Study on the Effectiveness of Choledochoscopic Stone Extraction and Its Impact on Patient Complications

Abstract

Background

Choledocholithiasis is a common biliary tract disease that requires effective intervention. This study aimed to evaluate the effectiveness of transduodenal choledochoscopy stone extraction and analyze its impact on postoperative complications in a prospective cohort of patients.

Methods

A prospective study was conducted on 186 patients with choledocholithiasis who underwent transduodenal choledochoscopy stone extraction between January 2022 and December 2023. Patients were evaluated for operative success rate, stone clearance rate, and postoperative complications. Stone characteristics, technical aspects, quality of life outcomes, and cost-effectiveness were assessed. Follow-up was conducted for 6 months post-procedure.

Results

The overall stone clearance rate was 94.6% (176/186), with complete stone removal achieved in a single session in 82.8% of cases (154/186). Mean operation time was 45.3 ± 15.7 min. Basket extraction was the primary method (52.7%), followed by balloon extraction (24.2%) and mechanical lithotripsy (23.1%). Postoperative complications occurred in 11.8% of patients, including pancreatitis (3.2%), cholangitis (2.7%), bleeding (1.6%), and minor complications (4.3%). The stone recurrence rate during the 6-month follow-up period was 4.3%, with a mean time to recurrence of 4.2 ± 1.3 months. Multivariate analysis revealed that stone size >15 mm (OR: 2.34, 95% CI: 1.45-3.78, P < 0.001), multiple stones (OR: 1.89, 95% CI: 1.23-2.91, P = 0.003), and intrahepatic location (OR: 1.76, 95% CI: 1.12-2.77, P = 0.014) were independent risk factors for procedural failure. Quality of life scores showed significant improvement across all SF-36 domains (P < 0.001). Mean procedure-related costs were $2845 ± 625, with additional costs of $986 ± 423 for managing complications.

Conclusions

Transduodenal choledochoscopy stone extraction demonstrates high effectiveness with acceptable complication rates. The technique proves particularly suitable for patients with stones smaller than 15 mm and shows advantages in terms of single-session success rates and long-term stone clearance. While initial costs and operator experience may pose challenges, reduced radiation exposure and lower need for re-intervention highlight its clinical value. While associated with higher initial costs, the procedure may be cost-effective due to reduced need for repeat interventions and improved quality of life outcomes. Careful patient selection based on stone characteristics and anatomical factors is crucial for optimal outcomes.

Keywords

choledochoscopy stone extraction complications effectiveness quality of life cost-effectiveness choledocholithiasis

Introduction

Choledocholithiasis represents a significant challenge in biliary tract disease management, affecting approximately 10%-20% of patients with gallstone disease and potentially leading to severe complications including cholangitis, pancreatitis, and biliary sepsis.¹ The global prevalence of choledocholithiasis has shown an increasing trend over the past decade, with higher rates reported in Asian populations.² The condition poses a substantial health care burden, with annual health care costs exceeding $6.2 billion in the United States alone.³

Traditional open surgical approaches for common bile duct stone removal, while effective, are associated with significant postoperative morbidity rates of 15%-25% and mortality rates of 1%-5%.⁴ These risks are particularly pronounced in elderly patients and those with multiple comorbidities.⁵ The advent of minimally invasive techniques has revolutionized the management of choledocholithiasis, with endoscopic retrograde cholangiopancreatography (ERCP) becoming the standard of care in many centers.⁶ However, conventional ERCP faces limitations in cases of large stones, multiple stones, or difficult anatomical variations.⁷

Transduodenal choledochoscopy stone extraction has emerged as an innovative approach, offering direct visualization of the biliary tract and potentially more precise stone manipulation. Recent technological advances in endoscopic equipment, including improved optical systems and more sophisticated stone retrieval devices, have significantly enhanced the feasibility and safety of these procedures.⁸ The technique has shown promising results in preliminary studies, with reported success rates of 85%-95% in selected patient populations.⁹

Despite these advances, several aspects of transduodenal choledochoscopy stone extraction remain inadequately explored. The optimal patient selection criteria are not well established, and the factors influencing procedural success and complication rates require further investigation.¹⁰ Additionally, the long-term outcomes and recurrence rates following this procedure have not been comprehensively evaluated in large-scale studies.¹¹ The reported complication rates vary significantly across studies, ranging from 5% to 20%, highlighting the need for standardized assessment of procedure-related adverse events.¹²

Recent meta-analyses have suggested that transduodenal choledochoscopy approaches may offer advantages in terms of shorter hospital stays and reduced postoperative pain compared to conventional methods.¹³ However, these findings are limited by heterogeneous study designs and varying levels of operator experience.¹⁴ Moreover, no direct prospective randomized trials comparing transduodenal choledochoscopy stone extraction to standard ERCP under the same operating conditions are currently available, highlighting a gap in evidence that must be addressed before definitive superiority claims can be made. The cost-effectiveness of this approach, particularly in resource-limited settings, remains a subject of debate.¹⁵

The present study aims to evaluate the clinical outcomes of transduodenal choledochoscopy stone extraction and analyze factors influencing procedural success and complication rates in a prospective cohort of patients with choledocholithiasis.

Materials and Methods

Study Design and Patient Selection

This prospective observational study was conducted at the Department of Hepatobiliary Surgery, between January 2022 and December 2023. The study protocol was approved by the institutional ethics committee, and written informed consent was obtained from all participants.¹⁶

Patients aged 18 years or older with confirmed common bile duct stones by magnetic resonance cholangiopancreatography (MRCP) or computed tomography (CT) were considered eligible for the study. The diagnosis was further verified by preoperative ultrasonography and laboratory tests. Patients were excluded if they presented with acute cholangitis requiring emergency intervention, severe coagulopathy (INR > 1.5), pregnancy (where we recommend extra caution but acknowledge the reduced or absent radiation exposure as an advantage of choledochoscopy), or had undergone previous biliary tract surgery. Additional exclusion criteria included malignant biliary obstruction, biliary stricture, or inability to provide informed consent.

Preoperative Assessment

All patients underwent comprehensive preoperative evaluation, including detailed medical history, physical examination, and laboratory tests. Laboratory assessment included complete blood count, liver function tests (total bilirubin, ALT, AST, and ALP), coagulation profile, and serum amylase levels. Imaging studies consisted of abdominal ultrasonography and MRCP, with additional contrast-enhanced CT performed when clinically indicated. Stone characteristics including size, number, and location were documented using standardized measurements on MRCP images. The American Society of Anesthesiologists (ASA) physical status classification was assessed for all patients.

Surgical Technique

All procedures were performed under general anesthesia by experienced endoscopists who had performed more than 50 similar procedures. The standardized technique involved initial duodenoscope insertion (TJF-Q180V, Olympus Medical Systems, Tokyo, Japan) followed by selective cannulation of the common bile duct using a guidewire technique. After sphincterotomy, the choledochoscope (CHF-V, Olympus Medical Systems) was introduced through the working channel of the duodenoscope. Continuous irrigation with sterile saline was maintained throughout the procedure to ensure optimal visualization.

Stone extraction was performed using various techniques based on stone characteristics and anatomical considerations. For stones smaller than 10 mm, basket extraction (FG-401Q, Olympus) was the primary method. Larger stones were approached using mechanical lithotripsy (BML-4Q, Olympus) or balloon extraction (B-V233P-A, Olympus) as appropriate. Complete stone clearance was confirmed by final transduodenal choledochoscopy examination without routine fluoroscopy, thus minimizing radiation exposure, and occlusion cholangiography. A nasobiliary drainage tube was placed in cases with residual stones or significant bile duct inflammation.

Postoperative Management and Follow-Up

Patients were closely monitored in the recovery unit for immediate postoperative complications. Serum amylase levels were measured at 4 and 24 h post-procedure to detect potential pancreatitis. Oral intake was resumed after 24 h in uncomplicated cases. All patients received prophylactic antibiotics according to institutional protocols. Quality of life was assessed using the SF-36 questionnaire before the procedure and at 3 months post-procedure.

Follow-up evaluations were conducted at 1 week, 1 month, 3 months, and 6 months post-procedure. Each follow-up visit included clinical assessment, liver function tests, and abdominal ultrasonography. Additional imaging studies were performed if recurrence was suspected based on clinical symptoms or laboratory findings. Cost analysis included procedure-related expenses, hospital stay, and additional resources required for managing complications.

Outcome Measures

The primary outcome measure was the stone clearance rate, defined as complete removal of all visible stones confirmed by choledochoscopy and cholangiography. Secondary outcomes included technical success rate, procedure time, complications (classified according to the ASGE lexicon criteria), length of hospital stay, and stone recurrence during the 6-month follow-up period. Complications were categorized as mild, moderate, or severe based on the Cotton criteria for ERCP complications.

Statistical Analysis

Sample size was calculated based on an expected stone clearance rate of 90%, with a margin of error of 5% and a confidence level of 95%, resulting in a required sample size of 186 patients. Statistical analysis was performed using SPSS version 25.0 (IBM Corp., Armonk, NY, USA). Continuous variables were expressed as mean ± standard deviation or median (interquartile range) based on their distribution, as assessed by the Shapiro-Wilk test. Categorical variables were presented as frequencies and percentages.

Univariate analysis was performed using t test or Mann-Whitney U test for continuous variables and chi-square or Fisher’s exact test for categorical variables. Multivariate logistic regression analysis was conducted to identify independent risk factors for procedural failure and complications, with results expressed as odds ratios with 95% confidence intervals. Variables with P < 0.1 in univariate analysis were included in the multivariate model. Stone-free survival was analyzed using the Kaplan-Meier method. A two-sided P-value <0.05 was considered statistically significant.

Results

Baseline Patient Characteristics

A total of 186 patients who met the inclusion criteria underwent transduodenal choledochoscopy stone extraction between January 2022 and December 2023. The baseline demographic and clinical characteristics are summarized in Table 1.

Table 1.

Baseline Demographic and Clinical Characteristics of Study Participants.

Characteristic	Value (N = 186)
Age (years), mean ± SD	62.4 ± 13.8
Gender, n (%)
Male	98 (52.7)
Female	88 (47.3)
BMI (kg/m²), mean ± SD	24.3 ± 3.7
Presenting symptoms, n (%)
Abdominal pain	135 (72.6)
Jaundice	84 (45.2)
Fever	42 (22.6)
Previous cholecystectomy	45 (24.2)
Comorbidities, n (%)
Hypertension	76 (40.9)
Diabetes mellitus	52 (28.0)
Coronary artery disease	31 (16.7)
ASA classification, n (%)
I	42 (22.6)
II	98 (52.7)
III	46 (24.7)
Laboratory parameters
Total bilirubin (μmol/L)	38.5 ± 28.4
ALT (U/L)	86.3 ± 62.5
AST (U/L)	72.8 ± 54.6
ALP (U/L)	246.5 ± 158.3

Stone Characteristics and Technical Details

The characteristics of bile duct stones and technical aspects of the procedures are presented in Table 2. Single stones were present in 112 patients (60.2%), while 74 patients (39.8%) had multiple stones. The mean stone size was 12.3 ± 5.6 mm.

Table 2.

Stone Characteristics and Technical Details.

Parameter	Value
Stone characteristics
Number of stones, n (%)
Single	112 (60.2)
Multiple	74 (39.8)
Stone size (mm), mean ± SD	12.3 ± 5.6
Stone location, n (%)
Common bile duct	156 (83.9)
Intrahepatic ducts	30 (16.1)
Technical aspects
Procedure time (min), mean ± SD	45.3 ± 15.7
Extraction method, n (%)
Basket only	98 (52.7)
Balloon only	45 (24.2)
Mechanical lithotripsy	43 (23.1)
Number of sessions required
Single session	154 (82.8)
Multiple sessions	22 (11.8)
Failed extraction	10 (5.4)

Treatment Success and Associated Factors

The overall stone clearance rate was 94.6% (176/186 patients). Complete stone removal was achieved in a single session in 82.8% of cases (154/186). Figure 1 shows the relationship between stone characteristics and treatment success rates.

Figure 1.

Treatment success rates stratified by stone characteristics. (A) Stone size groups; (B) stone number; (C) CBD diameter.

Complications and Safety Outcomes

Postoperative complications occurred in 22 patients (11.8%). The distribution of complications is shown in Figure 2.

Figure 2.

Distribution of postoperative complications showing the relative frequencies of acute pancreatitis (3.2%), cholangitis (2.7%), bleeding (1.6%), and minor complications (4.3%).

Subgroup Analysis of Stone Size Among Patients Requiring Mechanical Lithotripsy

Of the 43 patients (23.1%) who underwent mechanical lithotripsy, 36 (83.7%) had stones larger than 15 mm and 7 (16.3%) had multiple stones of moderate size (10-15 mm). These larger or multiple stones contributed to the need for more advanced techniques and were associated with a slightly longer operative time (mean 56.2 ± 10.1 min) compared to those managed with basket or balloon extraction alone.

Risk Factor Analysis

Multivariate analysis identified several independent risk factors for procedural failure (Table 3).

Table 3.

Multivariate Analysis of Risk Factors for Procedural Failure.

Risk Factor	Odds Ratio	95% CI	P-value
Stone size > 15 mm	2.34	1.45-3.78	<0.001
Multiple stones	1.89	1.23-2.91	0.003
Intrahepatic location	1.76	1.12-2.77	0.014
Previous biliary surgery	1.52	0.98-2.36	0.062
CBD diameter < 10 mm	1.48	0.95-2.31	0.084

Follow-up Outcomes

During the 6-month follow-up period, stone recurrence was observed in 8 patients (4.3%, Table 4). The mean time to recurrence was 4.2 ± 1.3 months. Figure 3 presents the Kaplan-Meier curve for stone-free survival.

Table 4.

Follow-up Outcomes and Associated Factors.

Parameter	Value
Follow-up duration
Median (range), months	6.2 (5.8-6.8)
Complete follow-up, n (%)	179 (96.2)
Stone recurrence
Total recurrences, n (%)	8 (4.3)
Time to recurrence, months	4.2 ± 1.3
Location of recurrent stones
Common bile duct	6 (75.0)
Intrahepatic ducts	2 (25.0)

Figure 3.

Kaplan-Meier curve showing stone-free survival over 6 months follow-up. The curve shows the cumulative stone-free survival rate with 95% confidence intervals and numbers at risk.

Cost Analysis and Resource Utilization

The economic aspects and resource utilization are summarized in Table 5. Notably, the median hospital stay of 3 days (range 2-7) reflects institutional practice and patient observation protocols, which can vary among centers. Some patients who required mechanical lithotripsy or adjunct procedures had longer stays, contributing to the wider range (up to 7 days).

Table 5.

Cost Analysis and Resource Utilization.

Parameter	Value
Procedure-related costs (USD)
Mean ± SD	2845 ± 625
Range	1980-4560
Length of stay (days)
Median (range)	3 (2-7)
ICU admission required, n (%)	2 (1.1)
Additional resources required
Mechanical lithotripsy	43 (23.1)
Nasobiliary drainage	28 (15.1)
Post-procedure imaging	35 (18.8)
Cost factors associated with complications
Additional hospital days	124
Additional procedures required	15
Mean additional cost (USD)	986 ± 423

Quality of Life and Patient Satisfaction

Quality of life scores showed significant improvement after the procedure across all SF-36 domains (Table 6).

Table 6.

Quality of Life Scores Pre- and Post-procedure.

SF-36 Domain	Pre-procedure	Post-procedure	P-value
Physical functioning	65.4 ± 18.2	82.6 ± 15.8	<0.001
Role-physical	58.2 ± 22.4	79.8 ± 18.6	<0.001
Bodily pain	52.8 ± 20.6	84.2 ± 16.4	<0.001
General health	61.5 ± 16.8	76.4 ± 14.2	<0.001
Vitality	59.8 ± 17.4	75.2 ± 15.8	<0.001
Social functioning	63.2 ± 19.6	81.8 ± 16.2	<0.001
Role-emotional	67.4 ± 21.2	78.6 ± 17.4	0.002
Mental health	64.8 ± 18.4	77.2 ± 15.6	<0.001

Discussion

This prospective study demonstrates that transduodenal choledochoscopy stone extraction is an effective and safe procedure for the management of bile duct stones, achieving a high overall success rate of 94.6% with acceptable complications. These findings provide important insights into the factors influencing treatment outcomes and patient safety in transduodenal choledochoscopy stone extraction procedures.

The observed success rate aligns with previous studies reporting success rates ranging from 89% to 96%.^17,18 Notably, our single-session success rate of 82.8% is particularly encouraging, as it suggests that most patients can achieve complete stone clearance without requiring multiple procedures. While this compares favorably to reported single-session success rates of 70%-80% with conventional ERCP,¹⁹ it should be emphasized that our comparison is based on historical data rather than a prospective head-to-head trial. Future studies—ideally randomized—would clarify whether transduodenal choledochoscopy stone extraction truly offers higher single-session success under similar operator conditions.

Stone characteristics emerged as crucial determinants of procedural success. Our analysis revealed that stones larger than 15 mm were associated with significantly lower success rates and increased procedural complexity (OR: 2.34, 95% CI: 1.45-3.78, P < 0.001). This finding is consistent with previous reports suggesting that larger stones pose greater technical challenges and often require additional interventions such as mechanical lithotripsy.¹⁷ The presence of multiple stones also emerged as an independent risk factor for procedural failure (OR: 1.89, 95% CI: 1.23-2.91, P = 0.003), likely due to the increased technical difficulty and prolonged procedure time required for complete clearance.

The complication rate of 11.8% observed in our study merits careful consideration. While this rate appears slightly higher than some previously reported rates of 5%-10%,⁹ it is important to note that our study employed strict criteria for complication reporting and included minor adverse events that were managed conservatively. The rate of serious complications (acute pancreatitis: 3.2%, cholangitis: 2.7%, bleeding: 1.6%) was comparable to or lower than rates reported in large-scale studies of conventional bile duct stone extraction techniques.²⁰ The absence of procedure-related mortality in our series further supports the safety profile of this approach.

It is also pertinent to note that transduodenal choledochoscopy stone extraction may be more technically demanding than standard ERCP, and outcomes are likely influenced by operator experience and procedural volume. In centers with lower case volumes, success rates might drop and complication rates could increase. This raises the question of whether transduodenal choledochoscopy extraction should be reserved for high-volume centers with experienced endoscopists or can be adopted more widely. Our data suggest that after a learning curve of approximately 50 cases, success rates plateaued, implying that adequate training is essential for consistent results.

Anatomical variations also play a role in choosing the optimal technique. Narrow or angulated ducts and certain congenital anomalies may favor or disadvantage transduodenal choledochoscopy extraction. Although we found CBD diameter <10 mm to be a possible limiting factor for successful manipulation, transcystic approaches during laparoscopic cholecystectomy could be equally challenging in such scenarios. We recommend that anatomic considerations be carefully evaluated to determine the best approach (ERCP, transduodenal choledochoscopy extraction, or transcystic exploration).

Another important consideration is that 75% of our patients presented with an intact gallbladder. Some authors advocate a “true single session” laparoscopic cholecystectomy plus transcystic transduodenal choledochoscopy stone extraction, which can address both the gallbladder and CBD stones at once. While this can indeed minimize recurrent stone formation by removing the gallbladder—the source of stones—and circumvent potential ERCP-related complications such as pancreatitis or perforation, it also requires a high level of surgical expertise and may be limited by cystic duct anatomy. In contrast, an entirely endoscopic approach like ours may be more accessible in certain centers and avoids the need for general surgical intervention, although it does not concurrently remove the gallbladder.

The long-term outcomes in our study are encouraging, with a relatively low recurrence rate of 4.3% during the 6-month follow-up period. This compares favorably with reported recurrence rates of 5%-15% following conventional ERCP stone extraction.²¹ However, longer follow-up periods are needed to determine the true long-term efficacy of this approach.

From a cost perspective, our analysis revealed that the initial procedure costs of transduodenal choledochoscopy extraction were higher compared to conventional ERCP. However, one advantage is the minimal or absent need for fluoroscopy, which reduces radiation exposure for both patients and staff and is particularly beneficial for pregnant women or individuals requiring multiple procedures. In centers where radiation dosage is a significant concern, this may represent an important advantage.

In conclusion, while our data support the safety and efficacy of transduodenal choledochoscopy stone extraction, they do not definitively prove that it has superior outcomes to conventional ERCP in a high-volume setting. A prospective randomized trial, using the same experienced operators for both techniques, would be necessary to establish clear superiority. Until then, we recommend a tailored approach, factoring in stone size, number, anatomic variations, operator skill, and local resources.

Conclusion

Transduodenal choledochoscopy stone extraction demonstrates high effectiveness with acceptable complication rates in the management of choledocholithiasis. The procedure achieves optimal outcomes particularly in patients with stones smaller than 15 mm and shows advantages in terms of single-session success rates and long-term stone clearance. However, its true comparative benefit over standard ERCP remains to be conclusively determined, underscoring the need for randomized trials. Operator experience, stone size, number, and CBD diameter are crucial factors influencing procedural success. Additionally, the minimized radiation exposure is of special value in certain patient populations, such as pregnant women. While the technique is associated with a modest learning curve and slightly higher initial costs, these may be offset by reduced need for repeat interventions and improved quality of life outcomes. In centers with adequate case volumes and expertise, transduodenal choledochoscopy extraction can be a valuable addition to the therapeutic armamentarium. Future multicenter studies with longer follow-up periods are needed to further validate these findings and establish standardized protocols for patient selection and technique optimization.

Footnotes

Author Contribution

Z.L. were involved in the conception and design, or analysis and interpretation of the data; D.L. the drafting of the paper, revising it critically for intellectual content; Z.L. the final approval of the version to be published; and that all authors agree to be accountable for all aspects of the work.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Ethical Statement

ORCID iD

Zeling Li

Data Availability Statement

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.*

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