Efficacy and safety of early pancreatic duct stenting for unresectable pancreatic cancer: A randomized controlled trial

Table 1 Early pancreatic duct stenting for unresectable pancreatic cancer

	The inclusion and exclusion criteria
Inclusion criteria	(1) Diagnosed with pancreatic cancer
	(2) Confirmed unresectable pancreatic cancer (according to 8th edition of the AJCC cancer staging manual)
	(3) Age ≥ 18 years old
	(4) Presence of biliary obstruction: Imaging showed that the bile duct diameter was greater than 1.0 cm with elevated direct bilirubin (greater than 50 mmol/L)
	(5) The diameter of the main pancreatic duct is less than 5 mm
	(6) Pain score ≤ 4 point
Exclusion criteria	(1) Unable to give informed consent
	(2) Life expectancy of less than 4 weeks
	(3) Pregnancy
	(4) Severe comorbidities precluding the endoscopic procedure (such as cardiopulmonary disease, sepsis, or a bleeding disorder)

AJCC: The American Joint Committee on Cancer.

Table 2 Comparison of background demographics between the two groups, n (%)

	Double-stent group (n = 40)	Single-stent group (n = 38)	P value
Sex, male/female, n	20/20	16/22	0.4841
Age, mean ± SD, years	73 ± 11	71 ± 12	0.3332
Hypertension	12 (30.0)	17 (44.7)	0.1781
Diabetes	14 (35.0)	12 (31.6)	0.7491
Diagnostic method			0.0141
Biopsy	21 (52.5)	30 (78.9)	-
Imaging	19 (47.5)	8 (21.1)	-
Tumor location			0.3421
Head	37 (92.5)	35 (92.1)	-
Neck	1 (2.5)	2 (5.3)	-
Body	2 (5.0)	0 (0.0)	-
Tail	0 (0.0)	1 (2.6)	-
Tumor staging			0.6871
III stage	27 (67.5)	24 (63.2)	-
IV stage	13 (32.5)	14 (36.8)	-
Chemotherapy	16 (40.0)	11 (28.9)	0.3341
Analgesic			> 0.999
None	23 (57.5)	23 (60.5)	-
Nonopioid analgesic	16 (40.0)	15 (39.5)	-
Moderate opioid	1 (2.5)	0 (0.0)	-
Strong opioids	0 (0.0)	0 (0.0)	-

¹χ² test.

²Student’s t-test.

The double-stent group underwent endoscopic retrograde cholangiopancreatography with a fully-covered self-expandable metallic biliary stent and a pancreatic duct stent, while the single-stent group underwent a fully-covered self-expandable metallic biliary stent only.

Table 3 Comparison of visual analogue scale scores between the two groups

Point, M (IQR)	Double-stent group (n = 40)	Single-stent group (n = 38)	P value
Preoperative	0 (2)	0 (2)	0.655
After 1 week	0 (1)	0 (2)	0.065
After 1 month	0 (2)	2.5 (4)	0.002
After 2 months	0 (1)	3 (4)	< 0.001
After 3 months	0 (1)	4 (2)	< 0.001
After 6 months	1.5 (3)	4 (1)	< 0.001

The double-stent group underwent endoscopic retrograde cholangiopancreatography with a fully-covered self-expandable metallic biliary stent and a pancreatic duct stent, while the single-stent group underwent a fully-covered self-expandable metallic biliary stent only. M: Median; IQR: Interquartile range.

Table 4 Comparison of pain level between the two groups, n (%)

	Pain-free/mild pain		Moderate/severe pain		Difference, % (95%CI)	P value
	Double-stent group	Single-stent group	Double-stent group	Single-stent group
Preoperative	39 (97.5)	36 (94.7)	1 (2.5)	2 (5.3)	0.056 (0.175, 0.063)	0.610
After 1 week	38 (95)	35 (92.1)	2 (5)	3 (7.9)	0.058 (0.207, 0.091)	0.671
After 1 month	37 (92.5)	31 (81.6)	3 (7.5)	7 (18.4)	0.218 (-0.407, -0.029)	0.187
After 2 months	38 (95)	26 (68.4)	2 (5)	12 (31.6)	0.532 (-0.711, -0.353)	0.003
After 3 months	38 (95.0)	18 (47.4)	2 (5.0)	20 (52.6)	0.85 (0.7304, 0.9656)	< 0.001
After 6 months	31 (77.5)	6 (15.8)	9 (22.5)	32 (84.2)	0.13 (1.0185, 1.4495)	< 0.001

Pain-free/mild pain: Visual analog scale (VAS) scores ≤ 3. Moderate/severe pain: VAS scores > 3. The double-stent group underwent endoscopic retrograde cholangiopancreatography with a fully-covered self-expandable metallic biliary stent and a pancreatic duct stent, while the single-stent group underwent a fully-covered self-expandable metallic biliary stent only.

Table 5 Comparison of analgesic drug use between the two groups, n (%)

		None	Nonopioid analgesic	Moderate opioid	Strong opioid	P value
After 1 month	Double-stent group	24 (60.0)	13 (32.5)	1 (2.5)	2 (5.0)	0.026
	Single-stent group	11 (28.9)	19 (42.1)	5 (13.2)	3 (7.9)
After 2 months	Double-stent group	22 (55.0)	14 (35.0)	2 (5.0)	2 (5.0)	0.051
	Single-stent group	10 (26.3)	18 (47.4)	4 (10.5)	6 (15.8)
After 3 months	Double-stent group	19 (57.5)	18 (57.5)	1 (2.5)	2 (5.0)	< 0.001
	Single-stent group	6 (15.8)	14 (36.8)	8 (21.1	10 (36.3)
After 6 months	Double-stent group	16 (40.0)	16 (40.0)	5 (12.5)	3 (7.5)	< 0.001
	Single-stent group	3 (7.9)	3 (7.9)	16 (42.1)	16 (42.1)

The double-stent group underwent endoscopic retrograde cholangiopancreatography with a fully-covered self-expandable metallic biliary stent and a pancreatic duct stent, while the single-stent group underwent a fully-covered self-expandable metallic biliary stent only.

Table 6 Comparison of nutritional status between the two groups

	Double-stent group (n = 40)	Single-stent group (n = 38)	P value
Albumin, mean ± SD, g/L
Preoperative	33.5 ± 5.4	33.7 ± 4.9	0.866
After 3 months	35.1 ± 4.2	35.0 ± 4.7	0.962
After 6 months	35.2 ± 4.6	32.2 ± 4.1	0.179
Serum total protein, mean ± SD, g/L
Preoperative	63.5 ± 6.8	62.2 ± 7.4	0.431
After 3 months	63.4 ± 7.1	62.6 ± 5.9	0.775
After 6 months	66.6 ± 8.4	60.4 ± 4.0	0.046
BMI, mean ± SD, kg/m2
Preoperative	21.3 ± 3.1	20.8 ± 3.1	0.448
After 3 months	19.7 ± 2.9	19.4 ± 3.2	0.756
After 6 months	20.3 ± 3.1	17.9 ± 2.7c	0.061

^cP < 0.001, at 6 months after endoscopic retrograde cholangiopancreatography, only the decrease of body mass index in the single-stent group was statistically significant.

The double-stent group underwent endoscopic retrograde cholangiopancreatography with a fully-covered self-expandable metallic biliary stent and a pancreatic duct stent, while the single-stent group underwent a fully-covered self-expandable metallic biliary stent only. BMI: Body mass index.

Table 7 Adverse events experienced in both groups, n (%)

	Double-stent group (n = 40)	Single-stent group (n = 38)	P value
Adverse events	4 (10.0)	6 (15.8)	0.710
Acute pancreatitis	3 (7.5)	5 (13.2)	-
Acute cholangitis	1 (2.5)	1 (2.6)	-
Hemorrhage	0 (0)	0 (0)	-
Perforation	0 (0)	0 (0)	-

The double-stent group underwent endoscopic retrograde cholangiopancreatography with a fully-covered self-expandable metallic biliary stent and a pancreatic duct stent, while the single-stent group underwent a fully-covered self-expandable metallic biliary stent only.