Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate

Not Applicable

• Conditions: Bladder Cancer
• Interventions: Procedure: en bloc resection, morcellation; Procedure: piecemeal resection, tissue removal by loop

• Registration Number: NCT04750590
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-11
• Status Verified: 2021-02
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-11
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-21
• Primary Completion: 2022-04-11
• Study Completion: 2022-06-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
en bloc resection group	en bloc resection, morcellation	Patients scheduled for laser en bloc tumor resection with subsequent morcellation of exophytic part of the tumor
piecemeal resection group	piecemeal resection, tissue removal by loop	Patients scheduled for piecemeal bladder tumor TUR with subsequent removing of tissue using the instrument loop or Janet's syringe.

Primary Outcome Measures

Name	Time	Method
Recurrence free survival	3 months	Absence of the tumor in the bladder during the follow-up cystoscopy

Secondary Outcome Measures

Name	Time	Method
Adverse events	3 months	Adverse events according to the Clavien-Dindo classification
Relapse-free rate in-site of previous surgery	3 months	Absence of the tumor in the place of resection of the bladder wall during the follow-up cystoscopy
Relapse-free rate out-site of previous surgery	3 months	Absence of the tumor out of the place of resection of the bladder wall during the follow-up cystoscopy
Duration of surgery	Intraoperatively	Time frame from the beginning of the procedure till the end of the procedure

Trial Locations

Locations (1)

Institute for Urology and Reproductive Health, Sechenov University.; 🇷🇺 Moscow, Russian Federation