UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000057441
Receipt number	R000065626
Scientific Title	Identification of risk factors for intraoperative and postoperative hypotension in patients undergoing transurethral bladder surgery after oral 5-aminolevulinic acid (5-ALA): a single-centre retrospective study
Date of disclosure of the study information	2025/03/28
Last modified on	2026/03/29 09:23:37

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Basic information

Public title

Identification of risk factors for intraoperative and postoperative hypotension in patients undergoing transurethral bladder surgery after oral 5-aminolevulinic acid (5-ALA): a single-centre retrospective study

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Bladder and urethral cancer

Classification by specialty

Urology Anesthesiology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

1. To clarify the effect of the use of photodynamic diagnosis (PDD) (oral 5-ALA) in transurethral bladder surgery on the incidence of intra- and postoperative hypotension, compared with the non-PDD group.
2. To identify independent risk factors for the incidence of intra- and postoperative hypotension in the PDD group (patients who took 5-ALA orally).

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Presence or absence of intraoperative hypotension (defined as systolic blood pressure of less than 80 mmHg or use of vasopressor agents)

Key secondary outcomes

Presence or absence of post-operative hypotension (defined as cases where hypotension persisted after the operation and it was necessary to continue infusion in the operating theatre, cases where the first systolic blood pressure after returning to the ward was less than 80 mmHg, or cases where continuous vasopressor administration was required after the operation)

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

18 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent TURBT or cystoscopic biopsy for bladder or urethral cancer between 01/01/2023 and 31/12/2024

Key exclusion criteria

1.In the case of the same patient undergoing multiple transurethral bladder surgeries with PDD during the research period, from the second time onwards
2.In the case of the same patient undergoing multiple transurethral bladder surgeries without PDD during the research period, from the second time onwards

Target sample size

200

Research contact person

Name of lead principal investigator

1st name Madoka

Middle name

Last name Makino

Organization

Nagasaki University Hospital

Division name

Department of Anesthesiology

Zip code

8528501

Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7370

Email

mmakino9494@nagasaki-u.ac.jp

Public contact

Name of contact person

1st name Madoka

Middle name

Last name Makino

Organization

Nagasaki University Hospital

Division name

Department of Anesthesiology

Zip code

8528501

Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7370

Homepage URL

Email

mmakino9494@nagasaki-u.ac.jp

Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name

Funding Source

Organization

None

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

Nagasaki University Hospital Clinical Research Ethics Committee

Address

1-7-1 Sakamoto, Nagasaki

Tel

095-819-7229

Email

gaibushikin@ml.nagasaki-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2025 Year 03 Month 28 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

Completed

Date of protocol fixation

2023 Year 01 Month 01 Day

Date of IRB

2025 Year 04 Month 24 Day

Anticipated trial start date

2023 Year 01 Month 01 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

None

Management information

Registered date

2025 Year 03 Month 28 Day

Last modified on

2026 Year 03 Month 29 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065626