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A multicenter phase ? clinical study on the effect of pre-operative supplementation of calcitriol and calcium in preventing hypocalcemia in patients undergoing total thyroidectomy and bilateral central compartment neck dissection

A multicenter phase ? clinical study on the effect of pre-operative supplementation of calcitriol and calcium in preventing hypocalcemia in patients undergoing total thyroidectomy and bilateral central compartment neck dissection - EPOC study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071168
Enrollment
Unknown
Registered
2023-05-06
Start date
2023-05-08
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypocalcemia

Interventions

Intervention group:a short-term preoperative administration of calcitriol and calcium: Starting from 2 days before surgery (-2 days), 0.25ug of calcitriol (rosiglitazone), qd, po
Simultaneously calcium carbonate tablets (calcium carbonate D), 600mg, bid, po
Take it for 3 days (including -2 days, -1 days, and 0 days on the day of surgery.
control group:none

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: All of the following must be met to be enrolled in the trial: (1) patients voluntarily participated in this study and signed informed consent; (2) older than 18 years old; (3) diagnosed with bilateral thyroid cancer, simultaneous total thyroidectomy and bilateral central compartment neck dissection should included (with or without lateral neck dissection).

Exclusion criteria

Exclusion criteria: Patients will be excluded if any of the following occurred: (1) previous thyroidectomy and/or central compartment neck dissection; (2) chronic renal failure, acute and chronic nephritis; serum creatinine and urea nitrogen are abnormal at the same time. (3) abnormal parathyroid function; (4) hypercalcemia is found in preoperative examination; (5) previous or current vitamin D overdose or vitamin D toxicity.

Design outcomes

Primary

MeasureTime frame
Preoperative calcium;Preoperative inorganic phosphorus;Preoperative PTH;calcium on the first postoperative day;inorganic phosphorus on the first postoperative day;PTH on the first postoperative day;calcium on the second postoperative day;inorganic phosphorus on the second postoperative day;PTH on the second postoperative day;the evaluation of symptomatic hypocalcemia;

Countries

China

Contacts

Public ContactXiangqian Zheng

Tianjin Medical University Cancer Institute and Hospital

xiangqian_zheng@163.com+86 18622220506

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026