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Predictors of Malignancy in Patients With Suspicious Gallbladder Lesions: Retrospective Analysis of 103 Patients Who Underwent Cholecystectomy At a Tertiary Hospital in South India
Dhiraj J. Sonbare^*1, Ravish S. Raju¹, Frederick Vyas¹, Philip Joseph¹, Betty Mani², Anu Eapen², Mahasampath Gowri³, Venkatramani Sitaram^1
1Department of HPB Surgery, Christian Medical College, Vellore, India; ²Department of Radiology, Christian Medical College, Vellore, India; ³Department of Biostatistics, Christian Medical College, Vellore, India

Background: Gallbladder cancer is common in India. While early lesions present with thickening of the gallbladder wall, locally advanced disease can present as a gallbladder mass. There is scarcity of data on the predictors of malignancy in patients with suspicious gallbladder lesions.
Aim: To analyze the pre-operative and intra-operative factors which predict malignancy in patients with suspicious gallbladder lesions.
Methodology: This is a retrospective analysis of patients who underwent cholecystectomy for suspicious gallbladder lesions in a single institution. There were 103 patients from January 2004 to May 2011. The gallbladder specimen was not available for analysis in 13 patients who underwent only biopsy or palliative procedure.
Results: There were 43 male and 60 females. The mean age was 51.23 years. The final histopathology was benign in 40 patients and malignant in 63 patients.
All patients were evaluated by pre-operative cross sectional imaging; Pre-operative image guided FNAC was done in some patients. Patients were divided into following categories:
1) Histological surprise in our hospital and pre-operative CT scan available:2
2) Extended cholecystectomy after pre-operative image guided FNAC/B or intra-operative frozen section reported as malignant:34
3) Extensive disease intra-operatively, only cholecystectomy, biopsy or palliative procedure performed:25
4) Clinical picture and imaging suspicious of malignancy but frozen section benign:38
5) Clinical picture and imaging suspicious of malignancy but frozen section incorrect (benign on frozen section and malignant on paraffin section and vice versa):4
The following pre-operative and intra-operative parameters were analysed in all patients: age, sex, symptoms, physical findings, blood investigations and findings on cross sectional imaging. The gallbladder morphology was classified as "thick walled only without mass" or "thick walled with presence of mass". The tumor location was either "tumor location at a single site" or "tumor at more than one site". The presence of enhancement pattern on contrast enhanced CT scan and involvement of cystic duct (CD) and common bile duct (CBD) was noted. The nodal involvement was classified as absent if node was absent or less than 1 cm (maximum dimension) and present, if node was more than 1 cm. Infiltration into the liver parenchyma, adjacent vessels and adjacent organ(s) was noted.
On multivariate analysis, the presence of polyp or tumor on intra-operative examination was the only factor which was statistically significant (p less than 0.001).
Conclusion: In an area endemic for gallbladder cancer, the presence of tumor or a polyp in a cut section of the gallbladder is highly suggestive of malignancy.

1

	Benign Mean (SD)	Malignant Mean (SD)	Univariate analysis
Age less than and equal to 40 more than 40	6 34	10 53	0.90
Sex Male Female	21 19	22 41	0.08
Clinical symptom Abdominal pain Jaundice Weight loss Vomiting Symptom duration(mon.)	35 4 6 9 10.88 (16.76)	53 22 17 16 10.6 (20.58)	0.64 0.01 0.16 0.74 0.89
Clinical examination No mass GB/ liver mass	30 10	27 36	0.001
Blood investigations Haemoglobin Total Bilirubin Direct Bilirubin Indirect Bilirubin Total Protein Albumin Globulin SGOT SGPT Alkaline phosphatase	11.71 (1.79) 1.08 (2.57) 0.64 (2.27) 0.44 (0.34) 7.85 (0.72) 4.16 (0.06) 3.62 (0.65) 37 (22.26) 47.73 (49.5) 149.55 (151.6)	11.59 (1.05) 5.96 (8.88) 4.03 (6.52) 1.92 (3.65) 7.79 (0.69) 3.94 (0.57) 3.8 (0.62) 57.87 (41.43) 48.14 (42.2) 188.83 (143.38)	0.66 0.026 0.016 0.027 0.71 0.13 0.16 0.033 0.58 0.060
Radiology GB Morpho. Thick wall only GB mass present Tumour location Single location More than one region Enhancement pattern CD involvement CBD involvement Nodal involvement Liver involvement Vascular involvement Adjacent organ involvement	21 17 12 26 33 12 1 8 10 3 6	17 42 31 28 56 24 14 21 25 13 11	0.009 0.042 0.26 0.37 0.01 0.13 0.92 0.07 0.72
Intra-operative findings Wall thickness 5 mm cut off Polyp/ tumour Stone	24 10 28	30 46 25	0.68 0.001 0.03

Predictors of malignancy in patients with suspicious gallbladder lesions - Univariate analysis.

Table 2

	Significance	Exposure	Lower limit of 95% CI	Upper limit of 95% CI
Age	0.465	1.982	0.316	12.438
Sex	0.904	0.918	0.227	3.706
Serum direct bilirubin	0.133	1.194	0.984	1.505
Presence of mass	0.153	2.711	0.690	10.647
single location on imaging	0.794	1.2	0.304	4.739
gall bladder mass on imaging	0.150	2.741	0.694	10.82
CBD involvement	0.626	0.493	0.029	8.498
Presence of stone	0.434	0.589	0.156	2.22
Presence of tumour or polyp	0.000	18.585	3.926	88.078

Multivariate analysis

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