NCT02993211

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

April 18, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2022

Completed
Last Updated

June 29, 2022

Status Verified

June 1, 2022

Enrollment Period

4.8 years

First QC Date

December 8, 2016

Last Update Submit

June 24, 2022

Conditions

Bladder Cancer

Keywords

Bladder cancerTransurethral resectionEn bloc resectionTURBT

Outcome Measures

Primary Outcomes (1)

  • One-year recurrence rate

    Rate of disease recurrence one year after the operation

    One year after the allocated treatment

Secondary Outcomes (9)

  • Detrusor muscle sampling rate

    One week after the allocated treatment

  • Occurrence of obturator reflex

    Intra-operative

  • Operative time

    Immediately post-operative

  • Rate of mitomycin C instillation

    One day after the allocated treatment

  • Hospital stay

    Three days after the allocated treatment

  • +4 more secondary outcomes

Study Arms (2)

Standard resection

ACTIVE COMPARATOR

For patients undergoing bipolar transurethral standard resection, bladder tumour is resected in a piecemeal manner.

Device: Bipolar transurethral standard resection

En bloc resection

EXPERIMENTAL

For patients undergoing bipolar transurethral en bloc resection, bladder tumour is resected and removed in one piece.

Device: Bipolar transurethral en bloc resection

Interventions

Bipolar transurethral standard resectionDEVICE

Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)

Standard resection
Bipolar transurethral en bloc resectionDEVICE

Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)

En bloc resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old with informed consent

You may not qualify if:

  • Bladder tumour base with maximal dimension of \>3cm (Anticipated difficulty in retrieving the specimen en bloc)
  • Bladder tumour detected during intravesical BCG therapy (BCG failure warrants more aggressive treatment, i.e. radical cystectomy)
  • Histological diagnosis other than NMIBC
  • Presence or prior history of upper urinary tract malignancy
  • ECOG performance status ≥ 3 (Confined to bed or chair more than 50% of waking hours)
  • ASA III or above (Patient with severe systemic disease)
  • History of bleeding disorder or use of anti-coagulants
  • Pregnancy
  • Presence of other active malignancy
  • Life expectancy of less than one year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Caritas Medical Centre

Hong Kong, Hong Kong

Location

Kwong Wah Hospital

Hong Kong, Hong Kong

Location

North District Hospital

Hong Kong, Hong Kong

Location

Our Lady of Maryknoll Hospital

Hong Kong, Hong Kong

Location

Pok Oi Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Princess Margaret Hospital

Hong Kong, Hong Kong

Location

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Tseung Kwan O Hospital

Hong Kong, Hong Kong

Location

Tuen Mun Hospital

Hong Kong, Hong Kong

Location

Tung Wah Hospital

Hong Kong, Hong Kong

Location

United Christian Hospital

Hong Kong, Hong Kong

Location

Related Publications (9)

  • 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: 16442208BACKGROUND

  • 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: 27324428BACKGROUND

  • 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: 12853793BACKGROUND

  • 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: 20303646BACKGROUND

  • 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: 16127800BACKGROUND

  • 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: 23988813BACKGROUND

  • 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: 22988482BACKGROUND

  • 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: 10687997BACKGROUND

  • 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: 25910478BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Jeremy YC Teoh, MBBS

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 8, 2016

First Posted

December 15, 2016

Study Start

April 18, 2017

Primary Completion

February 11, 2022

Study Completion

June 9, 2022

Last Updated

June 29, 2022

Record last verified: 2022-06

Locations

HK(13)