Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate

Last updated: February 19, 2021
Sponsor: I.M. Sechenov First Moscow State Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Urothelial Cancer

Urothelial Carcinoma

Treatment

N/A

Clinical Study ID

NCT04750590
ERBT -MORC20
  • Ages > 18
  • All Genders

Study Summary

According to clinical guidelines, endoscopic surgery (mono- or bipolar TURBT, laser resection, en bloc resection) is a standard treatment option for patients with primary non-muscle invasive bladder cancer (NMIBC) (excluding carcinoma in-situ). However, more than half of patients will experience local recurrence after surgery. It is believed that one of the main causes for this local recurrence is the reimplantation of tumor cells during endoscopic surgery. It is crucial to limit contact between the resected tumor and the bladder wall during the operation and to extract the specimen as quickly as possible. In the case of a small tumor, the surgeon can immediately remove it using an endoscopic instrument. There are a number of methods available for removing large tumors, but it is not yet clear which one is most optimal. Therefore, comparing the oncological results from evacuating bladder tumors using various methods is very timely.

Based on the previously mentioned studies, the investigators assume that the rate of bladder cancer relapse out site of the resection area would be lower in the morcellation group compared with piecemeal resection of the tumor. In order to prove this, the investigators plan to conduct a randomized study comparing the relapse rate in these two groups.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients scheduled for endoscopic bladder tumor removal
  2. Non-muscle invasive bladder cancer on contrast-enhanced MRI or CT (stage cT1N0M0 andlower)
  3. Diameter of tumor >3cm

Exclusion

Exclusion Criteria:

  1. Patient refused to participate in the trial
  2. Multiple (more than 2) bladder tumors
  3. Previous cold-cup biopsy or any other surgery for bladder tumor
  4. Muscle-invasive bladder cancer on postoperative histological evaluation
  5. Other malignant/benign tumors of the bladder (non-urothelial cancer)

Study Design

Total Participants: 180
Study Start date:
January 11, 2021
Estimated Completion Date:
June 11, 2022

Connect with a study center

  • Institute for Urology and Reproductive Health, Sechenov University.

    Moscow, 119991
    Russian Federation

    Active - Recruiting

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