Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate
Primary Purpose
Bladder Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
en bloc resection, morcellation
piecemeal resection, tissue removal by loop
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer
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)
Sites / Locations
- Institute for Urology and Reproductive Health, Sechenov University.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
en bloc resection group
piecemeal resection group
Arm Description
Patients scheduled for laser en bloc tumor resection with subsequent morcellation of exophytic part of the tumor
Patients scheduled for piecemeal bladder tumor TUR with subsequent removing of tissue using the instrument loop or Janet's syringe.
Outcomes
Primary Outcome Measures
Recurrence free survival
Absence of the tumor in the bladder during the follow-up cystoscopy
Secondary Outcome Measures
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
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
Duration of surgery
Time frame from the beginning of the procedure till the end of the procedure
Adverse events
Adverse events according to the Clavien-Dindo classification
Full Information
NCT ID
NCT04750590
First Posted
February 8, 2021
Last Updated
February 19, 2021
Sponsor
I.M. Sechenov First Moscow State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04750590
Brief Title
Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate
Official Title
Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2021 (Actual)
Primary Completion Date
April 11, 2022 (Anticipated)
Study Completion Date
June 11, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
en bloc resection group
Arm Type
Experimental
Arm Description
Patients scheduled for laser en bloc tumor resection with subsequent morcellation of exophytic part of the tumor
Arm Title
piecemeal resection group
Arm Type
Experimental
Arm Description
Patients scheduled for piecemeal bladder tumor TUR with subsequent removing of tissue using the instrument loop or Janet's syringe.
Intervention Type
Procedure
Intervention Name(s)
en bloc resection, morcellation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
piecemeal resection, tissue removal by loop
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence free survival
Description
Absence of the tumor in the bladder during the follow-up cystoscopy
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Relapse-free rate in-site of previous surgery
Description
Absence of the tumor in the place of resection of the bladder wall during the follow-up cystoscopy
Time Frame
3 months
Title
Relapse-free rate out-site of previous surgery
Description
Absence of the tumor out of the place of resection of the bladder wall during the follow-up cystoscopy
Time Frame
3 months
Title
Duration of surgery
Description
Time frame from the beginning of the procedure till the end of the procedure
Time Frame
Intraoperatively
Title
Adverse events
Description
Adverse events according to the Clavien-Dindo classification
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Enikeev, M.D.
Phone
+79670897154
Email
dvenikeev@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Taratkin, M.D.
Phone
+79670897154
Email
marktaratkin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitry Enikeev, M.D.
Organizational Affiliation
Sechenov University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Urology and Reproductive Health, Sechenov University.
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry Enikeev, M.D., Ph.D
Phone
+7 9670897154
Email
enikeev-dv@1msmu.ru
First Name & Middle Initial & Last Name & Degree
Mark Taratkin, MD
Phone
+7 9670897154
Email
marktaratkin@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Relationship Between Methods of Bladder Tumor Extraction and Local Recurrence Rate
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