European Journal of Cardiovascular Medicine

Laparoscopic cholecystectomy (LC) has become the gold standard for the surgical management of symptomatic gallstone disease since its introduction in the late 1980s, owing to its advantages of reduced postoperative pain, shorter hospital stay, and earlier return to work when compared with open cholecystectomy. [1] Despite these benefits, the widespread adoption of the laparoscopic approach has been accompanied by an increase in the incidence of bile duct injury (BDI) compared with the open era, largely attributable to misidentification of the biliary anatomy under the altered visual and tactile perspective of laparoscopy. [2]

Bile duct injury is a devastating complication that carries significant morbidity, need for reoperation, prolonged hospitalisation, medico-legal implications, and a measurable impact on long-term quality of life and survival. [3] Several Indian studies have reported BDI rates ranging from 0.3% to 0.8% in high-volume centres, with considerably higher rates reported from centres with lower laparoscopic case volumes and in cases converted from acute settings. [4]

In 1995, Strasberg et al. described the Critical View of

Safety (CVS) as a method of secure identification of the cystic duct and cystic artery prior to their division, requiring (i) clearance of the hepatocystic triangle of fat and fibrous tissue, (ii) separation of the lower one-third of the gallbladder from the liver bed to expose the cystic plate, and (iii) visualisation of only two structures entering the gallbladder. [3] The CVS technique shifts the principle of ductal identification from an ‘infundibular’ technique, which is prone to misidentification of the common bile duct as the cystic duct, to one of secure anatomical confirmation.

Multiple Indian series have evaluated the feasibility and safety benefit of CVS in both elective and emergency settings, with most authors reporting high rates of successful achievement and a corresponding reduction in ductal injury and conversion rates. [5] However, achievement of CVS is not universal, particularly in the setting of acute cholecystitis, dense adhesions, contracted or gangrenous gallbladder, and Mirizzi syndrome, where the hepatocystic triangle may be obscured by inflammation and fibrosis. [6] Studies from Indian teaching institutions have also highlighted inconsistent documentation of CVS in operative notes, underscoring the need for structured intraoperative photodocumentation as an audit tool. [7]

Given the continuing burden of BDI in both elective and emergency laparoscopic practice, and the variability in CVS achievement rates reported across settings, the present study was undertaken to prospectively assess the rate of achievement of CVS, its efficacy in preventing bile duct injury, and the clinical factors predisposing to failure of CVS achievement in a tertiary care surgical unit.

Aims and Objectives

• To determine the proportion of patients undergoing laparoscopic cholecystectomy in whom the critical view of safety is successfully achieved.
• To compare the incidence of bile duct injury between patients in whom CVS was achieved and those in whom it was not.
• To identify preoperative and intraoperative factors associated with failure to achieve CVS..

This was a hospital-based prospective observational study conducted in the Department of General Surgery of a tertiary care teaching hospital over a period of 12 months, after approval from the Institutional Ethics Committee. Written informed consent was obtained from all participants.

Sample Size

Based on an anticipated BDI rate of 0.5% in the CVS-achieved group and 6% in the CVS-not-achieved group from prior literature, with 80% power and a 5% level of significance, a minimum sample size of 200 was calculated; 210 consecutive patients were finally enrolled.

Inclusion Criteria

• Patients aged 18–70 years undergoing elective or emergency laparoscopic cholecystectomy for symptomatic cholelithiasis, acute cholecystitis, or chronic cholecystitis.
• Patients willing to give informed written

Exclusion Criteria

• Suspected or confirmed gallbladder

• Concomitant common bile duct stones requiring pre-operative ERCP with failed clearance.
• Patients converted to open surgery for reasons unrelated to biliary anatomy (e.g., bleeding, bowel injury) were excluded from CVS-specific analysis but included in conversion-rate reporting.

Surgical Technique and Data Collection

All procedures were performed using the standard four-port technique by consultant surgeons or senior residents under consultant supervision. Dissection of the hepatocystic triangle was performed with the explicit intention of achieving CVS prior to clipping or dividing any structure. Achievement of the three criteria of CVS was assessed intraoperatively by the operating surgeon and confirmed by a second observer, and was photodocumented in each case using the laparoscopic camera. Cases in which CVS could not be safely achieved after a reasonable dissection effort were managed using the fundus-first (dome-down) technique, subtotal cholecystectomy, or conversion to open surgery, at the discretion of the operating surgeon, consistent with the ‘culture of safety’ approach in difficult cholecystectomy.

Data recorded included patient demographics, duration of symptoms, ultrasonographic findings (gallbladder wall thickness, pericholecystic collection), intraoperative findings (Nassar difficulty grade), achievement or non-achievement of CVS, conversion to open surgery, operative time, and occurrence of bile duct injury. Bile duct injury was classified according to the Strasberg classification. All patients were followed up for a minimum of 3 months to detect delayed presentations of biliary injury or stricture.

Statistical Analysis

Data were entered in Microsoft Excel and analysed using SPSS version 26.0. Categorical variables were expressed as frequencies and percentages and compared using the Chi-square test or Fisher’s exact test as appropriate. Continuous variables were expressed as mean ± standard deviation and compared using the independent t-test. A p-value of <0.05 was considered statistically significant..

A total of 210 patients underwent laparoscopic cholecystectomy during the study period. The mean age of the study population was 44.6 ± 12.3 years, with a female preponderance (68.1%). Acute cholecystitis was present in 58 patients (27.6%), while the remainder underwent surgery for chronic/symptomatic cholelithiasis.

Table 1: Baseline Demographic and Clinical Characteristics (n = 210)

Table 2: Achievement of Critical View of Safety and Method of Cholecystectomy

Table 3: Incidence of Bile Duct Injury according to CVS Status

Table 4: Comparison of Outcomes between CVS-Achieved and CVS-Not-Achieved Groups

Table 5: Factors Associated with Failure to Achieve Critical View of Safety

Overall, 3 patients (1.43%) sustained bile duct injury – one Strasberg type A injury (minor cystic duct leak) in the CVS-achieved group managed conservatively with a drain, and one type D and one type E2 injury in the CVS-not-achieved group, both of which required Roux-en-Y hepaticojejunostomy. The difference in BDI rate between the two groups was statistically significant (p = 0.012). Conversion to open surgery, operative time, postoperative bile leak, and hospital stay were all significantly higher in the CVS-not-achieved group (Table 4). Acute cholecystitis, prolonged symptom duration, sonographic gallbladder wall thickening, higher Nassar difficulty grade, and prior upper abdominal surgery were significantly associated with failure to achieve CVS (Table 5).

The present study found that the critical view of safety could be achieved in 88.6% of patients undergoing laparoscopic cholecystectomy, comparable to rates reported in several Indian studies ranging from 85% to 95% in mixed elective and emergency cohorts. [8] The overall bile duct injury rate of 1.43% in this series is higher than the classically quoted rate of 0.3–0.5% for elective LC, reflecting the substantial proportion of acute and difficult cholecystectomies included; this is consistent with Indian tertiary-centre data showing higher BDI rates in units that manage a higher proportion of emergency and complicated gallstone disease. [4]

The significantly lower BDI rate in the CVS-achieved group (0.54%) compared with the CVS-not-achieved group (8.3%) in the present study reinforces the protective value of CVS demonstrated in earlier Indian and international series. [3] A multicentre Indian study similarly reported a

near ten-fold reduction in ductal injury when CVS was achieved and photodocumented, and emphasised routine photodocumentation as an intraoperative safety and audit measure rather than achievement of CVS being merely a subjective surgeon-reported endpoint. [9] Our findings of significantly higher conversion rate, operative time, and hospital stay in the CVS-not-achieved group are also concordant with similar comparative analyses from Indian institutions. [5]

Acute cholecystitis, prolonged duration of symptoms, sonographic gallbladder wall thickening, and a higher intraoperative difficulty grade emerged as significant predictors of failure to achieve CVS in this study, a pattern consistently reported by Indian authors evaluating predictors of difficult laparoscopic cholecystectomy. [6] These findings support the recommendation that surgeons should have a low threshold to adopt a ‘bail-out’ strategy – such as subtotal cholecystectomy or the fundus-

first technique – rather than persisting with attempts at complete ductal dissection when CVS cannot be safely established, a principle increasingly emphasised in Indian surgical training curricula and difficult cholecystectomy protocols. [7]Several Indian audits have also highlighted the gap between surgeons’ self-reported use of CVS and its objective demonstration on video or photographic review, underscoring under-recognition of inadequate dissection as a contributing factor to BDI even when surgeons believe they have achieved a safe view. [9] This reinforces the recommendation, echoed in the present study ’s methodology, that photodocumentation of CVS should be considered a mandatory step of laparoscopic cholecystectomy and incorporated into routine operative records and departmental audit systems, rather than being achieved inconsistently or left undocumented. [8]

The limitations of this study include its single-centre design, relatively modest sample size for a rare outcome such as bile duct injury, and dependence on surgeon and second-observer assessment of CVS achievement, which – despite photodocumentation – retains an element of subjectivity. Longer follow-up and multicentric data would be valuable in further validating the magnitude of protective benefit conferred by CVS, particularly for delayed presentations of biliary stricture.

The critical view of safety is a reproducible and effective intraoperative technique that can be achieved in the large majority of patients undergoing laparoscopic cholecystectomy, including a meaningful proportion of acute and difficult cases. Its achievement is associated with a significantly lower incidence of bile duct injury, reduced conversion rate, shorter operative time, and shorterduration, sonographic gallbladder wall thickening, and higher intraoperative difficulty grade predispose to failure of CVS achievement, and surgeons should adopt a low threshold for bail-out procedures such as subtotal cholecystectomy in such circumstances. Routine intraoperative photodocumentation of the critical view of safety is recommended as a standard component of laparoscopic cholecystectomy to enhance biliary safety and to serve as an objective audit tool.

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