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Study on application of indocyanine green in fluorescence imaging of nerve during radical prostatectomy

Study on application of indocyanine green in fluorescence imaging of nerve during radical prostatectomy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081324
Enrollment
Unknown
Registered
2024-02-28
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

prostate cancer

Interventions

indocyanine green group:Indocyanine green was injected intravenously 24 hours before surgery, and robotic-assisted laparoscopic or conventional laparoscopic radical prostatectomy was performed.

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-80 at the time of enrollment. (2) Pathologically diagnosed with prostate cancer by the biopsy and indicated for robotic-assisted laparoscopic or laparoscopic radical prostatectomy. (3) Patients who have not previously undergone transurethral surgery of prostate, pelvic surgery or radiotherapy. (4) The patients have signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with a history of other cancer diagnoses except non-melanoma skin cancer. (2) Patients who are not fitted for surgery with severe systemic diseases, including severe heart disease and pulmonary insufficiency, severe hepatic and renal insufficiency, uncontrolled diabetes(random blood glucose =12.0mmol/L), severe hypertension (consistently higher than 180/110 mmHg),active tuberculosis, etc. (3) Indocyanine green or iodine allergy. (4) Diagnosed with severe urinary incontinence (the Incontinence questionnaire of the International Urinary Incontinence Advisory Committee score =13) or severe penile erectile dysfunction (the International Erectile Function Index <8). (5) With a history of obturator nerve or genitofemoral nerve injury. (6) With severe mental disorder, including major depression, schizophrenia, etc. (7) In the opinion of the investigator, subjects may not be able to complete the study or comply with the requirements of the study (due to poor management, compliance, etc).

Design outcomes

Primary

MeasureTime frame
The presence of intraoperative fluorescence in neurovascular bundle (NVB);The presence of intraoperative fluorescence in obturator nerve;The presence of intraoperative fluorescence in genitofemoral nerve;

Secondary

MeasureTime frame
The intraoperative fluorescence intensity in obturator nerve;The intraoperative fluorescence intensity in genitofemoral nerve ;The intraoperative fluorescence intensity in neurovascular bundle (NVB);International Index of Erectile Function;The score of the incontinence questionnaire of the International Urinary Incontinence Advisory Committee;The rate of positive surgical margin;The incidence of postoperative complications;Quality of Life score;

Countries

China

Contacts

Public ContactLong Wang

The Third Xiangya Hospital of Central South University

doctorwanglong@163.com+86 138 7315 1645

Outcome results

None listed

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