Impact of biliary stent-related events in patients diagnosed with advanced pancreatobiliary tumours receiving palliative chemotherapy

Table 1 Demographic characteristics of patients included in the study

Variables		All patients (n = 96)	SRE group (n = 41; 43%)	no-SRE group (n = 55; 57%)	P-value for distribution within baseline parameter (χ2 test), SRE vs no-SRE groups
Gender	Female	42 (44)	20 (49)	22 (40)	0.391
	Male	54 (56)	21 (51)	33 (60)
Age1	Median (range)	66.6 (26-83.8)	64.9 (26-84)	67.6 (42.4-83.2)	0.88332
Primary tumour site	Ampulla	3 (3)	1 (2)	2 (4)	0.3803
	Bile duct (cholangiocarcinoma)	17 (18)	10 (24)	7 (13)
	Intrahepatic	5 (31)	3 (33)	2 (29)	1.0004
	Extrahepatic	11 (69)	6 (67)	5 (71)
	Gallbladder	1 (1)	0 (0)	1 (2)
	Pancreas	75 (78)	30 (73)	45 (82)
	Head	66 (89)	26 (90)	40 (89)	1.0005
	Body	8 (11)	3 (10)	5 (11)
Stage	Locally advanced	58 (60)	22 (54)	36 (65)	0.294
	Metastatic	38 (40)	19 (46)	19 (35)
ECOG-PS	0	17 (18)	9 (22)	8 (15)	0.547
	1	51 (53)	22 (54)	29 (53)
	≥ 2	28 (29)	10 (24)	18 (33)
Diabetic	No	68 (71)	29 (71)	39 (71)	1.000
	Yes	28 (29)	12 (29)	16 (29)
Comorbidities	None	31 (32)	14 (34)	17 (31)	0.428
	Mild	41 (43)	18 (44)	23 (42)
	Moderate	20 (21)	9 (22)	11 (20)
	Severe	4 (4)	0 (0)	4 (7)
Line of palliative chemotherapy	First	96 (100)	41 (100)	55 (100)	1.000
Type of chemotherapy	FOLFIRINOX	11 (11)	4 (10)	7 (13)	0.605
	Cisplatin Gemcitabine	13 (14)	8 (20)	5 (9)
	Gemcitabine Nab-paclitaxel	7 (7)	2 (5)	5 (9)
	Gemcitabine +/- TH302	2 (2)	0 (0)	2 (4)
	Gemcitabine Capecitabine	25 (26)	12 (29)	13 (24)
	Gemcitabine single agent	37 (39)	15 (37)	22 (40)
	FOLFOX	1 (1)	0 (0)	1 (2)
Time from first stent to starting chemotherapy1	Median (range)	1.8 (0.1-12.6)	1.6 (0.6-5.8)	1.9 (0.1-12.6)	0.18242
Time of chemotherapy duration1	Median (range)	3.2 (0.1-7.6)	3.8 (0.1-7.2)	3.1 (0.1-7.6)	0.45202

No differences were identified between SRE group and the no-SRE group.

¹Variables do not meet a normal distribution (as per Shapiro-Wilks test);

²Mann-Whitney P-value has been provided for variables not meeting normal distribution criteria;

³the P for χ² test for comparison of distribution of primary tumour [ampulla vs bile duct (cholangiocarcinoma) vs gallbladder vs pancreas] between SRE group and no-SRE group;

⁴the P for χ² test for comparison of distribution of primary tumour [type of bile duct tumour (cholangiocarcinoma): intrahepatic vs extrahepatic] between SRE group and no-SRE group;

⁵The P for χ² test for comparison of distribution of primary tumour (site of pancreatic cancer: head vs body) between SRE group and no-SRE group. SRE: Stent-related event; ECOG-PS: ECOG performance status; FOLFIRINOX: 5-fluorouracil, oxaliplatin and irinoetecan combination; FOLFOX: 5-fluorouracil and oxaliplatin combination.