Renal Pelvis and Ureter Urothelial Carcinoma
Conditions
Brief summary
This clinical trial tests how well office based ureteroscopy utilizing a single use digital, flexible ureteroscope works for the assessment of upper tract urothelial carcinoma. Ureteroscopy is a procedure in which a thin camera called a ureteroscope is used to assess patients with a known or suspected diagnosis of upper tract urothelial carcinoma. Ureteroscopy is traditionally performed in an operating room under general anesthesia. In this study, patients undergo ureteroscopy in the doctor's office using an ultra-thin ureteroscope, which is the narrowest instrument of its kind. Because of its small size, researchers believe this procedure can be completed in the office with minimal discomfort and high patient satisfaction, which may eliminate the risks of general anesthesia and reduce delays to diagnosis. Office based ureteroscopy utilizing a single use digital, flexible ureteroscope may be effective for the assessment of upper tract urothelial carcinoma.
Interventions
DRUGAnalgesic Agent
Given PO
OTHERElectronic Health Record Review
Ancillary studies
Given intraurethrally
DEVICEMedical Device Usage and Evaluation
Undergo ureteroscopy using 6.3 Fr single use digital ureteroscope
OTHERSurvey Administration
Ancillary studies
PROCEDUREUreteroscopy
Undergo ureteroscopy
Sponsors
University of Michigan Rogel Cancer Center
Shenzhen HugeMed Medical Technical Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥ 18 year. Both sexes are included to reflect the patient population with upper tract urothelial carcinoma (UTUC) already being followed at the University of Michigan and allow exploration of potential differences in tolerability of awake ureteroscopy based on sex * History of endoscopically managed UTUC at any time, or a suspected diagnosis of UTUC based on pre-procedure imaging, and is already planned for office-based ureteroscopic assessment * Ability and willingness to complete and adhere to survey questions and responses throughout study duration
Exclusion criteria
* Known ureteral strictures * Active urinary tract infection * Need for general anesthesia due to patient or procedural factors * History of inability to tolerate ureteroscopy under local anesthetic * Anticipated need for laser ablation during the surveillance procedure * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate | On day of procedure | Defined as the ability to successfully perform and complete upper and lower tract surveillance with the 6.3 French ureteroscope in an office setting. A study-wide successful outcome will be defined as a success rate of 70%. The success rate will be reported as the count and proportion of participants with a successful outcome out of the number of enrolled participants. The corresponding 95% binomial Clopper-Pearson confidence interval will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | From baseline up to 7-10 days post procedure | Assessed by intra- and peri-procedure patient reported outcomes with the visual analogue scale pain score, as well as the Patient-Reported Outcomes Measurement Information System Pain Interference and Intensity score. Will be summarized and displayed graphically with means, standard deviations and/or quartiles. |
| Satisfaction | At 7-10 days post procedure | Assessed by the International Consultation on Incontinence-Satisfaction. Will be summarized and displayed graphically with means, standard deviations and/or quartiles. |
| Unplanned healthcare use | From baseline up to 30 days post procedure | Will measure unplanned healthcare utilization including electronic messages, phone calls, lab and imaging tests, emergency department visits, hospitalizations, and secondary interventions. These will be reported as counts of events and counts of participants with corresponding proportions of enrolled participants. |
Countries
United States
Contacts
CONTACTMichael Uy, MD
PRINCIPAL_INVESTIGATORKhurshid Ghani, MD
University of Michigan Rogel Cancer Center
Outcome results
None listed