Safety and Efficacy of Using Stapler Device for Wide Cystic Duct Ligation in Acute Setting of Laparoscopic Cholecystectomy

doi:10.21203/rs.3.rs-4707439/v1

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Safety and Efficacy of Using Stapler Device for Wide Cystic Duct Ligation in Acute Setting of Laparoscopic Cholecystectomy

https://doi.org/10.21203/rs.3.rs-4707439/v1

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Introduction:

This research explores the challenges posed by variations in cystic duct anatomy during laparoscopic cholecystectomy and the potential use of stapler devices to address such complexities. It aims to assess the safety and efficacy of stapler devices, particularly in cases involving short, and wide cystic duct.

Methodology:

The study, conducted at King Abdulaziz Medical City in Riyadh, Saudi Arabia, between 2021 and 2023. The study design involved a retrospective cohort approach, and the sample size encompassed all cases meeting the inclusion criteria during the study period. Data was analyzed using SPSS program.

Results

The study involving 568 patients, with the predominant technique for ligation being clipping (89.3%). The primary indication for using the Endo GIA stapler was a wide cystic duct (6.2%). Analysis revealed a significant association between stapler device use and hypertension (p = 0.042), diabetes (p = 0.001), CKD (p = 0.011), and obstructive jaundice (p = 0.006). Multivariate regression demonstrated that older patients were 2.1 times more likely to use stapler devices (AOR = 2.125; p = 0.039), while those with obstructive jaundice had a 2.2 times higher likelihood (AOR = 2.168; p = 0.049).

Discussion

Conclusion

Use of Endo-GIA is a safe and effective method for patients with wide, short cystic duct. Selective usage of endo-GIA is considered cost effective and may add a positive impact in decreasing post operative biliary leak.

Health sciences/Anatomy

Health sciences/Gastroenterology/Gastrointestinal diseases

Health sciences/Signs and symptoms/Vomiting

Laparoscopic cholecystectomy

cystic duct

stapler devices

Endo-GIA

complications

Bile acid production and its essential role in the digestive process underscore the significance of an unimpeded biliary system¹. However, disruptions such as stones in the gallbladder can lead to acute cholecystitis, a painful condition affecting a notable percentage of individuals². The prevalent shift from open cholecystectomy to laparoscopic cholecystectomy has brought forth a transformative era in treating acute cholecystitis³, with documented advantages in terms of postoperative morbidity⁴. Challenges arise during laparoscopic cholecystectomy, particularly when dealing with variations in the cystic duct anomalies, inflammation, short length, or increased width can complicate the process of ligation⁵. In response to these challenges, the utilization of a stapler device has emerged as a potential solution to effectively occlude the duct and prevent undesirable leakage⁶. Despite its application, concerns persist regarding the safety and efficacy of the stapler device, with potential complications including peritonitis, sepsis, and fistulas^7,8. Particularly alarming is the increased risk of mortality associated with bile leakage postoperatively⁹. This research addresses the existing uncertainties surrounding the use of stapler devices in laparoscopic cholecystectomy, specifically focusing on cases with wide cystic ducts. The study aims to assess the safety, efficacy, and possible application of stapler devices in the laparoscopic cholecystectomy procedure. This article seeks to contribute valuable recommendations regarding practicality and outcomes associated with stapler device utilization during laparoscopic cholecystectomy for patients with wide cystic ducts. The findings aim to not only to improve the surgeons’ experience, and surgical practices, but also aid in enhancing patient outcomes and minimizing potential risks associated with this innovative approach. This research endeavors to bridge the existing gap in evidence, offering a clearer understanding of the role of stapler devices in the evolving landscape of laparoscopic cholecystectomy for a diverse patient population.

The study, conducted at King Abdulaziz Medical City in Riyadh, Saudi Arabia, aimed to assess the safety and efficacy of using stapling devices in laparoscopic cholecystectomy procedures performed between January 2021 and September 2023. Ethical approval was obtained from the Institutional Review Board at King Abdullah International Medical Research Center (KAIMRC), IRB approval number. : 2785/23, and the research was performed in accordance with relevant guidelines, and regulations. All patients meeting the inclusion criteria were included in this retrospective cohort study, with data sourced from the hospital’s chart review system, BESTCare. The inclusion criteria included patients who underwent laparoscopic cholecystectomy with stapling device usage during the specified period and had available intraoperative reports. Exclusion criteria excluded individuals aged less than 14 or older than 70, those without evidence of acute cholecystitis in the case of cholelithiasis, patients with known malignancy, those undergoing cholecystectomy as part of another major abdominal surgery, and individuals with cystic duct ligation using three 10 mm clips. The study design involved a retrospective cohort approach, and the sample size encompassed all cases meeting the inclusion criteria during the study period. No specific sampling or randomization was necessary, as all eligible patients admitted for laparoscopic cholecystectomy were automatically included. Data collection involved extraction from the BestCare system, utilizing a customized electronic data collection sheet. This sheet encompassed various parameters, including demographics (age, gender, BMI, smoking status), underlying medical conditions, preoperative diagnosis, morbidity, and management, radiological findings, and details of the intraoperative technique.

Statistical Analysis

The data were analyzed using the software program Statistical Packages for Software Sciences (SPSS) version 26 (Armonk, New York, IBM Corporation, USA). Categorical variables were given as numbers and percentages. Continuous variables were calculated and presented as mean and standard deviation. The relationship between the ligation technique according to the patient's demographic, clinical characteristics, management, and outcome of the patients has been conducted using the Chi-square test and independent sample t-test. Significant results were then gathered in a multivariate regression model to determine the independent significant factors associated with the stapler device. Values were considered significant with a p-value of less than 0.05.

This study analyzed 568 patients. 8.6% were referred to ERCP, with the predominant technique for ligation being clipping (89.3%). The primary indication for using the Endo GIA stapler was a wide cystic duct (6.2%). Analysis revealed a significant association between stapler device use and hypertension (p = 0.042), diabetes (p = 0.001), CKD (p = 0.011), and obstructive jaundice (p = 0.006). The stapler technique was also linked to an extended hospital stay (p < 0.001). Multivariate regression demonstrated that older patients were 2.1 times more likely to use stapler devices (AOR = 2.125; p = 0.039), while those with obstructive jaundice had a 2.2 times higher likelihood (AOR = 2.168; p = 0.049). Increasing hospital stay showed a marginal association with stapler device use (AOR = 0.913; p = 0.004), but chronic diseases like hypertension, diabetes, and CKD did not significantly influence stapler device usage (p > 0.05).

As seen in Table 1, the patient's mean age was 45.9 (SD 13.2) years, with 23.8% aged between 50 and 60 years old. Approximately 60% were female patients, and 53.2% were considered obese. The prevalence of smoking was 15.3%. Acute cholecystitis was the most prominent diagnosed disease. Clinical presentation mainly was positive Murphy (60.2%). The most common finding based on imaging was the presence of cholelithiasis in combination with the sonographic Murphy sign (73.6%). In addition, the mean duration between diagnosis and operation date was 11.5 (SD 63.5) days.

Table 1

Demographic and clinical characteristics of the patients ^(n=568)
Study variables	N (%)
Age group (mean ± SD)	45.9 ± 13.2
• 16–30 years	82 (14.4%)
• 31–40 years	135 (23.8%)
• 41–50 years	124 (21.8%)
• 51–60 years	135 (23.8%)
• 61–70 years	92 (16.2%)
Gender
• Male	227 (40.0%)
• Female	341 (60.0%)
BMI level
• Underweight (< 18.5 kg/m2)	07 (01.2%)
• Normal (18.5–24.9 kg/m2)	86 (15.1%)
• Overweight (25–29.9 kg/m2)	173 (30.5%)
• Obese (≥ 30 kg/m2)	302 (53.2%)
Smoking
• No	481 (84.7%)
• Yes	87 (15.3%)
Diagnosis
• Acute Chole	477 (84.0%)
• Non-Acute Chole	81 (14.3%)
• Biliary Pancreatitis	05 (0.90%)
• Acute Chole and Biliary Pancreatitis	05 (0.90%)
Clinical presentation
• Positive murphy	342 (60.2%)
• Biliary pancreatitis	15 (02.6%)
• Obstructive jaundice	49 (08.6%)
Imaging findings
• Presence of cholelithiasis in combination with the sonographic Murphy sign	418 (73.6%)
• Pericholecystic fluid	228 (40.1%)
• Gallbladder wall thickening (> 3 mm)	343 (60.4%)
• Adematous wall thickening	19 (03.3%)
• Others (i.e., hyperemia, gangrenous, etc.)	31 (05.5%)
Duration between diagnosis and the date of operation in days (mean ± SD)	11.5 ± 63.5
BMI – Body Mass Index

In Fig. 1, the most commonly associated chronic disease was diabetes (22.5%), followed by hypertension (19.7%) and DLP (15%).

In Table 2, patients who were referred to ERCP constitute 8.6%. The most frequently used technique for ligation was clipped (89.3%), while the most common reason dictated for Endo GIA stapler use was wide cystic duct (6.2%). Collection was the most common postop complication, and IR drainage was the most commonly used management for complication (1.8%). One patient did not survive after the procedure due to another unrelated cause (intracranial hemorrhage secondary to sickle cell anemia). The mean length of hospital stay was 4.33 (SD 3.84) days.

Table 2

Management and outcome ^(n=568)
Variables	N (%)
ERCP needed
• No	519 (91.4%)
• Yes	49 (08.6%)
Technique of ligation
• Clipped	507 (89.3%)
• Endo-GIA	55 (09.7%)
• Endo-loop	03 (0.50%)
• Other	03 (0.50%)
Reason dictated for Endo GIA stapler use
• Wide cystic duct	35 (06.2%)
• Short and wide cystic duct	18 (03.2%)
• Other reason	10 (01.8%)
Postop complication
• Bile	01 (0.20%)
• CBD injury	0
• Collection	16 (02.8%)
• Other	17 (03.0%)
Management of complication
• IR drainage	10 (01.8%)
• ERCP stenting	01 (0.20%)
• Others	21 (03.7%)
Mortality
• No	567 (99.8%)
• Yes	01 (0.20%)
Length of hospital stay in days (mean ± SD)	4.33 ± 3.84
IR – Interventional Radiology
ERCP – Endoscopic Retrograde Cholangiopancreatography

When measuring the relationship between the type of technique ligation according to the demographic, clinical characteristics, management, and outcome of the patients (Table 3), it was observed that the prevalence of patients who used stapler device was significantly more common among those with hypertension (p = 0.042), diabetes (p = 0.001), CKD (p = 0.011), and obstructive jaundice on clinical presentation (p = 0.006). Also, the stapler device technique was more associated with increasing days of hospital stay (p < 0.001).

Table 3

Relationship between the technique of ligation among demographic, clinical characteristics, management, and outcome of the patients ^(n=568)
Factor	Technique of ligation		P-value ^§
Factor	Stapler device N (%) ⁽ⁿ⁼⁶¹⁾	Clipped N (%) ^(n=507)	P-value ^§
Age group
• ≤ 40 years	12 (19.7%)	205 (40.4%)	0.002 **
• > 40 years	49 (80.3%)	302 (59.6%)	0.002 **
Gender
• Male	30 (49.2%)	197 (38.9%)	0.120
• Female	31 (50.8%)	310 (61.1%)	0.120
BMI level
• Normal or underweight	11 (18.0%)	82 (16.2%)	0.711
• Overweight or obese	50 (82.0%)	425 (83.8%)	0.711
Smoking
• No	49 (80.3%)	432 (85.2%)	0.317
• Yes	12 (19.7%)	75 (14.8%)	0.317
Associated chronic disease
• Hypertension	18 (29.5%)	94 (18.5%)	0.042 **
• Diabetes	24 (39.3%)	104 (20.5%)	0.001 **
• CHF	02 (03.3%)	07 (01.4%)	0.262
• CKD	04 (06.6%)	08 (01.6%)	0.011 **
• Pulmonary disease	08 (13.1%)	34 (06.7%)	0.071
• Others	26 (42.6%)	175 (34.5%)	0.211
Diagnosis
• Acute Chole	50 (82.0%)	427 (84.2%)	0.383
• Non-Acute Chole	11 (18.0%)	70 (13.8%)
• Acute Chole and Biliary Pancreatitis	0	10 (02.0%)
Clinical presentation
• Positive murphy	35 (57.4%)	307 (60.6%)	0.632
• Biliary pancreatitis	02 (03.3%)	13 (02.6%)	0.742
• Obstructive jaundice	11 (18.0%)	38 (07.5%)	0.006 **
Imaging findings
• Presence of cholelithiasis	44 (72.1%)	374 (73.8%)	0.784
• Pericholecystic fluid	24 (39.3%)	204 (40.2%)	0.893
• Gallbladder wall thickening (> 3 mm)	40 (65.6%)	303 (59.8%)	0.381
• Others	16 (26.2%)	82 (16.2%)	0.071
Postop complication
• No	55 (90.2%)	484 (95.5%)	0.076
• Yes	06 (09.8%)	23 (04.5%)	0.076
Mortality
• No	60 (98.4%)	506 (99.8%)	0.203
• Yes	01 (01.6%)	01 (0.20%)	0.203
	Mean ± SD	Mean ± SD	P-value ^‡
Duration from diagnosis to operation in days	12.2 ± 36.4	11.4 ± 66.0	0.931
Length of hospital stay in days	6.52 ± 6.25	4.06 ± 3.35	< 0.001 **
^§ P-value has been calculated using Chi-square test.
^‡ P-value has been calculated using independent sample t-test.
** Significant at p < 0.05 level.

When conducting a multivariate regression model (Table 4), it was found that compared to the younger age group, older patients were 2.1 times more likely to use stapler device technique (AOR = 2.125; 95% CI = 1.041–4.341; p = 0.039). Patients with obstructive jaundice were 2.2 times more likely to use the stapler device technique (AOR = 2.168; 95% CI = 1.004–4.685; p = 0.049). However, increasing days of hospital stay were associated with marginal use of the stapler device technique (AOR = 0.913; 95% CI = 0.859–0.971; p = 0.004). On the other hand, associated chronic diseases such as hypertension, diabetes, and CKD did not significantly influence the use of stapler devices after adjustment to a regression model (p > 0.05).

Table 4

Multivariate regression analysis to determine the factors that influence stapler device ^(n=568)
Factor	AOR	95% CI	P-value
Age group
• ≤ 40 years	Ref
• > 40 years	2.125	1.041–4.341	0.039 **
Associated chronic disease
• Hypertension	0.802	0.384–1.676	0.557
• Diabetes	1.897	0.959–3.749	0.066
• CKD	1.076	0.233–4.961	0.926
Obstructive jaundice	2.168	1.004–4.685	0.049 **
Length of hospital stay in days	0.913	0.859–0.971	0.004 **
AOR – Adjusted Odds Ratio; CI – Confidence Interval; CKD – Chronic Kidney Disease.
** Significant at p < 0.05 level.

Throughout the years, metal clips have shown the best prognosis compared to any other method for securing the cystic duct during closure in laparoscopic cholecystectomy. However, to avoid incomplete sealing of wide, short, or inflamed ducts, other instruments have emerged as possible alternatives for such conditions ¹⁰. The findings of this study demonstrate that the application of stapler devices for wide or short ducts has high rates of safety and efficacy. Acute care surgeons applied endo-GIA in 55 patients, revealing no significant post-operative bile leakage, common bile duct injury, or collections, nor an increase in mortality rates. On the other hand, a significant difference appeared in the hospital length of stay for cases where stapler devices were applied compared with metal clips.

Previously conducted research disclosed the safety of the devices. In a study conducted by M. Odabasi et al. on 19 patients using Endo-GIA for the closure of the cystic duct, with an average age of 62 years, none of them experienced intraoperative or postoperative complications. Surprisingly, the hospital length of stay was only 3.4 days, which showed approximately a twofold increase compared to our results⁶. This gap is a consequence of the lack of evidence supporting stapler usage in laparoscopic cholecystectomy. As a result, surgeons may increase the hospital stay for faster intervention in case of any possible complications in the first few days after the operation. Another retrospective study on 24 patients in Taipei, Taiwan, reported that 2 of them had postoperative complications¹¹. The first patient had a residual stone in the CBD, and the second had CBD injury as a result of additional metallic clips used for managing cystic duct bleeding. This contributes to the efficiency of staplers, as both complications were not related to them.

In 2009, a case report on 3 adults claimed that using staplers is dangerous for the closure of the cystic duct (CD) in laparoscopic cholecystectomy (LC). This assertion stemmed from the serious complications reported postoperatively, where staplers were used for the same indication, which is wide cystic ducts¹². Our study, which has satisfying statistical evidence, observed 35 patients with wide cystic ducts and supports the use of stapler closure.

Regarding the association between the technique of ligation and chronic medical conditions, the Saudi Arabian population has a high prevalence of diabetes mellitus (DM), hypertension (HTN), and chronic kidney disease (CKD). According to a nationwide cohort study on 18,034 patients, DM affects 25.4% of the population, a statistic supported by the World Health Organization (WHO), which ranks the Saudi Arabian population as the 7th most affected by DM worldwide^13,14. Moreover, a meta-analysis conducted to assess hypertension in Saudi Arabia revealed that 22.66% of 272,378 individuals were hypertensive¹⁵. Additionally, another study observed that 9,892 per 100,000 individuals in the Saudi population have CKD¹⁶. These statistics provide a reasonable explanation as to why chronic conditions are not considered independent risk factors for stapler application.

In our study, obstructive jaundice was the only clinical feature that increased the incidence of stapler use, raising questions about which signs and symptoms most commonly lead surgeons to use staplers and the relevance between obstructive jaundice and wide, short, or inflamed cystic ducts.

These results will significantly influence clinical practice as they demonstrate the reliability and feasibility of stapler devices, which will decrease the economic burden by reducing hospital length of stay. Additionally, it opens multiple fields where these devices could be used. Furthermore, it will aid in the implementation of these devices with no fear of serious complications and provide safe alternatives to metal clips in wide and short cystic ducts.

To sum up, the use of Endo-GIA is safe and effective method for patients with wide, short cystic duct. Selective usage of endo-GIA is considered cost effective and may add positive impact in decreasing post operative biliary leak ¹⁷.

In addressing the limitations of this study, the type of Endo-GIA, and other staplers were not specified. Moreover, while assessing the width and length of the cystic duct, the decision relied on the surgeon’s expertise to be applied and not on specific measures for the cystic duct dimensions, which may introduce a degree of subjectivity. These limitations lead us to initiate research on the safety and efficacy of different subtypes of stapler devices individually, as well as to study various types of cystic duct anomalies to prevent potential future complications, morbidities, and mortalities. Future research may also focus on a larger sample size and include different populations and races, as well as utilize imaging and radiology before surgeries to assess the cystic duct size.

‏The primary ligation technique and largely used is clipping technique, while the use of the Endo GIA stapler was notably associated with cases featuring a wide, short cystic duct. The Endo GIA stapler, when judiciously applied in laparoscopic cholecystectomy for patients with a wide, short cystic duct, presents an opportunity for enhanced safety and efficacy. Multivariate regression demonstrated that older age and the presence of obstructive jaundice increased the likelihood of stapler device utilization. These findings underscore the importance of personalized approaches in biliary surgeries, taking into account patient characteristics and clinical presentations for optimal outcomes.

DLP- Dyslipidemia

LC-laparoscopic cholecystectomy

CD-Cystic duct

BMI – Body Mass Index

IR – Interventional Radiology

ERCP – Endoscopic Retrograde Cholangiopancreatography

CHF – Congestive heart failure

CKD – chronic kidney disease

Ethics approval and consent to participate

Ethical approval was obtained from the Institutional Review Board at King Abdullah International Medical Research Center (KAIMRC). Due to the retrospective nature of the study IRB approval No. : IRB/2785/23, and study number: NRC23R/651/10 waived the need of obtaining informed consent.

Competing interests:

No conflicts of interest to declare.

Funding:

There was no financial support

Author Contribution

all authors (Rifan Alyami, Ahad Alotaibi, Bader Alhoumaily, Ibrahim Momen, Hatem Aljanfawe, Marya Algoblan) contributed equally to this work

Acknowledgements:

none

Data Availability

The datasets analysed during the current study available from the corresponding author on reasonable request.

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No competing interests reported.

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You are reading this latest preprint version

Safety and Efficacy of Using Stapler Device for Wide Cystic Duct Ligation in Acute Setting of Laparoscopic Cholecystectomy

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Introduction:

Methodology:

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Discussion

Conclusion

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Introduction

Methodology

Statistical Analysis

Results

Discussion

Conclusion

Abbreviations

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Ethics approval and consent to participate

Competing interests:

Funding:

Author Contribution

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References

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