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

NCT06796413 | Completed

• 1 other identifier: 17234
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer; Bladder Cancer Stage I; TURBT

Keywords

Bladder Cancer; Detrusor Muscle Sampling; Detrusor Muscle Representation; Loop Resection; Cold-Cup Biopsy; Artifacts

Outcome Measures

Primary Outcomes (1)

• Detrusor Muscle Representation

  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

Study Arms (2)

Cold-Cup Biopsy

ACTIVE COMPARATOR

Cold-Cup Biopsy of bladder tumor base

Procedure: Loop Resection or Cold-cup biopsy

Loop Resection of bladder tumor base

EXPERIMENTAL

Loop Resection of bladder tumor base

Procedure: Loop Resection or Cold-cup biopsy

Interventions

Loop Resection or Cold-cup biopsy PROCEDURE

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

Also known as: Loop Cautery, Cold-cup Biopsy

Cold-Cup Biopsy; Loop Resection of bladder tumor base

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who underwent cystoscopy and no loop resection
• Patients who underwent cystoscopy and only cold-cup biopsy

Sponsors & Collaborators

• University of Stellenbosch: lead

Study Sites (1)

Stellenbosch University - Faculty of Health Sciences - Department of Urology

Cape Town, Western Cape, 7500, South Africa

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Eduan Delport, MB, ChB

  University of Stellenbosch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Resident

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 28, 2025
• Study Start: July 14, 2022
• Primary Completion: May 23, 2024
• Study Completion: July 1, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

ZA (1)