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Thyroid Autotransplantation in Quadriceps Femoris Muscle

Primary Purpose

Thyroid

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Throid autotransplantation
Hormone
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Thyroid autotransplantation

    control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    normal level of thyroid hormone, and thyroid stimulating hormone

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2020
    Last Updated
    January 7, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04684953
    Brief Title
    Thyroid Autotransplantation in Quadriceps Femoris Muscle
    Official Title
    Implantation of Thyroid Gland After Total Thyroidectomy in Quadriceps Femoris Muscle
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Thyroid autotransplantation
    Arm Type
    Active Comparator
    Arm Description
    Implantation of 5-10 gm thyroid gland after mincing it in saline in quadriceps femoris muscle.
    Arm Title
    control group
    Arm Type
    Other
    Arm Description
    the patients in this group won't undergo thyroid autotransplantation. instead, hormonal replacement therapy shall be prescribed for them.
    Intervention Type
    Procedure
    Intervention Name(s)
    Throid autotransplantation
    Intervention Description
    Operative
    Intervention Type
    Drug
    Intervention Name(s)
    Hormone
    Intervention Description
    thyroid hormone replacement therapy
    Primary Outcome Measure Information:
    Title
    normal level of thyroid hormone, and thyroid stimulating hormone
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed A Hassan
    Phone
    01023858185
    Email
    mouhmed.ahmed@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdullah Badawy, professor
    Phone
    01001861127
    Email
    badawy@aun.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abdullah Badawy, professor
    Organizational Affiliation
    general surgery professor
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ashraf Helmy, professor
    Organizational Affiliation
    general surgery professor
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mohamed M Saad Elshafey, professor
    Organizational Affiliation
    general surgery professor
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Mohamed A Hassan, resident
    Organizational Affiliation
    resident physician at general surgery
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18449595
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11576947
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25735805
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11922738
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11800336
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    3349341
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    4226078
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26337375
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    2384054
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12884093
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    8594711
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26895488
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    8954028
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30594401
    Citation
    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.
    Results Reference
    result

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    Thyroid Autotransplantation in Quadriceps Femoris Muscle

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