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
About this trial
This is an interventional treatment trial for Thyroid
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
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
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
Learn more about this trial
Thyroid Autotransplantation in Quadriceps Femoris Muscle
We'll reach out to this number within 24 hrs