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Table 1 Patients’ characteristics

From: Feasibility of a fast-track randomized controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with refractory malignant ascites

Variable

CART

N = 10

Control

N = 10

Total

N = 20

Patients’ characteristics

   

Age (median [range])

71.0 [63.0, 87.0]

73.5 [41.0, 95.0]

71.5 [41.0, 95.0]

Sex, female (%)

8 (80)

8 (80)

16 (80)

Institution (%)

    A

5 (50)

8 (80)

13 (65)

    B

3 (30)

1 (10)

4 (20)

    C

2 (20)

1 (10)

3 (15)

    D

0 (0)

0 (0)

0 (0)

ECOG performance status (%)

    0–2

0 (0)

0 (0)

0 (0)

    3

8 (80)

8 (80)

16 (80)

    4

2 (20)

2 (20)

4 (20)

Primary tumor site (%)

    Pancreas

4 (40)

1 (10)

5 (25)

    Gastrointestinal

1 (10)

3 (30)

4 (20)

    Liver, bile duct

2 (20)

1 (10)

3 (15)

    Gynecological

0 (0)

2 (20)

2 (10)

    Urological

0 (0)

1 (10)

1 (5)

    Others

3 (30)

2 (20)

5 (25)

Liver metastasis (%)

    Absent

6 (60)

5 (50)

11 (55)

    Not massive

1 (10)

2 (20)

3 (15)

    Massive

3 (30)

3 (30)

6 (30)

Lung metastasis (%)

   

    Absent

10 (100)

9 (90)

15 (75)

    Present

0 (0.0)

1 (10)

5 (25)

Co-treatment

Opioid (%)

    0 mg/day

7 (70)

4 (40)

11 (55)

     < 60 mg/day

1 (10)

4 (40)

5 (25)

     >  = 60 mg/day

2 (20)

2 (20)

4 (20)

Diuretics (%)

    Absent

6 (60)

5 (50)

10 (50)

    Present

4 (40)

5 (50)

10 (50)

Hydration (mL, median [range])

0 [0, 300]

0 [0, 500]

0 [0, 500]

Ascites feature

Appearance

    Serous

7 (70)

7 (70)

14 (70)

    Hemorrhagic

3 (30)

3 (30)

6 (30)

    Chylous

0 (0)

0 (0)

0 (0)

Serum-ascites albumin gradient (g/dL, median [range])

1.40 [0.60, 1.80]

1.00 [0.20, 2.20]

1.30 [0.20, 2.20]

Previous time-to-next paracentesis (days, median [range])

6.0 [4.0, 15.0]

5.0 [3.0, 13.0]

7.00 [3.00, 15.00]

Laboratory findings

Total protein (g/dL, median [range])

5.55 [4.90, 7.30]

5.60 [4.60, 7.20]

5.60 [4.60, 7.30]

Albumin (g/dL, median [range])

1.95 [1.60, 3.80]

2.50 [1.60, 3.40]

2.30 [1.60, 3.80]

Total bilirubin (mg/dL, median [range])

0.68 [0.40, 2.50]

0.65 [0.30, 1.50]

0.68 [0.30, 2.50]

Creatinine (mg/dL, median [range])

0.65 [0.33, 2.00]

0.94 [0.67, 1.35]

0.84 [0.33, 2.00]

Physical symptoms

Abdominal distension NRS (median [range])

5.0 [2.0, 10.0]

6.0 [1.0, 9.0]

5.5 [1.0, 10.0]

ESAS:AM total score (median [range])

37.0 [10.0, 67.0]

30.0 [15.0, 73.0]

35.5 [10.0, 73.0]

  1. Abbreviations: CART Cell-free and concentrated ascites reinfusion therapy, ECOG Eastern Cooperative Oncology Group, NRS Numerical rating scale, ESAS:AM Edmonton Symptom Assessment System: Ascites Modification