Post-operative morbidity after neoadjuvant chemotherapy and resection for gallbladder cancer: A national surgical quality improvement program analysis

Table 1 Descriptive statistics for patients in the National Surgical Quality Improvement Program hepatectomy targeted dataset diagnosed gallbladder cancer, 2015-2019, n (%)

Characteristic	No neoadjuvant chemotherapy (n = 400)	Neoadjuvant chemotherapy (n = 52)	P value
Sex			0.72
Female	267 (59.1)	36 (8.0)
Male	133 (29.4)	16 (3.5)
Race			0.70
White	241 (53.3)	35 (7.7)
Black or African American	38 (8.4)	4 (0.9)
Asian	30 (6.6)	5 (1.1)
Other	2 (0.5)	0 (0)
Unknown/Not reported	89 (19.7)	8 (1.8)
Ethnicity			0.19
Not Hispanic	293 (64.8)	41 (9.1)
Hispanic	39 (8.6)	7 (1.6)
Unknown/not reported	68 (15.0)	4 (0.9)
Diabetes	93 (20.6)	8 (1.8)	0.20
History of smoking	43 (9.5)	3 (0.7)	0.26
Dyspnea	19 (4.2)	2 (0.4)	1.00
History of chronic obstructive pulmonary disease	19(4.2)	2 (0.4)	1.00
History of congestive heart failure	3 (0.7)	0 (0.0)	1.00
Hypertension requiring medication	238 (52.7)	24 (5.3)	0.07
Steroid use for chronic condition	9 (2.0)	2 (0.4)	0.37
> 10% loss body weight in last 6 mo	19 (4.2)	5 (1.1)	0.18
Biliary stent (Yes)	46 (10.3)	6 (1.3)	0.97
T (tumor) stage			0.91
T0 & T1	43 (9.5)	6 (1.3)
T2	140 (31.0)	17 (3.8)
T3 & T4	136 (30.1)	21 (4.7)
Tx & Unknown	68 (15.0)	7 (1.5)
N/A	13 (2.9)	1 (0.2)
N (node) stage			0.24
N0	147 (32.5)	14 (3.1)
N1 & N2	122 (27.0)	23 (5.1)
Nx & unknown	115 (25.5)	14 (3.1)
N/A	16 (3.5)	1 (0.2)
M (metastasis) stage			0.61
M0/Mx	224 (50.0)	34 (7.5)
M1	21 (4.6)	3 (0.7)
Unknown	95 (21.0)	9 (2.0)
N/A	60 (13.3)	6 (1.3)
	Mean (SD)	Mean (SD)
Age	67.0 (10.6)	64.6 (9.1)	0.07
Pre-operative serum albumin	3.9 (0.6)	3.9 (0.5)	0.65
Pre-operative total bilirubin	0.8 (1.2)	0.4 (0.2)	< 0.01
Pre-operative BUN	15.0 (6.0)	16.1 (6.8)	0.33
Pre-operative serum creatinine	0.9 (0.3)	0.9 (0.3)	0.45
Pre-operative INR	1.0 (0.1)	1.0 (0.1)	0.66

P values are the result of Chi-square, Fisher’s exact, and Wilcoxon rank sum test. INR: International normalized ratio of prothrombin time; BUN: Blood urea nitrogen; N/A: Note available.

Table 2 Odds ratios for 30-day postoperative complications among patients with gallbladder cancer who underwent neoadjuvant chemotherapy (n = 411¹)

Primary outcome2	Odds ratio	95% confidence Interval	P value
Post-operative bile leak	0.69	0.16, 2.10	0.55
Secondary outcomes3
Required blood transfusion	1.80	0.83, 3.61	0.11
On the ventilator > 48 h	3.96	0.54, 20.83	0.12
Length of ICU stay	1.09	0.97, 1.22	0.12
Readmission	0.68	0.23, 1.64	0.44
Superficial incisional wound infection	0.58	0.03, 3.02	0.61
Organ space wound infection	0.63	0.18, 1.63	0.39
Required secondary intervention	0.41	0.10, 1.17	0.15
Conversion rate to open	1.67	0.47, 4.67	0.37
Need for biliary reconstruction	1.15	0.54, 2.27	0.70

¹Patients with missing data were omitted from analysis.

²Adjusted odds ratio with the model including the primary predictor (neoadjuvant chemotherapy) and potential confounders (race, ethnicity, placement of a biliary stent, and preoperative bilirubin).

³Unadjusted odds ratios.

Comparison group is patients having surgery for gallbladder cancer without neoadjuvant chemotherapy. ICU: Intensive care unit.