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ORIGINAL ARTICLE
Year : 2022  |  Volume : 35  |  Issue : 2  |  Page : 716-721

Endoscopic papillary large balloon dilation with or without sphincterotomy for extraction of large bile duct stones


1 Department of General Surgery, Faculty of Medicine, Menoufia University, Menoufia, Egypt
2 Department of Tropical Medicine, Faculty of Medicine, Menoufia University, Menoufia, Egypt
3 Department of Internal Medicine, Faculty of Medicine, Menoufia University, Menoufia, Egypt

Date of Submission29-Jan-2022
Date of Decision05-Mar-2022
Date of Acceptance08-Mar-2022
Date of Web Publication27-Jul-2022

Correspondence Address:
Mahmoud M Alabassy
Shebin-Elkom, Menoufia
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mmj.mmj_41_22

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  Abstract 


Objectives
This work aimed to evaluate the safety and efficacy of endoscopic papillary large balloon dilatation (EPLBD) with or without endoscopic sphincterotomy (EST) in extraction of large common bile duct stones (CBDSs).
Background
EST combined with EPLBD has been proposed as an alternative to manage large bile duct stones. However, recent reports indicate that EPLBD alone may be safe and effective in this setting.
Patients and methods
From July 2019 to December 2021, we prospectively compared EPLBD alone (group I, n=100) with EST+EPLBD (group II, n=100) for the treatment of large CBDSs. CBDS clearance rate, frequency of mechanical lithotripsy usage, total procedure time, and intraendoscopic and postendoscopic complications were analyzed.
Results
Statistical analysis revealed that there were no significant differences between the studied groups regarding the use of mechanical lithotripsy (6 vs. 8%, P=0.579), overall and initial stone clearance rates (92 vs. 88%, P=0.346; and 81 vs. 76%, P=0.389, respectively), procedure-related pancreatitis (3 vs. 1%, P=0.312), or other intraendoscopic and postendoscopic adverse events, but there was a significant difference in terms of total procedure time (41.23±10.6 vs. 36.87±8.06, P=0.001).
Conclusion
The therapeutic outcomes and complications of sole EPLBD for the removal of large CBDSs were comparable to those of EPLBD with prior EST.

Keywords: common bile duct stones, endoscopic complications, large balloon dilation, mechanical lithotripsy, sphincterotomy


How to cite this article:
Alabassy MM, Soltan HM, Amer AA, Abdalla EM, Seddik RM, El-Feky AM. Endoscopic papillary large balloon dilation with or without sphincterotomy for extraction of large bile duct stones. Menoufia Med J 2022;35:716-21

How to cite this URL:
Alabassy MM, Soltan HM, Amer AA, Abdalla EM, Seddik RM, El-Feky AM. Endoscopic papillary large balloon dilation with or without sphincterotomy for extraction of large bile duct stones. Menoufia Med J [serial online] 2022 [cited 2024 Mar 28];35:716-21. Available from: http://www.mmj.eg.net/text.asp?2022/35/2/716/352200




  Introduction Top


Endoscopic sphincterotomy (EST) is the standard method for treatment of common bile duct stones (CBDSs)[1]. Because of concerns regarding short-term and long-term complications related to EST, another less-invasive technique, endoscopic papillary balloon dilation (EPBD), has been investigated[2]. With EPBD, the extraction of CBDSs becomes possible while preserving the biliary sphincter[3].

The efficacy of balloon dilation is similar to EST in the extraction of small-sized to moderate-sized stones. However, it frequently requires additional procedures, such as mechanical lithotripsy, especially in the extraction of large stones more than or equal to 10 mm[4]. A number of studies have been conducted using endoscopic papillary large balloon dilation (EPLBD) after EST to extract large bile duct stones[5].

Other studies have shown that hemorrhage and perforation might be reduced by EPLBD alone because dilation of the papilla is relatively slow, and this technique may reduce the need for mechanical lithotripsy during the retrieval of large bile duct stones by providing a large biliary opening[6].

So, we conducted this study to compare the therapeutic outcomes and complications between EPLBD alone and EPLBD with prior EST in the extraction of large CBDSs.


  Patients and methods Top


From July 2019 to December 2021, we conducted a prospective, randomized, comparative study on patients with large CBDSs. During the study period, 856 ERCPs were performed at the endoscopy units of Tropical Medicine, Internal Medicine, and General Surgery Departments, Menoufia University Hospitals. Patients with large CBDSs more than or equal to 10 mm in the maximum transverse diameter were included. CBDSs were identified in all patients by imaging studies such as pelvi-abdominal ultrasonography and magnetic resonance cholangiopancreatography. The exclusion criteria were patients with prior EST or EPLBD; acute pancreatitis or cholangitis; benign or malignant CBD strictures; previous hepatobiliary surgery; failure of selective cannulation; pregnancy; and patients with single CBDS less than 10 mm. Based on these criteria, 100 patients were included in the EPLBD alone group and 100 patients were included in the EPLBD plus EST group. This study was approved by the local ethics committee of the Faculty of Medicine, Menoufia University, and informed consents were obtained from all patients included in this study.

Endoscopic procedure: before ERCP, patients were sedated with intravenous 5 mg midazolam and 25-mg meperidine hydrochloride. Prophylactic antibiotics were routinely administered. ERCP was performed using a side-viewing duodenoscope (JF-260 or TJF-260; Olympus Optical Co. Ltd, Tokyo, Japan). The C-arm was SIEMENS AXIOM Sireskop SD, and the ERBE ICC 200 device was used for automatic cutting or coagulation using a blended current of 40-W cutting and 35-W coagulation. Selective cannulation of the bile duct was attempted using a soft hydrophilic tipped Teflon 0.035-inch guidewire (Boston Scientific, Natick, Massachusetts, USA or Wilson Cook, Winston Salem, North Carolina, USA) and a diagnostic cholangiogram was obtained for all patients. After successful cannulation of CBD, the studied patients were randomly classified using a computer-generated random number table (prepared by a statistician) into an EPLBD alone group or an EST+EPLBD group. EST: limited sphincterotomy was performed before EPLBD with a 20-mm cut-wire sphincterotome (Boston Scientific) and the length of the incision was decided by the endoscopist according to the size of the stones. The electrosurgical generator (ERBE) in the endocut mode was used. EPLBD was done using a wire-guided hydrostatic balloon catheter (5.5 cm in length, 12–20 mm in diameter) (Boston Scientific Microvasive, Cork, Ireland), and it was introduced across the major papilla with the balloon mid-portion placed at the sphincter of Oddi. Under endoscopic and fluoroscopic view, the hydrostatic balloon was gradually inflated with diluted contrast medium to the pressure equal to the smallest balloon diameter (12–20 mm) until the waist of the balloon had disappeared [Figure 1],[Figure 2]. The pressure for inflation of the balloon was gradually increased till the desired dilation was achieved according to the size of the stones and distal CBD diameter. After achieving the target diameter, the balloon was maintained in position for more than 2 min and then deflated and removed. Stone extraction: after the procedure, the CBDSs were removed with a Dormia basket or a balloon extractor (Extractor Three Lumen Retrieval Balloon, Boston Scientific Microvasive). Endoscopic mechanical lithotripsy was used to fragment the stones when previous techniques failed to extract the CBDSs. An occlusion cholangiogram was done at the end of the procedure to confirm complete clearance of CBDSs. When the stone had not been completely extracted, a plastic stent was inserted to ensure biliary drainage. Outcomes: all patients were interviewed by phone one month after ERCP to assess the potential complications. Endoscopic and postendoscopic assessments were done for technical data, including the frequency of mechanical lithotripsy use, balloon size, total procedure time, stone extraction, and initial and overall success rates, and procedure-related complications. The technical success rate was defined as the successful performance of the ERCP procedure, and it is often subjected to the endoscopist. Complete stone clearance was defined as the absence of filling defects on occlusion cholangiogram. The procedural time was the time from a successful selective cannulation of the bile duct up to the nasobiliary drain insertion. Postendoscopic pancreatitis (PEP) was defined as a new onset of abdominal pain with increase in the level of amylase and/or lipase above the upper limit of normal at more than 24 h after the procedure[7]. Procedure-related bleeding was classified as major bleeding (necessitating transfusion or immediate intervention) or minor bleeding (self-limited)[8]. Cholangitis was diagnosed by the presence of the Charcot's triad[7]. Perforation was defined as the leakage of contrast medium into the retroperitoneum or intraabdominal cavity during ERCP or evidence of retroperitoneal-free air on abdominal plain radiography or computed tomography[9].
Figure 1: Cholangiogram of large-balloon dilatation without biliary sphincterotomy. (a) Cholangiogram demonstrating a large stone within the dilated bile duct. (b) Large balloon inflated across over a guidewire.

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Figure 2: Endoscopic view of EPLBD without sphincterotomy. (a) Large balloon inflation within the papillary orifice; (b) Markedly dilated papillary orifice after EPLBD; (c) a large CBD stone was removed using a retrieval balloon catheter through the dilated papillary orifice. CBD, common bile duct; EPLBD, endoscopic papillary large balloon dilatation.

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Sample size calculation: the sample size was calculated as follows: 95% power and 90% noninferiority margin, based on the overall adverse event rate of 15% on EPLBD with EST in a previous study. So, the required sample size was calculated to be 100 patients per group.

Statistical analysis

The data analysis was conducted using SPSS (statistical package for social science; IBM, Chicago, Illinois, USA) program, version 13 for Windows. Descriptive statistics were used in which qualitative data were presented in the form of numbers and percentages (%) and quantitative data were presented in the form of SD, mean, and range. Statistical significance was demonstrated for results (P <0.05) using Student's t test. χ2 test was used to study the association between two qualitative variables.


  Results Top


There were no statistically significant differences between the two groups regarding age, sex, size and number of stones, bile duct diameter, or laboratory investigations. Demographic data and clinical characteristics of the patients included in this study are summarized in [Table 1].
Table 1: Demographic and clinical characteristics of the patients

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The use of mechanical lithotripsy was 6% in the EPLBD alone group and 8% in the EST+EPLBD group (P=0.579). Mean total procedure time tended to be greater in the EPLBD alone group than in the EPLBD with EST group (41.23±10.6 vs. 36.87±8.06; P=0.001). The mean balloon diameter used was 14.670±3.573 (range, 12–20) in the EPLBD alone group and 15.3±2.768 (range, 12–20 mm) in the EPLBD with EST group (P=0.165). A stone retrieval basket was required for nine patients in the EPLBD alone group and for 15 patients in the statistically EST+EPLBD group (P=0.192). CBDSs were extracted mainly using an extraction balloon catheter in both groups (EPLBD alone 91 and 85% in EST+EPLBD group). The technical success rate was 100% in both groups. Overall success rate in the EPLBD alone and EPLBD with EST groups were 92 and 88%, respectively (P=0.346). Stones were cleared during the first ERCP session in 81 patients in the EPLBD alone group and in 76 patients in the EST+EPLBD group (P=0.389). Failure of complete stone removal in the EPLBD alone and EST+EPLBD groups was 8 and 12%, respectively, and this was associated with larger transverse stone diameters (>2 cm) and all those patients underwent surgical removal of CBDSs. The endoscopic procedure details of the studied groups are shown in [Table 2].
Table 2: Comparison of outcomes between both groups

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The overall complications rates were similar in the EPLBD alone and EST+EPLBD groups (6 vs. 4%, P=0.516). The procedure-related pancreatitis in the EPLBD alone group was higher compared with the EST+EPLBD group, although nonsignificant (3 vs. 1%, P=0.312). In the EPLBD alone group, one patient experienced asymptomatic hyperamylasemia compared with none in the EST+EPLBD group. There were three patients with minor bleeding in the EST+EPLBD group compared with two patients in the EPLBD alone group (P=0.651). None of the studied patients died or developed procedure-related perforation or cholangitis. The procedure complications are summarized in [Table 3].
Table 3: Mortality and complications among both groups

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  Discussion Top


Procedural simplification and the maintenance of treatment efficacy are the developmental principles of new endoscopic treatment strategies. So, EPLBD alone is a more attractive option than EPLBD with EST, because it is easier to perform and it is more suitable for patients with large CBDSs and bleeding tendency[10]. So, this current study was conducted to evaluate the efficacy and safety of two therapeutic ERCP techniques: the EPLBD alone versus EST+EPLBD.

The present study revealed no significant difference in the need for mechanical lithotripsy between both groups (P=0.579). These findings suggest that EPLBD alone provides sufficient orifice dilation for stone clearance and that it is a reasonable alternative treatment for the removal of large CBDSs. These results agreed with Facciorusso et al.[11], who reported that there was no significance difference between EPLBD alone and EPLBD with prior EST regarding the use of mechanical lithotripsy. Moreover, Huang et al.[12] and Grande et al.[13] reported that mechanical lithotripsy is time consuming with high risk of complications and should be replaced by EPLBD in the era of removal of CBDSs.

The present study revealed that the procedure time was highly significant greater in the EPLBD alone group compared with the EST+EPLBD group (41.23±10.6 and 36.87±8.06, respectively; P=0.001)., These findings demonstrate that EPLBD alone does not reduce total procedure time compared with EPLBD with EST. These results agreed with Obata et al.[14] who reported that the total procedure time was longer for EPLBD alone (20.5 min) than for EPLBD with EST (18.0 min; P=0.08), which probably reflects the number of endoscopic sessions required for complete stone removal. Moreover, Yamauchi et al.[15] reported that EST combined with EPLBD can reduce the procedure time and fluoroscopy time for removal of large bile duct stones. However, Park et al.[16] demonstrated that the procedure time was significantly shorter for EPLBD alone than for EPLBD with EST (21.5 vs. 17.3 min; P=0.04).

In this study, EPLBD alone produced satisfactory results with respect to stone removal efficacy. The technical success rate was achieved in all patients of both groups. In EPLBD alone group, the overall success rate of complete stone removal was 92% compared with 88% in the EST+EPLBD group. Nearly 80% of patients in both groups achieved complete stone clearance in the initial endoscopic session, but there was insignificant difference between both groups regarding stone clearance rates (P >0.05). These results agreed with Kogure et al.[1] who reported that there was no significant difference in terms of stone clearance rates between EPLBD and EST+EPLBD groups.

The overall complications and PEP were similar in the EPLBD alone and EST+EPLBD groups (P >0.05). This might have been due to the adequately enlarged papillary orifices and nasobiliary drains in all patients. These results are supported by a previous study of Huang L, et al., who reported that the PEP rates of EPLBD alone and EPLBD with EST were founded to be similar (P=0.59).

There were debates for a long time regarding the safety of EPLBD alone for the treatment of large CBDSs, especially with respect to PEP. Zhu et al.[17] related the occurrence of PEP following sole EPLBD to obstruction of pancreatic orifice and/or direct pancreatic damage by balloon compression. In addition, it is difficult to enlarge biliary orifice enough to remove large CBDSs. Nakahara et al.[18] demonstrated that EPLBD with limited EST decreased the risk of PEP by adequate visualization and cannulation of the CBD, and this technique avoids pressure overload on the pancreatic duct. However, the current study showed that PEP was rare after EPLBD regardless of EST (3 vs. 1%, P=0.312).

Minor intraprocedural bleeding was noted in two patients in the EPLBD group and three cases in the EPLBD with EST group, but this was controlled easily in all cases by spraying diluted epinephrine solution. Delayed bleeding did not occur in any patient. The lower risk of bleeding with EPLBD may be related to effective compression done by the balloon, and this technique may be recommended especially in patients with risk of bleeding tendency[19],[20]. In previous studies, bleeding rates have been reported to be significantly higher for EPLBD with large EST than for EPLBD alone or EPLBD with minor EST[12],[20]. In the present study, limited incision to a third of the total ampulla length was performed before EPLBD in the EST+EPLBD group.

None of the studied groups' patients died or developed procedure-related perforation or cholangitis. These results were in agreement with Lyu et al.[10] who reported that there were no cases of cholangitis or perforation in EPLBD and EPLBD with EST groups. Perforation is a rare but the most serious adverse event after EPLBD, and it can be minimized by a cautious balloon inflation technique, whereby the balloon was gradually inflated up to the target diameter, and if a balloon waist was observed in the distal CBD during inflation, no further pressure was applied until the waist disappeared[21]. Many previous studies showed that acute cholangitis developed more often in the sphincterotomy group in comparison with the EPLBD group, and this might be explained by the loss of sphincter function after sphincterotomy, which enables colonization of intestinal organisms into the biliary system[22].

There were several limitations in the current study. First, our study only assessed short-term complications, not long-term complications, which could be important to evaluate the safety of the techniques. Second, a large CBDS was defined as a stone diameter of more than or equal to 10 mm because many authors have defined CBDSs more than 10–15 mm in diameter as 'large.' However, no consensus has been reached on the definition of a 'large CBDS.' Based on clinical experience, a stone of 10–11 mm can be removed effectively using conventional methods even if EPLBD is not used. Therefore, it is possible that the current study exaggerates the efficacy of EPLBD regardless of EST. Finally, a larger sample size or a noninferiority trial might be necessary to confirm these results.


  Conclusion Top


EPLBD without EST was as effective and safe as EST plus EPLBD in patients with large CBDSs, and it could be considered a useful alternative modality for the treatment of large CBDSs.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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Kogure H, Kawahata S, Mukai T, Doi S, Iwashita T, Ban T, et al. Multicenter randomized trial of endoscopic papillary large balloon dilation without sphincterotomy versus endoscopic sphincterotomy for removal of bile duct stones: MARVELOUS trial. Endoscopy 2020; 52:736–744.  Back to cited text no. 1
    
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Park JS, Jeong S, Lee DK, Jang SI, Lee TH, Park SH, et al. Comparison of endoscopic papillary large balloon dilation with or without endoscopic sphincterotomy for the treatment of large bile duct stones. Endoscopy 2019; 51:125–132.  Back to cited text no. 16
    
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