UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061775 |
|---|---|
| Receipt number | R000070677 |
| Scientific Title | Longitudinal changes in Kommerell diverticulum during conservative follow-up |
| Date of disclosure of the study information | 2026/06/03 |
| Last modified on | 2026/06/02 20:30:52 |
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Basic information
Public title
Safety of conservative follow-up for asymptomatic Kommerell diverticulum
Acronym
Safety of conservative follow-up for asymptomatic Kommerell diverticulum
Scientific Title
Longitudinal changes in Kommerell diverticulum during conservative follow-up
Scientific Title:Acronym
Longitudinal changes in Kommerell diverticulum during conservative follow-up
Region
| Japan |
Condition
Condition
Kommerell's diverticulum
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome in the conservatively managed cohort was the occurrence of KD-related adverse events during follow-up, including: (1) new KD-related symptoms (eg, hoarseness, dysphagia, or KD-attributable chest/back pain); (2) acute aortic syndromes involving the KD segment (aortic dissection or rupture); and (3) KD-related death .
Secondary outcomes included (1) longitudinal changes in CT-based indices and normalized ratios; (2) delayed intervention after initial conservative management (timing and indication); and (3) early and midterm operative outcomes among patients who underwent intervention (operative mortality and major perioperative complications).
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 28 | years-old | <= |
Age-upper limit
| 84 | 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 sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Takuro |
| Middle name | |
| Last name | Makiura |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Thoracic and Cardiovascular Surgery
Zip code
569-8686
Address
2-7 Daigaku-Machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
takurou.makiura@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Makiura |
Organization
Osaka Medical and Pharmaceutical University
Division name
Department of Thoracic and Cardiovascular Surgery
Zip code
569-8686
Address
2-7 Daigaku-Machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
Homepage URL
takurou.makiura@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-Machi, Takatsuki, Osaka, Japan
Tel
072-683-1221
takurou.makiura@ompu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
Results
Across the cohort, KD-related adverse events were rare. Operative management was associated with no operative mortality and no major perioperative complications in this series. In the conservatively managed cohort, CT-based indices and normalized ratios showed modest annualized change rates over midterm follow-up, with no KD-related dissection, rupture, or KD-related death, although 1 patient required delayed elective repair because of progressive morphologic enlargement.
Results date posted
| 2026 | Year | 06 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
CT measurements were extracted from clinical records and radiologic reports. The following indices were recorded at baseline and at each available follow-up CT
Asc ascending aorta diameter at the level of the pulmonary artery bifurcation.
Des descending thoracic aorta diameter at the same level.
DAW distance from the opposite aortic wall to the top of the KD.
DTAW maximum distance from the diverticulum wall adjacent to the trachea to the opposite descending aorta wall.
dLSA distal left subclavian artery diameter (recorded as dLSCA in the dataset).
KDA KD orifice diameter.
KDD depth of the KD.
We calculated normalized ratios at each time point: DAW/Asc, DTAW/Asc, KDA/Asc, KDD/Asc; DAW/Des, DTAW/Des, KDA/Des, KDD/Des; DAW/dLSA, DTAW/dLSA, KDA/dLSA, KDD/dLSA; and dLSA/Asc and dLSA/Des.
For longitudinal analyses, annualized change rates (mm/year) for each absolute index (Asc, Des, dLSA, DAW, DTAW, KDA, and KDD) were calculated as (latest follow-up value - baseline value) / elapsed follow-up time (years). Annualized change rates for normalized ratios (1/year) were calculated using the same approach.
Management information
Registered date
| 2026 | Year | 06 | Month | 02 | Day |
Last modified on
| 2026 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070677
