Loop Resection or Cold-cup Biopsy? a Study Comparing the Accuracy of Muscle Samples During Bladder Tumor Surgery

January 21, 2025 updated by: Dr Eduan Delport, University of Stellenbosch

Loop Resection or Cold-cup Biopsy? a Prospective Randomized Study Evaluating the Accuracy of Detrusor Muscle Representation During Transurethral Resection of Bladder Tumors

In this report the investigators compared two deep muscle sampling methods (Loop resection and Cold-Cup Biopsy) during endoscopic resection of bladder tumors for patients with suspected bladder cancer in Tygerberg hospital. The investigators found that both sampling methods are equal effective with regards to muscle representation, regardless of surgeon experience. An important finding is that Loop Resection produced less tissue artefacts in the deep muscle specimen for the more experienced surgeons, while there was no difference for less experienced surgeons. The investigators thus conclude that - from a practical point of view - Loop Resection should be the deep muscle sampling method of choice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7500
        • Stellenbosch University - Faculty of Health Sciences - Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • All patients requiring cystoscopy plus loop resection of bladder tumor.

Exclusion Criteria:

  • • Patients who underwent cystoscopy and no loop resection

    • Patients who underwent cystoscopy and only cold-cup biopsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cold-Cup Biopsy
Cold-Cup Biopsy of bladder tumor base
Procedure: Loop Resection or Cold-cup biopsy
Loop Resection or cold-cup biopsy of bladder tumor base - thus after the tumor has been resected and the deep muscle specimen needed to be obtained, the Loop Cautery or Lowsley Forceps (for cold-cup biopsy) was used to obtain the deep muscle specimen
Other Names:
  • Loop Cautery
  • Cold-cup Biopsy
Experimental: Loop Resection of bladder tumor base
Procedure: Loop Resection or Cold-cup biopsy
Loop Resection or cold-cup biopsy of bladder tumor base - thus after the tumor has been resected and the deep muscle specimen needed to be obtained, the Loop Cautery or Lowsley Forceps (for cold-cup biopsy) was used to obtain the deep muscle specimen
Other Names:
  • Loop Cautery
  • Cold-cup Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detrusor Muscle Representation
Time Frame: From enrollment to the end of treatment at 2-4 weeks when histology results are available
Histopathological confirmation of detrusor muscle representation in the Deep Muscle Specimen obtained by either the Loop Resection method or Cold-Cup Biopsy method
From enrollment to the end of treatment at 2-4 weeks when histology results are available

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Stellenbosch

Investigators

  • Principal Investigator: Eduan Delport, MB, ChB, University of Stellenbosch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2022

Primary Completion (Actual)

May 23, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Some of the personal detail of the participants may have changed or may not be so easily attainable.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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