Table 2 Outcomes and adverse events between benign and malignant groups.

From: Best period to replace or change plastic stents with self-expandable metallic stents using multivariate competing risk regression analysis

 

Benign group (n = 1,054)

Malignant group (n = 833)

p value

Technical success ratesa, % (95% CI)

96.2 (95.0–97.2)

91.7 (89.8–93.4)

< 0.001b

Normal anatomy

97.9 (96.9–98.7)

94.0 (92.2–95.4)

< 0.001b

Altered gastrointestinal anatomy

80.0 (71.3–87.0)

61.4 (49.0–72.8)

0.006b

Functional success ratesc

94.5 (92.9–95.8)

80.2 (77.4–82.9)

< 0.001b

PS

94.5 (92.9–95.8)

78.7 (75.3–81.8)

< 0.001b

7 Fr inside stent

100 (71.5–100)

78.6 (49.2–95.3)

0.23d

SEMS

1/1 (100)

86.4 (80.3–91.2)

1.00d

Time to functional successc, Mean ± SD, days

PS

3.3 ± 2.2

4.4 ± 3.4

0.001e

7 Fr inside stent

7.5 ± 5.0

5.1 ± 4.8

0.38e

SEMS

 

4.7 ± 3.5

 

Median time to RBOf, (IQR), days

PS

613 (191–1,329)

108 (39–270)

< 0.001g

7 Fr inside stent

112 (92–122)

20 (13–42)

0.23g

SEMS

 

220 (94–488)

 

Nonobstruction rates, % (95% CI)

3 months by PS

88.7 (86.2–90.8)

65.8 (61.2–69.9)

0.008b

6 months by PS

79.1 (74.4–83.0)

44.5 (36.6–52.0)

0.005b

12 months by PS

63.0 (53.2–71.3)

25.7 (15.4–37.3)

< 0.001b

3 months by 7 Fr inside stent

90.0 (47.3–98.5)

43.3 (7.5–76.3)

0.015 b

6 months by 7 Fr inside stent

N.A

N.A

 

12 months by 7 Fr inside stent

N.A

N.A

 

3 months by SEMS

 

77.5 (69.6–83.6)

 

6 months by SEMS

 

52.5 (42.2–61.7)

 

12 months by SEMS

 

36.1 (25.0–47.3)

 

The timing of RBO

Early (within 30 days)

41 (3.9)

105 (12.4)

< 0.001b

Late (≥ 31 days)

80 (7.6)

151 (18.1)

< 0.001b

Cause of RBO

Sludge

83 (7.9)

151 (18.1)

< 0.001b

 PS

80 (7.6)

143 (17.2)

< 0.001

 7Fr inside stent

3 (0.3)

5 (0.6)

0.31d

 SEMS

0(0)

3 (0.4)

0.09d

Tumor ingrowth with SEMS

 

45 (5.4)

 

Tumor overgrowth with SEMS

 

20 (2.4)

 

Symptomatic migration in distal

36 (3.5)

16 (2.0)

0.06b

 PS

36 (3.4)

14 (1.7)

0.020b

 7Fr inside stent

0 (0.0)

0 (0.0)

 

 SEMS

 

2 (0.2)

 

Symptomatic migration in proximal with PS

0 (0)

5 (0.6)

0.017d

Hemobilia

1 (0.1)

14 (1.7)

< 0.001d

 PS

1 (0.1)

10 (1.2)

0.003d

 7Fr inside stent

0 (0.0)

0 (0.0)

 

 SEMS

 

4 (0.5)

 

Food impaction

1 (0.1)

5 (0.6)

0.09d

 PS

1 (0.1)

0 (0)

 

 7Fr inside stent

0 (0.0)

0 (0.0)

 

 SEMS

0 (0.1)

5 (0.6)

 

Kinking of bile duct with SEMS

 

1 (0.1)

 

Other

0 (0)

2 (0.2)

 

Adverse events other than RBOh

Pancreatitis

36 (3.4)

28 (3.4)

0.95b

 Mild/ severe

32 (3.0) / 4(0.4)

21 (2.5) / 7 (0.8)

 

Cholecystitis

0 (0)

1 (0.1)

0.44d

 Severe

 

1 (0.1)

 

Non-occlusion cholangitis

32 (3.0)

125 (15.0)

< 0.001b

 Moderate

32 (3.0)

125 (15.0)

 

Bleeding

12 (1.13)

1 (0.1)

0.009d

 Mild

12 (1.13)

1 (0.1)

 

Ulceration

 

1 (0.1)

0.44d

 Moderate

 

1 (0.1)

 

Penetration

1 (0.1)

1 (0.1)

1.00d

 Mild

1 (0.1)

1 (0.1)

 

Perforation

1 (0.1)

4 (0.5)

0.18d

 Mild/severe

1 (0.1) / 0

3 (0.4) / 1 (0.1)

 

Adverse events associated with stentingh

Bleeding with scope

4 (0.4)

4 (0.5)

0.74d

 Mild/severe

4 (0.4) / 0

3 (0.4) / 1 (0.1)

 

Desaturation of oxygen

1 (0.1)

0 (0)

1.00d

 Mild

1 (0.1)

  
  1. Unless indicated otherwise, data are presented as n (%). Of note, percentages may not add up to 100% because of rounding.
  2. PS plastic stent, SEMS self-expandable metallic stent, RBO recurrent biliary obstruction, IQR interquartile range, CI confidence interval, NA not applicable.
  3. aAll cases which were requested for endoscopic biliary drainage, including endoscopic nasobiliary drainage.
  4. bChi-square test.
  5. c50% decrease in or normalization of the bilirubin level, if biliary stenting was successful.
  6. dFisher’s exact test.
  7. eMann–Whitney test.
  8. fEstimated by Kaplan–Meier method.
  9. gLog-rank test.
  10. hIncluding self-expandable metallic stent.
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