UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063411 |
|---|---|
| Receipt number | R000072287 |
| Scientific Title | Lung Preservation at 10 Degrees Celsius in Lung Transplantation: An Observational Study |
| Date of disclosure of the study information | 2026/10/25 |
| Last modified on | 2026/10/25 19:18:20 |
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Basic information
Public title
Lung Preservation at 10 Degrees Celsius in Lung Transplantation: An Observational Study
Acronym
Lung Preservation at 10 Degrees Celsius in Lung Transplantation
Scientific Title
Lung Preservation at 10 Degrees Celsius in Lung Transplantation: An Observational Study
Scientific Title:Acronym
Lung Preservation at 10 Degrees Celsius in Lung Transplantation
Region
| Japan |
Condition
Condition
chronic respiratory failure
Classification by specialty
| Cardiology | Pneumology | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Donor lungs are conventionally stored on ice, with ischemic time limited to 8 hours. At our institution, they are kept in a cooler box during transport until implantation; ischemic time sometimes exceeds 10 hours, e.g., in recipients with severe intrathoracic adhesions.
In 2021, storage at 10 degrees Celsius (10C) was reported to preserve graft function and allow longer preservation (Ali A, et al. Sci Transl Med. 2021). A multinational prospective trial (N=70) showed 10C storage safely extended ischemic time to a median of 14.1 hours, with short-term outcomes comparable to ice storage (median 6.1 hours) (Ali A, et al. NEJM Evid. 2023). Another prospective trial (N=181) found no differences in short-term outcomes among 10C storage for >=18 hours (mean 20.6) or <12 hours (mean 9.7) and short ice storage (mean 7.6) (Hoetzenecker K, et al. Ann Surg. 2025).
All these studies used Perfadex, and the safety of 10C storage with ET-Kyoto (ET-K) solution, used in Japan, is unknown. We showed that lung temperature during ice storage generally ranges from 4 to 10C with wide variability, and that a warmer final temperature is associated with less primary graft dysfunction (PGD) (Takada J, Kawashima M, et al. JHLT Open. 2026;12:100489). Thus, 10C is not an extreme setting and has likely occurred clinically.
This single-center, prospective, single-arm cohort study will enroll about 100 recipients. Donor lungs will be stored in an electric cooler box set at 10C. Short-term outcomes, such as PGD, will be compared with historical ice-stored controls. The study will follow the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects.
This study is novel in using 10C storage with ET-K. Although no clinical data exist, our rat lung transplant study (12-hour preservation) showed better graft function with 10C ET-K storage than with ice storage (manuscript in preparation). These findings support the scientific validity and safety of this study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoints will be the grade of primary graft dysfunction (PGD) immediately after surgery and at 24, 48, and 72 hours. Secondary endpoints will include duration of mechanical ventilation, length of ICU stay, length of hospital stay, and 1-year survival after transplantation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
lung graft storage at 10 degrees Celsius refrigerator
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be eligible:
1) Patients who undergo lung transplantation at our hospital between the date of institutional approval and March 31, 2030
2) Any age
3) Any sex
4) Patients for whom clinical data are available up to 1 month after surgery
5) Vulnerable participants (including minors): included
Reason for including vulnerable participants: 10C storage is considered advantageous when ischemic time is prolonged, and it should be performed when necessary even in pediatric patients.
Possibility of patient selection: Patients may be selected after assessing their suitability from medical and logistical perspectives.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded:
1) Patients whom the investigators judge unsuitable for participation (e.g., when air transport is required, the electric cooler box will not be used for the time being, because bringing it on board an aircraft is expected to be difficult)
2) Patients who have declined the use of their information in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Sato |
Organization
The University of Tokyo Hospital
Division name
Department of Thoracic Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8856
satom-sur@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuaki |
| Middle name | |
| Last name | Kawashima |
Organization
The University of Tokyo Hospital
Division name
Department of Thoracic Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-8856
Homepage URL
https://plaza.umin.ac.jp/~ctstokyo/dl/thoracic/rp261009.pdf
kawashimam-sur@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5800-8856
kawashimam-sur@h.u-tokyo.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 | 10 | Month | 25 | 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
Results
Results date posted
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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 25 | Day |
Last modified on
| 2026 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072287
