Evaluation of the Validity of Endoscopic Transpapillary Gallbladder Drainage for Acute Cholecystitis Based on the Tokyo Guidelines 2018

doi:10.21203/rs.3.rs-2482339/v1

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Evaluation of the Validity of Endoscopic Transpapillary Gallbladder Drainage for Acute Cholecystitis Based on the Tokyo Guidelines 2018

https://doi.org/10.21203/rs.3.rs-2482339/v1

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Background The Tokyo Guidelines 2018 recommend early laparoscopic cholecystectomy (Lap-C) for patients with acute cholecystitis (AC). We evaluated the validity of endoscopic transpapillary gallbladder drainage (ETGBD) as a bridging therapy prior to elective Lap-C.

Methods We performed a retrospective cohort analysis using data from our hospital records from 2018 to 2021. In total, 71 ETGBD procedures were performed in 61 patients with AC.

Results The technical success rate was 85.9%. Patients in the failure group had more complicated branching of the cystic duct. The length of time until feeding was started, length of time until the white blood cell count normalized, and length of hospital stay were significantly shorter in the success group. The median waiting period for surgery was 39 days in the ETGBD success group. The median operating time, amount of bleeding, and length of postoperative hospital stay were 134 min, 83.2 g, and 4 days, respectively. In patients who underwent Lap-C, the waiting period for surgery and the operating time were similar between the ETGBD success and failure groups. However, the temporary discharge period after drainage and the length of postoperative hospital stay were significantly longer in the ETGBD failure group. Patients who did not undergo Lap-C tended to have a higher American Society of Anesthesiologists physical status classification and Charlson comorbidity index score.

ConclusionsETGBD has equivalent efficacy prior to elective Lap-C despite some challenges that lower its success rate. Perioperative ETGBD can improve patients’ quality of life by eliminating the need for a drainage tube.

Tokyo guidelines 2018

acute cholecystitis

endoscopic retrograde cholangiopancreatography

endoscopic transpapillary gallbladder drainage

laparoscopic cholecystectomy

The Tokyo Guidelines 2018 (TG18) recommend early laparoscopic cholecystectomy (Lap-C) for patients with acute cholecystitis (AC). These guidelines recommend early Lap-C even for patients with the most severe form of AC (Grade III) as long as the patients have a low American Society of Anesthesiologists physical status classification (ASA-PS) and age-adjusted Charlson comorbidity index (CCI) score. Additionally, the Lap-C procedure should be performed by a skilled laparoscopic surgeon at an institution that can offer an appropriately high level of care[1].

However, some patients cannot undergo Lap-C because of their poor general condition or their specific background or comorbidities. Such patients include those who regularly take anticoagulants or have severe underlying disease.

While awaiting surgery, gallbladder drainage is usually required to stabilize the patient’s general condition. Percutaneous transhepatic gallbladder drainage (PTGBD) has been recommended as a standard drainage procedure for patients whose condition is too high-risk for surgery[2–4]. However, although PTGBD is widely recognized as an established and useful procedure, it is associated with several risks including bleeding, migration of the tube, and lengthening of the hospital stay[5]. Therefore, the TG18 also recommends endoscopic transpapillary gallbladder drainage (ETGBD) at institutions with physicians skilled in therapeutic endoscopy[1].

Many endoscopists have reported that ETGBD may provide effective and safe gallbladder drainage for patients with AC[6–9]. However, widespread use of ETGBD has not yet been adopted by many institutions because of concerns about the greater difficulty and longer procedure time involved[10].

In this study, we evaluated the validity of ETGBD as a bridging therapy prior to elective Lap-C.

Patient selection

This single-institute retrospective cohort study involved patients who underwent ETGBD at our institution from June 2018 to October 2021. ETGBD was performed as the first-choice therapy for patients with AC who were not eligible for early Lap-C. ETGBD was avoided in patients who had malignant tumors in the biliary tract, were in poor general condition and unable to endure a prolonged procedure, or had a history of gastrointestinal tract reconstruction.

Devices for ETGBD

All procedures were conducted under deep sedation. Duodenal fiberscopes (JF-260V or TJF-Q290V; Olympus Corporation, Tokyo, Japan) were used. In most cases, a disposable cannula (PR-V234Q or PR-V233Q SwingTip; Olympus Corporation) was chosen for cannulation into the major papilla. A guidewire (Pathcourse™; Boston Scientific, Marlborough, MA, USA) was used to allow deep cannulation into the cystic duct (CD). A 5-French pigtail endoscopic nasobiliary drainage tube (PBD-V813W-05; Olympus Corporation) was placed in the gallbladder as the drainage tube. In some cases, the end of the endoscopic nasobiliary drainage tube was cut while within the stomach to avoid self-removal by the patient.

Definitions of technical success and clinical efficiency

Technical success was defined as successful placement of the drainage tube into the gallbladder. Clinical efficiency was defined as both improvement of clinical symptoms and normalization of abnormal laboratory findings after the procedure.

Classification of CD branching type and visualization of the CD

Because ETGBD can sometimes be difficult, the branching of the CD was classified to estimate the expected difficulty. Four groups were defined based on the CD branching type (Fig. 1). Type I was the simplest branching type, appearing to be almost straight without any bends. Type Δ had a single bend with an obtuse angle. Type N had two bends or an acute angle. Type M had more than three bends and was expected to be the most complicated. Overall, we expected that Type I would be the easiest and type M the most difficult to complete.

We also evaluated whether the CD could be differentiated from the common bile duct (CBD). If no contrast was obtained from the CBD, a cannula was inserted into the bifurcation of the CD, and the possibility of selective contrast from the CBD was also evaluated.

Statistical analysis

Statistical significance between two groups of data was evaluated using the two-tailed Student’s t-test or chi-square test. Multiple comparisons were performed by one-way analysis of variance followed by the Bonferroni test among the three grades of AC, when comparing every mean with every other mean. The Mann–Whitney U test was used to evaluate ordinal variable data.

Differences were considered statistically significant at a p value of < 0.05.

Patients’ characteristics

In total, 71 ETGBD procedures were performed in 61 patients (Table 1). Nine patients underwent ETGBD twice, and one patient underwent ETGBD three times. The main reason for multiple procedures was dislocation of the ETGBD tube and recurrence of cholecystitis. There were also cases in which the ETGBD tube was reinserted because of lack of clinical efficacy, although the procedure was technically successful. The patients’ ages ranged from 48 to 97 years. Grade I AC was diagnosed in 24 (33.8%) procedures, grade II in 42 (59.2%) procedures, and grade III in 5 (7.0%) procedures. Anticoagulant drugs were administered in 38 (53.5%) procedures. Procedure-related complications were encountered in 8 (11.3%) of the 71 procedures, including CD injury (4 cases), cholangitis (2 cases), and pancreatitis (2 cases).

Success rate of ETGBD

The technical success rate of ETGBD was 85.9%, and the clinical efficiency rate was 93.4% (Table 2). There were no differences in the technical success rate or efficiency rate among the different severities of AC.

Comparison of technical success group with failure group

There were no significant differences in the patients’ background factors, such as age, sex, and body mass index, between the success and failure groups (Table 3). The branching type of the CD played an important role in determining the success or failure of the procedure, with a high incidence of type I and Δ branching found in the success group and type N and M in the failure group. The success and failure groups were then evaluated according to whether the CD was visualized. The success group had a higher rate of visualization of the CD from CBD injection. Furthermore, of the 61 patients in the success group, only 38 (62.3%) showed a positive CD from CBD injection; the CD turned positive by injection from the bifurcation of the CD in 22 (95.7%) of the remaining 23 patients. By contrast, only 20% and 50% of the patients in the failure group showed a positive CD from CBD injection and CD bifurcation injection, respectively.

The procedure time, time until feeding was started, and time until the white blood cell count normalized were shorter in patients in the success group. These results suggest that the outcome of drainage was better in the success group than in the failure group, in which most of the patients underwent PTGBD as an alternative drainage procedure. The ASA-PS classification and CCI score were significantly higher in the failure group than in the success group.

Comparison of severity

There were no significant differences in the CD branching type, diameter of the CBD, or presence of CBD stones among the three severities of AC (Table 4). The white blood cell count tended to be higher in severe cases, reflecting the severity of cholecystitis. However, there was no significant difference in the outcome of ETGBD in severe cases; therefore, ETGBD seemed to be equally effective for all severities of AC.

Comparison of success versus failure of ETGBD in patients who underwent surgery

We compared patients for whom ETGBD was and was not successful who then underwent Lap-C (Table 5). There was no difference in the patients’ background factors except age. The number of days of temporary discharge was significantly higher in the patients in the failure group who underwent PTGBD to provide alternative preoperative drainage. The ASA-PS classification and CCI score were higher in the failure group, but there was no difference in the outcome of surgery between the two groups. Patients in the failure group had a longer postoperative hospital stay.

Comparison between patients who did and did not undergo surgery among ETGBD cases

We examined the differences in the patients’ backgrounds between those who did and did not undergo surgery in the ETGBD success group (Table 6). The nonoperative group tended to be older and spend a longer time in the hospital. There were no differences in the complication rate or efficacy of preoperative gallbladder drainage between the two groups, but the nonoperative group had a longer duration of ETGBD tube placement, a higher ASA-PS classification and CCI score, and a higher rate of severe comorbidities.

Our data revealed the efficiency of ETGBD as an alternative preoperative drainage procedure for patients with AC who require elective Lap-C.

The success rate of ETGBD at our institution was 86%, which is comparable to previous reports[10–12]. The incidence of ETGBD-related complications was 11.3%. In previous reports, the rate of adverse events after ETGBD ranges from 0–14%, which is similar to our results[13]. Our results are comparable to those of PTGBD, which is reportedly associated with a complication rate of 5.9–16.1% (e.g., catheter displacement)[14–16]. In addition, when ETGBD fails, we can still choose alternative treatment methods such as endoscopic ultrasound-guided gallbladder drainage and PTGBD. Therefore, the complication rate of ETGBD is well within the acceptable range.

We found no differences in the technical success rate or efficiency rate among the severities of AC. There were also no differences in the procedure time or complication rate among the severities. Our study included 24 (33.8%) cases of grade I AC among the 71 procedures. According to TG18, early Lap-C is indicated for patients with grade I AC. However, most of our patients with grade I AC were at high risk for complications of emergency surgery because they were taking anticoagulants (58.3%), were very elderly, had a high ASA-PS classification or CCI score, or had serious underlying diseases. Therefore, emergency surgery was not an option for these patients, and preoperative drainage was unavoidable.

The results of this study indicate that ETGBD is effective for all severities of AC, from mild to severe. There was no difference in surgical outcomes between the successful and failed ETGBD procedures. However, patients who underwent failed ETGBD had a longer hospital stay, regardless of whether they underwent surgery.

Several reports have evaluated the factors that increase the success rate of ETGBD. Potential predictive factors include the gallbladder wall thickness, short-axis length of the gallbladder, age, presence of CBD stones, dilation of the CBD, and CD direction[10–12]. In this study, we focused not only on the CD direction but also on the type of branching of the CD. When the branching pattern was divided into four types, the success rate decreased as the branching became more complex. ETGBD was successful in 39 (97.5%) of 40 patients with types I and Δ but in only 22 (71.0%) of 31 patients with types N and M (Table 3). Therefore, the type of branching of the CD seems to be a predictive factor for success. Before performing ETGBD, magnetic resonance cholangiopancreatography should be performed to evaluate the branching of the CD. If a complicated branching type is suspected, it may be necessary to pursue intraductal ultrasonography or prepare various types of cannulas and guidewires.

Our results indicate that positive or negative visualization of the CD also plays a role in ETGBD success. In approximately 38% of the successful procedures, the CD was not visualized from the CBD. By contrast, the CD was visualized from the CD bifurcation in most of the successful procedures, but it was not visualized in half of the failed procedures. This result indicates that even if the CD is not visualized from the CBD, the probability of success is high; if the CD bifurcation is identified by intraductal ultrasonography, then the CD can be visualized from the bifurcation and the contrast agent successfully injected into the gallbladder. Conversely, cases in which the CD is not visualized even by injection from the bifurcation of the CD are unlikely to be successful.

It is important to understand the advantages and disadvantages of ETGBD for preoperative drainage and to perform it only in appropriate cases. The advantages of ETGBD are as follows.

(1) The efficiency is comparable to that of conventional PTGBD. (2) Equivalent effects can be achieved in all severities of AC from grade I to III. (3) ETGBD can potentially contribute to improved quality of life and a reduction in the length of the hospital stay because a tube does not need to be managed outside the body. (4) The ETGBD tube can be removed whenever the cholecystitis improves, whereas the PTGBD tube must be removed after 3 to 4 weeks because it penetrates the liver. (5) ETGBD carries no risk of bleeding.

By contrast, the disadvantages are as follows.

(1) ETGBD has a high degree of difficulty. (2) A longer procedure time is required. (3) The procedure carries a risk of perforation and bile duct injury.

ETGBD must be performed carefully, particularly in patients of advanced age. It is important to understand the advantages and disadvantages of ETGBD, and careful attention should be paid to patient selection.

We compared the present results with those from our previous report that discussed the impact of PTGBD on elective surgeries for AC (Table 7)[17]. There were no significant differences in the patients’ backgrounds or severities of AC. Furthermore, although there was no significant difference in the surgical outcome itself, the PTGBD group tended to have a longer hospital stay, both temporarily before surgery and postoperatively.

The main limitation of this study is that we only evaluated a series of treatment experiences at one institution. A clinical trial with prospective randomized assignment should be performed for comparison with a PTGBD-treated group. However, it is clear that ETGBD is at least as effective as PTGBD and can be an alternative to PTGBD as a bridging therapy prior to elective Lap-C.

ETGBD should be considered as the first-choice preoperative drainage technique instead of conventional PTGBD for patients who are not good candidates for early Lap-C or for whom surgery will be delayed.

Availability of data and materials

All data generated or analyzed during this study are included in the published article.

Acknowledgements

Not applicable.

Funding

This study was not supported by any grants.

Conflicts of Interest

The authors have no conflict of interest to declare.

Authors’ contributions

KS was responsible for the study design and planning, performance of the ETGBD procedure and surgery (Lap-C), analysis of the data, and writing of the article.

HN, EN, NY, TK, and TH performed the ETGBD procedure. KS, YY, and KO participated in the data collection and analysis. AT formulated, designed, and conducted the entirety of the study. All authors approved the final draft submitted. All authors were involved in the writing and revision of the manuscript.

Corresponding author

Correspondence to Keiichi Suzuki.

Ethics approval and consent to participate

This study was approved by the institutional review board comprising the ethical committee (National Hospital Organization, Tochigi Medical Center, Utsunomiya, Japan, No. 2020-17). This study was conducted in accordance with the Ethical Guidelines for Epidemiological Research in Japan and in accordance with the Declaration of Helsinki. All patients provided written informed consent for the endoscopic procedure.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

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Tables 1-7 is available in the Supplementary Files section.

No competing interests reported.

ETGBDtablesetc.xlsx

Download PDF

Journal Publication

published 24 May, 2023

Read the published version in Journal of Clinical Gastroenterology →

Version 1

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You are reading this latest preprint version

Evaluation of the Validity of Endoscopic Transpapillary Gallbladder Drainage for Acute Cholecystitis Based on the Tokyo Guidelines 2018

Status:

Journal Publication

Version 1

Abstract

Figures

Introduction

Methods

Patient selection

Devices for ETGBD

Definitions of technical success and clinical efficiency

Classification of CD branching type and visualization of the CD

Statistical analysis

Results

Patients’ characteristics

Success rate of ETGBD

Comparison of technical success group with failure group

Comparison of severity

Comparison of success versus failure of ETGBD in patients who underwent surgery

Comparison between patients who did and did not undergo surgery among ETGBD cases

Discussion

Conclusions

Declarations

References

Tables

Additional Declarations

Supplementary Files

Status:

Journal Publication

Version 1