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AzTrials

ThyroidNCT04684953

Thyroid Autotransplantation in Quadriceps Femoris Muscle

A study testing Throid autotransplantation and Hormone in people with Thyroid, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

providing an almost natural ectopic thyroid in patients undergoing total thyroidectomy, remains a challenging subject that can benefits patients with a non-pharmacological substitute for their normal gland. this study seeks to prove that thyroid autotransplantation is possible and reliable. Read more about this study

Who is it for?
Ages 15 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Thyroid
What is being tested?
Throid autotransplantation and Hormone
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Jan 2022to Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • adult male or female with simple nodular goitre.
  • patients who are fit for surgery.

Who cannot join

  • children (male or female)
  • patients with malignant or recurrent goitre
  • patients who are unfit for surgery

Trial locations and contacts

No sites are listed yet.

Mohamed A Hassan contact

01023858185

mouhmed.ahmed@gmail.com

Abdullah Badawy, professor contact

01001861127

badawy@aun.edu.eg

About this study

Official title: Implantation of Thyroid Gland After Total Thyroidectomy in Quadriceps Femoris Muscle

providing an almost natural ectopic thyroid in patients undergoing total thyroidectomy, remains a challenging subject that can benefits patients with a non-pharmacological substitute for their normal gland. this study seeks to prove that thyroid autotransplantation is possible and reliable.

Read the detailed description

Total thyroidectomy, rather thyroidectomy, is currently widely accepted as the modality of choice for treatment of benign thyroid disorders that require surgical excision. The goal of post-thyroidectomy management is to reach a "safe physiological status" of thyroid hormonal profile. Although exogenous levothyroxine replacement has long been safely used as a replacement after total thyroidectomy, it is not considered optimal, as it is bounded by patient's compliance with the treatment and follow-up schedule, effect of mal-absorption, and the inability to compensate for daily physiological alterations.

The concept of endocrinal tissue auto-transplantation has been largely investigated in the case of parathyroid gland, and to a lesser extent for pancreatic islets. Although both the experimental studies of thyroid autotransplantation and the early case reports of lingual thyroid autotransplantations have shown encouraging results, a very limited number of clinical studies investigated thyroid autotransplantation in adult patients with benign thyroid disorders. Moreover, the discrepancy in the patients' characteristics and thyroid autotransplantation technique in these studies hinders the standardization of thyroid autotransplantation for clinical practice. Hypothetically, thyroid autotransplantation offers and attractive alternative for subtotal thyroidectomy, as it enables the preservation of native responsive thyroid tissue in an accessible location, and, thus, evades the risk of possible regrowth in the neck region. The present preliminary clinical study is conducted to investigate the feasibility and outcome of thyroid autotransplantation after total thyroidectomy for patients with benign thyroid disorders (other than thyroiditis).

Conditions
Thyroid
Being tested
Throid autotransplantation, Hormone
Medical subject headings
Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Throid autotransplantationProcedure or surgery

    Operative

  • HormoneDrug

    thyroid hormone replacement therapy

Study groups in NCT04684953
Study groupRoleWhat they receive
Thyroid autotransplantationActive comparatorImplantation of 5-10 gm thyroid gland after mincing it in saline in quadriceps femoris muscle.
Receives: Procedure: Throid autotransplantation
control groupOtherthe patients in this group won't undergo thyroid autotransplantation. instead, hormonal replacement therapy shall be prescribed for them.
Receives: Drug: Hormone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. normal level of thyroid hormone, and thyroid stimulating hormone

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2020
  2. Study startJan 2022 (estimated)
  3. Primary completionOct 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04684953
Sponsor's protocol ID
thyroid autotransplantation
Status last verified
Jan 2022
First submitted
22 Dec 2020
Last updated
11 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Agarwal G, Aggarwal V. Is total thyroidectomy the surgical procedure of choice for benign multinodular goiter? An evidence-based review. World J Surg. 2008 Jul;32(7):1313-24. doi: 10.1007/s00268-008-9579-8.

    PubMed 18449595

  • Tominaga Y, Uchida K, Haba T, Katayama A, Sato T, Hibi Y, Numano M, Tanaka Y, Inagaki H, Watanabe I, Hachisuka T, Takagi H. More than 1,000 cases of total parathyroidectomy with forearm autograft for renal hyperparathyroidism. Am J Kidney Dis. 2001 Oct;38(4 Suppl 1):S168-71. doi: 10.1053/ajkd.2001.27432.

    PubMed 11576947

  • Wu Q, Zhang M, Qin Y, Jiang R, Chen H, Xu X, Yang T, Jiang K, Miao Y. Systematic review and meta-analysis of islet autotransplantation after total pancreatectomy in chronic pancreatitis patients. Endocr J. 2015;62(3):227-34. doi: 10.1507/endocrj.EJ14-0510. Epub 2015 Jan 7.

    PubMed 25735805

  • Papaziogas B, Antoniadis A, Lazaridis Ch, Makris J, Kotakidou R, Paraskevas G, Papaziogas T. Functional capacity of the thyroid autograft: an experimental study. J Surg Res. 2002 Apr;103(2):223-7. doi: 10.1006/jsre.2001.6348.

    PubMed 11922738

  • Shimizu K, Kumita S, Kitamura Y, Nagahama M, Kitagawa W, Akasu H, Oshina T, Kumasaki T, Tanaka S. Trial of autotransplantation of cryopreserved thyroid tissue for postoperative hypothyroidism in patients with Graves' disease. J Am Coll Surg. 2002 Jan;194(1):14-22. doi: 10.1016/s1072-7515(01)01115-2.

    PubMed 11800336

  • Al-Samarrai AY, Crankson SJ, Al-Jobori A. Autotransplantation of lingual thyroid into the neck. Br J Surg. 1988 Mar;75(3):287. doi: 10.1002/bjs.1800750333. No abstract available.

    PubMed 3349341

  • Swan H, Jenkins D, Schemmel J. Thyroid autograft. A 12-year follow-up. Arch Surg. 1967 Jun;94(6):817-20. doi: 10.1001/archsurg.1967.01330120071014. No abstract available.

    PubMed 4226078

  • Mohsen AA, Nada AA, Ibrahim MY, Ghaleb AH, Abou-Gabal MA, Mohsen AA, Wassef AT. Technique and outcome of autotransplanting thyroid tissue after total thyroidectomy for simple multinodular goiters. Asian J Surg. 2017 Jan;40(1):17-22. doi: 10.1016/j.asjsur.2015.05.007. Epub 2015 Aug 31.

    PubMed 26337375

  • Okamoto T, Fujimoto Y, Obara T, Ito Y, Kodama T, Kusakabe K. Trial of thyroid autotransplantation in patients with Graves' disease whose remnant thyroid has unintentionally been made too small at subtotal thyroidectomy. Endocrinol Jpn. 1990 Feb;37(1):95-101. doi: 10.1507/endocrj1954.37.95.

    PubMed 2384054

  • Roy PG, Saund MS, Thusoo TK, Roy D, Sankar R. Fate of human thyroid tissue autotransplants. Surg Today. 2003;33(8):571-6. doi: 10.1007/s00595-003-2557-8.

    PubMed 12884093

  • Sheverdin IuP. [The results of a 15-year observation of patients with an autotransplant of thyroid gland fragments performed to prevent postoperative hypothyroidism]. Vestn Khir Im I I Grek. 1992 Feb;148(2):152-6. Russian.

    PubMed 8594711

  • Ozdemir D, Cuhaci FN, Ozdemir E, Aydin C, Ersoy R, Turkolmez S, Cakir B. The role of postoperative Tc-99m pertechnetate scintigraphy in estimation of remnant mass and prediction of successful ablation in patients with differentiated thyroid cancer. Nucl Med Commun. 2016 Jun;37(6):640-5. doi: 10.1097/MNM.0000000000000492.

    PubMed 26895488

  • Uzzan B, Campos J, Cucherat M, Nony P, Boissel JP, Perret GY. Effects on bone mass of long term treatment with thyroid hormones: a meta-analysis. J Clin Endocrinol Metab. 1996 Dec;81(12):4278-89. doi: 10.1210/jcem.81.12.8954028.

    PubMed 8954028

  • Katna R, Kalyani N, Deshpande A; Mumbai Oncology Group - Head and Neck. Free thyroid transfer to anterolateral thigh for prevention of radiation induced hypothyroidism: An initial experience. Am J Otolaryngol. 2019 Mar-Apr;40(2):160-163. doi: 10.1016/j.amjoto.2018.12.013. Epub 2018 Dec 21.

    PubMed 30594401

Questions about this trial

What is this clinical trial studying?

A study testing Throid autotransplantation and Hormone in people with Thyroid, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed A Hassan (01023858185, mouhmed.ahmed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

normal level of thyroid hormone, and thyroid stimulating hormone (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04684953, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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