CTC Quantification During TURBT and PKVBT of Transitional Cell Carcinoma in Purging Fluid and Blood
NCT ID: NCT04811846
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2021-03-14
2025-10-31
Brief Summary
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Detailed Description
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Against any existing oncological principle, during TURBT bladder tumors are resected in a piecemeal manner. This results in tumor fragmentation and floating cancer cells inside the bladder during surgery. These cells may have the ability to re-attach on and re-implant into the bladder wall and may be responsible for early disease recurrence which is commonly seen after initial surgery. It has been shown that tumor cells may access the circulatory system through cut vessels. Circulating tumor cells (CTCs) can be detected in up to 20% in T1 high grade disease and are commonly seen in metastasized disease. They have shown to be an independent predictor of disease progression and relapse in several studies and reflect biological aggressiveness.
In the current study the investigators want to quantify CTCs for recurrent intermediate risk transitional cell carcinoma in purging fluid and blood for two different surgical methods: TURBT and Plasma-kinetic vaporisation of bladder tumors (PKVBT). Also correlations for recurrence will be investigated for the two different surgical methods.
In 2 urological centers (LKH Hall, LKH Salzburg) participants with diagnosed intermediate risk recurrent transitional cell carcinoma of the bladder will be randomly enrolled for either TURBT or PKVBT. Before surgery CTCs will be analyzed in peripheral blood and purging fluid. (preoperative CTCs blood and purging fluid, morphological aspect of CTCs in purging fluid) After resection for TURBT and vaporization for PKVBT, a tumor ground biopsy will be taken for both groups. After coagluation, CTCs will again be drawn in peripheral blood (intraoperative CTCs blood). After completion of surgery an indwelling catheter is inserted and purging fluid is again analyzed (postoperative CTCs purging fluid, morphological aspect of CTCs in purging fluid). Blood is again taken on day 2 after surgery during the morning routine to assess CTCs after surgery (postoperative CTCs blood). Patients will be dismissed on earliest day 2 after surgery after indwelling catheter removal.
Recurrence will be assessed during follow-up by cystoscopic controls (From 3 to 36 months after surgery). If recurrence is detected the study is terminated. If no recurrence is detected up to 36 months after surgery, the study is likewise terminated.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TURBT (Transurethral Resection of Bladder Tumor)
For patients undergoing bipolar transurethral resection, bladder tumor is resected in a piecemeal manner.
Bipolar transurethral resection of bladder tumor (TURBT)
Standard resection in piecemeal technique with standard bipolar cutting loop. (Storz medical, 27040 GP1)
PKVB (Plasma Kinetic Vaporization of Bladder Tumor)
For patients undergoing bipolar plasma kinetic vaporization of bladder tumor, bladder tumor is vaporized.
Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT)
Vaporization of bladder tumor with standard bipolar vaporization electrode. (Storz medical, 27040 NB)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* recurrent bladder tumor
* preoperative cystoscopy
* CT or MRI scan of abdomen not older than 30 days prior to surgery without suspicion of advanced disease (MIBC, metastasis)
* max. non-invasive papillary tumor (pTa) staging in prior histology
* max. low grade grading in prior histology
* max. 5 lesions in actual cystoscopy (all \< 3cm)
* exophytic tumors
* transitional cell cancer of urinary bladder
* patient able to give consent
* signed consent form
Exclusion Criteria
* flat lesion
* \> 3cm
* carcinoma in situ (CIS) in prior histology or suspicious CIS-finding in actual cystoscopy
* high grade grading in prior histology
* ≥ pT1 (tumor infiltration into subepithelial connective tissue) staging in prior histology
* \> 5 lesions
* different entity from transitional cell carcinoma of urinary bladder
* prior radiation
* emergency surgery
* prior indwelling catheter (extraction \< 1 week prior to surgery)
* pregnancy
* orthotopic neobladder
18 Years
ALL
No
Sponsors
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Salzburger Landeskliniken
OTHER
University Teaching Hospital Hall in Tirol
OTHER
Responsible Party
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Gernot Ortner
Sub-Investigator
Principal Investigators
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Udo Nagele, MD, Prof.
Role: STUDY_CHAIR
Head of Department LKH Hall in Tirol
Lukas Lusuardi, MD, Prof.
Role: STUDY_CHAIR
Heas of Department LKH Salzburg
Locations
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LKH Hall in Tirol, Department of Urology and Andrology
Hall in Tirol, , Austria
LKH Salzburg, Department of Urology and Andrology
Salzburg, , Austria
Countries
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References
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Burger M, Catto JW, Dalbagni G, Grossman HB, Herr H, Karakiewicz P, Kassouf W, Kiemeney LA, La Vecchia C, Shariat S, Lotan Y. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol. 2013 Feb;63(2):234-41. doi: 10.1016/j.eururo.2012.07.033. Epub 2012 Jul 25.
Comperat E, Larre S, Roupret M, Neuzillet Y, Pignot G, Quintens H, Houede N, Roy C, Durand X, Varinot J, Vordos D, Rouanne M, Bakhri MA, Bertrand P, Jeglinschi SC, Cussenot O, Soulie M, Pfister C. Clinicopathological characteristics of urothelial bladder cancer in patients less than 40 years old. Virchows Arch. 2015 May;466(5):589-94. doi: 10.1007/s00428-015-1739-2. Epub 2015 Feb 20.
Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17.
Babjuk M, Bohle A, Burger M, Capoun O, Cohen D, Comperat EM, Hernandez V, Kaasinen E, Palou J, Roupret M, van Rhijn BWG, Shariat SF, Soukup V, Sylvester RJ, Zigeuner R. EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol. 2017 Mar;71(3):447-461. doi: 10.1016/j.eururo.2016.05.041. Epub 2016 Jun 17.
Wilby D, Thomas K, Ray E, Chappell B, O'Brien T. Bladder cancer: new TUR techniques. World J Urol. 2009 Jun;27(3):309-12. doi: 10.1007/s00345-009-0398-9. Epub 2009 Mar 4.
Rink M, Schwarzenbach H, Vetterlein MW, Riethdorf S, Soave A. The current role of circulating biomarkers in non-muscle invasive bladder cancer. Transl Androl Urol. 2019 Feb;8(1):61-75. doi: 10.21037/tau.2018.11.05.
Engilbertsson H, Aaltonen KE, Bjornsson S, Kristmundsson T, Patschan O, Ryden L, Gudjonsson S. Transurethral bladder tumor resection can cause seeding of cancer cells into the bloodstream. J Urol. 2015 Jan;193(1):53-7. doi: 10.1016/j.juro.2014.06.083. Epub 2014 Jul 1.
Zare R, Grabe M, Hermann GG, Malmstrom PU. Can routine outpatient follow-up of patients with bladder cancer be improved? A multicenter prospective observational assessment of blue light flexible cystoscopy and fulguration. Res Rep Urol. 2018 Oct 9;10:151-157. doi: 10.2147/RRU.S141314. eCollection 2018.
Donat SM, North A, Dalbagni G, Herr HW. Efficacy of office fulguration for recurrent low grade papillary bladder tumors less than 0.5 cm. J Urol. 2004 Feb;171(2 Pt 1):636-9. doi: 10.1097/01.ju.0000103100.22951.5e.
Gazzaniga P, de Berardinis E, Raimondi C, Gradilone A, Busetto GM, De Falco E, Nicolazzo C, Giovannone R, Gentile V, Cortesi E, Pantel K. Circulating tumor cells detection has independent prognostic impact in high-risk non-muscle invasive bladder cancer. Int J Cancer. 2014 Oct 15;135(8):1978-82. doi: 10.1002/ijc.28830. Epub 2014 Mar 13.
Sievert KD, Amend B, Nagele U, Schilling D, Bedke J, Horstmann M, Hennenlotter J, Kruck S, Stenzl A. Economic aspects of bladder cancer: what are the benefits and costs? World J Urol. 2009 Jun;27(3):295-300. doi: 10.1007/s00345-009-0395-z. Epub 2009 Mar 7.
Other Identifiers
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1
Identifier Type: -
Identifier Source: org_study_id