Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate

I.M. Sechenov First Moscow State Medical University

Status: Unknown

Conditions: Bladder Cancer

Treatments: Procedure: piecemeal resection, tissue removal by loop; Procedure: en bloc resection, morcellation

Study type: Interventional

Funder types: Other

Identifiers

NCT04750590

ERBT -MORC20

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

en bloc resection group

Experimental group

Description:

Patients scheduled for laser en bloc tumor resection with subsequent morcellation of exophytic part of the tumor

Treatment:

Procedure: en bloc resection, morcellation

piecemeal resection group

Experimental group

Description:

Patients scheduled for piecemeal bladder tumor TUR with subsequent removing of tissue using the instrument loop or Janet's syringe.

Treatment:

Procedure: piecemeal resection, tissue removal by loop