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Clinical application of innovative blue laser-mediated theranostic strategies in the diagnosis, surgery and recurrent prevention of high-risk non-muscle invasive bladder cancer (NMIBC): a multicenter randomized controlled clinical trial

Clinical application of innovative blue laser-mediated theranostic strategies in the diagnosis, surgery and recurrent prevention of high-risk non-muscle invasive bladder cancer (NMIBC): a multicenter randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067336
Enrollment
Unknown
Registered
2023-01-04
Start date
2023-01-04
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer

Interventions

group 1:White light cystoscopy + TURBT
group 2:preoperative PDD + blue laser en bloc resection + postoperative PDT

Sponsors

First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. All cystoscopic examination and imaging data are determined to be non-muscle invasive bladder cancer (NMIBC), which requires transurethral surgery (non-diagnostic purpose), and is determined to be high-risk NMIBC according to the risk of recurrence and progression (meet any of the following: ?T1 tumor; ?G3 or high-grade urothelial carcinoma; ?CIS; ?Meet at the same time: multiple, recurrent, and TaG1-2 or low-grade urothelial carcinoma with a diameter > 3 cm); 2. Age between 18 and 80 years old; 3. ECOG score 0-1; 4. Women of childbearing age should have a negative urine pregnancy test; 5. Take reliable contraceptive measures during the study; 6. The patient voluntarily participated and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Low- and intermediate-risk NMIBC (that is, NMIBC that does not meet the high-risk conditions); 2. Severe urinary tract obstruction who cannot undergo transurethral surgery; 3. People with uncontrollable urinary tract infection; 4. Those who have serious systemic diseases or chronic wasting diseases are not suitable for surgery; 5. The patient has a history of other malignant tumors in the past five years; 6. Those who are receiving anticoagulant therapy and cannot stop the drug due to reasonable medical considerations; 7. Pregnant and lactating women; 8. Participants in other clinical trials; 9. Other conditions that the researchers think are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Tumor recurrence rate at 1 year after surgery;

Countries

China

Contacts

Public ContactWu Kaijie

The First Affiliated Hospital of Xi'an Jiaotong University

kaijie_wu@163.com+86 153 8929 9128

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026