/stenoses) or previous biliary procedures.

Intervention methods

CBDE group: CBDE was performed under general anesthesia. An artificial pneumoperitoneum was first established, followed by laparoscopic insertion. The common bile duct was carefully dissected with an electrocoagulation hook. Under direct choledochoscopic visualization, the biliary tract was assessed to accurately localize stones and identify their exact number. After puncturing the duct, bile was aspirated, and choledochotomy was performed for stone removal. Finally, a drainage tube was placed, and the incision was closed with sutures.

ERCP group: After 8 hours of fasting, patients were placed in the left lateral decubitus position and administered with anesthesia. A duodenoscope was introduced orally and advanced to the major duodenal papilla. A contrast catheter was then cannulated into the bile duct, enabling bile aspiration and contrast medium injection. This facilitated detailed biliary and pancreatic ductal anatomy visualization, including the location, size, and number of stones. The optimal intervention (endoscopic sphincterotomy or papillary balloon dilation) was determined based on each patient’s anatomical characteristics. Sphincterotomy was conducted to directly incise the papilla to facilitate stone removal when papillary strictures or impacted stones were present. Conversely, balloon dilation was the technique of choice for patients demonstrating narrow yet relatively patent papillary openings. This technique effectively widens the biliary orifice to permit smooth choledochoscope and retrieval basket insertion. Stones were then fragmented with a mechanical lithotripter and completely extracted using the retrieval basket. A nasobiliary drainage tube was placed. A follow-up cholangiogram was performed on postoperative day 3 to assess for residual stones.

The CBDE and ERCP groups received standard postoperative antibiotic therapy and comprehensive perioperative care. The nursing protocol included preoperative preparation, intraoperative management (including proper patient positioning, intravenous access establishment, and electrocardiograph monitoring under the surgeon’s guidance), as well as postoperative surgical detail documentation, continuous vital sign assessment, and drainage output close monitoring.

Data collection and outcome measures

(1) Efficacy: Treatment efficacy was assessed as cured (complete stone clearance with overall clinical symptom resolution), improved (partial stone removal with symptomatic relief), or ineffective (failure to meet the above criteria or symptom worsening). The total effective rate was calculated as the proportion of patients classified as “cured” or “improved” relative to the total number of cases; (2) Surgical success rate: The success rate of the surgical procedure was documented and compared between the CBDE and ERCP groups; (3) Clinical safety: Adverse events including bile leakage, surgical site infection, acute pancreatitis, and acute cholangitis, were recorded, with incidence rates calculated for each group; (4) Postoperative biochemical markers: Fasting venous blood samples (3 mL) were collected from the antecubital vein preoperatively and 24 hours postoperatively. After centrifugation, serum total bilirubin (TBil) and amylase (AMS) levels were measured using a fully automated three-part hematology analyzer; (5) Surgery-related parameters: Surgical metrics, including stone removal time, operation time, intraoperative blood loss, and hospitalization time, were recorded for both groups; and (6) Postoperative recovery indicators: Recovery outcomes were evaluated by monitoring postoperative intestinal recovery, jaundice resolution, biliary drainage removal, and postoperative activity recovery.

Data anonymization process

To safeguard patient privacy and data security, this study employed a data anonymization protocol with key steps as follows. Before initiating data analysis, all fields that contain personally identifiable information, including names, national identity numbers, and contact details, were systematically eliminated. Medical record numbers were used as encrypted unique identifiers, ensuring traceability while effectively preventing leakage of patient identity information. Throughout the research process, data analyses were conducted exclusively on de-identified datasets, with research personnel granted no access to the original personally identifiable information. All publicly shared data for result publication were aggregated to eliminate any risk of individual identification, thereby ensuring that only research findings and statistical summaries were disclosed. The final research report provides exclusively consolidated statistical outcomes, avoiding the disclosure of detailed information about individual patients.

Statistical analysis

GraphPad Prism version 7.0 and IBM SPSS Statistics version 20.0 was used for all statistical analysis. Categorical variables are expressed as n (%), whereas continuous variables are presented as mean ± SD of the mean. Intergroup comparisons of categorical data employed χ² tests, whereas independent sample t-tests were conducted for continuous variables. Paired t-tests were utilized to assess within-group pre-post differences. Statistical significance was set at a P < 0.05.

RESULTS

Baseline characteristics

No significant differences in terms of baseline characteristics, including age, gender, disease duration, stone diameter, and stone number, were observed between the CBDE and ERCP groups (P > 0.05; Table 1).

Table 1 Baseline characteristics of the common bile duct exploration and endoscopic retrograde cholangiopancreatography groups, n (%).

Category	CBDE group, N = 50	ERCP group, N = 53	χ2/t	P value
Age, years	44.50 ± 9.41	43.25 ± 9.46	0.672	0.503
Gender			0.418	0.518
Male	28 (56.00)	33 (62.26)
Female	22 (44.00)	20 (37.74)
Disease duration, years	3.86 ± 1.44	4.42 ± 1.93	1.662	0.100
Stone diameter, cm	1.87 ± 0.84	1.59 ± 0.68	1.864	0.065
Stone number	3.54 ± 1.16	3.92 ± 1.31	1.555	0.123

CBDE: Common bile duct exploration; ERCP: Endoscopic retrograde cholangiopancreatography.

Treatment efficacy

The total treatment efficacy rate was significantly higher in the ERCP group (94.34%) than in the CBDE group (74.00%, P < 0.05; Table 2).

Table 2 Comparison of clinical efficacy, n (%).

Category	CBDE group, N = 50	ERCP group, N = 53	χ2	P value
Cured	21 (42.00)	28 (52.83)
Improved	16 (32.00)	22 (41.51)
Ineffective	13 (26.00)	3 (5.36)
Total effective rate	37 (74.00)	50 (94.34)	8.783	0.003

CBDE: Common bile duct exploration; ERCP: Endoscopic retrograde cholangiopancreatography.

Surgical success rate and safety

Both groups demonstrated similar surgical success rates (P > 0.05). However, the ERCP group (3.77%) exhibited a significantly lower overall incidence of postoperative complications, including bile leakage, surgical site infection, acute pancreatitis, and acute cholangitis, compared with the CBDE group (16.00%, P < 0.05; Table 3).

Table 3 Surgical success rates and safety, n (%).

Category	CBDE group, N = 50	ERCP group, N = 53	χ2	P value
Surgical success rate	45 (90.00)	50 (94.34)	0.676	0.411
Bile leakage	2 (4.00)	0 (0.00)
Surgical site infection	3 (6.00)	2 (3.77)
Acute pancreatitis	1 (2.00)	0 (0.00)
Acute cholangitis	2 (4.00)	0 (0.00)
Total complications	8 (16.00)	2 (3.77)	4.387	0.036

CBDE: Common bile duct exploration; ERCP: Endoscopic retrograde cholangiopancreatography.

Postoperative biochemical markers

Pre-treatment TBil and AMS levels did not significantly differ between the CBDE and ERCP groups (P > 0.05). After treatment, both groups demonstrated significant reductions in TBil and AMS levels (P < 0.05), although the magnitude of improvement did not significantly differ between them (P > 0.05; Figure 1).

Figure 1 Changes in total bilirubin and amylase levels before and after treatment. A: Total bilirubin levels pre- and post-treatment; B: Amylase levels pre- and post-treatment. TBil: Total bilirubin; AMS: Amylase; CBDE: Common bile duct exploration; ERCP: Endoscopic retrograde cholangiopancreatography. ^cP < 0.001 vs pretreatment values, ^bP < 0.01 vs pretreatment values.

Surgery-related indicators in two groups

We assessed and compared key surgical parameters, including stone removal time, operation time, intraoperative blood loss, and hospitalization time, between the ERCP and CBDE groups. The results revealed that the ERCP group demonstrated a comparable stone removal time (P > 0.05), while exhibiting significantly shorter operation time, reduced intraoperative blood loss, and a decreased hospital stay compared with the CBDE group (P < 0.05; Figure 2).

Figure 2 Surgery-related indicators in two groups. A: Stone removal time; B: Operation time; C: Intraoperative blood loss; D: Hospitalization time. CBDE: Common bile duct exploration; ERCP: Endoscopic retrograde cholangiopancreatography. ^cP < 0.001 vs common bile duct exploration group, ^bP < 0.01 vs common bile duct exploration group.

Postoperative recovery

Postoperative recovery parameters, including time to intestinal recovery, jaundice resolution, biliary drainage removal, and postoperative activity recovery, were evaluated. The ERCP group demonstrated significantly faster recovery across all these measures compared with the CBDE group (P < 0.01; Figure 3).

Figure 3 Postoperative recovery in two groups. A: Intestinal recovery time; B: Time to jaundice resolution; C: Time to biliary drainage removal; D: Time to postoperative activity recovery. CBDE: Common bile duct exploration; ERCP: Endoscopic retrograde cholangiopancreatography. ^cP < 0.001 vs common bile duct exploration group, ^bP < 0.01 vs common bile duct exploration group.

DISCUSSION

The pathogenesis of BDSs is closely associated with age-related physiological changes and dietary habit modifications, which collectively contribute to progressive hepatobiliary function impairment, diminished digestive capacity, and gallbladder function deterioration[16]. Moreover, this condition predisposes patients to biliary stasis, thereby exacerbating cholecystitis development and accelerating lithogenesis[17]. To mitigate disease progression and promote optimal recovery, surgical approach improvement is imperative to enhance therapeutic outcomes while minimizing postoperative complications.

Our comparative analysis revealed markedly superior overall treatment efficacy for ERCP than conventional CBDE, thereby establishing ERCP’s clinical superiority in BDS treatment. During ERCP procedures, three cases experienced initial treatment failure due to varying clinical complexities. The first case involved a 65-year-old male patient presenting with a 4.2 cm impacted calculus and concomitant stricture of the distal common bile duct (luminal diameter < 3 mm). The primary ERCP attempt failed as the mechanical lithotripter basket failed to secure the stone. This patient subsequently underwent successful stone extraction through laparoscopic CBDE. The second case involved a 70-year-old female patient demonstrating intrahepatic bile duct calculi within the left hepatic duct, accompanied by aberrant biliary anatomy characterized by severe ductal angulation and tortuosity. The ERCP procedure was discontinued when cannulation attempts failed to navigate the guidewire into the targeted biliary branch. The patient eventually underwent percutaneous transhepatic cholangial drainage, followed by a second-stage surgery. The third case concerned a 58-year-old male patient with multiple BDSs (maximum diameter of 2.8 cm) and a periampullary duodenal diverticulum. The procedure was temporarily suspended after precut sphincterotomy due to a significant hemorrhage that compromised endoscopic visualization. After successful endoscopic hemostasis, delayed ERCP was successfully performed to complete the treatment.

Subsequently, the ERCP cohort demonstrated a significantly lower incidence of overall complications, including biliary leakage, surgical site infections, acute pancreatitis, and acute cholangitis, underscoring its improved safety profile, whereas both techniques demonstrated comparable surgical success rates. Biochemical marker analysis revealed equivalent efficacy between the two interventions in reducing TBil and AMS levels, thereby confirming their comparable capacity to relieve biliary obstruction and restore pancreatic function. Noteworthily, a decrease in TBil indicates successful biliary obstruction resolution and bile drainage restoration, whereas a decline in AMS indicates a protective effect on the pancreas postoperatively[18]. The observed biochemical normalization reflects distinct decompression mechanisms such as endoscopic stenting in ERCP vs surgical T-tube drainage in CBDE[19].

Notably, ERCP outperforms CBDE in terms of key surgical metrics, including operative time (shorter), intraoperative hemorrhage volume (lower), and postoperative recovery period (reduced), but their stone removal time was comparable. Moreover, patients undergoing ERCP experienced quicker jaundice resolution, earlier gastrointestinal function recovery, lower biliary drainage utilization, and faster functional recovery. This evidence substantiates ERCP’s greater procedural efficiency and safety while confirming its recovery improvement potential. Previous studies corroborate our results, with Li et al[20] revealing ERCP’s advantages in reducing both procedural duration and hospital stay for common BDSs. Likewise, study of Wang et al[21] on pediatric pancreatobiliary disorders revealed superior outcomes with ERCP vs conventional surgery, including reduced complications and accelerated recovery, aligning with our observations. However, long-term follow-up data indicate ERCP’s higher recurrence risk, with a retrospective comparative study reporting 8.9% recurrence vs 2.0% for CBDE over a 4.5-year follow-up period[22]. Zhang et al[23] conducted economic analyses and revealed comparable drug costs and total expenses between approaches, with ERCP demonstrating lower surgical/nursing expenses and CBDE exhibiting advantages in treatment/supply costs, thereby supporting ERCP’s clinical feasibility in BDS management despite its limitations in terms of recurrence.

Several surgical modalities have been assessed for BDS treatment. Thai Binh et al[24] confirmed the safety and effectiveness of percutaneous transhepatic endoscopic holmium laser lithotripsy, particularly in complex cases. Similarly, Wang et al[25] revealed that dual-modality endoscopy (combining duodenoscopy and laparoscopy) outperformed conventional laparotomy in patients with BDS, thereby providing superior efficacy, fewer postoperative complications, accelerated recovery, and mitigated inflammatory responses. Furthermore, Liu et al[26] observed that laparoscopic reoperation for BDSs provided significant clinical advantages over open surgery, including reduced intraoperative blood loss, shorter hospital stays, and lower postoperative analgesic requirements.

This study has limitations. First, the restricted participant pool may introduce potential sampling bias, emphasizing the need for broader subject recruitment in subsequent studies. Second, the absence of long-term follow-up data (e.g., > 5 years) hinders the comparison of the prognostic effects between the two surgical approaches. Furthermore, the economic aspects were not assessed; hence, incorporating cost-effectiveness analyses in subsequent research would provide valuable information about the medical cost profiles of these procedures. Future investigations will focus on addressing these limitations.

CONCLUSION

In conclusion, ERCP demonstrates notable benefits in treating BDSs, which significantly improve clinical outcomes, procedural safety, and surgical efficiency while facilitating postoperative recovery. These results support its widespread adoption in clinical practice.