Tokyo, June 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061775) titled 'Safety of conservative follow-up for asymptomatic Kommerell diverticulum' on June 3.
Study Type:
Observational
Primary Sponsor:
Institute - Osaka Medical and Pharmaceutical University
Condition:
Condition - Kommerell's diverticulum
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evidence guiding surveillance and indications for intervention for Kommerell diverticulum remains limited. We evaluated clinical outcomes and longitudinal morphologic changes on noncontrast computed tomography in adults managed with an empirical, symptom- and size-based strategy.
Basic objectives2 - Safety
Eligibility:
Age-lower limit - 28
years-old
=
Gender - Male and Female
Key inclusion criteria - We identified all consecutive patients diagnosed with Kommerell's diverticulum associated with aberrant left subclavian artery associated with a right aortic arch on CT between 2015 and 2024. KD was defined as a focal saccular dilation at the origin of the aberrant left subclavian artery.
Key exclusion criteria - (1) neonatal KD resected during surgery for other congenital cardiac or aortic anomalies; (2) aneurysmal change at the origin of a previously ligated aberrant left subclavian artery; (3) incomplete clinical or imaging follow-up because of loss to follow-up; and (4) acute aortic dissection involving the descending thoracic aorta at the time of KD diagnosis.
Target Size - 16
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 08 Month 01 Day
Date of IRB - 2025 Year 04 Month 21 Day
Anticipated trial start date - 2025 Year 04 Month 21 Day
Last follow-up date - 2029 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070677
Disclaimer: Curated by HT Syndication.
