Efficacy of Endoscopic Gallbladder Drainage in Patients with Acute Cholecystitis

Abstract

Background. Early cholecystectomy is recommended for patients with acute cholecystitis. However, emergency surgery may not be indicated due to complications and disease severity. Patients requiring drainage are usually treated with percutaneous transhepatic gallbladder drainage (PTGBD), whereas patients with biliary duct stones undergo endoscopic stones removal followed by endoscopic gallbladder drainage (EGBD). Herein, we investigated the efficacy of EGBD in patients with acute cholecystitis.

Methods. Overall, 101 patients receiving laparoscopic cholecystectomy between September 2019 and September 2020 in our department were retrospectively analyzed.

Results. The patients (n = 101) were divided into three groups: control group that did not undergo drainage (n = 67), a group that underwent EGBD (n = 7), and a group that underwent PTGBD (n = 27). Average surgery time was 124.0, 191.9, and 150.7 minutes, respectively. Control group had a significantly shorter surgery time, whereas it did not significantly differ between EGBD and PTGBD groups. The average amount of bleeding was 11.8 g, 7.1 g, and 30.6 g, respectively, and control group had significantly less bleeding than PTGBD group. We further divided patients into the following subgroups: patients requiring a 5-mm clip to ligate the cystic duct, patients requiring a 10-mm clip due to the thickness of the cystic duct, patients requiring an automatic suturing device, and patients undergoing subtotal cholecystectomy due to impossible cystic duct ligation. There was no significant difference between EGBD and PTGBD regarding the clip used or the need for an automatic suturing device and subtotal cholecystectomy.

Conclusion. There was no significant difference between EGBD and PTGBD groups regarding surgery time or bleeding amount when surgery was performed after gallbladder drainage for acute cholecystitis. Therefore, EGBD was considered a useful preoperative drainage method requiring no drainage bag.

Background

Early cholecystectomy is a standard therapy for acute cholecystitis (AC) [1, 2]. However, early surgical intervention may result in increased morbidity and mortality in the elderly, patients with multiple comorbidities, or those with advanced cholecystitis [3]. According to Tokyo guidelines 2018, early gallbladder drainage is should be considered for patients with severe local inflammation and/or severe (grade III) AC [4].

Percutaneous transhepatic gallbladder drainage (PTGBD) is a widely performed and established method for gallbladder drainage. However, PTGBD is generally prohibited in patients with a breeding tendency, massive ascites, and anatomically inaccessible gallbladders. In addition, PTGBD is associated with adverse events, including bleeding, and catheter dislodgement. There are several reports on the usefulness and safety of endoscopic gallbladder drainage (EGBD), including endoscopic nasogallbladder drainage (ENGBD) and endoscopic gallbladder stenting, and endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) in patients with AC [5–7]. However, there have been few studies comparing the feasibility of laparoscopic cholecystectomy (LC) for AC after EGBD and LC after PTGBD [8, 9]. The objective of this study was to evaluate the feasibility of LC after EGBD compared with PTGBD.

Methods

Study population

Overall, 101 patients who underwent LC for AC between September 2019 and September 2020 in our department were retrospectively analyzed. Of these, 33 patients who underwent LC for AC after gallbladder drainage were included in the analysis (Fig. 1). This retrospective study was approved by the Medical Ethics Committee of Kensei Hospital (no. 2021-03) and performed following the ethical guidelines for clinical studies.

Treatment

In our institution, urgent or semi-urgent LC was performed for AC patients tolerant for surgery. If surgery was unsuitable, AC patients were treated in a gastroenterology department. In addition to antibiotic treatment, gallbladder drainage was performed depending on disease course and severity. In most cases, PTGBD was selected as the drainage method. EGBD was selected for patients suspected of choledocholithiasis, bleeding tendency, and dementia with a risk of drainage tube self-removal.

PTGBD

PTGBD was guided by ultrasound. After an 18-gauge needle was inserted into the gallbladder, a guidewire was coiled into the gallbladder. And then, a pigtail catheter was placed using a guidewire under fluoroscopy.

EGBD

The term EGBD generally includes ENGBD and EUS-GBD, but these are not performed in our institution. In the text, EGBD means endoscopic trans-papillary gallbladder drainage. Following endoscopic retrograde cholangiopancreatography (ERCP), a 0.035-inch Radifocus guidewire (Terumo, Tokyo, Japan) was advanced into the cystic duct and subsequently into the gallbladder. A 5-French IYO-stent^TM (32 cm, Gadelius Medical K.K., Tokyo, Japan) was inserted into the gallbladder along the guidewire (Fig 2).

Surgery after drainage

Because most studies determined that a short interval between PTGBD and LC can increase the intraoperative difficulty [10-12], LC was basically performed at least 2 months after drainage so that edema and inflammation around the gallbladder subsided. All EGBD tubes were removed before LC.

Patient variables

The characteristics of EGBD and PTGBD patients before gallbladder drainage were compared. Surgical results in patients with and without gallbladder drainage were compared. In addition, surgical results in EGBD and PTGBD patients were compared. The severity of AC was determined by the Tokyo guideline criteria [4].

Statistical analysis

Categorical variables were compared using the chi-square test and Fisher’s exact test, and continuous variables were compared using Mann–Whitney U-test. A P < 0.05 was considered significant for all tests. The statistical analysis was performed with js-STAR XR release 1.1.3j.

Results

Patient status before drainage is summarized in Table 1. There were no significant differences in age, sex, anticoagulant therapy, and severity of AC between the two groups. The time to operation day was significantly shorter in PTGBD group. There was no significant difference, but five PTGBD patients had severe Tokyo grade III AC whereas there were no grade III patients in EGBD group.

Surgical results in patients with and without gallbladder drainage are shown in Table 2. There are significant differences in the variables as follows; surgery time, blood loss, cystic duct closure, and hospital stay. In all of these, non-drainage group had a better result, but only the non-drainage group had postoperative complications.

Intra- and postoperative factors in EGBD and PTGBD groups are summarized in Table 3. The median surgery times were 166 min (range, 76–299) for EGBD and 143 min (range, 75–264) for PTGBD (P = 0.4). In both groups, there was no conversion to open surgery.

If the critical view of safety could not be established, Fundus first technique was performed. Furthermore, if it was difficult to identify the cystic duct, laparoscopic subtotal cholecystectomy was performed. There was no significant difference between the groups in cystic duct closure, but ligation with a 5-mm clip was difficult in EGBD group, and automatic suturing devices tended to be used more often. There were no postoperative complications in both groups. There was no significant difference in postoperative hospital stay between the two groups.

Discussion

According to 2018 Tokyo guidelines, the first surgical treatment of choice for mild or moderate AC is LC. Gallbladder drainage is required as the initial treatment in severe AC for whom urgent surgery is contraindicated due to comorbidity and organopathy [4]. Since drainage is often performed in severe cases, inflammation increases the difficulty of cholecystectomy. The optimal timing of cholecystectomy after drainage is still without consensus, but there are some reports that delayed surgery after drainage can be performed more safely than early surgery [10–13]. Then, we required most patients to undergo LC at least 2 months after drainage. In drainage group, although surgery time, blood loss, and hospital stay increased, postoperative complications did not increase, demonstrating the adequacy of the treatment strategy (Table 2).

PTGBD is a frequently performed and established method for gallbladder drainage. A previous systematic review showed that the technical success rate of PTGBD was 98% [14]. However, we speculate that the external tube might decrease the quality of life (QOL) while awaiting surgery due to postprocedural pain and discomfort. Additional associated risks include catheter dislodgment, bile leakage, bleeding, and pneumothorax [15]. On the other hand, EGBD is a complex procedure with a reported success rate of 77–91% [9, 16–21]. Failure of EGBD was mostly attributable to the inability to detect the cystic duct and insert the guidewire or the stent due to an obstruction caused by severe inflammation and gallstones within the duct [7]. Therefore, EGBD requires an expert endoscopist. EGBD had a similar technical success rate to PTGBD but seems to be safer because it has lower complication rate than PTGBD, according to a meta-analysis [22]. It has also been reported that EGBD is superior to PTGBD in the patient’s QOL and hospitalization period [9, 21, 23]. We did not evaluate QOL after the drainage, but as shown in Table1, it is considered that a significantly longer time to operation was possible because of less discomfort and stent trouble in the EGBD group. In most cases, the ultimate goal of treating AC is safe cholecystectomy. Although the efficacy of EGBD is gradually being established, there are few reports on its effect on surgery. There are concerns that surgery after EGBD might be more difficult because inflammation around the cystic duct and cannulation of the drainage tube interfere with dissection in Calot’s triangle. In this patient series, only in one case in EGBD group, a ligation with a 5-mm clip was possible; thus, the cystic duct may tend to thicken after EGBD. However, there was no significant difference between EGBD and PTGBD in cystic duct closure. Cannulation of the drainage tube may not affect dissection in Calot’s triangle so much. And then EGBD did not increase the difficulty of surgery compared with PTGBD. Surgery time and blood loss were equivalent. The postoperative complication and hospital stay were also equivalent (Table 3). Therefore, EGBD was considered useful as a preoperative drainage method.

The limitation of this study was its retrospective analysis, a small number of patients, and investigation in a single institution. In order to further explore the actual feasibility of LC after EGBD, it needs to be investigated by prospective studies.

Conclusion

EGBD could be a safe and effective alternative treatment to PTGBD for patients with AC who are unsuitable for emergency cholecystectomy. This study showed that LC was performed successfully and safely after either EGBD or PTGBD. The feasibility of LC after EGBD was comparable to LC after PTGBD. However, based on the limits of the current study, large sample, multi-center studies are still needed.

Abbreviations

AC Acute cholecystitis

EGBD Endoscopic gallbladder drainage

LC Laparoscopic cholecystectomy

PTGBD Percutaneous transhepatic gallbladder drainage

Declarations

Ethics approval and consent to participate

This retrospective study was approved by the Medical Ethics Committee of Kensei Hospital (no. 2021-03) and performed following the ethical guidelines for clinical studies. Informed consent was obtained in the form of opt-out on the web-site of our institution.

Consent for publication

Not applicable.

Availability of data and materials

The data and materials used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests

The authors confirm that they no competeng interests.

Funding

Not applicable.

Authors’ contributions

HS contributed to research design. AK, TM, and HS collected the data. AK and HS analyzed the data. AK drafted the manuscript. HS, SS, TS, TM, and TH contributed to revising the manuscript. All authors read and approved the final manuscript.

Acknowledgements

The authors would like to thank Enago (www.enago.jp) for the English language review.

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Tables

Table 1 Characteristics of EGBD and PTGBD patients before gallbladder drainage

 Data are presented as median (range) or number

Table 2 Surgical results in patients with and without drainage

Data are presented as median (range) or number

Table 3 Surgical results in EGBD and PTGBD patients

Data are presented as median (range) or number