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Hormone Therapy

Hormone Monitoring for Hyperparathyroidism (PEREGRINE Trial)

N/A

Waitlist Available

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidate for subtotal parathyroidectomy or total thyroidectomy with or without autotransplantation

Tertiary hyperparathyroidism and/or recurrent hyperparathyroidism OR secondary hyperparathyroidism diagnosed with any stage of chronic kidney disease

Must not have

Undergoing parathyroidectomy for primary hyperparathyroidism

Undergoing revision parathyroidectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the end the trial at 6 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if using intraoperative parathyroid hormone (IOPTH) criteria during surgery for secondary and tertiary hyperparathyroidism is feasible. Patients will be randomly assigned to have surgery

Who is the study for?

This trial is for individuals with hyperparathyroidism, which causes high calcium levels and can lead to bone and kidney problems. Participants should be scheduled for parathyroid surgery. There are specific criteria they must meet to join the study, but these have not been detailed here.

What is being tested?

The study tests if monitoring parathyroid hormone levels during surgery (IOPTH) helps guide the procedure better than surgeries without this monitoring. Patients will be randomly assigned to one of four IOPTH-guided surgery groups or a control group without IOPTH guidance.

What are the potential side effects?

Since the intervention involves a surgical procedure, potential side effects may include typical surgical risks such as infection, bleeding, or reaction to anesthesia. Specific side effects related to IOPTH monitoring are not provided.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a candidate for surgery to remove part of my parathyroid or my entire thyroid.

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I have been diagnosed with a type of hyperparathyroidism.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am having surgery to remove parathyroid glands due to primary hyperparathyroidism.

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I am scheduled for a second parathyroid surgery.

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I am having a minimally invasive surgery on my parathyroid.

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I cannot attend all required study follow-up visits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the end the trial at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the end the trial at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end the trial at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Randomization rate

Secondary study objectives

Blinding effectiveness

Follow-up completion

Surgeon compliance and crossover

+1 more

Other study objectives

Chronic kidney disease progression, cardiovascular death, or renal death (composite outcome)

Cognitive function

Emergency room visits and hospital readmission rates

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: 25 minute armExperimental Treatment1 Intervention

Surgery for patients randomized to this arm will need to use IOPTH monitoring. Surgeons in this arm will decide to end surgery or perform surgical re-exploration if the IOPTH level at 25 minutes following ligation of all hyperfunctioning parathyroid tissue is \>=50% from the highest pre-incision or pre-excision baseline IOPTH level.

Group II: 20 minute armExperimental Treatment1 Intervention

Surgery for patients randomized to this arm will need to use IOPTH monitoring. Surgeons in this arm will decide to end surgery or perform surgical re-exploration if the IOPTH level at 20 minutes following ligation of all hyperfunctioning parathyroid tissue is \>=50% from the highest pre-incision or pre-excision baseline IOPTH level.

Group III: 15 minute armExperimental Treatment1 Intervention

Surgery for patients randomized to this arm will need to use IOPTH monitoring. Surgeons in this arm will decide to end surgery or perform surgical re-exploration if the IOPTH level at 15 minutes following ligation of all hyperfunctioning parathyroid tissue is \>=50% from the highest pre-incision or pre-excision baseline IOPTH level.

Group IV: 10 minute armExperimental Treatment1 Intervention

Surgery for patients randomized to this arm will need to use IOPTH monitoring. Surgeons in this arm will decide to end surgery or perform surgical re-exploration if the IOPTH level at 10 minutes following ligation of all hyperfunctioning parathyroid tissue is \>=50% from the highest pre-incision or pre-excision baseline IOPTH level.

Group V: No IOPTH monitoring armActive Control1 Intervention

Surgery for patients randomized to this arm will not require guidance with any IOPTH monitoring. These will be allowed to use frozen section analysis, if deemed appropriate by the surgeon.

0 / 7Eligibility criteria met