Published online Jun 27, 2026. doi: 10.4240/wjgs.120524
Revised: March 12, 2026
Accepted: March 25, 2026
Published online: June 27, 2026
Processing time: 116 Days and 0.3 Hours
Management of difficult bile duct stones (DBDS) remains challenging when complete ductal clearance cannot be achieved during the initial endoscopic re
To evaluate outcomes of plastic stents (PS) vs fully covered self-expandable metal stents (cSEMS) after unsuccessful bile duct stone extraction.
This retrospective single-center study included patients who underwent ERCP with PS or cSEMS biliary stent placement between January 2020 and May 2025 due to complex choledocholithiasis following unsuccessful initial ductal clearance. The primary outcome was presence of residual stones at second-look ERCP. Se
Seventy-seven patients were included (47 PS and 30 cSEMS). After PSM, 48 ma
In patients with DBDS and incomplete initial ductal clearance, temporary cSEMS placement achieved higher bile duct clearance and lower reintervention rates compared with PS, without increasing complications. Prospective randomized studies are needed to confirm these findings.
Core Tip: This study compared the clinical efficacy of fully covered self-expandable metal stents and plastic stents in patients with difficult bile duct stones following unsuccessful initial endoscopic retrograde cholangiopancreatography (ERCP). In this retrospective single-center cohort, propensity score matching minimized selection bias and ensured baseline comparability. Residual stone rates at second-look ERCP were lower in the metal stent group. Re-intervention and repeat stenting were also reduced, while complication rates were similar between groups. Multivariate analysis identified metal stent placement as an independent predictor of ductal clearance. Temporary metal stent placement appears safe and clinically beneficial.
- Citation: Balli E, Bilgi Kirmaci M, Shahryar GR, Yilmaz S. Fully covered metal vs plastic stents after failed endoscopic retrograde cholangiopancreatography: Impact on residual stones. World J Gastrointest Surg 2026; 18(6): 120524
- URL: https://www.wjgnet.com/1948-9366/full/v18/i6/120524.htm
- DOI: https://dx.doi.org/10.4240/wjgs.120524
Approximately 10%-20% of patients with gallbladder stones also have concomitant bile duct stones (choledocholithiasis)[1]. In most cases, choledocholithiasis results from the migration of gallbladder stones into the bile ducts[2]. The incidence of choledocholithiasis in patients with gallbladder stones increases with advancing age[3]. Difficult bile duct stones (DBDS) are generally defined as stones larger than 1.5 cm, the presence of three or more stones, intrahepatic stones, or impacted stones[4]. Advanced age, male sex, and Asian ethnicity have also been identified as risk factors, particularly for DBDS[5].
Patients with choledocholithiasis may present with right upper quadrant pain, elevated cholestatic liver enzyme levels, jaundice, or, in severe cases, cholangitis. Magnetic resonance cholangiopancreatography (MRCP) is the most commonly used noninvasive radiologic modality for diagnosis and demonstrates high sensitivity for detecting bile duct stones[6].
Since its first description in 1968, endoscopic retrograde cholangiopancreatography (ERCP) has evolved substantially and is now a cornerstone in the management of choledocholithiasis[7]. ERCP provides both diagnostic evaluation and therapeutic intervention, allowing bile duct stones to be removed through a minimally invasive approach and often avoiding the need for surgery. However, in some centers, particularly for patients with multiple or large bile duct stones, open surgery may still be considered in selected cases[8]. The presence of more than three stones or stones larger than 1.5 cm frequently requires extended sphincterotomy and multiple ERCP sessions to achieve complete ductal clearance[9]. In patients with large, multiple, or endoscopically difficult-to-remove stones, temporary biliary stenting has been reported as an effective strategy to facilitate bile duct clearance[10]. This strategy is typically performed over multiple sessions using plastic stents (PS), which are removed once complete ductal clearance is achieved.
During ERCP, two main types of stents are used: Metal and plastic. Uncovered metal stents, which were used pre
Due to technical limitations, lithotripsy was not available in our center until May 2025. Therefore, both covered metal stents and PS were used for large, irretrievable bile duct stones or in cases with multiple stones when complete ductal clearance could not be achieved during ERCP. This study compares cSEMS and PS in the management of DBDS and tests the hypothesis that cSEMS placement improves bile duct clearance rates while reducing the need for repeated interventions.
This study was approved by the Non-Interventional Clinical Research Ethics Committee of Afyonkarahisar Health Sciences University and was conducted in accordance with the ethical standards of the Declaration of Helsinki.
This study included patients who underwent ERCP for DBDS between January 2020 and May 2025 at the General Surgery Clinic of Afyonkarahisar University of Health Sciences.
Patients in whom bile duct clearance could not be achieved during ERCP, resulting in termination of the procedure with biliary stenting, were included in the study. Based on the type of stent used, patients were divided into two groups: Group P consisting of patients who received PS and group M consisting of patients who received metal stents.
All patients exhibited elevated cholestatic enzyme levels and clinical jaundice on laboratory evaluation. The diagnosis of choledocholithiasis was established preoperatively using computed tomography and MRCP. All patients had either more than three bile duct stones or stones larger than 1.5 cm, and stone extraction could not be achieved despite extensive sphincteroplasty and basket attempts, with bile duct dilation consistent with these findings. Eligible patients were between 18 years and 90 years of age.
Patients were excluded if they had a history of biliary stenting during a prior ERCP, evidence of malignancy associated with choledocholithiasis, a history of choledochotomy with stone extraction, or benign biliary strictures diagnosed during ERCP.
All ERCP procedures were performed by the experienced endoscopy team listed as authors. General anesthesia was administered to all patients, and procedures were performed with patients in the left lateral decubitus position using a side-viewing duodenoscope (Fujinon ED-530XT8; Fujifilm Corporation, Tokyo, Japan).
When complete bile duct clearance could not be achieved using standard ERCP techniques, biliary stenting with either PS or cSEMS was performed. As noted in the Introduction, mechanical lithotripsy was not available in our clinic until May 2025 due to technical limitations. The choice of stent was based on the endoscopist’s preference. In the metal stent group, Micro-Tech biliary fully covered stents [Micro-Tech (Nanjing) Co., Ltd.] with dimensions of 100 mm × 8 mm were used. In the plastic stent group, a Micro-Tech 10 Fr × 10 cm straight biliary plastic stent [Micro-Tech (Nanjing) Co., Ltd.] was used.
Patients were scheduled for a follow-up ERCP 8 weeks after the initial procedure for stent removal. If residual stones were detected during the second ERCP, standard extraction methods (balloon sphincterotomy, basket extraction, etc.) were first attempted. If these methods were unsuccessful, repeat stenting was performed. In the plastic stent group, multiple stents were placed when the common bile duct (CBD) was sufficiently dilated. These patients were then scheduled for another follow-up ERCP in 6-8 weeks. Representative images of the papilla after metal stent placement (Figure 1A) and after metal stent removal (Figure 1B) are shown.
Data on procedure outcomes, as well as patients’ biochemical and demographic characteristics, were collected from the hospital’s electronic medical record system.
To minimize selection bias resulting from the nonrandomized study design, propensity score matching (PSM) was performed. Propensity scores were calculated using a logistic regression model including age, stone size, and stone count as covariates. Patients were matched 1:1 using the nearest-neighbor method without replacement, with a caliper width of 0.2 of the standard deviation of the logit of the propensity score (Figure 2).
Covariate balance before and after matching was assessed using standardized mean differences, with < 0.10 considered indicative of adequate balance. After matching, outcomes were compared using paired statistical tests as appropriate. A P value < 0.05 considered statistically significant.
Multivariate logistic regression analysis was performed to identify independent predictors of residual stone formation. Given the limited number of outcome events, the number of variables included in the multivariate model was restricted to clinically relevant covariates to reduce the risk of overfitting. Effect estimates were reported as ORs with 95%CIs. A two-sided P value < 0.05 was considered statistically significant. Model calibration was assessed using the Hosmer-Lemeshow goodness-of-fit test, and model discrimination was evaluated using the area under the receiver operating characteristic curve.
Normality tests were performed for age and serum amylase levels. Both variables were found not to follow a normal distribution according to the Kolmogorov-Smirnov test. Therefore, the nonparametric Mann-Whitney U test was used to compare age and amylase levels between groups. Categorical variables were analyzed using the χ2 test or Fisher’s exact test, as appropriate. All statistical analyses were performed using IBM SPSS Statistics (version 25; IBM Corp., Armonk, NY, United States).
Between January 2020 and May 2025, 83 patients underwent CBD stenting during ERCP due to incomplete ductal clearance caused by DBDS. Two patients were excluded because of missing hospital records, and four were excluded due to missed follow-up. Ultimately, 77 patients were included in the final analysis.
Of the 77 patients, 47 (61.0%) were assigned to group P (plastic stent) and 30 (39.0%) to group M (metal stent). The mean age was 64.62 years in group P and 69.72 years in group M; this difference was not statistically significant (P = 0.62). In group P, 53.2% of patients were female and 46.8% were male, whereas in group M, 56.7% were female and 43.3% were male, with no statistically significant difference in sex distribution (P = 0.475).
The mean stone size was 1.35 ± 0.88 cm in group P and 1.48 ± 0.89 cm in group M (P = 0.348). Similarly, the mean stone count was 1.85 ± 0.12 in group P and 1.83 ± 0.17 in group M (P = 0.737; Table 1).
| Variable | Group P (n = 47) | Group M (n = 30) | P value | SMD |
| Age (years) | 64.62 ± 2.64 | 69.70 ± 1.58 | 0.620 | 0.62 |
| Gender | 0.475 | |||
| Female | 25 (53.19) | 17 (56.66) | ||
| Male | 22 (46.81) | 13 (43.33) | ||
| Stone size (cm) | 1.35 ± 0.88 | 1.48 ± 0.89 | 0.348 | 0.35 |
| Stone count | 1.85 ± 0.12 | 1.83 ± 0.17 | 0.737 | 0.22 |
After PSM, 24 patients (50.0%) were included in group P and 24 (50.0%) in group M. The mean age was 67.14 years in group P and 68.36 years in group M, with no statistically significant difference (P = 0.58). In group P, 14 patients were female and 10 were male, whereas group M included 15 females and 9 males, with no significant difference in sex distribution (P = 0.625).
The mean stone size was 1.44 ± 0.82 cm in group P and 1.46 ± 0.85 cm in group M (P = 0.835). The mean number of stones was 1.84 ± 0.15 in group P and 1.86 ± 0.14 in group M, with no statistically significant difference between the groups (P = 0.379; Table 2).
| Variable | Group P (n = 24) | Group M (n = 24) | P value | SMD |
| Age (years) | 67.1 ± 7.2 | 68.3 ± 6.9 | 0.582 | 0.09 |
| Gender | 0.625 | |||
| Female | 14 (58.33) | 15 (62.50) | ||
| Male | 10 (41.67) | 9 (37.50) | ||
| Stone size (cm) | 1.44 ± 0.82 | 1.46 ± 0.85 | 0.835 | 0.03 |
| Stone count | 1.84 ± 0.15 | 1.86 ± 0.14 | 0.379 | 0.04 |
Serum amylase levels were measured on the first post-procedural day for all patients. The mean amylase level was 405.17 ± 124.96 U/L in group P and 251.55 ± 73.62 U/L in group M, with no statistically significant difference between the groups (P = 0.303), indicating comparable distributions of amylase levels. Similarly, procedure duration did not differ significantly between the groups (P = 0.705).
Post-ERCP pancreatitis (PEP) was defined as an amylase level ≥ 250 U/L accompanied by epigastric pain. PEP occurred in 4 patients (8.5%) in group P and 2 patients (6.7%) in group M, with no statistically significant difference between the groups (P = 0.462). Procedure-related bleeding was defined as active bleeding following sphincterotomy requiring local epinephrine injection or endoscopic intervention. Bleeding occurred in 2 patients in group P and 1 patient in group M, with no significant difference between the groups (P = 0.665). None of the patients required surgical intervention; all were managed conservatively.
During the second ERCP, performed 8 weeks after the initial procedure, residual stones were observed in 14 patients (29.8%) in group P and 3 patients (10.0%) in group M, a difference that was statistically significant (P = 0.036). Of the 14 patients in group P, 8 required re-stenting with PS, whereas stones in the remaining 6 patients were removed using balloon and basket techniques. In group M, residual stones in all 3 patients were completely cleared during the second ERCP, and no repeat stenting was required. Overall, 8 patients in group P underwent repeat stenting, compared with none in group M; this difference was statistically significant (P = 0.015; Table 3).
Serum amylase levels were measured on the first post-procedural day for all patients. The mean amylase level was 418.23 ± 136.81 U/L in group P and 269 ± 76.12 U/L in group M, with no statistically significant difference between the groups (P = 0.29), indicating comparable distributions of amylase levels. Similarly, procedure duration did not differ significantly between the groups (P = 0.638).
PEP occurred in 1 patient in group P and 1 patient in group M (P = 1), with no significant difference between the groups. Similarly, no significant difference in procedure-related bleeding was observed between the groups (P = 1). Residual stones were detected in 6 patients (25.0%) in group P and 2 patients (8.33%) in group M (P = 0.041). In group P, 5 patients required repeat stenting with PS. In group M, residual stones in both patients were completely cleared during the second ERCP, and no repeat stenting was required. The difference in repeat stenting rates between the two groups was statistically significant (P = 0.020; Table 4).
No perforation occurred in any patient who underwent ERCP. In each group, 1 patient experienced stent migration from the bile duct. The migrated stents in the CBD were successfully removed using balloon and basket techniques, and the procedure was completed without complications.
Using plastic stent placement as the reference category, multivariate logistic regression analysis demonstrated that metal stent placement was independently associated with a reduced risk of residual stones (OR = 0.31, 95%CI: 0.11-0.98, P = 0.039). In addition, increasing stone size was associated with a higher likelihood of residual stones (OR = 1.73, 95%CI: 1.44-3.17, P = 0.041; Table 5). Due to the limited number of outcome events, the number of variables included in the multivariate logistic regression model was restricted to clinically relevant factors to reduce the risk of overfitting.
| Variable | OR | 95%CI | P value |
| Metal stent | 0.31 | 0.11-0.98 | 0.039 |
| Stone size | 1.73 | 1.44-3.17 | 0.041 |
Since the advent of ERCP and the introduction of biliary sphincterotomy in 1974, the treatment of bile duct stones has shifted from open surgical exploration to minimally invasive endoscopic interventions[14]. Despite advances in technology, approximately 15% of patients have bile duct stones that cannot be removed using standard ERCP tools, such as baskets and balloons[15]. In such cases, three management strategies are generally considered: Referral for open or laparoscopic bile duct surgery, mechanical lithotripsy to fragment the stones, or biliary stenting to maintain bile flow. In our clinic, stenting was the primary approach until May 2025, when mechanical lithotripsy became available.
The literature reports that for retained or non-extractable bile duct stones, either multiple PS or fully cSEMS have been used as therapeutic strategies[16-18]. In our study, no significant differences were observed between the two groups in terms of age or sex distribution. Female patients predominated in both groups, consistent with previous reports[19].
PEP is the most common complication associated with ERCP, with incidence rates reported as high as 13% in Asian populations[20]. In the present study, no significant differences in pancreatitis rates were observed between the groups. A multicenter study from Türkiye, which included our clinic, reported similar findings[21]. Kato et al[22] also reported that the absence of sphincterotomy was associated with a higher rate of post-procedural pancreatitis in patients who underwent stent placement.
During the second ERCP session, residual stones were observed in 6 patients (25.0%) in the PS group and 2 patients (8.33%) in the cSEMS group. We believe this difference may be explained by the mechanisms of cSEMS. Fully cSEMS provide temporary biliary drainage while exerting continuous outward radial force along the bile duct wall, which may contribute to progressive stone fragmentation and ductal remodeling. This sustained expansion can gradually increase the luminal diameter of the CBD, facilitating mechanical compression of stones against the duct wall and promoting microfragmentation. In addition, persistent radial pressure may induce biliary remodeling by reducing local edema and improving ductal compliance, thereby enhancing stone mobilization. Another potential mechanism is the papillary dilation effect, as prolonged stent expansion across the papilla may lead to functional widening of the papillary orifice, allowing spontaneous passage of smaller fragments into the duodenum. In contrast, PS exert limited and nonuniform radial pressure, which may explain their lower efficacy in achieving complete ductal clearance in DBDS.
A study by Hartery et al[18] reported bile duct clearance in up to 82% of patients treated with metal stents. Similarly, another study using cSEMS for complex bile duct stones reported a clearance rate of 83%[23]. In a recent study by Grande et al[24] evaluating difficult biliary stones, cSEMS placement achieved a 54% clearance rate. In our study, the bile duct clearance rate was 90% among patients who received cSEMS during ERCP. We attribute this higher rate to leaving the stents in place for at least 6 weeks and selecting patients with relatively smaller stones.
In our cohort, repeat stenting was required in 5 patients (16.7%) in the PS group, whereas no patients in the cSEMS group required a second stent. Previous studies have reported that stenting achieves successful bile duct clearance in approximately 70% of cases, which is consistent with our findings[25]. In the PS group, repeat stenting was required due to residual stones or insufficient stone size reduction, and multiple stents were placed during the second procedure. Metal stents not only contribute to stone size reduction but also widen the papilla of Vater, facilitating the spontaneous passage of small or fragmented stones into the duodenum. The absence of reintervention in the metal stent group may offer advantages in terms of patient comfort and healthcare costs.
Although comparative studies have evaluated multiple PS vs cSEMS for benign biliary and pancreatic duct strictures[26,27], comparative data on their use in complex choledocholithiasis remain limited.
In multivariate analysis, cSEMS use was independently associated with a lower risk of residual stones (OR = 0.28, 95%CI: 0.09-0.88; P = 0.029). This difference persisted after PSM, indicating that the observed benefit was not attributable to baseline imbalances.
Given the goal of minimizing the number of procedures per patient, cSEMS may represent a viable option for the management of complex choledocholithiasis. However, prospective randomized trials are needed to establish their role as a first-line treatment. Although fully covered metal stents incur higher initial costs than PS, the reduced need for repeat ERCP procedures observed in our study may offset this expense. Avoiding additional interventions may lower cumulative procedural costs, reduce anesthesia exposure, shorten the overall treatment duration, and improve patient convenience. Therefore, from a broader healthcare utilization perspective, cSEMS placement may represent a cost-effective strategy in selected patients with DBDS—a hypothesis that warrants confirmation in formal cost-analysis studies.
This study has several limitations. First, its retrospective, single-center design may limit the generalizability of the findings and introduce potential selection bias, despite the use of PSM to balance baseline characteristics. Second, the relatively small sample size resulted in a limited statistical power (approximately 36%), which may increase the risk of type II error. Therefore, the findings should be interpreted with caution and validated in larger prospective studies. Third, stent type selection was based on endoscopist preference rather than random allocation, which may have introduced treatment allocation bias. Although PSM was performed to minimize confounding, residual confounding cannot be entirely excluded. Furthermore, the lack of data on patient comorbidities and bile duct diameters represent additional limitations. Additionally, mechanical lithotripsy was not available at our center during the study period, which many limit the applicability of our findings to centers where lithotripsy is routinely performed. Finally, long-term outcomes, including late stone recurrence, stent-related late complications, and cost-effectiveness, were not evaluated and therefore warrant further investigation in prospective, randomized, multicenter studies.
Stenting is a commonly used approach for the management of DBDS. To minimize the number of invasive procedures per patient, cSEMS may represent an effective treatment option. In centers without access to mechanical lithotripsy, metal stents may be particularly advantageous. However, further prospective, randomized studies are needed to establish the role of cSEMS as a first-line treatment for DBDS.
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