Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Levobupivacaine

Patients who underwent obturator nerve block with spinal anesthesia prior to TURBT

Patients who underwent spinal anesthesia prior to TURBT

Following the confirmation of spinal anesthesia level in the patients in the ONB group while in the lithotomy position, ONB was applied unilaterally or bilaterally, depending on the tumor position. A needle with a nerve stimulator was advanced vertically 2 cm below and 2 cm from the pubic tubercle. The needle is inserted through the skin and into the lower ramus of the pubic bone. When contraction was observed in the adductor muscle groups and the aspiration was negative, 10 mL 0.25% levobupivacaine at 0.3-0.5 mA was administered. The operation was started 10 minutes after the injection. TURBT operations were performed with a 30 degree optic and a 26 F bipolar resectoscope. All spinal anesthesia and ONB procedures were performed by the same anesthesia team. All TURBT operations were performed by the same surgeon.

Nerve Stimulator-guided Obturator Nerve Block

Ali Kaan Yildiz

In this prospective randomized controlled study, the effects of obturator nerve block (ONB) on obturator reflex, incomplete resection, perforation, tumor recurrence and progression, presence of muscle tissue in the specimen, need for second transurethral resection of bladder tumours (TURBT) and postoperative complications were investigated in patients who underwent TURBT for intermediate and high risk lateral wall non-muscle invasive bladder tumours (NMIBC).

Bladder cancer is among the ten most common types of cancer in the world, with about 550,000 new cases per year. According to GLOBOCAN (Global Cancer Incidence, Mortality and Prevalence) data, bladder cancer accounts for 3% of cancer diagnoses worldwide. It is more common, especially in developed countries. A total of 90% of bladder cancer diagnoses are made in people 55 years of age or older, and the disease is four times more common in men than in women. NMIBC are divided into four groups as low-medium-high and very high risk according to EORTC (European Organization for Research and Treatment of Cancer). Early recurrence was reported as 15%, late recurrence as 25% and progression as 9% with BCG treatment in medium and high risk NMIBC. TURBT is the basic approach in diagnosis and treatment.

The obturator nerve passes through the obturator foramen of the pubis and innervates the adductor muscles of the thigh. It lies within the pelvic cavity close to the prostatic urethra, bladder neck and inferolateral bladder wall. In TURBT, when the bladder is filled with irrigation fluid, the obturator nerve is very close to the bladder sidewall. While performing TURBT of lateral wall bladder tumors, neighboring obturator nerve stimulation may occur during surgical resection, resulting in adductor contraction and leg jerking. This condition, called the obturator reflex, occurs between 55.3% and 100% of lateral bladder tumors.

Serious complications can occur in TURBT, one of which is bladder perforation that may require laparotomy and open repair. Perforation is also associated with poor patient outcomes due to the spread of the tumor into the abdominal cavity and the inability to apply single immediate instillation of intravesical chemotherapy. One of the most important factors affecting the success of TURBT is the presence of residual tumor as a result of incomplete resection. Incomplete resection is associated with both general recurrence and particularly local recurrence, as well as shortening disease-free survival. One of the most important indicators of complete resection is the presence of the detrusor muscle in the TURBT specimen. However, in 10% of all cases, it has been reported that there is no detrusor muscle tissue in the TURBT specimen. Various methods such as administration of muscle relaxants under general anesthesia, less filling of the bladder, reduction of electric current, using a 90-degree classical loop, using bipolar plasmakinetic energy and performing tumor resection with small pieces have been proposed in order to prevent the failure and complications due to obturator reflex that may occur in TURBT.

In combination with spinal anesthesia, ONB is one of the most effective methods used to inhibit the obturator reflex. The importance of spinal anesthesia has increased especially due to the COVID-19 outbreak. Surgery under local / regional anesthesia is recommended as much as possible, especially during the pandemic process, compared to general anesthesia. In this way, it is aimed to reduce the risk of aerosol generating procedures and subsequent viral transmission. ONB has gained more importance in recent years as a result of being performed together with spinal anesthesia.

Efficacy and Safety of Obturator Nerve Block During Transurethral Resection on Non-muscle Invasive Intermediate and High Risk Lateral Wall Bladder Tumours

Efficacy and Safety of Obturator Nerve Block During Transurethral Resection on Non-muscle Invasive Intermediate and High Risk Lateral Wall Bladder Tumours Comparing Nerve Stimulator-guided Obturator Nerve Block With Spinal Anaesthesia and Spinal Anaesthesia: A Prospective Randomized Controlled Study

Rate of patients who had an obturator reflex during the operation

Ankara Training and Research Hospital

Principal Investigator

Symptoms and General Pathology

Carcinoma

Recurrence

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

BCG Vaccine

Altretamine

Cohorts of at least 3 participants each will be treated with escalating doses of sEphB4-HAS at 25mg, 50 mg, 75mg, 100 mg, and 125 mg administered intravesically over 2 hours once a week for 6 consecutive weeks to determine the maximum tolerated dose (MTD) and recommended phase II dosing (RP2D). Cycle repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Pharmacokinetic Study

Recombinant EphB4-HSA Fusion Protein

Monish Aron, MD

This phase I trial studies the side effects and best dose of recombinant EphB4-HSA fusion protein (sEphB4-HSA), and to see how well it works in treating participants with bladder cancer that has come back or that isn't responding to bacillus Calmette-Guerin (BCG) vaccine treatment. sEphB4-HAS prevents tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. Giving sEphB4-HSA may work better in treating participants with bladder cancer.

PRIMARY OBJECTIVES:

I. To establish the maximum tolerated dose (MTD) and recommended phase II dosing (RP2D) of intravesical sEphB4-HSA administration.

II. To describe the dose limiting toxicities and adverse event profile of intravesical sEphB4-HSA administration in patients with bladder carcinoma in situ (CIS) and/or high grade T1/Ta bladder cancer (BCa).

III. To describe the pharmacokinetics of intravesical sEphB4-HSA administration.

IV. To explore the anti-tumor activity of intravesical sEphB4-HSA administration as manifested by responses to treatment.

OUTLINE: This is a dose-escalation study.

Participants receive sEphB4-HSA intravesically over 2 hours on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up at 30 days, and again at 3 and 6 months.

sEphB4-HSA in Treating Participants With BCG-Unresponsive or Refractory Bladder Cancer

A First-in-Human Phase I Study of Intravesical sEphB4-HSA in Patients With "BCG-Unresponsive" Bladder Carcinoma In Situ (CIS), Completely Resected High Grade Ta/T1, to Establish the Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)

Adverse events will be evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

The MTD is defined as the highest dose tested in which none or only one patient experienced DLT attributable to the study drug, when 6 patients were treated at that dose and are evaluable for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the study drug. The MTD will be the RP2D.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of Obturator Nerve Block During Transurethral Resection on Non-muscle Invasive Intermediate and High Risk Lateral Wall Bladder Tumours	NCT04885309	Bladder Cancer ... Bladder Cancer ...	Nerve Stimulato...	18 Years - 90 Years	Ankara Training and Research Hospital
sEphB4-HSA in Treating Participants With BCG-Unresponsive or Refractory Bladder Cancer	NCT03552796	Recurrent Bladd... Bladder Cancer ... Bladder Cancer ...	Pharmacokinetic... Recombinant Eph...	18 Years - 80 Years	University of Southern California
sEphB4-HSA in Treating Participants With BCG-Unresponsive or Refractory Bladder Cancer	NCT03552796	Recurrent Bladd... Bladder Cancer ... Bladder Cancer ...	Pharmacokinetic... Recombinant Eph...	18 Years - 80 Years	University of Southern California

Spots Global Cancer Trial Database for bladder cancer stage 0