Thyroid Autotransplantation in Quadriceps Femoris Muscle

NCT ID: NCT04684953

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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

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Thyroid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Thyroid autotransplantation

Implantation of 5-10 gm thyroid gland after mincing it in saline in quadriceps femoris muscle.

Group Type ACTIVE_COMPARATOR

Throid autotransplantation

Intervention Type PROCEDURE

Operative

control group

the patients in this group won't undergo thyroid autotransplantation. instead, hormonal replacement therapy shall be prescribed for them.

Group Type OTHER

Hormone

Intervention Type DRUG

thyroid hormone replacement therapy

Interventions

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Throid autotransplantation

Operative

Intervention Type PROCEDURE

Hormone

thyroid hormone replacement therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* children (male or female)
* patients with malignant or recurrent goitre
* patients who are unfit for surgery
Minimum Eligible Age

15 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ahmed Hassan Aly

Resident surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdullah Badawy, professor

Role: STUDY_DIRECTOR

general surgery professor

Ashraf Helmy, professor

Role: STUDY_CHAIR

general surgery professor

Mohamed M Saad Elshafey, professor

Role: STUDY_CHAIR

general surgery professor

Mohamed A Hassan, resident

Role: PRINCIPAL_INVESTIGATOR

resident physician at general surgery

Central Contacts

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Mohamed A Hassan

Role: CONTACT

01023858185

Abdullah Badawy, professor

Role: CONTACT

01001861127

References

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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.

Reference Type BACKGROUND
PMID: 18449595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11576947 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25735805 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11922738 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11800336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3349341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4226078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26337375 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2384054 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12884093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8594711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26895488 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8954028 (View on PubMed)

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.

Reference Type RESULT
PMID: 30594401 (View on PubMed)

Other Identifiers

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thyroid autotransplantation

Identifier Type: -

Identifier Source: org_study_id

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