Benefits of endoscopic gallbladder stenting following percutaneous transhepatic gallbladder drainage

Abstract

BACKGROUND

Endoscopic transpapillary gallbladder drainage is challenging because of the complexity of the procedure and high incidence of adverse events (AEs). To overcome these problems, endoscopic gallbladder stenting (EGBS) after percutaneous transhepatic gallbladder drainage (PTGBD) can be effective, as it mitigates inflammation and adhesion.

AIM

To examine the benefits of EGBS after PTGBD to assess its efficacy and impact on AEs.

METHODS

We retrospectively analyzed data from 35 patients who underwent EGBS after PTGBD at a single center between January 2016 and December 2023. The primary outcomes were technical success and AEs, and the rate of recurrent cholecystitis was evaluated. In addition, the reasons for the failure of the procedure were identified.

RESULTS

Among the 35 patients, the technical success rate was 77.1% and the final contrast of the cystic duct was successful in 97.1% of patients. The incidence of early AEs was relatively low (11.4%), with no instances of cystic duct perforation. The rate of recurrent cholecystitis was 3.7%, and no other biliary events were observed.

CONCLUSION

EGBS after PTGBD may be significantly beneficial, with a substantial success rate and minimal AEs in both short- and long-term follow-ups.

Key Words: Endoscopy; Gallbladder; Stents; Drainage; Adverse events; Cholecystitis; Follow-up; Cystic duct

Core Tip: The placement of gallbladder stents is considered a technically challenging procedure and is only recommended in specialized facilities. Our findings suggest that endoscopic gallbladder stenting after percutaneous transhepatic gallbladder drainage may simplify this technique. This approach has the potential to reduce the risk of adverse events, both immediately after the procedure and in the long term, and may be beneficial for patients with a high surgical risk. This is the first study to investigate endoscopic gallbladder stenting after percutaneous transhepatic gallbladder drainage, which may have possible implications as a technique that could be a valuable addition to clinical treatment strategies.

INTRODUCTION

Acute cholecystitis (AC) is a prevalent cause of acute abdominal conditions that often necessitates urgent surgical interventions[1]. The Tokyo Guidelines 2018 (TG18) outlined a graded approach for managing AC, emphasizing tailored severity-based treatment strategies[2,3]. According to the TG18, gallbladder drainage is recommended under severe conditions, such as when the patient's overall health precludes anesthesia, when mild and conservative treatments fail to improve the condition, and when surgical options are limited owing to the capabilities of the surgical team. For patients unsuitable for surgery, noninvasive gallbladder drainage methods, such as percutaneous transhepatic gallbladder drainage (PTGBD), endoscopic transpapillary gallbladder drainage (ETGBD), and endoscopic ultrasound-guided gallbladder drainage, offer effective alternatives to relieve gallbladder pressure.

PTGBD is a widely used method of gallbladder drainage[4]. Additionally, PTGBD is considered the first alternative treatment for AC because it is a simple technique. However, patients who do not undergo cholecystectomy after removal of the percutaneous catheter have significant cholecystitis recurrence rates, which have been reported to range between 22%-47%[5,6]. Consequently, elective internalization of a gallbladder stent is desirable for patients at high surgical risk.

ETGBD is an alternative option for the management of patients with AC[7]. However, this technique presents considerable challenges, with success rates ranging from 64%-100%[8]. These difficulties are attributed to challenges in identifying the cystic duct and the tendency of the duct to adhere to or become fragile owing to inflammation. To mitigate inflammation and adhesions, performing a PTGBD beforehand may be useful in addressing this issue. Regarding cholecystectomy for AC there has been some reports on the benefits of preoperative PTGBD[9,10]. These studies have shown that preoperative PTGBD, compared to emergency cholecystectomy, can result in a reduction in postoperative adverse events (AEs) and a decrease in the length of hospital stay.

Based on these findings, the use of PTGBD to mitigate inflammation and adhesions, thereby reducing AEs, is believed to offer benefits not only in the context of surgery, but also for endoscopic gallbladder stenting (EGBS). However, there have been no reports on the outcomes of EGBS after PTGBD placement. This study aimed to investigate the short- and long-term outcomes of EGBS after PTGBD placement.

MATERIALS AND METHODS

Study population

This single-center retrospective analysis focused on patients who underwent EGBS after PTGBD between January 2016 and December 2023. The exclusion criteria were patients with surgically altered gastrointestinal anatomy, except those who underwent B-I reconstruction. Ethical compliance was ensured in accordance with the guidelines set by the hospital’s Institutional Review Board (No. 2024-073-A), and the study was conducted in accordance with the tenets of the Declaration of Helsinki.

Intervention procedure for ETGBS

All the participants underwent endoscopic retrograde cholangiopancreatography (ERCP) under sedation using standard duodenoscopes (JF-260V, TJF-Q260V, or TJF-Q290V; Olympus Medical Systems, Tokyo, Japan) for the procedure. After successful bile duct cannulation, cholangiography was performed to determine the location of the cystic duct. In cases in which transpapillary cystic duct opacification proved challenging, contrast was injected via the PTGBD to facilitate identification (Figure 1A). Endoscopic removal of CBD stones was performed as required. A 0.025-inch guidewire (Visi Glide2; Olympus Medical Systems) and an ERCP catheter (PR-V614M, Olympus Medical Systems) were used to navigate and advance through the cystic duct into the gallbladder. This was followed by advancement of the guidewire and cannula into the cystic duct, with contrast medium injection to assess, and if necessary, dilate the cystic duct structure using a 6-Fr Soehendra dilation catheter. An ERCP catheter was inserted over the guidewire for bile aspiration and saline irrigation of the gallbladder. The intervention concluded with the insertion of a plastic stent (IYO-stent, Gadelius Medical, Tokyo, Japan), which was determined by the endoscopist based on the individual case requirements.

Figure 1 Fluoroscopic images of the cystic duct. A: Fluoroscopic images of the cystic duct contrast via percutaneous transhepatic gallbladder drainage; B: Fluoroscopic images of cystic duct perforation. The yellow head shows the leakage of the contrast medium into the peritoneal cavity from the cystic duct lumen.

Study outcomes and definitions

Data were gathered on various parameters, including patient background, disease severity, common and cystic duct diameters, and the presence or absence of cystic duct stones and perforations. The primary endpoint of this study were the technical success rate and AEs.

The severity of AC was categorized based on the TG18. Cystic duct perforation was identified using device dislocations such as guidewires or cannulas, or by fluoroscopic observation of contrast medium leakage from the cystic duct lumen into the peritoneal cavity (Figure 1B). Technical success was defined as successful insertion of a stent into the gallbladder via the cystic duct. AEs were identified and classified according to the Tokyo Criteria[11], and severity levels were assigned according to the lexicon guidelines of the American Society of Gastrointestinal Endoscopy[12]. The location of the cystic duct was conclusively determined using ERCP, computed tomography, and magnetic resonance cholangiopancreatography. Contrast cystic duct on cholangiography was defined as successful visualization of the cystic duct contrast from the CBD, and the final contrast cystic duct was defined as successful visualization of the cystic duct, including the contrast introduced via PTGBD.

Statistical analysis

We presented continuous data using median values with ranges and categorical variables using proportions. The time to recurrent cholecystitis and cholangitis was estimated using the Kaplan-Meier method.

RESULTS

Patient characteristics

The patient characteristics are presented in Table 1. A total of 35 patients underwent EGBS after PTGBD between January 2016 and December 2023. The median age was 75 years (range, 49-90). The majority of patients were male (85.7%, 30/35). Most cases were of moderate cholecystitis severity (77.1%, 27/35). The median diameter of the cystic duct was 3 mm (range, 2-5.5). Stone impaction in the cystic duct was observed in 22.9% of patients. The median diameter of the CBD was 7 mm (range, 4-13). Stones in the CBD were observed in 31.4% of patients.

Table 1 Patient characteristics, n (%).

Characteristics	n = 35
Age, years, median (range)	75 (49-90)
Sex, male	30 (85.7)
Severity of cholecystitis
Mild	2 (5.7)
Moderate	27 (77.1)
Severe	6 (17.1)
Cystic duct diameter, mm, median (range)	3 (2-5.5)
Stone impaction in the cystic duct	8 (22.9)
CBD diameter, mm, median (range)	7 (4-13)
Presence of a CBD stone	11 (31.4)

CBD: Common bile duct.

Endoscopic procedural outcomes

The outcomes of the endoscopic procedures are summarized in Table 2. Technical success was achieved in 77.1% (27/35) of the patients. Regarding contrast cystic duct cholangiography, a success rate of 60% (21/35) was observed. The final contrast cystic duct, which included contrast from PTGBD, was successful in 97.1% (34/35) of cases. The median procedure time was 24 minutes (range, 8-53). Early AEs occurred in 11.4% (4/35) of patients, wherein pancreatitis occurred in 8.6% (3/35) and cholangitis occurred in 2.9% (1/35) of the patients. No cystic duct perforations or bleeding was observed.

Table 2 Endoscopic procedure, n (%).

Characteristics	n = 35
Technical success	27 (77.1)
Contrast cystic duct via cholangiogram	21 (60)
Final contrast cystic duct	34 (97.1)
Procedure time, mm, median (range)	24 (8-53)
Early adverse events	4 (11.4)
Pancreatitis	3 (8.6)
Cholangitis	1 (2.9)
Cystic duct perforation	0
Bleeding	0

Long term outcomes

Late AEs were focused on following the endoscopic procedures in 27 patients who achieved initial technical success (Table 3). Late AEs occurred in 3.7% (1/27) of the patients, including one case of cholecystitis recurrence. The median time to onset of all biliary events was not reached (Figure 2).

Figure 2 Time to recurrent cholecystitis after endoscopic gallbladder stenting. The Kaplan-Meier curve for the time to recurrent cholecystitis is shown. Median time to recurrent cholecystitis was not reached.

Table 3 Late adverse events, n (%).

Characteristics	n = 27
Late adverse events
Cholecystitis	1 (3.7)
Cholangitis	0
Median follow-up period, days, median (range)	123 (20-1435)

Characteristics of failed procedures

Characteristics of failed procedures are listed in Table 4. This group included eight patients, predominantly male, with ages ranging from 31-89 years. All cases involved calculous cholecystitis, with the majority being of moderate severity. CBD stones were observed in five patients. Cystic duct contrast was successfully achieved. The diameters of the cysts and CBD ranged from 2.5-4 mm and 4-12 mm, respectively. Procedural failure was predominantly due to difficulties with wire or catheter insertion. Stone impaction was an obstacle in several cases. No AEs were reported in these instances of technical failure.

Table 4 Characteristics of failed procedures.

Age, year/sex	Type of cholecystitis	Severity grade	Presence of a CBD stone	Contrast cystic duct	Cystic diameter, mm	CBD diameter, mm	Cause of failed procedure	Adverse events
31/M	Calculous	Moderate	Yes	Yes	3.5	9	Failure of catheter insertion due to stone impaction	No
40/M	Calculous	Moderate	Yes	Yes	3.5	9	Failure of wire insertion	No
41/M	Calculous	Moderate	No	Yes	3	8.5	Failure of wire insertion	No
56/M	Calculous	Moderate	No	Yes	2.5	9	Failure of wire insertion	No
57/M	Calculous	Moderate	Yes	Yes	2.5	4	Failure of wire insertion	No
70/F	Calculous	Mild	No	Yes	3	12	Failure of wire insertion	No
71/F	Calculous	Moderate	Yes	Yes	3.5	9	Failure of catheter insertion due to stone impaction	No
89/M	Calculous	Moderate	Yes	Yes	4	12	Failure of wire insertion due to stone impaction	No

CBD: Common bile duct; M: Male; F: Female.

DISCUSSION

In this study, we reported the outcomes of EGBS after PTGBD. PTGBD facilitated the identification of the cystic duct in 97.1% of cases, leading to a technical success rate of 77.1%. Although the placement of gallbladder stents is considered a technically challenging procedure and is only recommended in specialized facilities, our findings suggest that EGBS after PTGBD may simplify this technique. Moreover, this approach has the potential to reduce the risk of AEs, both immediately after the procedure and in the long term.

Several factors contribute to the difficulty of the technique during EGBS: (1) The inability to visualize and identify the cystic duct; (2) Tortuosity of the cystic duct hindering the advancement of the wire; (3) Inflammatory strictures and adhesions preventing stent passage; and (4) Stone impaction blocking the progression of the wire or stent. Contrasting the cystic duct is considered to be one of the most crucial aspects of procedures targeting the gallbladder. Previous reports indicate that in the context of ETGBD, the success rate of contrasting the cystic duct was unsatisfactory in approximately 59%-68.7% of cases[13-15]. Hirakawa et al[14] reported that wire insertion into the duct was achieved in 100% of the 57 cases in which the cystic duct was successfully visualized under fluoroscopic guidance. Furthermore, stent placement was successful in 91.2% (52/57) of cases. This underscores the importance of identifying the cystic duct as a critical factor.

In this analysis, transpapillary opacification of the cystic duct was not achieved in 40% (14/35) of the cases, which is less than that reported in previous studies. This improvement may be attributed to the placement of PTGBD, which potentially reduced inflammation and eased adhesions, thereby allowing for smoother contrast imaging. Furthermore, in cases where transpapillary opacification was unsuccessful, PTGBD-enabled contrast allowed for cystic duct imaging. In our study, we achieved final opacification of the cystic duct in 97.1% (34/35) of cases, underscoring the utility of PTGBD placement.

The reasons for the unsuccessful procedure were also investigated. In our series, eight cases (22.9%) resulted in unsuccessful procedures. Five cases were attributed to the inability of the wire to pass through the cystic duct, while three cases were attributed to the impaction of stones in the cystic duct. Wire manipulation within the cystic duct was challenging, and contributed to the procedural failure. Employing guidewires that specialize in seeking solutions may provide a solution. Additionally, peroral cholangioscopy (POCS)-guided cystic duct cannulation could be a viable backup method if conventional fluoroscopically guided cannulation fails. The POCS technique offers an additional 20% technical success rate after unsuccessful ETGBD under fluoroscopic guidance[16]. However, stone impaction within the cystic duct is also a cause of unsuccessful procedures, which often prevents the passage of wires and stents. Ban et al[17] reported the successful fragmentation of impacted stones using a Soehendra stent retriever, which facilitated successful ETGBD. Although these devices could not be used in this study, their incorporation in the future could potentially improve ETGBD outcomes.

Regarding AEs, early and late complication rates ranged from 0%-26.5%[18-21]. Early complications included pancreatitis from ERCP, bleeding, choledocholithiasis, cystic duct perforation induced by guidewire use or cannulation, cholangitis, sepsis, stent migration, and bile leakage. During ETGBD, cystic duct perforation may occur as an AE when advancing a device, such as a guidewire, cannula, or stent, through the cystic duct. The incidence of cystic duct perforations during ETGBD has been reported to be between 2.9% and 15.8%[20,22,23]. Furthermore, cystic duct perforation has been reported as a risk factor for procedural failure and is considered a significant AE of ETGBD[24]. In this study, the incidence of early AEs was relatively low (11.4%), and there were no instances of cystic duct perforation. Sofuni and Itoi[25] reported that cystic duct perforation, a critical AE of ETGBD, is associated with inflammatory edematous changes in the cystic duct. It is conceivable that the placement of PTGBD to mitigate inflammation and adhesions may have contributed to the absence of this AE in our study. Regarding late AEs, cholecystitis recurrence has been reported in 0%-11.8% of cases, while other AEs have been documented at rates of 3.2%-11.8%[26-29]. In our study, late AEs were limited to a single recurrence of cholecystitis, accounting for 3.7% of cases, which is lower than the previously reported rates, and no other complications were observed. During internal drainage during ERCP, a two-step approach that initially uses external drainage to reduce inflammation before internalization is often employed to mitigate the risk of sludge[30]. In our study, ETGBS after inflammation reduction by PTGBD may have contributed to the low incidence of late AEs.

This study had some limitations. This was a single-center retrospective analysis with a relatively small cohort, which may have constrained the generalizability of the findings. The retrospective nature of the study could have potentially led to bias in data collection and interpretation. However, this is the first study to investigate EGBS following PTGBD, suggesting that this technique could be a valuable addition to clinical treatment strategies. Further studies are required to examine the effectiveness of this method in a larger number of patients.

CONCLUSION

In conclusion, EGBS after PTGBD may offer benefits for patients at high surgical risk, with the potential to simplify the procedure and reduce the occurrence of AEs.