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出境医 / 临床实验 / Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation (HHT)
Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation (HHT)
Study Description
Brief Summary:
Liver transplantation (LT) has been proposed as a curative treatment in hereditary hemorrhagic telangiectasia (HHT) with severe hepatic involvement. The investigating team provides a long-term evaluation of graft status after LT for HHT with a focus on the risk of recurrence. The present study included all patients prospectively followed up after LT for HHT in the Lyon Liver Transplant Unit from 1993 to 2010 with a survival of more than 1 year.
| Condition or disease | Intervention/treatment |
|---|---|
| Hereditary Haemorrhagic Telangiectasia Liver Transplant | Other: Data collection from standard follow-up after liver transplant |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 14 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation: Clinical Implications and Physiopathological Insights. |
| Actual Study Start Date : | January 1, 2011 |
| Actual Primary Completion Date : | February 1, 2018 |
| Actual Study Completion Date : | December 1, 2018 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Liver transplant in Hereditary Hemorrhagic Telangiectasia
Hereditary Hemorrhagic Telangiectasia (HHT) patients who underwent a liver transplant in Lyon between 1993 and 2010, and who survived more than 1 year after transplantation.
|
Other: Data collection from standard follow-up after liver transplant
All patients underwent regular follow-up every 6 to 12 months after the first year post-liver transplant (LT). Complete laboratory investigations were performed at each visit. Doppler ultrasonography was performed every 1 to 3 years after LT. Computed tomography (CT) scan and/ or magnetic resonance imaging (MRI) was performed at 1, 5, 10, 15, and 20 years after LT, or when clinically indicated. All available radiological material was reviewed. Cardiac evaluation was performed regularly in patients who received transplant for cardiac failure.
|
Outcome Measures
Primary Outcome Measures :
- Change in graft status after liver transplant for Hereditary Haemorrhagic Telangiectasia (HHT) (risk of recurrence) [ Time Frame: Every 6 months after transplantation up to 5 years ]Recurrent clinical examinations (including laboratory, histological and radiological investigations)
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant
Criteria
Inclusion Criteria:
- Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant for HHT
Exclusion Criteria:
- Patient who died in the year following transplantation
Contacts and Locations
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Jérôme DUMORTIER, MD | Hospices Civils de Lyon (Hôpital Edouard Herriot ) |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 2, 2019 | ||||
| First Posted Date | May 8, 2019 | ||||
| Last Update Posted Date | May 8, 2019 | ||||
| Actual Study Start Date | January 1, 2011 | ||||
| Actual Primary Completion Date | February 1, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Change in graft status after liver transplant for Hereditary Haemorrhagic Telangiectasia (HHT) (risk of recurrence) [ Time Frame: Every 6 months after transplantation up to 5 years ] Recurrent clinical examinations (including laboratory, histological and radiological investigations)
|
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| 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 | Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation | ||||
| Official Title | Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation: Clinical Implications and Physiopathological Insights. | ||||
| Brief Summary | Liver transplantation (LT) has been proposed as a curative treatment in hereditary hemorrhagic telangiectasia (HHT) with severe hepatic involvement. The investigating team provides a long-term evaluation of graft status after LT for HHT with a focus on the risk of recurrence. The present study included all patients prospectively followed up after LT for HHT in the Lyon Liver Transplant Unit from 1993 to 2010 with a survival of more than 1 year. | ||||
| 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 | Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant | ||||
| Condition |
|
||||
| Intervention | Other: Data collection from standard follow-up after liver transplant
All patients underwent regular follow-up every 6 to 12 months after the first year post-liver transplant (LT). Complete laboratory investigations were performed at each visit. Doppler ultrasonography was performed every 1 to 3 years after LT. Computed tomography (CT) scan and/ or magnetic resonance imaging (MRI) was performed at 1, 5, 10, 15, and 20 years after LT, or when clinically indicated. All available radiological material was reviewed. Cardiac evaluation was performed regularly in patients who received transplant for cardiac failure.
|
||||
| Study Groups/Cohorts | Liver transplant in Hereditary Hemorrhagic Telangiectasia
Hereditary Hemorrhagic Telangiectasia (HHT) patients who underwent a liver transplant in Lyon between 1993 and 2010, and who survived more than 1 year after transplantation.
Intervention: Other: Data collection from standard follow-up after liver transplant
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
14 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | December 1, 2018 | ||||
| Actual Primary Completion Date | February 1, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03942315 | ||||
| Other Study ID Numbers | HHT | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Hospices Civils de Lyon | ||||
| Study Sponsor | Hospices Civils de Lyon | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
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| PRS Account | Hospices Civils de Lyon | ||||
| Verification Date | May 2019 | ||||
