Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04979156 |
| Other study ID # |
LaserEn |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 4, 2021 |
| Est. completion date |
December 31, 2023 |
Study information
| Verified date |
November 2021 |
| Source |
University of Kansas Medical Center |
| Contact |
Katie Glavin |
| Phone |
9135888721 |
| Email |
kglavin[@]kumc.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Conventional monopolar or bipolar transurethral resection of bladder tumors is the most
common method for resection of a bladder mass. En bloc resection has demonstrated success in
the literature utilizing different techniques and lasers, including utilizing the Ho:YAG and
Tm:YAG lasers. A recent metanalysis revealed several benefits to laser en bloc resection
including less complications and lower recurrence rate.22 Subsequently, laser technology has
also advanced with the development of a super pulsed TFL which overcomes many limitations of
prior traditional lasers. Olympus' SOLTIVE™ TFL, which has demonstrated improved
maneuverability and control, has a shallow depth of tissue penetration at 0.15mm leading to
precise resection and optimal hemostasis. Despite these beneficial characteristics and
qualities along with the promising utility of en bloc resection, the Olympus SOLTIVE™ TFL has
not been described in en bloc resection of bladder tumors. The investigator seek to determine
if the proposed benefits of this device can be realized both pathologically and clinically in
en bloc resection of bladder tumors.
Description:
This is a prospective study investigating the use of the SOLTIVE™ Thulium Super pulse laser
for the treatment of bladder tumors via en bloc resection in patients who present for
treatment at the University of Kansas Health System. The study pretreatment evaluation and
follow up schedule are the same as used routinely in daily practice, in accordance with
standard of care practices. Routine labs (e.g. complete blood count, basic or complete
metabolic panel, urinalysis and urine culture), and imaging will be obtained as per standard
care at the provider's discretion based on the patient's history and physical exam.
A prospective data collection of the patients with bladder cancer undergoing en bloc
resection will be conducted in this study.
A complete medical, surgical and bladder cancer history will be obtained by the surgical team
in the pre-operative setting, per standard of care practices.
Patients will be taken to the operating room per standard of care for resection of one or
more bladder tumors. The SOLTIVE™ Super Pulsed Thulium laser will be utilized for resection
of the tumors in an en bloc fashion.
Technique for en bloc resection of bladder tumor Tumor marked with a circular coagulation
blockage border approximately 1.0 cm away from the edge. All visible vessels around the tumor
will be coagulated and lasered before the incision to reduce bleeding. Along this mark, a
fan-shaped incision into the bladder wall is made until the muscle layer is visible uplift
tumor by the force of the irrigation and use of the laser tip, gradually exposing the tumor
base tumor base is disconnected tumor is then removed en bloc. If it is unable to be removed
through the resectoscope in one piece due to its size, it may be cut into 2 pieces at the
surgeon's discretion.
At the surgeon's discretion, the procedure may be converted to a traditional TURBT utilizing
either monopolar or bipolar loop electrocautery. Other intraoperative/postoperative decisions
based on surgeon discretion and standard of care treatment:
Each specimen will be collected and sent en bloc to the pathology department. Ameer Hazma,
MD, a genitourinary pathologist, will review all specimens to decrease interobserver
variation.
Urinary symptoms before and after the procedure will be evaluated. This will be assessed via
an electronic questionnaire that will be sent to study participants. Symptoms will be
evaluated pre-operatively the morning of surgery as well as on post-operative day #3, 7, and
14.
No validated questionnaire for evaluation of urinary symptoms after bladder tumor resection
currently exists. From clinical experience, the symptoms patients most commonly report
include frequency, urgency, dysuria, or hematuria. The investigator will therefore modified
the existing American Urological Association's Symptom score to address these symptoms on a
shorter term basis.
