NCT02555163

Brief Summary

Randomized clinical trial aiming to assess Holmium Laser En Bloc Resection Of Bladder Tumor (HoLERBT) in comparison with Conventional Transurethral Resection Of Bladder Tumors (cTURBT) in tumor histopathological staging quality, detrusor muscle sampling in biopsy, completeness of tumor resection and peri procedure complication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

September 16, 2015

Last Update Submit

September 16, 2020

Conditions

Bladder Cancer

Keywords

bladder cancer, laser

Outcome Measures

Primary Outcomes (1)

  • residual disease at re-staging transurethral bladder biopsy

    Rebiopsy of the tumor base for detection of any residual disease at re staging TUR 4 weeks after primary procedure. Number of patients with residual disease at restaginf TUR will be counted in each arm and compared

    4 weeks after primary procedure

Secondary Outcomes (2)

  • periprocedure complications

    2 days

  • recurrence free survival

    1 year

Study Arms (2)

HoLERBT

EXPERIMENTAL

Holmium (Ho: YAG) Laser En Bloc Resection Of Bladder Tumor

Device: HoLERBT

cTURBT

ACTIVE COMPARATOR

Conventional Transurethral Resection Of Bladder Tumors

Device: cTURBT

Interventions

HoLERBTDEVICE

Using holmium laser, the tumour will be removed as one piece from its base working underneath the muscle layer

HoLERBT
cTURBTDEVICE

using the conventional electrocautery device with the cutting hot loop the tumor will be removed in pieces

cTURBT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Tumor criteria
  • Non papillary gross features of the tumor
  • Anteriorly located tumor
  • Patients criteria
  • Poor performance status
  • History of BCG sepsis
  • History of bladder irradiation
  • Contracted bladder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nprhology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

Related Publications (1)

  • Hashem A, Mosbah A, El-Tabey NA, Laymon M, Ibrahiem EH, Elhamid MA, Elshal AM. Holmium Laser En-bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle-invasive Bladder Cancer: A Randomized Clinical Trial. Eur Urol Focus. 2021 Sep;7(5):1035-1043. doi: 10.1016/j.euf.2020.12.003. Epub 2020 Dec 30.

    PMID: 33386289DERIVED

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

  • Ahmed M Elshal, MD

    Mansoura urology and nephrology center, Mansoura University, Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 21, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2019

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations

EG(1)