Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate

NCT04750590 | Unknown

• 1 other identifier: ERBT -MORC20
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival

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

  3 months

Secondary Outcomes (4)

• Relapse-free rate in-site of previous surgery

  3 months

• Relapse-free rate out-site of previous surgery

  3 months

• Duration of surgery

  Intraoperatively

• Adverse events

  3 months

Study Arms (2)

en bloc resection group

EXPERIMENTAL

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

Procedure: en bloc resection, morcellation

piecemeal resection group

EXPERIMENTAL

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

Procedure: piecemeal resection, tissue removal by loop

Interventions

en bloc resection, morcellation PROCEDURE

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.

en bloc resection group

piecemeal resection, tissue removal by loop PROCEDURE

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.

piecemeal resection group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Institute for Urology and Reproductive Health, Sechenov University.

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Morcellation

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Dmitry Enikeev, M.D.

  Sechenov University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitry Enikeev, M.D.

CONTACT

+79670897154; dvenikeev@gmail.com

Mark Taratkin, M.D.

CONTACT

+79670897154; marktaratkin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director for Research

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 11, 2021
• Study Start: January 11, 2021
• Primary Completion: April 11, 2022
• Study Completion: June 11, 2022
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)