Gallstone disease is one of the most frequent biliary diseases leading to hospitalization and imposing a significant financial burden. The worldwide prevalence of gallstones presents a rising tendency due to the change of dietary structure and routine living customs in recent years[1,2]. Of the patients who suffered from gallstones, approximately 10%-15% were found to have synchronous common bile duct (CBD) stones[3,4]. The clinical manifestations of CBD stones are varied from biliary colic to a combination of complications, such as acute pancreatitis or cholangitis; sometimes, CBD stones even may be asymptomatic[5]. Treatment and management of CBD stones have changed considerably during the last three decades. With the popularization of minimally invasive surgery in clinical practice, endoscopic retrograde cholangiopan-creatography (ERCP) is currently recognized as a standard therapy for patients with CBD stones[6,7]. Despite this, a risk of complications after ERCP cannot be avoided, and it is even associated with increased morbidity and mortality[8]. In addition, there is evidence showing that in some patients with gallstones received ERCP and routine care at first admission, re-admission and longer preoperative stay were caused[9]. Due to the growing complexity of CBD stone treatments and care, it is crucial to develop a standardized multidisciplinary approach to avoid chaotic management of this disease.

A clinical pathway (CP) is an advanced medical diagnosis, treatment, and management mode, which may optimize medical treatment by facilitating clinical assessments, improving utilization efficiency of medical sources, and reducing economical expenses[10-12]. Nowadays, a CP is thought to be an effective tool to be explicit about the sequencing, timing and provision of interventions in clinical practice and can guide physicians and nursing staff in providing evidence-based results[13,14]. Moreover, analysis of evaluating indexes (including clinical outcome, efficiency indicators, financial indicators, and antibiotic use indicators) can guarantee the effectiveness of the CP implementation and optimization[15,16]. One study has demonstrated that a CP presents sustainable effects in gallstone-related care, resulting in shorter length of hospital stay (LOHS) and lower hospital expenses[9]. In addition, several studies conducted in other surgical domains also presented similar results[17-19]. However, implementation of the CP in China is in its start-up stage, especially in the field of hepatobiliary surgery. The status and value of the CP in the management of patients with CBD stones after ERCP remain to be explored. Given this concern, a retrospective study based on a big-data, intelligence database platform was launched. The aim of the present study was to analyze the impact of a CP on LOHS, readmission, treatment outcomes, hospital costs, and postoperative complication rate in patients with CBD stones undergoing ERCP.

Two thousand six hundred and sixty-three eligible patients were included finally, of whom 467 were in the non-pathway group and 2196 in the clinical-pathway group (Figure 1). Table 1 shows the comparison of demographic and clinical characteristics between the patients who received routine care and CP care. There were no differences between the two groups in terms of age, gender, insured status, health behaviors, or maximum diameter of stones. The percentage of patients with multiple stones was found to be significantly different between the two groups (P < 0.001). The number of patients suffering from comorbidities was similar, although the percentage of patients with cholangitis was higher in the non-pathway group (P = 0.041). Although WBC counts in both groups were within the normal range, there was a significantly higher WBC count among the patients in the non-pathway group (P = 0.005).

Table 2 presents the outcomes of efficiency, treatment, hospital costs, and antibiotic use following the CP implementation. The median total LOHS was 8 (range, 6-11) d in the non-pathway group, while it was one day shorter (7, 5-9) in the CP group (P < 0.001). The pre-operative LOHS was found to be similar between the two groups. There were no significant changes with respect to the treatment outcomes (recovered, improved, not improved, and died) in both groups, and even no patients died in our study. Thirty-four (7.28%) patients in the non-pathway group required readmission to hospital, while readmission rate (173, 7.88%) was increased after pathway complementation, although this difference was not statistically significant (P = 0.661). A considerably decreasing trend in the costs was observed among patients with the CP implementation, including hospitalization, medication, operation, nursing, materials, and preoperative examination (P < 0.001). In addition, implementation of the CP was associated with a reduced proportion of antibiotic use (P < 0.001). The median time of antibiotic use [11 (7.0-17.0) d] in the CP group was one day shorter than that before the CP complementation [12 (8.0-18.5) d] (P = 0.004). For patients in the CP group, secondary procedure occurred more frequently, although this difference was not statistically significant (16.94 vs 14.78%, P = 0.253).

The postoperative complication rates are compared in Table 3. About 26.77% of patients with routine care had at least one complication, while the incidence of complications dropped to 14.39% after the CP complementation (P < 0.001). The incidence rates of acute pancreatitis and liver abscess were considerably lower in patients after CP implementation, with significant differences between the two groups (P < 0.001).

The effect of the CP complementation on each outcome was also assessed by univariate and multivariate logistic regression through controlling age, gender, smoking and drinking habits, the number of stones, and WBC count at hospital admission (Tables 4 and 5). After adjusting for differences between the two groups, antibiotic use and postoperative complications were less in patients with the CP complementation [odds ratio (OR) = 0.72, 95% confidence interval (CI) 0.55-0.93, P = 0.012; and OR = 0.44, 95%CI 0.33-0.59, P < 0.001, respectively]. The costs of hospitalization, operation, nursing, medication, and materials (P < 0.001 for all) and LOHS (P < 0.001) decreased significantly after implementation of the CP.

Despite wide adoption of CPs throughout different departments currently, their evaluation and optimization remain doubtful[20]. The purpose of this study was to compare the indicators of CP implementation in five domains (clinical outcome, efficiency indicators, financial indicators, and antibiotic use indicators) for patients with CBD stones undergoing ERCP. Our results confirmed that pathway implementation in CBD stones was associated with reduced total LOHS, costs, antibiotic use, antibiotic use duration, and complication rate. More importantly, the decrease has not been achieved at the expense of increased readmission rate or mortality.

With the development of endoscopic technique, ERCP is considered a preferred therapeutic method in management of CBD stones. However, it can be still challenging in some cases, such as high total hospital expenses and high risk of post-ERCP complications[21,22]. CP, one of the main modes to standardize treatment and care, is increasingly adopted by hospitals to strive to better outcomes and lower costs. However, the definition of CP has not yet been fully elucidated in clinical practice, and the impact of pathway complementation is varied by different factors and conditions[23,24]. Findings of our study are consistent with those obtained by Kristin et al who demonstrated a considerable reduction in terms of costs and LOHS in patients with complicated gallstone disease after the CP implementation[9]. More recent studies showed similar improvements in other specialties of diseases, such as acute pancreatitis[25], breast cancer[15], and chronic obstructive pulmonary disease[26]. However, pre-operative length of stay showed no distinct disparity in our study, and the implementation of pathway might have greater impact on postoperative hospital stay. Similar to our results in terms of antibiotic use, Dona et al[27] reported that there was a reduction of antibiotic prescriptions in patients with community-acquired pneumonia after introducing a CP. Our study provided further evidence that the CP implementation can also significantly reduce the duration of antibiotic use and three-line antibiotic prescriptions. Thus, it is possible to conclude that a marked reduction of costs appears to be associated with several factors, such as effective pre-operative examination and rational use of medications and materials. Moreover, CP seems to be one of key approaches to maximize cost-effectiveness, while without sacrificing good treatment outcomes[28]. The most common causes of dropout from CP were postoperative complications that needed additional treatment. The findings of the present study demonstrated that rates of complications were lower in patients operated upon admission who implemented the CP compared to patients receiving routine care. There have been multiple previous publications in various domains which have demonstrated the lower incidence of complications following critical pathways[29-31]. However, critical factors may have affected outcomes, such as patients’ characteristics, living habits, disease features, and individual laboratory measurements. Thus, these factors did not affect the findings that CP use achieved a significantly shorter LOHS, lower costs, and reduced complications after adjustments.

Large-scale populations with gallstones and data process and application platform utilization are the main strengths in the present study. Furthermore, the findings were demonstrated by adjusting the potential confounders. However, this study was limited by its single-center retrospective design, indicating that further multiple-center trials with larger variable are in need to confirm the results.

In conclusion, findings of our study have demonstrated that patients with CBD stones who accepted the CP appear to be significantly lower in the LOHS, the costs, the rate of antibiotic use, and the incidence of complications. Our study provides further evidence of CP use in Chinese patients and also standardizes gallstone management and treatment.

We sincerely appreciate Yidu Cloud (Beijing) Technology Co. Ltd., China for providing technical support in extracting data by using the big-data intelligence platform.