LaserEn: SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To determine the ability to obtain identifiable pathologic characteristics of bladder tumor specimens by use the SOLTIVE™ laser during en bloc resection.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 years of age or older.
- •Patient presenting for resection of papillary bladder tumor visualized on cystoscopy
- •New bladder tumor
- •Recurrent tumors
- •Tumor <3cm
排除标准
- •Patient unwilling to undergo en bloc resection
- •Non papillary lesions/tumors
结局指标
主要结局
To determine the ability to obtain identifiable pathologic characteristics of bladder tumor specimens by use the SOLTIVE™ laser during en bloc resection.
时间窗: 6 months
To determine the ability to obtain identifiable pathologic characteristics of bladder tumor specimens by use the SOLTIVE™ laser during en bloc resection.
次要结局
- To evaluate the overall recurrence rate as well as the recurrence rate at the prior resection site after SOLTIVE™ en bloc resection of bladder tumors.(6 months)
- To evaluate patient symptoms before and after en bloc tumor resection(6 months)
- • To evaluate short-term complications within 3 months after SOLTIVE™ en bloc resection of bladder tumors.(6 months)
研究者
Jeffrey Holzbeierlein
Principal Investigator
University of Kansas Medical Center