Abstract
Background and study aims
The management of difficult pancreatobiliary duct stones remains challenging, particularly in patients with large or impacted stones, unfavorable anatomy, or prior failed endoscopic interventions. Peroral cholangioscopy-guided laser lithotripsy has emerged as a promising therapeutic approach; however, real-world data from consecutive single-center experiences are limited. This study aimed to describe the technical feasibility, procedural outcomes, and safety of cholangioscopy-guided laser lithotripsy in patients with difficult pancreatobiliary duct stones.
Patients and methods
This retrospective single-center study included a consecutive series of 16 patients with difficult pancreatobiliary duct stones who underwent peroral cholangioscopy-guided Holmium:YAG laser lithotripsy after unsuccessful conventional endoscopic extraction. Technical success, complete duct clearance, procedural characteristics, and adverse events were analyzed.
Results
Technical success was achieved in all patients (100%; exact 95% CI 79.4–100%), with complete duct clearance obtained in a single session in all cases.The median procedure time was 70 min (IQR 59–85; range 50–130). All patients had undergone prior ERCP attempts, with a median of 2 previous procedures. Adverse events occurred in 3 patients (18.7%) and were all mild, including post-procedural pain (12.5%) and mild post-ERCP pancreatitis (6.2%). No severe complications, such as perforation, clinically significant bleeding, or cholangitis, were observed.
Conclusions
In this small, heterogeneous single-center series, cholangioscopy-guided laser lithotripsy was technically feasible and was associated with complete duct clearance in a single treatment session in all patients, with only mild adverse events observed. These findings provide descriptive data supporting the potential role of this technique in selected patients with difficult pancreatobiliary duct stones, particularly after unsuccessful conventional endoscopic interventions.
Keywords: Cholangioscopy, Laser lithotripsy, ERCP, Difficult pancreatobiliary stones, Single-session duct clearance
Introductıon
Endoscopic retrograde cholangiopancreatography (ERCP) is widely accepted as the primary therapeutic approach for pancreatobiliary duct stones and achieves successful ductal clearance in most patients [1, 2]. Nevertheless, approximately 5%–15% of pancreatobiliary duct stones are categorized as difficult because of factors including large stone burden, multiple calculi, stone impaction, or unfavorable biliary anatomy, which may limit the effectiveness of standard endoscopic techniques such as balloon extraction, basket retrieval, and mechanical lithotripsy [3–6].
Management of these complex stones continues to represent a major therapeutic challenge and frequently necessitates advanced endoscopic approaches. In recent years, peroral cholangioscopy has become an important adjunctive modality to ERCP by enabling direct intraductal visualization and targeted therapeutic interventions [7–9]. Advances in cholangioscopy technology, particularly the development of digital single-operator systems, have improved image resolution, maneuverability, and access to complex biliary anatomy, thereby broadening the therapeutic spectrum for difficult stone disease [10–12].
Among available intraductal lithotripsy techniques, laser lithotripsy provides several potential advantages, including accurate stone fragmentation, minimal surrounding tissue injury, and effectiveness across stones with different sizes and compositions [13–15]. Earlier investigations demonstrated the feasibility of laser lithotripsy for large and complex bile duct stones, while randomized studies suggested improved outcomes compared with extracorporeal shock-wave lithotripsy in selected patient populations [16].In the era of digital single-operator cholangioscopy, Holmium:YAG laser lithotripsy has demonstrated favorable technical and clinical results in both biliary and pancreatic duct stones [17].
Recent multicenter and comparative studies have reported high rates of ductal clearance using cholangioscopy-guided laser lithotripsy [18, 19].However, data reflecting real-world experience from consecutive single-center cohorts remain relatively scarce.
The present study was designed to assess the technical success, clinical outcomes, and safety profile of peroral cholangioscopy-guided laser lithotripsy in consecutive patients with difficult pancreatobiliary duct stones treated at a tertiary referral center.
Methods
Study design and patient selection
This study was designed as a retrospective, single-center case series conducted at a tertiary care university hospital. Consecutive adult patients who underwent peroral cholangioscopy-guided laser lithotripsy for difficult pancreatobiliary stones between January 2025 and June 2025 were included in the analysis.
Difficult stones were defined as stones that could not be completely removed using conventional endoscopic techniques, including standard balloon/basket extraction and/or mechanical lithotripsy. Factors contributing to stone complexity in the present cohort included large stone size, multiple stones, intrahepatic or cystic duct location, pancreatic duct stones, and previous unsuccessful ERCP attempts[20].
The inclusion criteria were: (1) age ≥ 18 years, (2) the presence of difficult pancreatobiliary stones according to the predefined study definition, (3) failure of conventional endoscopic stone extraction techniques, (4) treatment with peroral cholangioscopy-guided laser lithotripsy during the study period, and (5) availability of complete clinical, procedural, and follow-up data. Consecutive eligible patients were included without selection.
Exclusion criteria were pregnancy, uncorrectable coagulopathy, inability to safely undergo ERCP under deep sedation or general anesthesia, and incomplete clinical or procedural data.
Pre-procedural evaluation
All patients underwent standard pre-procedural evaluation, including clinical assessment, laboratory tests, and cross-sectional imaging or magnetic resonance cholangiopancreatography (MRCP) to assess stone characteristics and biliary anatomy.Written informed consent was obtained from all patients prior to the procedure.
Endoscopic procedure
All procedures were performed at a high-volume tertiary referral center with an annual ERCP volume exceeding 500 cases, surpassing the commonly accepted threshold for high-volume centers (> 300 ERCPs/year). Cholangioscopy-guided laser lithotripsy procedures were performed by two expert endoscopists with extensive experience, each having performed over 1,000 ERCP procedures, consistent with previously reported characteristics of experienced ERCP practitioners. All procedures were conducted under deep sedation administered and monitored by an anesthesiologist and the anesthesia team. [21]. Rectal NSAID prophylaxis was selectively administered in patients with pancreatic duct cannulation and was not routinely used in all patients.
After selective biliary cannulation, endoscopic sphincterotomy was performed when indicated. Peroral cholangioscopy was performed using a single-operator digital cholangioscopy system (MicroTech™, Nanjing, China and Leinzett™, Germany). Initially, the MicroTech™ system was available at our institution; subsequently, the Leinzett™ platform was introduced and became the primary cholangioscopy system. Device selection was therefore determined by chronological availability rather than patient characteristics, stone location, stone complexity, or anticipated procedural difficulty. Under direct visualization, laser lithotripsy was carried out using a Holmium laser system.
Holmium laser lithotripsy was performed using a laser platform manufactured by Asclepion Laser Technologies together with a dedicated 365-µm laser fiber. Energy settings ranged between 800 and 1500 mJ, with frequencies varying from 8 to 15 Hz according to stone location and characteristics. In biliary interventions, settings of 12 Hz and 1200–1500 mJ were most commonly applied, while pancreatic duct stones were generally treated using lower frequencies (8–10 Hz) and energy levels of 800–1200 mJ. A green aiming beam enabled precise targeting of the stone under direct endoscopic visualization, and appropriate fiber positioning was verified cholangioscopically or pancreatoscopically. The laser fiber was maintained approximately 1–2 mm away from the stone surface, and pulse delivery was performed within a saline-filled environment using continuous or intermittent irrigation to facilitate effective fragmentation. Lithotripsy was continued until the remaining fragments were sufficiently small, non-obstructive, and readily mobilized by irrigation. Pancreatic duct stents were not used routinely for prophylaxis against post-ERCP pancreatitis. In the present series, pancreatic duct stenting was performed only in the patient undergoing pancreatic duct stone treatment. Biliary stenting was reserved for patients with inadequate biliary contrast drainage.
Outcome measures
The primary outcomes were technical success and clinical success.
Technical success was defined as successful fragmentation of pancreatobiliary duct stones using cholangioscopy-guided laser lithotripsy.
Complete duct clearance was defined as complete clearance of the pancreatobiliary duct, confirmed by cholangiography at the end of the procedure.
Secondary outcomes included procedure duration, number of sessions required and procedure-related adverse events.
Safety assessment
Procedure-related adverse events were recorded and classified according to the American Society for Gastrointestinal Endoscopy (ASGE) lexicon [2]. Post-ERCP pancreatitis, bleeding, cholangitis, abdominal pain, fever and perforation were specifically evaluated. Post-ERCP pancreatitis (PEP) was defined as new-onset or worsening abdominal pain with serum amylase or lipase levels at least three times the upper limit of normal measured more than 24 h after the procedure, requiring hospitalization or prolongation of planned admission. The severity of PEP was graded based on the duration of hospitalization (mild: 2–3 days; moderate: 4–10 days; severe: > 10 days or requiring intensive care). Post-procedural bleeding was defined as clinical evidence of bleeding requiring endoscopic, radiologic, or surgical intervention, blood transfusion, or resulting in a hemoglobin drop of ≥ 2 g/dL. Cholangitis was defined as the presence of fever (> 38 °C), abdominal pain, and/or jaundice with supportive laboratory or imaging findings requiring antibiotic therapy. Fever was defined as a body temperature > 38 °C occurring after the procedure without an alternative source of infection. Abdominal pain was defined as persistent or clinically significant pain requiring analgesics or prolonging hospitalization, in the absence of diagnostic criteria for PEP. Perforation was defined as radiologic or endoscopic evidence of gastrointestinal wall disruption.
Statistical analysis
Descriptive statistical analysis was performed using the Statistical Package for Social Sciences [Version 24 for Mac, IBM Corporation]. Continuous variables were expressed as median and range (minimum–maximum), while categorical variables were presented as frequencies and percentages.
Ethical considerations
The study was conducted in accordance with the Declaration of Helsinki. Approval was obtained from the Marmara university Ethics committee (Approval Number:25–0531).
Results
During the study period, a total of 219 ERCP procedures were performed. Among these, 128 patients underwent ERCP for pancreatobiliary stones. Conventional endoscopic stone extraction was successful in 112 patients, whereas 16 consecutive patients fulfilled the predefined criteria for difficult pancreatobiliary stones and underwent peroral cholangioscopy-guided laser lithotripsy. No eligible patients were excluded because of incomplete clinical or procedural data. The patient selection pathway is shown in Fig. 1.
Fig.1.
Patient selection flow diagram
The median age was 65 years (range 21–81), and 10 patients were male. According to ASA classification, 9 patients were ASA I–II and 7 were ASA III–IV. Eight patients had a history of cholecystectomy. All patients had undergone prior ERCP, with a median of 2 previous procedures, and half had undergone more than three ERCP sessions, reflecting prior unsuccessful endoscopic management. All patients had undergone previous unsuccessful ERCP attempts prior to referral. Conventional endoscopic management generally consisted of endoscopic sphincterotomy followed by balloon and/or basket extraction. In cases where complete stone clearance could not be achieved, temporary biliary stenting was performed, and patients were subsequently referred for cholangioscopy-guided laser lithotripsy. The median common bile duct diameter was 15 mm (range 10–25) (Table 1).
Table 1.
Patient characteristics
| Age, years (median, min–max) | 65 (21–81) |
|---|---|
| Sex, Male/Female | 10/6 |
| ASA score, n (%) | |
| ASA I–II | 9 (56,2%) |
| ASA III–IV | 7 (43,7%) |
| Previous cholecystectomy | 8 |
| Prior ERCP procedure | |
| Median number | 2 |
| 1 | 2 |
| 2 | 6 |
| > 3 | 8 |
| Previous temporary biliary stenting; n (%) | 14 (88%) |
| Common bile duct diameter, mm (median, min–max) | 15 (10–25) |
Regarding stone characteristics, biliary stones had a median size of 15 mm, with a median stone number of 1; multiple stones (> 3) were present in two patients. One patient had pancreatic duct stones with a median size of 6 mm. Stone location within the biliary tree included the common bile duct in 9 patients, central intrahepatic ducts in 5 and the cystic duct in 1 patient. One stone was located in the pancreatic duct head (Table 2). During the study period, two different cholangioscopy systems were utilized without a predefined selection strategy: MicroTech™ (Nanjing, China) in 3 patients and Leinzett™ (Germany) in 13 patients. System-specific descriptive patient characteristics and procedural outcomes are summarized in Table 3. No statistical comparison between the two cholangioscopy systems was performed because of the descriptive nature of the study and the limited sample size.
Table 2.
Stone characteristics and location
| Stone characteristics | |
|---|---|
| Biliary | |
| Stone size, median (range) | 15 mm(10–30 mm) |
| Number of stone | |
| Median number of stone | 1 |
| 1 | 11 |
| 2 | 2 |
| > 3 | 2 |
| Pancreatic | |
| Stone size, median | 6 |
| Number of stone | 1 |
| Stone location | |
| Biliary tree | |
| Common bile duct | 9 |
| Central intrahepatic | 5 |
| Cystic duct | 1 |
| Pancreatic duct | |
| Body | 0 |
| Head | 1 |
Table 3.
System-specific descriptive characteristics and outcomes of patients undergoing cholangioscopy-guided laser lithotripsy
| Leinzett cholangioscopy system (n = 13) | MicroTech cholangioscopy system (n = 3) | |
|---|---|---|
| Age, years; median (range) | 70 (66–72) | 64 (28–81) |
| Sex, Male/Female | 8/5 | 2/1 |
| ASA score, n (%) | ||
| ASA I-II | 8 (61.5%) | 1 (33.3%) |
| ASA III-IV | 5 (38.5%) | 2 (66.7%) |
| Previous cholecystectomy, n (%) | 6 (46.2%) | 2 (66.7%) |
| Prior ERCP procedure; median (range) | 3 (1–4) | 2 (2–3) |
| Common bile duct diameter, mm; median (range) | 15 (10–25) | 15 (13–15) |
| Stone location, n (%) | ||
| CBD | 7 (53.8%) | 2 (66.7%) |
| Intrahepatic duct | 5 (38.5%) | 0 (0%) |
| Cystic duct | 0 (0%) | 1 (33.3%) |
| Pancreatic duct | 1 (7.7%) | 0 (0%) |
| Stone size, mm; median (range) | 15 (5–30) | 15 (13–15) |
| Multiple stones, n (%) | 3 (23.1%) | 1 (33.3%) |
| Technical success, n (%) | 13 (100.0%) | 3 (100.0%) |
| Complete duct clearance, n (%) | 13 (100.0%) | 3 (100.0%) |
| Procedure time, min; median (range) | 70 (50–130) | 75 (60–80) |
| Adverse events, n (%) | 2 (15.4%) | 1 (33.3%) |
| Repeat ERCP durig follow-up, n (%) | 0.0(0%) | 0.0 (0%) |
| Follow-up duration, months; median (range) | 9 (7–11) | 10 (9–11) |
Data are presented as median (range) or n (%), as appropriate. No statistical comparison between cholangioscopy systems was performed because of the descriptive nature of the study and the small sample size
Cholangioscopy-guided laser lithotripsy achieved technical success and complete duct clearance in all 16 patients (100%; exact two-sided 95% CI: 79.4–100%).Notably, all procedures were completed in a single session, without the need for repeat interventions. The median procedure time was 70 min (IQR 59–85; range 50–130). Stent placement was required in 2 of 16 patients: one pancreatic stent for pancreatic duct stones and one biliary stent due to inadequate drainage. Overall complications occurred in 3 patients (18.7%), including post-procedural pain in 2 patients (12.5%) and mild post-ERCP pancreatitis in 1 patient (6.2%). Two patients experienced post-procedural abdominal pain. Neither patient fulfilled the diagnostic criteria for post-ERCP pancreatitis according to the Cotton criteria. Serum amylase levels were normal in one patient and remained below three times the upper limit of normal in the other. Neither patient required prolonged hospitalization. No cases of bleeding, cholangitis, or fever were observed (Table 4).
Table 4.
Clinical and Technical Outcomes of Laser Lithotripsy
| Technical success, n (%) | 16 (100%) |
|---|---|
| Complete duct clearance, n (%) | 16 (100%) |
| Procedure time, min (median, min–max) | 70 (IQR 59–85) |
| Number of session, n (%) | |
| Single session | 16 |
| > 1 session | 0 |
| Complication rate, n (%) | |
| Overall | 3 (18.7%) |
| Fever | 0 (0.0%) |
| Pain | 2 (12.5%) |
| Post-ERCP pancreatitis | 1 (6.2%) |
| Bleeding | 0 (0.0%) |
| Cholangitis | 0 (0.0%) |
| Repeat ERCP during follow-up | 0 |
| Follow-up duration,months; median(range) | 9 (7–11) |
Follow-up data were available for all patients. During a median follow-up period of 9 months, no recurrent pancreatobiliary duct stones requiring repeat ERCP or additional stone-directed intervention were observed.
Discussion
The treatment of difficult biliary stones continues to be a demanding area of therapeutic endoscopy, particularly in patients presenting with large calculi, impacted stones, altered anatomy, or previous unsuccessful ERCP procedures [3–6]. In the current series, peroral cholangioscopy-guided laser lithotripsy achieved technical success in all patients, with complete duct clearance obtained during a single treatment session in all cases. The consistently high single-session clearance rate observed in our cohort represents one of the most notable findings of this study. However, direct comparisons with previously published studies should be interpreted cautiously given differences in patient selection, study design, and the limited sample size of the present series [19, 22–24]. Our findings are consistent with the expanding body of evidence suggesting that cholangioscopy-assisted intraductal lithotripsy may represent a useful therapeutic option for selected patients with complex biliary stone disease, particularly when standard extraction methods are unsuccessful [1, 3].
Previous studies evaluating cholangioscopy-guided laser lithotripsy have generally demonstrated favorable efficacy outcomes. In the randomized study conducted by Buxbaum et al., cholangioscopy-guided laser lithotripsy produced higher endoscopic clearance rates than conventional treatment strategies for large bile duct stones, although procedure duration was longer [19].Similarly, data from large multicenter registries have shown high overall and single-session duct clearance rates following cholangioscopy-guided lithotripsy [23, 25]. Additional reports from both single-center and multicenter experiences have also confirmed high technical success and acceptable safety profiles in patients with difficult biliary stones refractory to standard endoscopic treatment [18, 26, 27]. Current ESGE and ASGE guidelines recommend endoscopic sphincterotomy combined with endoscopic papillary large-balloon dilation (EPLBD) as an effective first-line strategy for the management of large and difficult common bile duct stones [1, 3]. Despite these recommendations, complete stone extraction may remain challenging in a subset of patients because of factors such as large stone burden, unfavorable stone location, intrahepatic extension, or previous unsuccessful endoscopic interventions. In such cases, cholangioscopy-guided laser lithotripsy serves as an important adjunctive or rescue technique that may facilitate complete duct clearance when conventional methods are unsuccessful.
Procedural efficiency remains an important consideration in advanced biliary interventions. In our cohort, the median procedure duration was 70 min, which is comparable to durations reported in recent studies involving single-operator cholangioscopy-guided lithotripsy [14, 17, 27]. Notably, complete duct clearance was achieved in all patients during the initial treatment session. Compared with pooled evidence from previous studies, the procedural outcomes observed in our cohort fall within the range of published experience and suggest that favorable results may be achievable in selected patients [24, 28]. Several factors may potentially have contributed to these outcomes, including direct endoscopic visualization, precise laser targeting, and management within a high-volume tertiary referral center by experienced endoscopists. Importantly, complete duct clearance was achieved without major complications in this cohort.
The safety outcomes in the present study were also encouraging. All adverse events were mild in severity, and no major complications such as perforation, clinically significant bleeding, or cholangitis were encountered. These observations are in agreement with previously published studies reporting relatively low rates of severe adverse events associated with cholangioscopy-guided laser lithotripsy. In multicenter cohorts and systematic reviews, overall complication rates have generally ranged between 5 and 10%, with most events described as mild and self-limited [18, 24, 26]. Post-ERCP pancreatitis and transient abdominal pain remain among the most frequently described complications in the literature, consistent with our experience [26–28]. The absence of severe adverse events in this small series is reassuring and is consistent with previously published reports from experienced centers.
Earlier studies investigating laser systems demonstrated effective fragmentation of large and difficult bile duct stones and suggested improved clearance efficiency compared with older extracorporeal techniques [13, 14, 16]. More recently, the systematic review by Amaral et al. reported higher median duct clearance rates with laser lithotripsy than with electrohydraulic lithotripsy [22]. Likewise, the meta-analysis by McCarty et al. confirmed that peroral cholangioscopy-guided intraductal lithotripsy is both highly effective and safe, while comparative randomized studies have suggested that single-operator cholangioscopy-guided lithotripsy performs at least comparably to large-balloon-based strategies in difficult bile duct stones [24, 28]. Previous comparative studies have suggested potential procedural advantages of laser lithotripsy over electrohydraulic lithotripsy. However, the present study was not designed to compare different lithotripsy modalities, and no conclusions regarding comparative effectiveness can be drawn from our data. Accordingly, the present findings should be interpreted as descriptive real-world clinical outcomes associated with cholangioscopy-guided laser lithotripsy.
From a clinical perspective, achieving complete duct clearance within a single session is highly valuable because repeated ERCP procedures are associated with greater healthcare utilization, cumulative complication risk, and increased patient burden. Furthermore, ERCP-related adverse events are not uncommon, and each additional intervention may contribute incremental risk [29]. Current guidelines therefore emphasize the importance of complete duct clearance during the initial session whenever possible [3]. Consequently, therapeutic approaches that may reduce the need for repeated interventions may offer potential clinical and economic advantages. In the present series, no patient required repeat ERCP or additional stone-directed intervention during a median follow-up period of 9 months. Although the follow-up duration was limited, these findings suggest that durable duct clearance may be achievable following cholangioscopy-guided laser lithotripsy in appropriately selected patients.
Overall, our findings suggest that cholangioscopy-guided laser lithotripsy may represent a feasible minimally invasive treatment option for selected patients with complex biliary stone disease. In this series, complete duct clearance was achieved in all patients, with only mild adverse events observed.These results are consistent with previous studies reporting high duct clearance rates and favorable safety outcomes for cholangioscopy-guided lithotripsy. The absence of repeat stone-directed interventions during follow-up is encouraging; however, larger prospective comparative studies are warranted to determine whether this approach reduces the need for subsequent procedures while maintaining procedural safety [30].
Limitations
Despite these encouraging results, this study has several limitations. The retrospective design and small sample size limit the generalizability of the findings. Additionally, the absence of a control group precludes direct comparison with other treatment modalities. Although follow-up data were available for all patients, follow-up assessments were not standardized with respect to symptom resolution, biochemical improvement, or imaging findings. Furthermore, the median follow-up duration of 9 months may not be sufficient to fully evaluate long-term stone recurrence. In addition, the observed 100% success rate should be interpreted cautiously given the small sample size, which results in relatively wide confidence intervals around the estimated treatment effect. Nevertheless, our study reflects real-world clinical practice and adds descriptive real-world data to the growing literature on cholangioscopy-guided laser lithotripsy as a rescue approach for difficult pancreatobiliary stones.
Conclusion
In this small, single-center retrospective series, peroral cholangioscopy-guided laser lithotripsy was technically feasible and complete duct clearance was achieved in all patients, with only mild adverse events observed. These findings suggest that cholangioscopy-guided laser lithotripsy may represent a feasible minimally invasive treatment option for selected patients with difficult pancreatobiliary stones following unsuccessful conventional endoscopic interventions. However, given the retrospective design, small sample size, heterogeneous patient population, and absence of a control group, these findings should be interpreted with caution. Larger prospective comparative studies are warranted to confirm these observations and further define the role of cholangioscopy-guided laser lithotripsy in the management of difficult pancreatobiliary stones.
Acknowledgements
Not applicable.
Declaration of generative AI and AI-assisted technologies in the writing process
The manuscript was originally prepared in Turkish and subsequently translated into English using the DeepL Translator (deepl.com/en/translator). To improve linguistic accuracy, readability, grammar, and overall language quality, AI-assisted tools, including ChatGPT (chat.openai.com), were used solely for editorial support. These technologies were applied exclusively for copy-editing purposes and did not contribute to the generation of original scientific content. Following the use of these tools, the author carefully reviewed and revised the manuscript and accepts full responsibility for the integrity and content of the final published version.
Authors’ contributions
Conceptualization: ŞK, MC, Methodology: ŞK, MC,, Formal analysis and investigation: ŞK, MC, Writing—original draft preparation: ŞK, MC, Writing—review and editing: ŞK, MC, Funding acquisition: ŞK, MC, Resources: ŞK, MC, Supervision: ŞK, MC.
All listed authors meet these conditions:
a. Substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; and.
b. Drafting the article or revising it critically for important intellectual content; and.
c. Final approval of the version to be published; and.
d. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding
All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Data availability
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Declarations
Ethics approval and consent to participate
This study was performed in line with the principles of the Declaration of Helsinki, and this study was approved by the Marmara University School of Medicine Clinical Research Ethics Committee (Approval Number:25–0531). Written informed consent was obtained from all participants prior to inclusion in the study.
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.