- 标题
- 摘要
- 关键词
- 实验方案
- 产品
-
DaBlaCa-11: Photodynamic diagnosis in flexible cystoscopy - initial findings in a randomized controlled trial
摘要： Patients with non-muscle invasive bladder cancer (NMIBC) face the risk of having several transurethral resections of the bladder (TURBT) performed because of the high recurrence rate of the disease. Photodynamic diagnosis (PDD) is recommended in primary TURBTs because of a higher detection rate than white light (WL) cystoscopy. In the surveillance program, however, WL flexible cystoscopy is still the standard approach. The aim of this randomized controlled trial is to examine the potential benefits from a PDD guided flexible cystoscopy in the outpatient clinic in patients with previous NMIBC. From February 2016 to September 2017, 605 patients were enrolled from three urological department in Denmark. All patients were scheduled for a routine surveillance cystoscopy following a TURBT because of Ta bladder cancer (low or high grade) 4 months earlier. Patients were randomized 1:1 to either an intervention group where Hexaminolevulinate (Hexvix?Photocure, NO) was instilled in the bladder one hour before the cystoscopy with PDD video cystoscope (PDD 11272 VPI, D-Light C-Light Source; Karl Storz), or a control group where cystoscopy was performed with WL flexible cystoscope. In both patient groups, detection of multiple and large recurrences estimated > 1 cm were scheduled for a TURBT in general anesthesia whereas solitary or small multiple recurrences, as well as suspect mucosa, were biopsied or fulgurated directly in the flexible procedure. A total of 304 patients were allocated to the intervention group (flexible PDD) and 301 to the control group (flexible WL). Approximately half of all patients in both groups were recurrence free (control group, n= 150 and intervention group, n=157). The number of patients undergoing biopsy or fulguration because of suspect mucosa were higher in the intervention group compared to the control group (n=66 vs. n=36, p<0.05). Significantly more patients in the intervention group were treated in the outpatient clinic (n=95) compared to the control group (n=76) (n=95 vs n=76, p <0.05), whereas fewer patients were scheduled for a TURBT in the intervention group (n=52) than in the control group (n=75) (n=52 vs n=75, p<0.05). These initial results indicate that PDD guided flexible cystoscopy can reduce the need of TURBT when biopsy and fulguration of small tumors is possible in the outpatient clinic. Further follow-up data on recurrences in patients in the study will be needed to estimate the clinical impact on this regarding reduction of recurrence risk and repeated procedures.
关键词： randomized controlled trial,flexible cystoscopy,Photodynamic diagnosis,non-muscle invasive bladder cancer
更新于2025-09-23 15:19:57
-
Transient liver toxicity as a result of the oral administration of 5-aminolevulinic acid for photodynamic diagnosis in patients with bladder cancer
摘要： The clinical benefit of PDD-assisted TURBT with 5-ALA is evident from several studies.1–3 We carried out a phase III study of this new diagnostic technique in Japan using a preoperative oral administration of 20 mg/kg 5-ALA.2 On the basis of the reported high diagnostic accuracy and good safety profile, oral 5-ALA has been approved as an intraoperative diagnostic drug in Japan since December 2017. The toxicity induced by 5-ALA is reported to be low, because 5-ALA is a non-fluorescent natural amino acid produced by the mitochondria in animals and plants.3,4 However, 5-ALA administered into the body is predominantly incorporated by the liver, kidney, muscle and malignant tumor tissue, and metabolized to protoporphyrin IX in a heme synthetic pathway.5,6 Administration of 5-ALA is associated with a potential risk of liver toxicity as a result of the substantial accumulation of its metabolites.6,7 Although evidence regarding its liver toxicity has been reported in Europe and the USA, such data are significantly lacking for Japanese patients. In the present study, we systematically evaluated liver parameter reactions in patients with bladder cancer who underwent 5-ALA-mediated PDD-TURBT to recommend the routine surveillance required in the regular clinical setting.
关键词： liver toxicity,5-aminolevulinic acid,photodynamic diagnosis,bladder cancer
更新于2025-09-09 09:28:46