Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate

Bladder Cancer Clinical Trial

Official title:

Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04750590
• Other study ID #: ERBT -MORC20
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: June 11, 2022

Study information

• Verified date: February 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Dmitry Enikeev, M.D.
• Phone: +79670897154
• Email: dvenikeev[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 11, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Cancer
• Recurrence
• Urinary Bladder Neoplasms

Intervention

Procedure:
• en bloc resection, morcellation
Laser en bloc resection with subsequent tumor morcellation will be performed. This tissue will be sent for histology in order to estimate the histological subtype and differentiation grade. Next stage laser resection of the tumor basis will be performed with subsequent histology to determine the depth of invasion and the status of surgical margin.
• piecemeal resection, tissue removal by loop
Tumor piecemeal resection will be performed with electric loop. Then fragments of the tumor will be removed by the loop or Janet's syringe. Fragments from the base of the tumor will be sent separately in order to assess which stage the tumor is at and its surgical margin status.

Locations

Country	Name	City	State
Russian Federation	Institute for Urology and Reproductive Health, Sechenov University.	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence free survival	Absence of the tumor in the bladder during the follow-up cystoscopy	3 months
Secondary	Relapse-free rate in-site of previous surgery	Absence of the tumor in the place of resection of the bladder wall during the follow-up cystoscopy	3 months
Secondary	Relapse-free rate out-site of previous surgery	Absence of the tumor out of the place of resection of the bladder wall during the follow-up cystoscopy	3 months
Secondary	Duration of surgery	Time frame from the beginning of the procedure till the end of the procedure	Intraoperatively
Secondary	Adverse events	Adverse events according to the Clavien-Dindo classification	3 months