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The risk factors affecting effect of extracorporeal shock wave lithotripsy for pancreatic duct stones

BMC Gastroenterology volume 25, Article number: 333 (2025) Cite this article

Abstract

Objectives

This study aimed to investigate the factors affecting effect of extracorporeal shock wave lithotripsy (ESWL) for pancreatic duct stones.

Materials and methods

The data of 160 patients who underwent ESWL for pancreatic duct stones in Department of Gastroenterology, First People’s Hospital of Hangzhou, Westlake University School of Medicine, from July 2017 to June 2023, were retrospectively analyzed. The age and sex of the patients were recorded. All patients underwent spiral computed tomography (CT) abdominal plain scan. The placement of the pancreatic duct stent was recorded. The maximum CT value of stones was manually measured. The regions of interest (ROI) was delineated using ITK-SNAP software, and the stone volume was recorded. According to the size of residual stones after lithotripsy, 99 patients were included in the complete lithotripsy group (CL Group) and 61 patients in the incomplete lithotripsy group (ICL Group). SPSS 26.0 software was used for processing and analysis. A P value < 0.05 was considered statistically significant.

Results

The Sex, maximum CT value, and volume of pancreatic duct stones were statistically significant in both groups. Binary logistic regression analysis showed that female sex, maximum CT value, and volume of pancreatic duct stones were independent risk factors affecting incomplete ESWL fragmentation in pancreatic duct stones. ICL group had a higher mean number of treatments and mean number of impacts than CL group.

Conclusion

The Sex, maximum CT value, and volume of stones were related to the therapeutic effect of ESWL. Female sex, maximum CT value, and volume of stones were independent risk factors affecting incomplete stone fragmentation.

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Introduction

Chronic pancreatitis (CP) is a long-term progressive recurrent inflammatory disorder that causes irreversible damage to the pancreatic parenchyma and ductal system [1], leading to pain and internal and external secretory insufficiency [2]. The incidence and prevalence of CP are low, approximately 4 and 42 per 100,000 [3], pancreatic duct stones occur in 50% of patients with CP, which increase over time, reaching up to 100% within 14 years after onset [4]. The incidence is higher in men than in women [5,6,7], possibly because alcoholism is the most common cause of CP [8]. Men are more likely to develop alcoholic pancreatitis than women. A total of 1124 of 1486 patients with CP were found to have pancreatic duct stones in a large-sample study, of which 69.1% were men, andthe risk of pancreatic stone occurrence was significantly higher in patients with an older age at the onset of CP and patients with smoking history. Higher BMI, history of DM, pancreatic pseudocyst, biliary stricture, and severe acute pancreatitis before the diagnosis of CP are protective factors for pancreatic stones development [9].

Pancreatic duct stones are mainly composed of calcium carbonate and protein, and 95% of stones are radiopaque. Radiolucent stones are typically composed of microprotein plugs and have a very soft texture.,they can usually be removed directly via endoscopy without the need for ESWL treatment. When pancreatic duct stones could not be treated by traditional means, including pancreatic sphincterotomy, pancreatic duct stent, and so forth [10], the advent of extracorporeal shock wave lithotripsy (ESWL) provides the possibility of treatment [11]. ESWL is the use of shock wave energy principles to perform lithotripsy [12]. ESWL is indicated for large radiopaque obstructive stones (> 5 mm) present in the main pancreatic duct in the head and body of the pancreas. It fragments the stones (≤ 3 mm) so that the stones are self-excluded after ESWL. Endoscopic retrograde cholangiopancreatography (ERCP) stone extraction is performed for stones that fail to self-exclude or are associated with pancreatic duct stenosis. The 2018 European Society of Gastrointestinal Endoscopy guidelines recommend the use of ESWL to remove radiopaque stones or stones greater than 5 mm in diameter in the main pancreatic duct and ERCP to treat radiolucent stones or stones less than 5 mm [13]. The effect of ESWL on pancreatic duct stones has been clinically recognized with the increasing maturity of lithotripsy techniques. The present study mainly explored the related factors affecting the effect of ESWL on pancreatic duct stones.

Materials and methods

Data collection

Medical records of patients who underwent ESWL for pancreatic duct stones in the Department of Gastroenterology, the First People’s Hospital of Hangzhou, from July 2017 to June 2023, were retrospectively analyzed. All patients underwent spiral CT abdominal plain scan. This study was approved by the Institutional Review Board(IRB) (approved number: IIT-20240117–0016-01) and was conducted in accordance with the guidelines of the Declaration of Helsinki (1989 revision). All data were fully anonymized and the IRB waived the requirement for informed consent.

Study design and patients

The data of 176 patients with pancreatic duct stones who received ESWL were collected (Fig. 1). Among them, 12 patients did not undergo abdominal computed tomography (CT) plain scan before ESWL, 2 patients had incomplete records of ESWL surgery, and one patient had a history of pancreatic surgery. One patient had negative calculus. Finally, the data of 160 patients were included for retrospective analysis. The patients were divided into two groups: the complete lithotripsy group (CL Group, n = 99) and the incomplete lithotripsy group (ICL Group, n = 61). Complete lithotripsy was defined as stones less than 3 mm in diameter after lithotripsy, and incomplete lithotripsy was defined as stones more than 3 mm in diameter after lithotripsy [14, 15]. The inclusion criteria were as follows: (1) preoperative and postoperative abdominal CT scan conducted, to accurate localization of the target stone (2) stone diameter ≥ 5 mm, and (3) radiopaque stones, (4) stones located in the head and neck of the pancreas. The exclusion criteria were as follows: (1) incomplete ESWL surgery record, (2) history of pancreatic surgery, and (3) target stones not determined.

Fig. 1
figure 1

Patients with pancreatic duct stones who received extracorporeal shock wave lithotripsy from 2017–2023

Full size image

Equipment and methods

CT

Abdominal CT plain scan (including upper abdominal CT plain scan and whole abdominal CT plain scan) was performed using a lightspeed 16-slice spiral CT (GE Healthcare, Waukesha, WI, USA). The scanning range included the whole pancreatic tissue. All patients underwent breath-holding training before scanning. The scanning parameters were as follows: 120 kV, 250 mA, slice thickness 5 mm, interslice distance 5 mm, pitch 1.375:1, and field of view 200 cm.

ESWL treatment

German Dornier Delta II lithotripter was used, which integrated the C-arm system and other designs to ensure that the shock wave and imaging system move around a single point for x-ray localization and accurate calibration of the shock wave focus. The patient was placed in the left oblique decubitus position; grade 4–6 (14–16 kV) was selected for energy grade, and 0.4–0.6 mJ/mm2 was selected for focal energy during treatment at a frequency of 90 beats/min. During the operation, the stone morphology was observed, and the treatment was terminated if the stone shadow disappeared or the number of single ESWL shock waves reached 6000. Fasting was performed within 24 h after ESWL treatment, and vital signs and serum amylase were monitored. According to the treatment effect, whether there are complications and the severity of complications, the next treatment plan is proposed. For patients who did not respond well to one lithotripsy, ESWL was performed again, and the interval between the two lithotripsy sessions was not less than 24 h. After lithotripsy treatment, pancreatic CT scan was reexamined to evaluate the lithotripsy effect. According to the patient’s pancreatic duct lithotripsy, stone extractor and balloon were selected. If the stone was not removed or there was main pancreatic duct stenosis, pancreatic duct stent was implanted for drainage.

Measurement index

CT values

All patients underwent spiral CT abdominal plain scanning before surgery. The CT plain scan images were observed at the image archiving and communication system (PACS) workstation. By adjusting the window width and window level, the CT value was manually measured layer by layer, and the maximum of the entire stone was recorded.

Volume

The volume was analyzed using the ITK-SNAP analysis software. The original images were imported into ITK. The regions of interest (ROI) of target stone was continuously manually delineated on a two-dimensional cross-section by two radiologists (with 10 and 14 years of experience in imaging, respectively), after which the ROI images were saved, and the volume of the stone was recorded (Fig. 2).

Fig. 2
figure 2

The volume of pancreatic duct stones was analyzed using the ITK-SNAP analysis software

Full size image

Statistical analysis

The data of this study were processed and analyzed using Statistical Package for Social Science (SPSS) 26.0 software. Measurement data were expressed as mean ± standard deviation, and an independent variance t test was performed for comparison between the groups. The enumeration data were expressed as n (%), and the chi-square test was performed for comparison between the groups. The multivariate analysis was performed with binary logistic for independent risk factors of incomplete fragmentation of pancreatic duct stones by ESWL. P value < 0.05 was considered statistically significant in which continuous variables were grouped by the median.

Results

All 160 patients underwent ESWL for pancreatic duct stones, including 96(60%) male and 64(40%) female, aged 10–81 years, with a mean age of 49.63 ± 14.74 years, were eligible for this study. Among them, 99 patients received ESWL treatment once, 51 patients received it twice, 7 patients received it three times, 2 patients received it four times, and 1 patient received it five times, resulting in a total of 235 ESWL sessions. The mean maximum CT value was 1178.59 ± 416.22 HU, the plain stone volume was 989.31 ± 1220.56 mm3, and 50 patients had pancreatic duct stent implantation before ESWL.

Statistical differences were found in sex, maximum CT value, and volume between the two groups. No statistical significance was found in age and pancreatic duct stent implantation. The maximum CT value and volume of the incomplete lithotripsy group were higher than those of the complete lithotripsy group, and the incidence of incomplete lithotripsy in women (31/64) was higher than that in men (30/96), as shown in Table 1.

Table 1 Demographic and clinical data of 160 patients
Full size table

CT images of pancreatic duct stones before and after ESWL

Both groups of patients with pancreatic duct stones of approximately similar size, location, and shape underwent ESWL. The preoperative and postoperative CT images are shown in Fig. 3. The red arrows are target stones.

Fig. 3
figure 3

Incomplete lithotripsy group: A preoperative CT; B postoperative CT. Complete lithotripsy group: C preoperative CT; D postoperative CT

Full size image

Analysis of independent risk factors affecting incomplete lithotripsy after ESWL for pancreatic duct stones

Binary logistic regression analysis was performed with patient’s age, sex, stone volume, maximum stone CT value, and preoperative pancreatic duct stent placement as independent variables and complete lithotripsy as dependent variable (complete lithotripsy, 0 group; incomplete lithotripsy, 1 group). The stone volume and maximum CT value were grouped in median digits: CT value ≥ 1241.5 HU in 1 group and CT value < 1241.5 HU in 0 group; volume ≥ 807.1 mm3 in 1 group and volume < 807.1 mm3 in 0 group. The results showed that age and preoperative pancreatic duct stent implantation were not risk factors for incomplete lithotripsy of pancreatic duct stones. However, sex, stone volume, and maximum CT value of stones were independent risk factors affecting the incomplete ESWL of pancreatic duct stones, with an odds ratio (OR) of about 2.359, 3.915, and 3.273, respectively, as shown in Table 2.

Table 2 Analysis of independent risk factors affecting incomplete lithotripsy after ESWL for pancreatic duct stones
Full size table

Comparison of ESWL treatment times and impact times between the two groups of patients with pancreatic duct stones

In the complete lithotripsy group, the number of ESWL treatments was one complete lithotripsy. In the incomplete lithotripsy group, 51 lithotripsies were performed twice, 7 lithotripsies were performed 3 times, 2 lithotripsies were performed 4 times, and 1 lithotripsy was performed 5 times (2.23 times on average). The mean number of impacts in the incomplete lithotripsy group was significantly higher than that in the complete lithotripsy group. Significant differences were found in ESWL treatment times and impact times between the two groups (P < 0.05), as shown in Table 3.

Table 3 Comparison of ESWL treatment times and impact times between the two groups
Full size table

Discussion

In this study, 160 CP patients with pancreatic duct stones were studied by retrospective analysis. The results showed that sex, maximum CT value, and volume of stones were related to the therapeutic effect of ESWL. Female sex, maximum CT value, and volume of stones were independent risk factors affecting incomplete stone fragmentation. Moreover, the mean number of treatments and mean number of impacts were also statistically significant between the two groups.

Pancreatic duct stones usually obstruct the main pancreatic duct and increase intraductal pressure, which in turn causes abdominal pain in patients [16]. It affects patients’ quality of life and has an increased risk of pancreatic cancer. ESWL is a relatively safe operation with few complications, including bleeding, perforation, infection, pancreatitis, and steinstrasse, with the most common being post-operative acute pancreatitis [17,18,19,20]. In a study involving 634 patients with chronic pancreatitis who underwent 1470 sessions of ESWL, the overall complication rate was 6.73%, with post-operative acute pancreatitis occurring in 4.35% of cases. In our study, 11 patients (6.8%) experienced post-operative complications, including 7 cases (4.4%) of pancreatitis, 3 cases (1.9%) of infection, and 1 case (0.6%) of bleeding. The primary reason for these complications may be related to the loss of part of the energy as the shock waves pass through the conduction pathway before reaching the target stone. Additionally, the movement of the pancreas with respiration can prevent the shock wave generator from delivering all its energy to the target stone, leading to injury to adjacent organs. In a systematic review and meta-analysis, 3868 patients treated with ESWL resulted in 86.3% complete stone fragmentation, 69.8% complete stone clearance (more than 90% stone clearance), and 64.2% complete pain freedom [18]. Although ESWL is effective for stone clearance and rupture, recurrent stones may develop after long-term follow-up, in a follow-up study, the mid-term follow-up group (2–5 years after the first ESWL surgery) showed a stone recurrence rate of 14.01% (51/364), while the long-term follow-up group (more than 5 years) had a recurrence rate of 22.8% (62/272). During this follow-up, most patients who experienced complete pain relief did not have stone recurrence [21]. Although many studies have reported on the CT value in ESWL of urinary calculi, studies on pancreatic duct calculi are few. According to the literature, only two scholars used the CT value to predict the effect of ESWL on pancreatic duct calculi [22, 23]. Their study found that the mean CT value was < 375.4 HU or < 820.5 HU, which can better remove stones. The present study investigated the relationship between the maximum CT value of stones and the ESWL effect of pancreatic duct stones. The maximum CT value was not affected as it was relatively objective and unique when measured, and hence more accurate. The results showed that the mean maximum CT value of the complete lithotripsy group was lower than that of the incomplete lithotripsy group. The binary logistic regression analysis was performed to further verify that the maximum CT value could predict the ESWL treatment effect. The analysis showed that age and preoperative pancreatic duct stent implantation were not risk factors for complete lithotripsy of pancreatic duct stones, while female sex, maximum CT value, and volume of stones were independent risk factors affecting the incomplete ESWL of pancreatic duct stones. Pancreatic duct stones with higher CT values typically indicate greater density, hardness, and higher calcium content. ESWL generates stress within the stones through shock waves, causing crack propagation and eventual fragmentation. Harder stones require greater stress to initiate cracks, and the crack propagation speed is slower. Stones with high CT values usually have higher calcium content, and calcium salts (such as calcium oxalate and calcium phosphate) have high density. When shock wave energy is absorbed by these calcium salts, the effective stress within the stone is reduced, making it difficult to reach the stress level required for fragmentation. High-density stones absorb more shock wave energy, leading to reduced energy transfer efficiency and uneven stress distribution within the stone. Shock waves attenuate more rapidly as they pass through the stone, making it difficult to achieve sufficient stress concentration inside the stone. These characteristics make such stones more challenging to fragment during ESWL. Clinical factors (such as stone location and patient body type) may not be fully exposed to shock wave energy, leading to incomplete fragmentation. In this study, the incomplete lithotripsy rate in female patients was found to be higher than that in male patients, which may be related to the fact that female patients are more likely to suffer from sphincter of Oddi dysfunction(SOD), gender differences may lead to variations in body structure, exocrine and endocrine functions, and hormone levels, potentially exacerbating SOD symptoms and complicating ESWL treatment. Additionally, SOD can hinder the effective expulsion of stone fragments from the pancreatic duct, increasing the risk of pancreatitis complications and resulting in suboptimal ESWL outcomes. Relevant studies showed that female patients are also risk factors for post-ERCP pancreatitis and complications after ESWL, possibly because women with sphincter of Oddi dysfunction are more likely to have a predilection [24]. However, the results of many scholars showed that sex was not related to the success of lithotripsy [25, 26]. A previous study also reported that a tendency for successful lithotripsy existed among women and younger age, but the sample size was only 24, which needs further validation by more diversity [27]. The present study also found that pancreatic duct stent implantation was not statistically significant for pancreatic stone lithotripsy. However, relevant studies showed that preoperative stent implantation was a successful factor for ESWL of pancreatic duct stones [28, 29], while stent implantation after ESWL helped relieve stone recurrence and pain symptoms in patients [30]. Although age was found to have no guiding significance for lithotripsy success in this study, older people could achieve adequate pain relief after ESWL [31]. The average number of treatments and average number of impacts in the incomplete lithotripsy group were higher than those in the complete lithotripsy group, suggesting that the higher the CT value of stones, the more the number of treatments and shock waves required. This further supported that the stones with higher CT values were less likely to be fragmented, and the effect of ESWL was worse. This study included a small sample size and was conducted at a single center; therefore, a larger sample size as well as a multicenter study are needed to further confirm the findings of this study.

In summary, sex, maximum CT value, and volume of stones were closely related to the therapeutic effect of ESWL. Therefore, before ESWL treatment, it is important to focus on factors such as the size of the pancreatic duct stones, the diameter of the pancreatic duct, and the overall health of the patient. Optimizing shock wave energy, frequency, and the number of treatment sessions, as well as establishing standardized post-operative monitoring and intervention protocols—including imaging studies and the timing of endoscopic treatments—can help detect complications early and balance the effectiveness and safety of the procedure.

Data availability

Data is provided within supplementary information files.

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Acknowledgements

We thank all the study participants.

Funding

Hangzhou Agricultural and Social Development Sector Project (20241029Y089).

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  1. Sammad Abdul and Xiaofei Jiao co-first author.

Authors and Affiliations

  1. International Education College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China

    Sammad Abdul

  2. Department of Radiology, Affiliated Hangzhou First People’s Hospital, Westlake University School of Medicine, Hangzhou, Zhejiang, China

    Xiaofei Jiao & Chunying Wu

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Contributions

Sammad Abdul contributed to the design of the study, the data collection, and manuscript writing. Xiaofei Jiao contributed to the data collection and analysis. Chunying Wu contributed to the review, editing, and revision of the draft. All authors have read and agreed to the published version of the manuscript.

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Correspondence to Chunying Wu.

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Ethics approval and consent to participate

This study was conducted in accordance with the Declaration of Helsinki and approved by the Medical Ethics Committee of Hangzhou First People’s Hospital(ethics number: IIT-20240117–0016-01). The Medical Ethics Committee of Hangzhou First People’s Hospital waived the need for informed consent.

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Abdul, S., Jiao, X. & Wu, C. The risk factors affecting effect of extracorporeal shock wave lithotripsy for pancreatic duct stones. BMC Gastroenterol 25, 333 (2025). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12876-025-03801-6

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BMC Gastroenterology

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