<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02993211</url>
  </required_header>
  <id_info>
    <org_study_id>CRE Ref. No. 2016.553</org_study_id>
    <nct_id>NCT02993211</nct_id>
  </id_info>
  <brief_title>Transurethral En Bloc Versus Standard Resection of Bladder Tumour</brief_title>
  <official_title>Transurethral En Bloc Versus Standard Resection of Bladder Tumour: A Multi-centre Randomised Controlled Trial (EB-StaR Study).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kwong Wah Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>North District Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Our Lady of Maryknoll Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pok Oi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tseung Kwan O Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tuen Mun Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tung Wah Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Princess Margaret Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Caritas Medical Centre, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Queen Elizabeth Hospital, Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Conventionally, transurethral standard resection (SR) of bladder tumour is performed in a&#xD;
      piecemeal manner. Transurethral en bloc resection (EBR) has been described as an alternate&#xD;
      surgical technique in bladder tumour resection. By preventing tumour fragmentation and&#xD;
      ascertaining complete tumour resection by histological assessment of the EBR specimen, we&#xD;
      hypothesized that EBR could reduce disease recurrence as compared to SR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bladder cancer is the 9th most commonly diagnosed cancer in men worldwide, with a&#xD;
      standardized incidence rate of 9.0 per 100,000 person-years for men and 2.2 per 100,000&#xD;
      person-years for women. In Hong Kong, more than 400 new cases of bladder cancer are diagnosed&#xD;
      every year. It is a common and important disease which carries a significant burden to the&#xD;
      health medical system.&#xD;
&#xD;
      For patients who are diagnosed to have bladder tumours upon flexible cystoscopy,&#xD;
      transurethral resection of bladder tumour (TURBT) should be offered. Being a minimally&#xD;
      invasive procedure, it has become the standard for the initial management of bladder cancer.&#xD;
      This operation aims to ascertain the diagnosis, to correctly stage the tumour (T-stage) and&#xD;
      to cure the disease in the case of non-muscle-invasive bladder cancer (NMIBC). However, in a&#xD;
      combined analysis of 2,596 patents from 7 randomised controlled trials in patients with&#xD;
      NMIBC, it was shown that 1-year recurrence rate ranged from 15-61%, and 5-year recurrence&#xD;
      rate ranged from 31-78%. Despite possible complete tumour resection during TURBT, the&#xD;
      oncological control of NMIBC is far from satisfactory.&#xD;
&#xD;
      There are two main problems with the conventional standard resection (SR) procedure. First,&#xD;
      the bladder tumour is resected in a piecemeal manner. This results in tumour fragmentation&#xD;
      and floating tumour cells inside the bladder. The tumour cells may re-implant on to the&#xD;
      bladder wall and lead to early disease recurrence. Second, 'complete tumour resection' is&#xD;
      often determined by endoscopic vision only. Due to the inherited nature of piecemeal&#xD;
      resection, it is not possible to assess the resection margin by histological means. The&#xD;
      charring effect to the resection bed may also hinder the judgement of a 'complete tumour&#xD;
      resection'. Routine second-look TURBT has been advocated for selected patients (Any presence&#xD;
      of T1 disease, G3 disease, or any absence of detrusor muscle in the first TURBT specimen)&#xD;
      even after a 'complete tumour resection' during the first TURBT. Second-look TURBT has been&#xD;
      shown to detect residual disease in 33-55% of the patients and upstaging of disease in 4-45%&#xD;
      of the patients. These results highlighted the limitations of TURBT in ascertaining complete&#xD;
      tumour resection.&#xD;
&#xD;
      Transurethral en bloc resection (EBR) has been described as an alternate surgical technique&#xD;
      in bladder tumour resection. By preventing tumour fragmentation and ascertaining complete&#xD;
      tumour resection by histological assessment of the EBR specimen, we hypothesized that EBR&#xD;
      could reduce disease recurrence as compared to SR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 18, 2017</start_date>
  <completion_date type="Actual">June 9, 2022</completion_date>
  <primary_completion_date type="Actual">February 11, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>One-year recurrence rate</measure>
    <time_frame>One year after the allocated treatment</time_frame>
    <description>Rate of disease recurrence one year after the operation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detrusor muscle sampling rate</measure>
    <time_frame>One week after the allocated treatment</time_frame>
    <description>Rate of presence of detrusor muscle in the pathological specimen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of obturator reflex</measure>
    <time_frame>Intra-operative</time_frame>
    <description>Number of participants with obturator reflex encountered by the operating surgeon during the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>Immediately post-operative</time_frame>
    <description>Duration of operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of mitomycin C instillation</measure>
    <time_frame>One day after the allocated treatment</time_frame>
    <description>Rate of mitomycin C instillation given after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>Three days after the allocated treatment</time_frame>
    <description>Patients undergoing transurethral resection surgery have an average hospital stay of three days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day complications</measure>
    <time_frame>Thirty days after the allocated treatment</time_frame>
    <description>Complications which occur within 30 days after the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual disease upon second look transurethral resection surgery</measure>
    <time_frame>Seven weeks after the allocated treatment</time_frame>
    <description>Second look transurethral resection surgery is expected to perform within six weeks after the allocated treatment and one more week is allowed for histological assessment of the second look transurethral resection specimen. Residual disease is measured by the number of participants with the presence of urothelial carcinoma in the second look transurethral resection specimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Upstaging of disease upon second look transurethral resection surgery</measure>
    <time_frame>Seven weeks after the allocated treatment</time_frame>
    <description>Second look transurethral resection surgery is expected to perform within six weeks after the allocated treatment and one more week is allowed for histological assessment of the second look transurethral resection specimen. Upstaging of disease is measured by the number of participants with upstaging of disease from non-muscle-invasive bladder cancer to muscle-invasive bladder cancer in the second look transurethral resection specimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One-year progression rate</measure>
    <time_frame>One year after the allocated treatment</time_frame>
    <description>Rate of disease progression one year after the operation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">350</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Standard resection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For patients undergoing bipolar transurethral standard resection, bladder tumour is resected in a piecemeal manner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>En bloc resection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For patients undergoing bipolar transurethral en bloc resection, bladder tumour is resected and removed in one piece.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bipolar transurethral standard resection</intervention_name>
    <description>Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)</description>
    <arm_group_label>Standard resection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bipolar transurethral en bloc resection</intervention_name>
    <description>Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)</description>
    <arm_group_label>En bloc resection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old with informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bladder tumour base with maximal dimension of &gt;3cm (Anticipated difficulty in&#xD;
             retrieving the specimen en bloc)&#xD;
&#xD;
          -  Bladder tumour detected during intravesical BCG therapy (BCG failure warrants more&#xD;
             aggressive treatment, i.e. radical cystectomy)&#xD;
&#xD;
          -  Histological diagnosis other than NMIBC&#xD;
&#xD;
          -  Presence or prior history of upper urinary tract malignancy&#xD;
&#xD;
          -  ECOG performance status ≥ 3 (Confined to bed or chair more than 50% of waking hours)&#xD;
&#xD;
          -  ASA III or above (Patient with severe systemic disease)&#xD;
&#xD;
          -  History of bleeding disorder or use of anti-coagulants&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Presence of other active malignancy&#xD;
&#xD;
          -  Life expectancy of less than one year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeremy YC Teoh, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Caritas Medical Centre</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kwong Wah Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North District Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Our Lady of Maryknoll Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pok Oi Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tseung Kwan O Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tuen Mun Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tung Wah Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Christian Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>16442208</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27324428</PMID>
  </reference>
  <reference>
    <citation>Grimm MO, Steinhoff C, Simon X, Spiegelhalder P, Ackermann R, Vogeli TA. Effect of routine repeat transurethral resection for superficial bladder cancer: a long-term observational study. J Urol. 2003 Aug;170(2 Pt 1):433-7. doi: 10.1097/01.ju.0000070437.14275.e0.</citation>
    <PMID>12853793</PMID>
  </reference>
  <reference>
    <citation>Divrik RT, Sahin AF, Yildirim U, Altok M, Zorlu F. Impact of routine second transurethral resection on the long-term outcome of patients with newly diagnosed pT1 urothelial carcinoma with respect to recurrence, progression rate, and disease-specific survival: a prospective randomised clinical trial. Eur Urol. 2010 Aug;58(2):185-90. doi: 10.1016/j.eururo.2010.03.007. Epub 2010 Mar 19.</citation>
    <PMID>20303646</PMID>
  </reference>
  <reference>
    <citation>Jahnson S, Wiklund F, Duchek M, Mestad O, Rintala E, Hellsten S, Malmstrom PU. Results of second-look resection after primary resection of T1 tumour of the urinary bladder. Scand J Urol Nephrol. 2005;39(3):206-10. doi: 10.1080/00365590510007793-1.</citation>
    <PMID>16127800</PMID>
  </reference>
  <reference>
    <citation>Lazica DA, Roth S, Brandt AS, Bottcher S, Mathers MJ, Ubrig B. Second transurethral resection after Ta high-grade bladder tumor: a 4.5-year period at a single university center. Urol Int. 2014;92(2):131-5. doi: 10.1159/000353089. Epub 2013 Aug 23.</citation>
    <PMID>23988813</PMID>
  </reference>
  <reference>
    <citation>Vasdev N, Dominguez-Escrig J, Paez E, Johnson MI, Durkan GC, Thorpe AC. The impact of early re-resection in patients with pT1 high-grade non-muscle invasive bladder cancer. Ecancermedicalscience. 2012;6:269. doi: 10.3332/ecancer.2012.269. Epub 2012 Sep 18.</citation>
    <PMID>22988482</PMID>
  </reference>
  <reference>
    <citation>Ukai R, Kawashita E, Ikeda H. A new technique for transurethral resection of superficial bladder tumor in 1 piece. J Urol. 2000 Mar;163(3):878-9.</citation>
    <PMID>10687997</PMID>
  </reference>
  <reference>
    <citation>Kramer MW, Rassweiler JJ, Klein J, Martov A, Baykov N, Lusuardi L, Janetschek G, Hurle R, Wolters M, Abbas M, von Klot CA, Leitenberger A, Riedl M, Nagele U, Merseburger AS, Kuczyk MA, Babjuk M, Herrmann TR. En bloc resection of urothelium carcinoma of the bladder (EBRUC): a European multicenter study to compare safety, efficacy, and outcome of laser and electrical en bloc transurethral resection of bladder tumor. World J Urol. 2015 Dec;33(12):1937-43. doi: 10.1007/s00345-015-1568-6. Epub 2015 Apr 25.</citation>
    <PMID>25910478</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>June 24, 2022</last_update_submitted>
  <last_update_submitted_qc>June 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Jeremy Yuen Chun TEOH</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Bladder cancer</keyword>
  <keyword>Transurethral resection</keyword>
  <keyword>En bloc resection</keyword>
  <keyword>TURBT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02993211
org study id: CRE Ref. No. 2016.553
nct id: NCT02993211
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Conventionally, transurethral standard resection (SR) of bladder tumour is performed in a
      piecemeal manner. Transurethral en bloc resection (EBR) has been described as an alternate
      surgical technique in bladder tumour resection. By preventing tumour fragmentation and
      ascertaining complete tumour resection by histological assessment of the EBR specimen, we
      hypothesized that EBR could reduce disease recurrence as compared to SR.
Bladder cancer is the 9th most commonly diagnosed cancer in men worldwide, with a
      standardized incidence rate of 9.0 per 100,000 person-years for men and 2.2 per 100,000
      person-years for women. In Hong Kong, more than 400 new cases of bladder cancer are diagnosed
      every year. It is a common and important disease which carries a significant burden to the
      health medical system.

      For patients who are diagnosed to have bladder tumours upon flexible cystoscopy,
      transurethral resection of bladder tumour (TURBT) should be offered. Being a minimally
      invasive procedure, it has become the standard for the initial management of bladder cancer.
      This operation aims to ascertain the diagnosis, to correctly stage the tumour (T-stage) and
      to cure the disease in the case of non-muscle-invasive bladder cancer (NMIBC). However, in a
      combined analysis of 2,596 patents from 7 randomised controlled trials in patients with
      NMIBC, it was shown that 1-year recurrence rate ranged from 15-61%, and 5-year recurrence
      rate ranged from 31-78%. Despite possible complete tumour resection during TURBT, the
      oncological control of NMIBC is far from satisfactory.

      There are two main problems with the conventional standard resection (SR) procedure. First,
      the bladder tumour is resected in a piecemeal manner. This results in tumour fragmentation
      and floating tumour cells inside the bladder. The tumour cells may re-implant on to the
      bladder wall and lead to early disease recurrence. Second, 'complete tumour resection' is
      often determined by endoscopic vision only. Due to the inherited nature of piecemeal
      resection, it is not possible to assess the resection margin by histological means. The
      charring effect to the resection bed may also hinder the judgement of a 'complete tumour
      resection'. Routine second-look TURBT has been advocated for selected patients (Any presence
      of T1 disease, G3 disease, or any absence of detrusor muscle in the first TURBT specimen)
      even after a 'complete tumour resection' during the first TURBT. Second-look TURBT has been
      shown to detect residual disease in 33-55% of the patients and upstaging of disease in 4-45%
      of the patients. These results highlighted the limitations of TURBT in ascertaining complete
      tumour resection.

      Transurethral en bloc resection (EBR) has been described as an alternate surgical technique
      in bladder tumour resection. By preventing tumour fragmentation and ascertaining complete
      tumour resection by histological assessment of the EBR specimen, we hypothesized that EBR
      could reduce disease recurrence as compared to SR.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: One-year recurrence rate
time frame: One year after the allocated treatment
description: Rate of disease recurrence one year after the operation
measure: Detrusor muscle sampling rate
time frame: One week after the allocated treatment
description: Rate of presence of detrusor muscle in the pathological specimen
measure: Occurrence of obturator reflex
time frame: Intra-operative
description: Number of participants with obturator reflex encountered by the operating surgeon during the operation
measure: Operative time
time frame: Immediately post-operative
description: Duration of operation
measure: Rate of mitomycin C instillation
time frame: One day after the allocated treatment
description: Rate of mitomycin C instillation given after the operation
measure: Hospital stay
time frame: Three days after the allocated treatment
description: Patients undergoing transurethral resection surgery have an average hospital stay of three days.
measure: 30-day complications
time frame: Thirty days after the allocated treatment
description: Complications which occur within 30 days after the operation
measure: Residual disease upon second look transurethral resection surgery
time frame: Seven weeks after the allocated treatment
description: Second look transurethral resection surgery is expected to perform within six weeks after the allocated treatment and one more week is allowed for histological assessment of the second look transurethral resection specimen. Residual disease is measured by the number of participants with the presence of urothelial carcinoma in the second look transurethral resection specimen.
measure: Upstaging of disease upon second look transurethral resection surgery
time frame: Seven weeks after the allocated treatment
description: Second look transurethral resection surgery is expected to perform within six weeks after the allocated treatment and one more week is allowed for histological assessment of the second look transurethral resection specimen. Upstaging of disease is measured by the number of participants with upstaging of disease from non-muscle-invasive bladder cancer to muscle-invasive bladder cancer in the second look transurethral resection specimen.
measure: One-year progression rate
time frame: One year after the allocated treatment
description: Rate of disease progression one year after the operation
arm group label: Standard resection
arm group type: Active Comparator
description: For patients undergoing bipolar transurethral standard resection, bladder tumour is resected in a piecemeal manner.
arm group label: En bloc resection
arm group type: Experimental
description: For patients undergoing bipolar transurethral en bloc resection, bladder tumour is resected and removed in one piece.
intervention type: Device
intervention name: Bipolar transurethral standard resection
description: Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)
arm group label: Standard resection
intervention type: Device
intervention name: Bipolar transurethral en bloc resection
description: Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)
arm group label: En bloc resection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeremy YC Teoh, MBBS
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Hong Kong
citation: 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.
PMID: 16442208
citation: 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.
PMID: 27324428
citation: Grimm MO, Steinhoff C, Simon X, Spiegelhalder P, Ackermann R, Vogeli TA. Effect of routine repeat transurethral resection for superficial bladder cancer: a long-term observational study. J Urol. 2003 Aug;170(2 Pt 1):433-7. doi: 10.1097/01.ju.0000070437.14275.e0.
PMID: 12853793
citation: Divrik RT, Sahin AF, Yildirim U, Altok M, Zorlu F. Impact of routine second transurethral resection on the long-term outcome of patients with newly diagnosed pT1 urothelial carcinoma with respect to recurrence, progression rate, and disease-specific survival: a prospective randomised clinical trial. Eur Urol. 2010 Aug;58(2):185-90. doi: 10.1016/j.eururo.2010.03.007. Epub 2010 Mar 19.
PMID: 20303646
citation: Jahnson S, Wiklund F, Duchek M, Mestad O, Rintala E, Hellsten S, Malmstrom PU. Results of second-look resection after primary resection of T1 tumour of the urinary bladder. Scand J Urol Nephrol. 2005;39(3):206-10. doi: 10.1080/00365590510007793-1.
PMID: 16127800
citation: Lazica DA, Roth S, Brandt AS, Bottcher S, Mathers MJ, Ubrig B. Second transurethral resection after Ta high-grade bladder tumor: a 4.5-year period at a single university center. Urol Int. 2014;92(2):131-5. doi: 10.1159/000353089. Epub 2013 Aug 23.
PMID: 23988813
citation: Vasdev N, Dominguez-Escrig J, Paez E, Johnson MI, Durkan GC, Thorpe AC. The impact of early re-resection in patients with pT1 high-grade non-muscle invasive bladder cancer. Ecancermedicalscience. 2012;6:269. doi: 10.3332/ecancer.2012.269. Epub 2012 Sep 18.
PMID: 22988482
citation: Ukai R, Kawashita E, Ikeda H. A new technique for transurethral resection of superficial bladder tumor in 1 piece. J Urol. 2000 Mar;163(3):878-9.
PMID: 10687997
citation: Kramer MW, Rassweiler JJ, Klein J, Martov A, Baykov N, Lusuardi L, Janetschek G, Hurle R, Wolters M, Abbas M, von Klot CA, Leitenberger A, Riedl M, Nagele U, Merseburger AS, Kuczyk MA, Babjuk M, Herrmann TR. En bloc resection of urothelium carcinoma of the bladder (EBRUC): a European multicenter study to compare safety, efficacy, and outcome of laser and electrical en bloc transurethral resection of bladder tumor. World J Urol. 2015 Dec;33(12):1937-43. doi: 10.1007/s00345-015-1568-6. Epub 2015 Apr 25.
PMID: 25910478
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Jeremy Yuen Chun TEOH
investigator title: Assistant Professor
mesh term: Urinary Bladder Neoplasms
sharing ipd: Undecided