Internal vs oral bile reinfusion for hepatic recovery after percutaneous transhepatic cholangiodrainage

Table 1 Baseline characteristics of study participants, n (%)/mean ± SD

Characteristic	Observation group (n = 55)	Control group (n = 45)	P value
Age (years)	64.3 ± 10.5	63.8 ± 11.2	0.812
Male	32 (58.2)	25 (55.6)	0.786
BMI (kg/m2)	22.5 ± 3.2	22.3 ± 3.5	0.758
Primary tumor			0.972
Pancreatic cancer	29 (52.7)	24 (53.3)
Cholangiocarcinoma	16 (29.1)	12 (26.7)
Ampullary carcinoma	6 (10.9)	5 (11.1)
Metastatic disease	4 (7.3)	4 (8.9)
ECOG performance status			0.845
0-1	38 (69.1)	30 (66.7)
2	17 (30.9)	15 (33.3)
Baseline laboratory values
Total bilirubin (μmol/L)	152.3 ± 35.8	148.7 ± 38.2	0.616
Direct bilirubin (μmol/L)	105.8 ± 28.5	102.3 ± 30.1	0.542
ALT (U/L)	95.3 ± 28.5	92.7 ± 31.2	0.653
AST (U/L)	108.5 ± 32.3	105.2 ± 35.8	0.625
ALP (U/L)	385.5 ± 95.3	378.2 ± 102.5	0.718
Albumin (g/L)	32.5 ± 4.8	32.1 ± 5.2	0.690

ALT: Alanine aminotransferase; ALP: Alkaline phosphatase; AST: Aspartate aminotransferase; BMI: Body mass index; ECOG: Eastern Cooperative Oncology Group.

Table 2 Temporal changes in bilirubin and hepatocellular enzymes, mean ± SD

Parameter	Time	Observation group (n = 55)	Control group (n = 45)	Difference	P value
TBIL (μmol/L)	Baseline	152.3 ± 35.8	148.7 ± 38.2	3.6	0.616
	1 week	98.5 ± 22.3	115.8 ± 26.5	-17.3	0.001
	2 weeks	68.3 ± 15.8	89.5 ± 21.2	-21.2	< 0.001
	4 weeks	42.5 ± 12.3	68.7 ± 18.5	-26.2	< 0.001
ALT (U/L)	Baseline	95.3 ± 28.5	92.7 ± 31.2	2.6	0.653
	4 weeks	38.5 ± 12.3	56.8 ± 18.5	-18.3	< 0.001

ALT: Alanine aminotransferase; TBIL: Total bilirubin.

Table 3 Cholestatic enzymes and synthetic function at 4 weeks, n (%)/mean ± SD

Parameter	Observation group (n = 55)	Control group (n = 45)	P value
ALP (U/L)	185.3 ± 42.5	248.7 ± 58.3	< 0.001
GGT (U/L)	125.8 ± 35.2	178.5 ± 48.7	< 0.001
Albumin (g/L)	38.5 ± 4.2	34.2 ± 5.1	< 0.001
Normal albumin (≥ 35 g/L)	43 (78.2)	21 (46.7)	0.001
INR	1.15 ± 0.18	1.32 ± 0.25	< 0.001

ALP: Alkaline phosphatase; GGT: Gamma-glutamyl transferase; INR: International normalized ratio.

Table 4 Nutritional status and quality of life outcomes at 4 weeks, mean ± SD

Outcome	Observation group (n = 55)	Control group (n = 45)	P value
Prealbumin (mg/L)	285.5 ± 45.3	215.8 ± 52.7	< 0.001
Hemoglobin (g/L)	118.5 ± 15.3	105.8 ± 18.5	< 0.001
Body weight change (kg)	-2.3 ± 1.5	-5.8 ± 2.3	< 0.001
BMI change (kg/m2)	-0.9 ± 0.6	-2.3 ± 0.9	< 0.001
EORTC QLQ-C30 global health	78.5 ± 9.2	62.3 ± 11.5	< 0.001
Physical functioning	82.3 ± 10.5	68.5 ± 12.8	< 0.001

BMI: Body mass index; EORTC QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30.

Table 5 Gastrointestinal symptoms during reinfusion period, n (%)/mean ± SD

Symptom	Observation group (n = 55)	Control group (n = 45)	P value
Nausea	8 (14.5)	18 (40.0)	0.003
Vomiting	3 (5.5)	12 (26.7)	0.003
Diarrhea	5 (9.1)	15 (33.3)	0.002
Abdominal discomfort	6 (10.9)	16 (35.6)	0.002
GI symptom score (0-10)	1.8 ± 1.2	4.5 ± 2.3	< 0.001

GI: Gastrointestinal.

Table 6 Safety profile and complications, n (%)

Adverse event	Observation group (n = 55)	Control group (n = 45)	P value
Catheter-related complications	7 (12.7)	6 (13.3)	0.926
Catheter site infection	4 (7.3)	4 (8.9)	0.760
Catheter obstruction	2 (3.6)	1 (2.2)	0.665
Catheter dislodgement	1 (1.8)	1 (2.2)	0.873
Cholangitis	2 (3.6)	3 (6.7)	0.661
Hyponatremia	3 (5.5)	8 (17.8)	0.048
Hypokalemia	2 (3.6)	7 (15.6)	0.038
Protocol completion	52 (94.5)	38 (84.4)	0.081