NCT02194920

Brief Summary

The purpose of this study is to evaluate safety and effectiveness of normal parathyroid tissue reimplantation in forearm subcutaneous tissue in case of accidental removal of parathyroid gland during thyroid surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

Same day

First QC Date

July 3, 2014

Last Update Submit

November 4, 2014

Conditions

Thyroid GoiterThyroid CarcinomaMultinodular GoiterGraves Diseases

Outcome Measures

Primary Outcomes (1)

  • Assessment of parathyroid tissue graft function by selective (left or right) parathormone measurement by vein blood sample

    The primary outcome will be the assessment of reimplanted parathyroid function, evaluated by intact Parathormone (iPTH) measurement by separate blood samples (left and right arm) at 7 days, 1 month and 3 months after surgery. Ratio of 1.5 between the iPTH levels in the arm receiving graft and the opposite arm will be predictive of graft functionality

    up to 3 months

Study Arms (1)

Parathyroid reimplantation

Procedure: Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue

Interventions

Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissuePROCEDURE
Parathyroid reimplantation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients receiving thyroid surgery with accidental removal or devascularization of normal parathyroid gland

You may qualify if:

  • Patients affected by benign thyroid disease undergoing thyroidectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Surgery Unit, ICOT Hospital

Latina, 04100, Italy

Location

MeSH Terms

Conditions

GoiterThyroid Neoplasms

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Giuseppe Cavallaro, MD PhD

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 18, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

IT(1)