Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06167057
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-04
Brief Title:
POST URS Chemotherapy Instillation
Sponsor:
Carmel Medical Center
Organization:
Carmel Medical Center
Study Overview
Official Title:
Single Bladder Instillation With Chemotherapy Following Endoscopic Treatment for Upper Tract Urothelial Carcinoma to Reduce Bladder Recurrence
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to evaluate the safety and oncological outcomes of single chemotherapy bladder instillation following endoscopic treatment for UTUC in UTUC suspected patients The main aim is to determine the efficacy of a single post URS chemotherapy bladder instillation to reduce IVR
Participants will be given single chemotherapy bladder instillation within 24h following ureteroscopy and will follow routine follow-up for IVR which will include white light cystoscopy patients with suspected IVR based on either imaging or cystoscopy will undergo TURBT
Participants will be given single chemotherapy bladder instillation within 24h following ureteroscopy and will follow routine follow-up for IVR which will include white light cystoscopy patients with suspected IVR based on either imaging or cystoscopy will undergo TURBT
Detailed Description:
URS is routinely used for both diagnosis and treatment of UTUC - it is used either as an initial diagnostic procedure or as a curative procedure in cases amenable for endoscopic tumor ablation either with low-risk disease or an imperative indication due to impaired renal function
Following extirpative surgery patients are prone to IVR Those patients undergo routine follow-up with cystoscopy and in cases of IVR require TURBT and further management based on bladder cancer protocols In this setting a single post-operative bladder instillation with various chemotherapeutic agents has shown a significant reduction in IVR rates following RNU
Retrospective evidence suggests there is an increase IVR rates following URS for UTUC
In this study the investigators seek to evaluate the efficacy of a single post URS bladder instillation with chemotherapy to reduce IVR
Following extirpative surgery patients are prone to IVR Those patients undergo routine follow-up with cystoscopy and in cases of IVR require TURBT and further management based on bladder cancer protocols In this setting a single post-operative bladder instillation with various chemotherapeutic agents has shown a significant reduction in IVR rates following RNU
Retrospective evidence suggests there is an increase IVR rates following URS for UTUC
In this study the investigators seek to evaluate the efficacy of a single post URS bladder instillation with chemotherapy to reduce IVR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None