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An Analysis of the Relative Risk for Low Triiodothyronine Syndrome in Patients With Chronic Radiation Enteritis

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ClinicalTrials.gov Identifier: NCT02452073
Recruitment Status : Completed
First Posted : May 22, 2015
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Shengxian Fan, Jinling Hospital, China

Tracking Information
First Submitted Date May 15, 2015
First Posted Date May 22, 2015
Last Update Posted Date May 22, 2015
Study Start Date January 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2015)
morbidity [ Time Frame: one year ]
The results will be expressed as percentage
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Analysis of the Relative Risk for Low Triiodothyronine Syndrome in Patients With Chronic Radiation Enteritis
Official Title Not Provided
Brief Summary

Radiation enteritis (RE) is by simple definition an inflammatory process occurring at the level of the intestines as a response to abdominal or pelvic radiation energy exposure. Due to the dosage of radiation, sensitivity of organs to radiation, and some patient characteristics, RE can present as either an acute or chronic syndrome. Clinical manifestations differ but may include abdominal pain, malabsorption, diarrhea, cachexia, intestinal bleeding, obstruction, and even perforation, which compromise quality of life. For many years, radiotherapy of the abdominal or pelvic region is commonly used for a significant percentage of patients with rectosigmoid and genitourinary system tumors. Different techniques have been developed to prevent the occurrence of radiation induced injury. However, the incidence of CRE is expected to continue to rise during the coming years. What's more, abdominal or pelvic radiotherapy can also lead to other side effects in addition to RE, such as skin desquamation, local soft tissue injury, and so on. Till now, lots of attention is only paid to local complications, there is little report on systemic damage of abdominal or pelvic radiotherapy.

Low triiodothyronine syndrome (LT3S), a condition characterized by low circulating triiodothyronine (T3) levels, normal thyroxine (T4), free thyroxine (FT4) and thyroid-stimulating hormone (TSH) levels in the absence of an intrinsic thyroid disease, is variously known as the "nonthyroidal illness syndrome (NTIS)". This condition is frequently detected in critical illness. Reichlin et al. first noticed that some aspects of thyroid hormone metabolism might change during many chronic illnesses as early as 1973. Data has shown that about 35-70% of acute and chronic critical conditions were associated with a significant abnormal thyroid hormone metabolism, of which LT3S was the most common type. Furthermore, these changes have been shown to be associated with disease severity and have been connected with poor short-term prognosis.

To date, there are lots of literatures include detailed reports on the relationship between LT3S and chronic illnesses such as rheumatoid arthritis, systemic lupus erythematosus, sepsis, and so on. However, no systematic analysis of LT3S in patients with CRE has been undertaken. As such, the present study aimed to investigate the frequency of LT3S in CRE patients.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients and volunteers who were admitted to our hospital
Condition The Clinical Incidence of Low Triiodothyronine Syndrome
Intervention Other: Thyroid function tests
Study Groups/Cohorts
  • CRE group
    patients with chronic radiation enteritis
    Intervention: Other: Thyroid function tests
  • malignancy group
    patients with some kinds of malignant tumors but had not previously received radiotherapy
    Intervention: Other: Thyroid function tests
  • control group
    age-matched healthy volunteers
    Intervention: Other: Thyroid function tests
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 21, 2015)
48
Original Actual Enrollment Same as current
Actual Study Completion Date April 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients with chronic radiation enteritis
  • patients with some kinds of malignant tumors but had not previously received radiotherapy
  • age-matched healthy volunteers

Exclusion Criteria:

  • Patients with a chronic disease other than CRE, including RA, SLE, thyroid illness, infectious diseases, and hepatic or renal disorders were excluded.
  • patients have taken any drugs that may influence thyroid hormone secretion and metabolism during the previous 3 months.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02452073
Other Study ID Numbers JinlingH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Shengxian Fan, Jinling Hospital, China
Study Sponsor Shengxian Fan
Collaborators Not Provided
Investigators Not Provided
PRS Account Jinling Hospital, China
Verification Date May 2015