Title: Evaluating Nasobiliary and Stent Drainage in Acute Cholecystitis and Cholangitis: Insights from a National Inpatient Survey

doi:10.21203/rs.3.rs-4289420/v1

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Research Article

Title: Evaluating Nasobiliary and Stent Drainage in Acute Cholecystitis and Cholangitis: Insights from a National Inpatient Survey

https://doi.org/10.21203/rs.3.rs-4289420/v1

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Background:

Acute cholecystitis is typically managed with cholecystectomy. However, in patients with underlying co-morbidities who are not suitable for surgery, drainage procedures are recommended. Traditionally, these procedures have been performed percutaneously, but endoscopic techniques have gained popularity in recent years due to their physiological approach and lower complication rates.

Aims:

This study aims to compare endoscopic modalities of drainage (nasobiliary and internal drainage with stenting) in patients with acute cholecystitis and acute cholangitis. We also compared percutaneous drainage with endoscopic retrograde drainage procedures.

Methods:

We analyzed the National Inpatient Sample (NIS) database (2016-2020) to compare outcomes of acute cholecystitis and cholangitis patients undergoing endoscopic nasobiliary drainage and stent placement. Differences in outcomes between percutaneous and various endoscopic drainages were highlighted. Statistical significance was assessed using χ² and t-tests for categorical and continuous data respectively, with P<0.05 considered significant. Multivariate analyses were performed to assess study outcomes and adverse events for each procedure.

Results:

Patients subjected to nasobiliary drainage exhibited a higher mean age compared to those undergoing internal drainage (68.56 +/- 1.84 years vs 64.62 +/- 0.39 years, p-value < 0.05). Both groups shared similar demographic parameters and comorbidities. Internal drainage with stenting correlated with elevated incidences of acute pancreatitis (14.68% vs 13.04%, p-value <0.05) and intestinal perforation (4.24% vs 2.17%, p-value <0.05) compared to nasobiliary drainage. Conversely, nasobiliary drainage was associated with increased occurrences of bleeding (2.17% vs 0.98%, p-value < 0.05) and ileus (10.87% vs 5.22%, p-value < 0.05). Additionally, internal drainage with stenting exhibited a higher rate of subsequent cholecystectomy compared to nasobiliary drainage (3.20% vs 2.17%, p-value < 0.05).

Percutaneous drainage predominated among older individuals (70.36 +/- 0.16 years vs 64.15 +/-0.35, p-value < 0.05). The adjusted odds ratio for mortality for percutaneous drainage versus endoscopic drainage was (5.15 +/- 0.88 vs 0.2 +/- 0.03, p-value < 0.05). Those undergoing endoscopic drainage demonstrated a substantially higher rate of subsequent cholecystectomy (26.50% vs 0.24%, p-value < 0.05).

Conclusion:

Patients undergoing nasobiliary or internal drainage with stent shared similar demographic characteristics and comorbidities. Internal drainage with stenting correlated with a heightened risk of acute pancreatitis and intestinal perforation, whereas bleeding and ileus were more prevalent with nasobiliary drainage. Moreover, internal drainage with stent was associated with a higher incidence of subsequent cholecystectomy.

acute cholecystitis

acute cholangitis

endoscopic retrograde cholangiopancreatography

percutaneous drainage

nasobiliary drainage

Acute cholecystits is a common condition in the United States [1]. Its incidence increased by 44% from 1997 to 2012 [2]. It is usually caused by an obstruction of the cystic duct by a gall stone [3]. The consequences of not treating acute cholecystitis is the development of gallbladder gangrene, perforation leading to sepsis, shock and peritonitis with mortality approaching 65% [4].

The standard of treatment of acute cholecystitis is laparoscopic cholecystectomy [5]. It has been shown to lead to shorter hospital stay, lower complication rates and a better postoperative period [5–7]. Although laparoscopic cholecystectomy is among one of the commonest surgeries, the morbidity can be as high as 50% [8].

In high risk individuals who cannot undergo surgical procedures, nonsurgical interventions like percutaneous or endoscopic drainage is feasible [1]. These procedures can act as temporary measures for conditions like sepsis or temporary organ failure, while they may offer a permanent solution for conditions such as cirrhosis or malignancy [9, 10].

Percutaneous drainage of gallbladder has traditionally been shown to benefit patients with acute cholecystitis in patients who are not a suitable candidate for cholecystectomy [11, 12]. In the more recent times, endoscopic drainage of the gall bladder using endoscopic retrograde cholangiopancreaticography (ERCP) which is another validated procedure has been gaining traction [13–15]. Percutaneous drainage is associated with a requirement of a drain that remains in place for a long period and might result in infection, hematoma formation, peritonitis or non-healing cholecystocutaneous fistula [16]. Endoscopic drainages are also becoming more popular as repeat interventions are not necessary at times [13–15]. Endoscopic drainage can be performed through internal drainage via biliary stenting or external drainage through nasobiliary route [17, 18].

Acute cholangitis is infection of the biliary tree usually secondary to obstruction [19]. The management depends on fluid, antibiotics and drainage usually in the form of endoscopic approach [20]. In altered surgical anatomy or cases where ERCP is not possible, percutaneous drainage can be considered in acute cholangitis [21].

To date, no head-to-head randomized controlled trials have compared nasobiliary and internal drainage with stenting. There is limited data available on the outcomes of endoscopic biliary drainage procedures. This study aims to address this gap by examining mortality, complications, and healthcare utilization using the National Inpatient Sample (NIS) database.

Design and Data Source

This is a cross-sectional retrospective study of the data analyzed from National Inpatient Sample (NIS). The NIS database is the largest publicly available database in the United States for inpatient admissions. NIS database is a part of the Healthcare Cost and Utilization Project (HCUP) sponsored by the Agency for Healthcare Research and Quality (AHRQ). The database represents a 20% sample of all nonfederal US hospital discharges across the United States. This database includes a unique identifier for the hospitalization and clinical information extracted from inpatient and discharge data. It has nearly 100 patient- and hospital-related variables. Quality control procedures performed by HCUP has conducted quality control procedures on the data and have established reliability and accuracy [22]. It has further been demonstrated that the NIS database outcomes are accurate representation of national outcomes especially when diseases are identified using the principal diagnosis. For the purpose of this study, we used the NIS database from year 2016 to 2020. The outcomes from this study can be reliably used to extrapolate the outcomes to all patients undergoing different modality of endoscopic biliary drainage and their comparison. We have further analyzed the differences between percutaneous and endoscopic biliary drainage among patient with acute cholecystitis and cholangitis regardless of the etiology.

Study Population

The study population consisted of all hospitalized adult patients of age eighteen and over with the primary diagnosis of acute cholecystitis (acute, acute on chronic and unspecified) and acute cholangitis from the year 2016–2020. The patients who underwent more than one procedure were excluded in order to get a clearer picture of each procedure outcome. We chose to study the outcomes of endoscopic nasogastric biliary drainage and endoscopic biliary stenting and their complications which has not been studied until now for the given years. We further went on to identify the differences in outcomes of percutaneous biliary drainage and endoscopic biliary drainage.

The study population was selected based on procedural coding in accordance with the International Classification of Diseases, Tenth Revision (ICD-10). The principal diagnoses of acute cholecystitis and cholangitis were identified using ICD-10 diagnostic codes K81.0, K81.2 K81.9 and K83.0. Patients who underwent percutaneous biliary drainage were identified with procedural codes 0F753DZ, 0F753ZZ,0F754,0F773ZZ, 0F774DZ, 0F774ZZ, 0F783DZ, 0F783ZZ", 0F784DZ, 0F784ZZ, 0F793ZZ ,0F793DZ, 0F793ZZ, 0F794DZ, 0F794ZZ, 0F7C3ZZ, 0F9430Z, 0F784ZZ, 0F9530Z, 0F9630Z, 0F9730Z and 0F9930Z". Similarly, patients who underwent endoscopic biliary drainage were identified with the following procedural codes, 0F758DZ, 0F768DZ, 0F788DZ, 0F798DZ`var' 0F7C8DZ, 0F7C8ZZ, 0F9C8ZZ, 0F9580Z, 0F9680Z, 0F9880Z, 0F9C80Z, 0F9C80Z, 0F758DZ, 0F788ZZ, 0F798ZZ, 0F7C8ZZ, 0F9C8ZZ, 0F9580Z, 0F79680Z, 0F9880Z and 0F9980Z.

Outcome and Predictor Variables

The primary outcomes evaluated were ERCP guided biliary drainage by nasobiliary drain or stent placement in patients with acute cholangitis and cholecystitis. We also focused on the outcome differences in percutaneous biliary drainage and endoscopic modality of biliary drainage in our study population. We further studied the adverse outcomes in each sub group which consisted of acute pancreatitis, perforation, bleeding (external and internal), peritonitis (including choleperitonitis) and ileus. We also studied the incidence of cholecystectomy in each subgroup. The secondary outcomes evaluated included length and total cost of hospitalization. We evaluated the comorbidities using the Charleston comorbidity index. The Charlson Comorbidity Index (CCI) originally was developed to predict the risk of mortality within 1 year of hospitalization. It assigns scores based on various comorbidities, with each assigned a weighted integer ranging from one to six, reflecting the severity of the condition. A CCI score of 1–2 or a score of ≥ 3, in contrast to a score of 0, has been linked with a higher likelihood of mortality and is correlated with a composite of adverse outcomes [23]. The results of the primary and secondary outcomes were adjusted for the comorbidities and demographic confounders. The odd’s ratio has also been adjusted for the comorbidities and demographic variables including age, race/ethnicity, health insurance, comorbidity, hospital bed-size, teaching hospital status, hospital region and location (rural/urban) and median household income.

Statistical Analysis

Data analysis was performed using STATA statistical software (version 18; STATA/ Standard Edition). Statistical analysis using the χ² test for categorical data and t test for continuous data were performed. P < .05 was considered statistically significant. Multivariate analysis were performed to assess study outcomes including adverse events for each procedures mentioned. To address independent relationship between various intervention modalities, we also used logistic regression to assess the association between adverse events and type of procedure while adjusting for age, race/ethnicity, health insurance, comorbidity, hospital bed size, teaching hospital status, hospital region and location (rural/urban) and median household income. Data analyses and interpretation were validated by multiple authors to eliminate potential bias.

Ethical Considerations

The present study was exempt from institutional review board of John H. Stroger Jr. Hospital of Cook County as NIS sample uses unidentified data in keeping with HIPPA. A data user agreement was completed with AHQR prior to the study.

There were a total of 52230 patients included in the study. Those who underwent endoscopic biliary drainage were 10360 and 41870 underwent percutaneous drainage. Among the patient who underwent biliary drainage, stent was placed in 9700 cases and 259 patients underwent nasobiliary drainage.

The average age of patients undergoing nasobiliary drainage was 68.56 +/- 1.84 years, while for those undergoing internal drainage with a stent, it was 64.62 +/- 0.39 years (p-value < 0.05). However, there were no significant differences among the groups in terms of gender, race, comorbidities, insurance category, and median household income as demonstrated in Table 1. The adjusted odds ratio for mortality for nasobiliary drainage was 0.66 +/- 0.47, and for internal drainage with a stent, it was 0.24 +/- 0.01 with a p-value of 0.32. Hospital stays for nasobiliary drainage averaged 9.82 +/- 1.06 days, with total costs of $124,628 +/- $17,498, whereas for internal drainage with a stent, stays averaged 9.59 +/- 0.27 days, with costs of $128,882 +/- $4,854. Endoscopic drainage with a stent was linked to higher rates of acute pancreatitis (14.68% vs. 13.04%, p-value < 0.05) and intestinal perforation (4.24% vs. 2.17%, p-value < 0.05) compared to nasobiliary drainage. Conversely, nasobiliary drainage was associated with higher incidences of bleeding (2.17% vs. 0.98%, p-value < 0.05) and ileus (10.87% vs. 5.22%, p-value < 0.05) compared to endoscopic drainage with a stent. Moreover, internal drainage with a stent was correlated with a higher rate of subsequent cholecystectomy compared to nasobiliary drainage (3.20% vs. 2.17%, p-value < 0.05). Further clinical outcomes are presented in Table 2.

Patients undergoing percutaneous biliary drainage were older (70.36 +/- 0.16 years) compared to those undergoing endoscopic drainage (64.15 +/-0.35 years), with a statistically significant p-value < 0.05. Additionally, a higher proportion of patients with a Charlson comorbidity index of 3 or more underwent percutaneous drainage compared to endoscopic drainage (51.20% vs. 38.56%, p-value < 0.05). The details are provided in Table 3. The adjusted odds ratio for mortality was significantly higher for patients undergoing percutaneous drainage (5.15 +/- 0.88) compared to endoscopic drainage (0.2 +/- 0.03, p-value < 0.05). Percutaneous drainage was associated with longer hospital stays (11.39 +/- 0.14 days) and higher costs ($147,437 +/- $3,141.28) compared to endoscopic drainage (8.86 +/- 0.21 days and $119,776.3 +/- $3,793.5, respectively, p-value < 0.05). Moreover, patients undergoing endoscopic drainage had a notably higher rate of subsequent cholecystectomy compared to those undergoing percutaneous drainage (26.50% vs. 0.24%, p-value < 0.05). Further clinical outcomes are presented in Table 4.

Table 1

Demographic and clinical characteristics of patients undergoing nasobiliary and internal drainage with stent
	Nasobiliary drainage	Internal drainage with stent	p-value
Mean Age	68.56 +/- 1.84	64.62 +/- 0.39	0.23
Age Category			< 0.05
18 to 45	4.35%	11.81%
45 to 65	32.61%	32.22%
More than 65	63.04%	55.97%
Female	38.94%	38.42%	< 0.05
Race			0.2
White	76.09%	67.97%
Blacks	10.87%	9.26%
Hispanics	2.17%	12.20%
Others	10.87%	10.57%
Charleston comorbidity Index			0.34
0	31.25%	23.22%
1	15.62%	19.69%
2	12.50%	15.74%
> = 3	40.62%	41.36%
Insurance Category			0.64
Medicare	71.74%	57%
Medicaid	8.70%	12.50%
Private	15.22%	26.28%
Others	4.35%	3.76%
Median Household Income			0.4
1 to 24999	37.21%	27.42%
25000 to 34999	16.28%	26.56%
35000 to 44999	32.56%	24.97%
45000 or more	13.95%	21.06%
Regional Hospital			0.28
Northeast	23.91%	20.22%
Mid-West	21.74%	23.55%
South	30.88%	36.14%
West	13.04%	20.09%
Hospital Location			0.5
Rural	2.17%	3.26%
Urban	97.83%	96.74%
Hospital Type			0.07
Non-teaching	19.57%	22.90%
Teaching	80.43%	77.10%

Table 2

Clinical outcomes of patients undergoing nasobiliary and internal drainage with stent
	Nasobiliary drainage	Internal drainage with stent	p-value
Adjusted OR for mortality	0.66 +/- 0.47	0.24 +/- 0.01	0.32
Length of Hospital stay	9.82 +/- 1.06 days	9.59 +/- 0.27 days	< 0.05
Total charge	124628 +/- 17498	128882 +/- 4854	< 0.05
Complications
Acute pancreatitis	13.04%	14.68%	< 0.05
Bleeding	2.17%	0.98%	< 0.05
Perforation	2.17%	4.24%	< 0.05
Peritonitis	6.52%	6.50%	0.32
Ileus	10.87%	5.22%	< 0.05
Cholecystectomy	2.17%	3.20%	< 0.05

Table 3

Demographic and clinical characteristics of patients undergoing percutaneous drainage and endoscopic drainage
	Percutaneous biliary drainage	Endoscopic drainage	p-value
Mean Age	70.36 +/- 0.16	64.15 +/-0.35	< 0.05
Age Category			< 0.05
18 to 45	5.77%	12.89%
45 to 65	25.10%	32.24%
More than 65	69.13%	54.87%
Female	37.90%	43.63%	< 0.05
Race			< 0.05
White	66.88%	67.86%
Blacks	4.35%	9.41%
Hispanics	10.62%	12.40%
Others	10.15%	10.62%
Charleston comorbidity Index			< 0.05
0	13.59%	25.88%
1	17.67%	19.95%
2	17.53%	15.62%
> = 3	51.20%	38.56%
Insurance Category			< 0.05
Medicare	70.25%	57%
Medicaid	9.94%	13.03%
Private	17.64%	26.65%
Others	2.17%	3.73%
Median Household Income			0.4
1 to 24999	27.18%	28.03%
25000 to 34999	25.25%	26.11%
35000 to 44999	24.63%	24.69%
45000 or more	22.94%	21.17%
Regional Hospital			< 0.05
Northeast	24.80%	20.03%
Mid-West	21.49%	22.35%
South	34.28%	36.97%
West	19.43%	20.66%
Hospital Location			0.4
Rural	3.55%	3.23%
Urban	96.45%	96.77%
Hospital Type			0.58
Non-teaching	20.29%	24.32%
Teaching	79.91%	75.68%

Table 4

Clinical outcomes of patients undergoing percutaneous drainage and endoscopic drainage
	Percutaneous biliary drainage	Endoscopic drainage	p-value
Adjusted OR for mortality	5.15 +/- 0.88	0.2 +/- 0.03	< 0.05
Length of Hospital stay	11.39 +/- 0.14 days	8.86 +/- 0.21 days	< 0.05
Total charge	147437 +/- 3141.28	119776.3 + 3793.5	< 0.05
Complications
Acute pancreatitis	3.90%	14.96%	< 0.05
Bleeding	0.43%	0.92%	< 0.05
Perforation	3.01%	3.43%	< 0.05
Peritonitis	3.51%	5.50%	< 0.05
Ileus	5.87%	0.16%	0.2
Cholecystectomy	0.24%	26.50%	< 0.05

In our study, we found that patients undergoing nasobiliary drainage were significantly older than those undergoing endoscopic drainage with stenting. Similarly, in a single-center retrospective analysis, no difference in age was observed between the two groups of patients undergoing endoscopic retrograde biliary drainage via stent or nasobiliary drainage for malignant biliary obstruction [24].

In our study, we found no significant differences among the groups undergoing nasobiliary drainage or internal drainage with a stent in terms of gender, race, comorbidities, insurance category, and median household income. This suggests that the two groups were similar in baseline characteristics. Furthermore, the limited data categories in nasobiliary drainage may have hindered the detection of statistical significance. Additionally, there were no statistically significant differences between the two groups in terms of mortality, length of hospital stay, or total cost incurred. However, naso-biliary drainage is considered to be superior to stenting alone as it is more physiological [25].

Endoscopic approach with stenting was associated with increased rates of acute pancreatitis and intestinal perforation. It is similar to the findings of a meta-analysis analyzing the use of those two techniques in malignant perforation [25]. Another meta-analysis analyzing these two interventions for malignant obstruction of the biliary tree done by Lin et al. had similar findings [26]. In a randomized study done by Sharma et.al, the success rates of biliary drainage in cholangitis did not depend on the approach, no ERCP related complications were noted and it was concluded that both the procedures were equally safe and effective [27]. However, it's important to note that the previous study was limited to cholangitis patients only and was conducted about two decades earlier. In contrast, our study includes both acute cholecystitis and cholangitis cases, utilizing real-world data from a larger and more recent dataset. This broader scope enhances the generalizability and relevance of our findings to current clinical practice. Our study also demonstrated that endoscopic drainage with stenting had a statistically significant increased rate of cholecystectomy. However, a retrospective study determined that nasobiliary drainage was similar in outcomes in terms of cholecystectomy to endoscopic drainage with stenting in patient with calculous cholecystitis [28].

Patients undergoing percutaneous drainage were found to be older than those undergoing endoscopic drainage. This is similar with another study using the NIS database from 2005 to 2014, which showed that patients undergoing percutaneous drainage for acute cholecystitis were significantly older compared to those undergoing cholecystectomy or no intervention [29]. However, various meta-analyses analyzing different drainage modalities for cases of acute cholecystitis and malignant obstruction have shown no correlation with age [30, 31].

Patients with co-morbidity burden were more likely to undergo percutaneous drainage rather than endoscopic drainage. Another NIS database study comparing ERCP with percutaneous drainage had similar findings [32].

Our study determined that the length of hospital stay as well as the cost incurred were higher for patients undergoing percutaneous drainage. Various other studies have concluded similar findings [32, 33].

In our study, endoscopic drainage was significantly associated with increase in acute pancreatitis, perforation, and peritonitis. However, in a study that utilized these procedures as a bridge before cholecystectomy in cases of acute cholecystitis, percutaneous versus endoscopic drainage showed no difference in postoperative complications [34].

Study Limitations:

This study is limited to inpatient data from the years 2016 to 2020. Since the data relies on admission diagnoses, establishing causal or temporal relationships between diagnoses and procedures is challenging, potentially hampering causal associations drawn from the data. Furthermore, the management of acute cholecystitis often hinges on its underlying cause, yet the NIS database restricts the analysis in this regard. Another significant limitation to consider is the potential for incorrect code assignment for both disease processes and procedures performed. This is particularly important as endoscopists increasingly adopt EUS-guided biliary drainage procedures, for which specific ICD codes may be lacking. The introduction of new ICD codes may indeed be necessary to accurately distinguish specific procedures, particularly in this evolving field. By refining coding systems to capture the nuances of different procedures, healthcare professionals can improve data accuracy, facilitate research, and enhance clinical decision-making.

Patients undergoing nasobiliary or internal drainage with a stent exhibited similar demographic characteristics and comorbidities. However, internal drainage with stenting was associated with a heightened risk of acute pancreatitis and intestinal perforation, while bleeding and ileus were more prevalent with nasobiliary drainage. Additionally, internal drainage with a stent was linked to a higher incidence of subsequent cholecystectomy. Further studies with larger sample sizes are necessary to accurately assess the statistical association between these procedures.

Acknowledgements: None

Author's contribution:

Ayusha Poudel and Anurag Adhikari contributed towards the conceptualization, data analysis and manuscript writing and editing. Aayush Poudel contributed towards data analysis and manuscript writing and editing. Eric Montminy contributed in conceptualization, supervision, validation, manuscript writing and revisions.

Funding: None

Data availability: The National Inpatient Sample (NIS) is a publicly available dataset.

Conflict of Interest: The authors declare that the study was performed in the absence of conflict of interest.

Ethical approval: The data utilized in this study were from National Inpatient Sample (NIS) database. Informed patient consent and Institutional Review Board clearance were not required due to the nature of data.

AHRQ Agency for Healthcare Research and Quality

ERCP Endoscopic retrograde cholangiopancreatography

HCUP Healthcare Cost and Utilization Project

ICD International Classification of Diseases

NIS National Inpatient Sample

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Title: Evaluating Nasobiliary and Stent Drainage in Acute Cholecystitis and Cholangitis: Insights from a National Inpatient Survey

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Methods

Design and Data Source

Study Population

Outcome and Predictor Variables

Statistical Analysis

Ethical Considerations

Results

Discussion

Study Limitations:

Conclusion

Declarations

Abbreviations

References

Additional Declarations

Status:

Version 1