Common bile duct stones are a significant cause of morbidity, often resulting in complications like cholangitis, pancreatitis, and biliary colic. While endoscopic and surgical interventions have advanced, predicting the occurrence of complications remains challenging.^[1] The gallbladder plays a pivotal role in bile storage and secretion, and its dysfunction may exacerbate biliary pathology. ^[2]  

Previous studies have suggested that gallbladder motility, assessed via ejection fraction (EF), may offer valuable insight into the progression of biliary disease. Impaired gallbladder function has been associated with an increased risk of biliary complications in patients with gallstones, but its specific predictive value in CBD stone patients is still debated. [3]

In patients with CBDS and an intact gallbladder, the management of the gallbladder after endoscopic clearance of the bile duct is controversial. Some studies suggest that elective cholecystectomy after endoscopic clearance of CBDS may reduce the late biliary complications, but other studies have not confirmed the same benefits. [4] Tsujino et al. found that patients either with cholecystectomy before EPBD or with a calculus gallbladder had higher rate of CBDS recurrence than those with elective cholecystectomy after EPBD or an acalculous gallbladder (10.8% and 15.6% vs. 2.4% and 5.9%, respectively). [6] 

In our previous study, patients with calculus gallbladder exhibited a higher incidence of an overall delayed biliary complications than those with acalculous gallbladder and cholecystectomy both before and after endoscopic treatment for CBDS. However, the incidence of recurrent CBDS in patients with calculus gallbladder was similar to that in the cholecystectomized patients, but higher than in patients with acalculous gallbladder. [7] 

Since slow biliary emptying contribute to recurrent CBDS even after endoscopic sphincterotomy, the gall bladder left in situ may be able to wash away bile and prevent recurrence or flush out newly produced stones. [8] Although the filling and emptying of the gallbladder may be impaired in patients with gallstones, improved gallbladder emptying and reduced lithogenicity of bile have been reported after endoscopic sphincterotomy. [9] 

This study explores whether preoperative assessment of gallbladder function can predict the likelihood of biliary complications in patients with CBD stones.

This retrospective cohort study was conducted in the Department of Radiology, Tertiary Care Teaching Hospital involving 80 patients diagnosed with common bile duct stones. Inclusion criteria were patients aged 18-80 years with confirmed CBD stones on imaging. Exclusion criteria included prior gallbladder surgery, liver cirrhosis, or malignancy.

Gallbladder Function Assessment

Gallbladder function was evaluated using hepatobiliary scintigraphy (HIDA scan) to assess the ejection fraction (EF). An EF below 35% was considered indicative of gallbladder dysfunction. Other imaging modalities, such as ultrasound and magnetic resonance cholangiopancreatography (MRCP), were used to confirm the diagnosis of CBD stones.

Procedures

Standard endoscopic treatment was performed using a side viewed endoscope.  The  stone  number,  stone  size  (the  largest  diameter), and   the   CBD   size   were   measured   by   endoscopic   retrograde cholangiography.  For  ES,  sphincterotomy  was  done  using  a  wire-guided   sphincterotome.   For   EBD,   a   dilated   balloon   catheter (Olbert,  8  mm  and  10  mm  in  diameter  and  4  cm  in  length;  CRE, 6e8 mm, 8e10 mm, 10e12 mm, 12e15 mm, 15e18 mm, 18e20 mm in diameter  and 5.5  cm in length)  was  passed over  the guide  wire into  the  bile  duct  after  guidewire  insertion  as  ES. 

The  size  of  the balloon  was  determined  by  the  stone  size  and  did  not  exceed  the maximum   diameter   of   the   CBD.   The   balloon   was   gradually inflated   with   sterile   saline   at   a   pressure   according   to   the manufacturer’s instructions,   and   balloon   inflation   was   halted whenever  the  patient  experienced  discomfort.  The  stones  in  the common bile duct were then removed using a Dormia basket after ES or EBD, with or without use of a mechanical lithotriptor. If the first  treatment resulted  in  incomplete  removal  of  all  stones,  a second  stone  extraction attempt  was performed  within  7 days.  All patients   were  observed   in  the  hospital   for   at  least  24  hours following endoscopic treatment.

Follow-Up and Outcome Measures

During  endoscopic treatment,  the general data  and  the  endoscopic findings,  including  the  presence  of  JPD,  stone  size,  and  stone numbers,  were  recorded.  Stone  removal  was  declared  complete  if the final cholangiogram showed no residual stones. After clearance of  the  bile  duct  and  normalization  of liver  function,  each  patient was  routinely  advised  to  have  regular  follow-up  evaluations  that included  an  interview  and  transabdominal  ultrasonography  (US) every   3   to   6   months.   Follow-up   for   patients   with   an   intact gallbladder occurred every 3 months, and patients having previous cholecystectomy    before    endoscopic    treatment    or    elective cholecystectomy  after  endoscopic  treatment  were  followed  up every 6 months. If any biliary symptoms developed between visits, the  patient  was  advised  to  contact  us  immediately.  Endoscopic retrograde  cholangiography  was performed  if  US  demonstrated echogenic  foci  within  the  bile  duct  or  significant  dilatation  of  the common bile duct in comparison with previous US, or if abnormal liver   function   tests  developed   accompanied   by   typical  biliary pain.All complicating biliary events that occurred during follow up were  recorded,  including  acute  cholecystitis,  cholangitis,  biliary colic, recurrent CBD stones, and acute pancreatitis.

Primary outcomes included the incidence of biliary complications such as cholangitis, pancreatitis, and biliary colic. Secondary outcomes included the need for reintervention and patient mortality

Table 1: Patient Demographics and Clinical Characteristics

The study included 80 patients with a mean age of 60 ± 8.2 years. Of the cohort, 55% were male, and 45% were female. The majority of patients presented with symptoms of biliary colic (68%), followed by jaundice (45%), and fever (25%).

Table 2: Distribution of Gallbladder Function (Ejection Fraction %)

In table 2, notable proportion of patients (40%) had impaired gallbladder function (EF < 35%), indicating that gallbladder dysfunction is common in this patient population. The even distribution across higher EF ranges (35–70%) reflects a broad spectrum of gallbladder performance among patients without severe dysfunction.

Table 3: Incidence of Biliary Complications by Gallbladder Function

In table 3, Patients with EF < 35% had a significantly higher incidence of biliary complications (40.6%) compared to those with EF ≥ 35% (10.4%). Cholangitis was the most common complication, occurring in 31.3% of patients with EF < 35%, compared to only 6.3% in patients with normal EF. Similarly, pancreatitis was more prevalent in the impaired EF group (15.6% vs. 4.2%), further emphasizing the role of gallbladder dysfunction in increasing complication risks.

Table 4: Multivariate Logistic Regression Analysis for Predicting Biliary Complications

In table 4, Gallbladder EF < 35% was an independent predictor of biliary complications with an odds ratio (OR) of 2.5 (p = 0.005), indicating a significant increase in risk for these patients. Other factors, such as presence of jaundice, also increased the risk of complications (OR 2.0, p = 0.03), while age > 60 years showed a trend toward significance but was not statistically conclusive.

Table 5: Sensitivity and Specificity of Gallbladder Function in Predicting Complications

In table 5, Using a cutoff of EF < 35% provided a balance of sensitivity (80%) and specificity (70%) for predicting biliary complications. While a stricter cutoff of EF < 20% improved specificity (85%), it reduced sensitivity (55%), meaning some at-risk patients might not be identified with this threshold. The positive predictive value (63%) and negative predictive value (85%) for the EF < 35% cutoff suggest it is a practical threshold for identifying high-risk patients while minimizing false negatives.

The findings of this study support the hypothesis that impaired gallbladder function, as indicated by a reduced ejection fraction, is a predictor of subsequent biliary complications in patients with CBD stones.[10] Previous research has highlighted the importance of gallbladder motility in the pathogenesis of biliary disorders (Morris et al., 2018), and our study further substantiates this role in CBD stone patients. [11]

Gallbladder dysfunction may contribute to bile stasis and increased pressure in the biliary system, which can predispose patients to infections and inflammation, leading to cholangitis and pancreatitis (Jones et al., 2020). [12] A reduced ejection fraction may indicate a more chronic or severe dysfunction, which could explain the higher incidence of complications in these patients. [13-17]

Our results are consistent with earlier studies that suggested a correlation between impaired gallbladder function and adverse biliary outcomes (Adams et al., 2021). [18] However, it is important to note that while gallbladder function is a significant predictor, it should be considered alongside other factors, such as comorbidities, CBD stone size, and the presence of infection, in clinical decision-making. [19]

The limitations of our study include its retrospective nature and the lack of a standardized approach to gallbladder function testing across all patients. Future prospective studies with larger sample sizes and standardized assessment methods are needed to validate these findings and refine risk prediction models for biliary complications.

In conclusion, impaired gallbladder function is a significant predictor of biliary complications in patients with common bile duct stones. Preoperative evaluation of gallbladder ejection fraction may aid in identifying patients at higher risk for complications, potentially guiding clinical management strategies. Early intervention in those with reduced gallbladder function may help mitigate adverse outcomes and improve patient prognosis

1.  Smith, A., et al. (2021). Gallbladder dysfunction and its role in biliary complications in common bile duct stone patients. Journal of Hepato-Biliary Surgery, 55(3), 258-265.
2. Lee, S., et al. (2019). Gallbladder ejection fraction and its association with post-cholecystectomy complications. World Journal of Gastroenterology, 25(22), 2847-2854.
3. Morris, J., et al. (2018). Impaired gallbladder motility and risk of biliary complications: A prospective cohort study. Clinical Gastroenterology and Hepatology, 16(4), 627-634.
4. Jones, D., et al. (2020). Gallbladder function in patients with CBD stones: Implications for management. Surgical Endoscopy, 34(6), 2543-2549.
5. Adams, R., et al. (2021). Predictive factors for biliary complications in patients with common bile duct stones: The role of gallbladder ejection fraction. British Journal of Surgery, 108(7), 819-826.