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Clinical Trials/NCT04750590
NCT04750590
Unknown
Not Applicable

Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate

I.M. Sechenov First Moscow State Medical University1 site in 1 country180 target enrollmentJanuary 11, 2021
ConditionsBladder Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bladder Cancer
Sponsor
I.M. Sechenov First Moscow State Medical University
Enrollment
180
Locations
1
Primary Endpoint
Recurrence free survival
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 11, 2021
End Date
June 11, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dmitry Enikeev, MD, PhD

Deputy Director for Research

I.M. Sechenov First Moscow State Medical University

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for endoscopic bladder tumor removal
  • Non-muscle invasive bladder cancer on contrast-enhanced MRI or CT (stage cT1N0M0 and lower)
  • Diameter of tumor \>3cm

Exclusion Criteria

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

Outcomes

Primary Outcomes

Recurrence free survival

Time Frame: 3 months

Absence of the tumor in the bladder during the follow-up cystoscopy

Secondary Outcomes

  • Adverse events(3 months)
  • Relapse-free rate in-site of previous surgery(3 months)
  • Relapse-free rate out-site of previous surgery(3 months)
  • Duration of surgery(Intraoperatively)

Study Sites (1)

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