LKH Hall in Tirol, Department of Urology and Andrology 6060 Hall In Tirol AustriaRekrutierend» Google-Maps Ansprechpartner: Gernot Ortner, MD E-Mail: gernot.ortner@tirol-kliniken.at» Ansprechpartner anzeigenLKH Salzburg, Department of Urology and Andrology 5020 Salzburg AustriaNoch nicht rekrutierend» Google-Maps Ansprechpartner: David Oswald, MD Phone: +43 57 2550 E-Mail: d.oswald@salk.at» Ansprechpartner anzeigen
1. intraoperative CTC-number in blood [n/ml] (Time Frame - During surgery: after evacuation of snippets for TURBT and after full vaporization for PKVBT.): Circulating tumor cells (CTCs) are measured in 15ml of peripheral blood which is taken during surgery. CTCs are quantified via automated immunofluorescence-microscopy. CK20+, p53+, DAPI+ and CD45- cells will be classified transitional cancer CTCs.
2. postoperative CTC-number in blood [n/ml] (Time Frame - 2nd postoperative day during morning routine.): Circulating tumor cells (CTCs) are measured in 15ml peripheral blood which is taken after surgery. CTCs are quantified via automated immunofluorescence-microscopy. CK20+, p53+, DAPI+ and CD45- cells will be classified transitional cancer CTCs.
3. postoperative CTC-number in purging fluid [n/ml] (Time Frame - For both gruops (TURBT and PKVB) after insertion of indwelling catheter before finishing surgery.): Circulating tumor cells (CTCs) are measured in purging fluid after the surgical intervention. After insertion of a new indwelling catheter the bladder is fully emptied and 100ml of sterile NaCl 0,9% is injected and extracted 5 times into and out of the bladder to mix CTCs. CTCs are quantified via automated immunofluorescence-microscopy. CK20+, p53+, DAPI+ and CD45- cells will be classified transitional cancer CTCs.
4. postoperative CTC morphology in purging fluid (Time Frame - After insertion of indwelling catheter before finishing the surgery.): Cytological morphology of CTCs in purging fluid. CTCs will be examined for both groups and their morphological aspect (e.g. vital, non-vital, necrotic, deformed) is classified.
5. pre-to-intraoperative change of CTC-number in blood [n/ml] (Time Frame - Preoperative CTCs will be taken right before the start of surgery. Intraoperative CTCs will be taken after evacuation of snippets for TURBT and after full vaporization for PKVBT.): The difference of the preoperative and intraoperative CTC-number in blood is calculated. Due to the intervention in both groups a difference in CTC-number is to be expected.
6. pre-to-postoperative change of CTC-number in blood [n/ml] (Time Frame - Preoperative CTCs will be taken right before the start of surgery. Postoperative CTCs will be taken on day 2 after surgery during the morning routine.): The difference of the preoperative and postoperative CTC-number in blood is calculated. Due to the intervention in both groups a difference in CTC-number is to be expected.
7. intra-to-postoperative change of CTC-number in blood [n/ml] (Time Frame - Intraoperative CTCs will be taken after evacuation of snippets for TURBT and after full vaporization for PKVBT. Postoperative CTCs will be taken on day 2 after surgery during the morning routine.): The difference of the intraoperative and postoperative CTC-number in blood is calculated. Due to the intervention in both groups a difference in CTC-number is to be expected.
8. pre-to-postoperative change of CTC-number in purging fluid [n/ml] (Time Frame - Preoperative CTCs in purging fluid are taken via an indwelling catheter right before start of the surgery. Postoperative CTCs in purging fluid are taken after insertion of a new indwelling catheter before finishing the surgery.): The difference of the preoperative and postoperative CTC-number in purging fluid is calculated. Due to the intervention in both groups a difference in CTC-number is to be expected.
Secondary outcome:
1. Tumor recurrence [yes/no] (Time Frame - According to follow up cystoscopy at 3, 6, 12, 24, 36 months after intervention.): Tumor recurrence is evaluated between 3 months and 36 months after surgery with follow-up cystoscopy.
2. Time to recurrence [days] (Time Frame - Through study completion, recurrence can occur within a maximum follow up of 36 months.): The time difference from date of surgery to date of cystoscopic detection of recurrence. Including analysis of influencing factors.
3. preoperative CTC-number in purging fluid [n/ml] (Time Frame - Right before surgery.): Circulating tumor cells (CTCs) are measured in purging fluid before the surgical intervention. After insertion of an indwelling catheter the bladder is fully emptied and 100ml of sterile NaCl 0,9% is injected and extracted 5 times into and out of the bladder to mix CTCs. CTCs are quantified via automated immunofluorescence-microscopy. CK20+, p53+, DAPI+ and CD45- cells will be classified transitional cancer CTCs.
4. preoperative CTC-number in blood [n/ml] (Time Frame - Right before start of surgery.): Circulating tumor cells (CTCs) are measured in 15ml peripheral blood which is taken right before surgery. CTCs are quantified via automated immunofluorescence-microscopy. CK20+, p53+, DAPI+ and CD45- cells will be classified transitional cancer CTCs.
5. preoperative CTC morphology in purging fluid (Time Frame - Right before start of surgery.): Cytological morphology of CTCs in purging fluid. CTCs will be examined for both groups and their morphological aspect (e.g. vital, non-vital, necrotic, deformed) is classified.
Active Comparator: TURBT (Transurethral Resection of Bladder Tumor) For patients undergoing bipolar transurethral resection, bladder tumor is resected in a piecemeal manner.
Active Comparator: PKVB (Plasma Kinetic Vaporization of Bladder Tumor) For patients undergoing bipolar plasma kinetic vaporization of bladder tumor, bladder tumor is vaporized.
Bipolar transurethral resection of bladder tumor (TURBT): Standard resection in piecemeal technique with standard bipolar cutting loop. (Storz medical, 27040 GP1)
Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT): Vaporization of bladder tumor with standard bipolar vaporization electrode. (Storz medical, 27040 NB)
Quelle: ClinicalTrials.gov
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"CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood"
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