Safety Analysis and Oncological Outcomes in HoLERT vs TURBT

NCT05833997 | Unknown

• 1 other identifier: NP1537/2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Bladder urothelial cancer is the second most common urologic tumor and represents a worldwide public health problem. Most cases are diagnosed as non-muscle invasive tumors, and can be treated with transurethral resection of bladder tumor (TURBT). However, the electrical energy-based TURBT fragments the tumor, burning it to its own muscular layer leading to artifacts that may spoil the histopathological analysis, resulting in understaging after the first TURBT ranging from 30-64%, depending on the presence of detrusor muscle. Modern laser technologies have been emerging as an alternative to classical TURB using en bloc tumor resection technique (ERBT). Therefore, the laser is applied on tumor's pedicle to resect the whole and intact tumor without fragmentation or fulguration as occurs in TURBT. The purpose of using laser if to improve the resection quality, decrease intra and perioperative complications, avoid re-TURBT and reduce recurrence rates at the resection site and in distant sites. Thus, the purpose of this study is to evaluate Laser Holmium use for large tumors resection (\>3cm), reducing complications, costs, and the need for new approaches, and improving the muscle layers samples.

Conditions

Bladder Urothelial Carcinoma; Bladder Cancer

Keywords

Bladder urothelial cancer; bladder cancer; transurethral resection of bladder tumor; En-bloc Resection of Bladder Tumors

Outcome Measures

Primary Outcomes (1)

• Presence of Detrusor Muscle (DM) on histopathological analysis of morcellated tumor from HoLERBT and TRUBT

  Evaluate the presence of muscle layer in the samples of tumor resection

  Up to 1 month after the first surgery

Secondary Outcomes (4)

• Compare intraoperative an peri-operative complications

  During surgery

• Clinical recurrence-free survival

  Until 2 years after surgery

• Clinical progression-free survival

  Until 2 years of surgery

• Overall and cancer-specific survival

  Until 2 years of surgery

Study Arms (2)

Holmium Laser En-bloc Resection of Bladder Tumors (HoLERBT) arm

EXPERIMENTAL

Patients randomized to HoLERBT group will have their tumor resected using the Megapulse 70w (Richard Wolf).

Procedure: Holmium Laser resection of bladder tumor (HoLEBT)

Control arm

ACTIVE COMPARATOR

Patients randomized to control arm will undergo a monopolar transurethral resection of bladder tumor.

Procedure: Monopolar Transurethral resection of bladder tumor

Interventions

Monopolar Transurethral resection of bladder tumor PROCEDURE

Patients randomized to Monopolar TURBT will be operated using a 26F continuous-flow resectoscope sheaths and a single-pole working element to exclusive use of the resection. The power will be set to cut in 80w and 60w. The technique that will be performed will be the classic endoscopic resection from the top of the tumor until reaching the base, taking a sample from the base of the lesion (muscle layer). Fragments will be removed through an Ellik evacuator, and the solution used will be 3% glycine. After the procedure, the patient will will be catheterized with a silicon catheter number 22F with three ways and continuous irrigation. After 30-60 days of the first procedure, all patients diagnosed with a lamina propria invasion in the uro-pathology analysis (T1) will be submitted to a new monopolar TURBT.

Control arm

Holmium Laser resection of bladder tumor (HoLEBT) PROCEDURE

It will be used a 24-26F continuous-flow resectoscope sheath with a specific working element to use with a 600µm fiber to Laser Holmium. Patients will be operated with the Megapulse 70w (Richard Wolf) and laser will be set to deliver the energy of 0,5J and 30-40Hz frequency, 15-20W of final energy. The solution used will be 0,9% saline solution. The resection will start from the base of the lesion, reaching the muscle layer to obtain a sample and resection of the whole tumor, without fragmentation. After this, the morcellation will be performed in the apex of tumor sparing the base with a long nephroscope, and the patient will will be catheterized with a silicon catheter number 22F with three ways and continuous irrigation. The morcellated product will be sent to the pathology lab for detailed analysis.

Holmium Laser En-bloc Resection of Bladder Tumors (HoLERBT) arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 80 years old;
• Presence of bladder tumor \> 3cm without signals of MIBC or advanced disease (US, CT scan or MRI 3 months before surgery)
• Able to understand and willing to sign a written informed consent document
• Satisfactory clinical pre operatory conditions for surgery with regional or general anesthesia.

You may not qualify if:

• Previous diagnosis of muscle-invasive bladder cancer;
• Tumor's Invasive aspect (T2 or more) on image (US, TC or RNM);
• Previous TURBT in the last 5 years;
• Urethral stenosis;
• Previous intra-vesical os systemic chemotherapy or radiotherapy;
• Previous treatment with intravesical BCG
• No clinical conditions for regional or general anesthesia;
• Any other significant disease or disorder which, in the opinion of the investigator may either put the participant at risk because of trial participation or may influence the trial result, or the participant's ability ti participate in the trial.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Cancer do Estado de São Paulo (ICESP)

São Paulo, Brazil

RECRUITING

Related Publications (9)

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  PMID: 23906669 BACKGROUND

• Herrmann TR, Liatsikos EN, Nagele U, Traxer O, Merseburger AS; EAU Guidelines Panel on Lasers, Technologies. EAU guidelines on laser technologies. Eur Urol. 2012 Apr;61(4):783-95. doi: 10.1016/j.eururo.2012.01.010. Epub 2012 Jan 17.

  PMID: 22285403 BACKGROUND

• Kramer MW, Rassweiler JJ, Klein J, Martov A, Baykov N, Lusuardi L, Janetschek G, Hurle R, Wolters M, Abbas M, von Klot CA, Leitenberger A, Riedl M, Nagele U, Merseburger AS, Kuczyk MA, Babjuk M, Herrmann TR. En bloc resection of urothelium carcinoma of the bladder (EBRUC): a European multicenter study to compare safety, efficacy, and outcome of laser and electrical en bloc transurethral resection of bladder tumor. World J Urol. 2015 Dec;33(12):1937-43. doi: 10.1007/s00345-015-1568-6. Epub 2015 Apr 25.

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  PMID: 24284200 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• William Nahas, MD, PhD

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre Iscaife, MD, PhD

CONTACT

+5511976280082; alexandre.iscaife@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md, PhD

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 27, 2023
• Study Start: December 10, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)