Hepatocellular Carcinoma, Liver Function, Postoperative Complications
Conditions
Keywords
Vitamin D Supplementation, Hepatectomy, Perioperative
Brief summary
High concentrations of parathyroid hormone (PTH) are common in patients with hepatocellular carcinoma (HCC). This study is aimed to investigate effects of vitamin D status and its multiple mega-dosage supplementation on PTH and clinical outcomes in HCC patients before and after hepatectomy. It's a single-center, prospective, parallel, double-blind, placebo-controlled study for 120 eligible subjects. The subjects will receive consecutively 3-day intervention treatments from 7th day before surgery. 30-day postoperative mortality, postoperative complications, and laboratory data will be evaluated.
Interventions
OTHERVitamin D
Oral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days
OTHERPlacebo
Oral supplementation of placebo in 3 consecutive days.
Sponsors
Taoyuan General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. ≥ 20-year HCC subjects receiving laparoscopic hepatectomy * 2.Sign the informed consent
Exclusion criteria
* 1\. Using estrogen drugs, bisphosphonates, or drugs for bone disease. * 2\. Consume calcium tablets within 2 weeks before operation * 3\. Sarcoidosis, multiple myeloma * 4\. Pregnant women or plan to become pregnant within 3 months after surgery * 5\. Autoimmune hepatitis (AIH) * 6\. Early liver recurrence * 7\. Used to participate in other clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of liver failure | 7 days pre- OP (day -7) |
| Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association | During the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of hypercalcemia | Baseline (day -7), day -1, day 1 and 1 day before discharge | — |
| Prevalence of hypomagnesemia | Baseline (day -7), day -1, day 1 and 1 day before discharge | — |
| 25(OH)D status | Baseline (day -7), day -1, day 1 and 1 day before discharge | — |
| Clinical outcomes | day 1 post-OP and 1 day before discharge | Including level of C-reactive protein and white blood cell (WBC) count |
| Complications after surgery | day 1 post-OP and 1 day before discharge | Including in-hospital infectious complications, Dindo-Clavien classification, volume of ascites, duration of ascites, intra-abdominal abscess, postoperative haemorrhage, pleural effusion, wall abscess, and eventration. |
| 30-day mortality | day 1 post-OP and 1 day before discharge | — |
| Prevalence of high PTH | Baseline (day -7), day -1, day 1 and 1 day before discharge | — |
Contacts
Primary ContactYuan-Hao Ku, MD
Outcome results
None listed