Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Urinary Bladder Neoplasms

Urologic Neoplasms

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Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

patient subjected to bipolar Needlescopic En bloc resection of NMIBC

patient subjected to Monopolar Needlescopic En bloc resection of NMIBC

patients subjected to Bipolar resection of bladder tumor by Collins loop

Bipolar En bloc TURBT

patients subjected to Monopolar resection of bladder tumor by Collins loop (hot Knife)

Monopolar En bloc TURBT

Waleed El-Shaer, M.D

Non-muscle invasive bladder cancers (NMIBC) compose about 80% of bladder tumors. the stranded treatment of these tumors is TURBT.

en bloc resection of NMIBC yields better mascularis propria with better oncological outcomes

Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT

Bipolar Versus Monopolar Needlescopic En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer: A Prospective Randomized Study

Presence of residual tumor at the bed of previously resected NMIBC

Modified Clavien-Dindo classification scale

Benha University

Associate professor

Non-Muscle Invasive Bladder Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

The bladder tumour will be resected en bloc and removed in total, if possible.

The bladder tumour will be removed by conventional piecemeal resection.

Tumour is resected and removed from the bladder in one piece, if possible.

En Bloc resection

Conventional TURB

Jørgen Bjerggaard J, Professor MD

Ninna Kjær Nielsen, MD

Knud Fabrin, MD

Gitte W Lam, MD

Kasper Olsen, MD

Per Holt, MD

Juan Luis Vásquez, MD

Egils Vjaters

Karlis Kaufmanis

Erik Haug, MD

Aim: To compare the surgical method of En Bloc resection to the conventional transurethral resection of non-muscle invasive bladder cancer (NMIBC) in terms of complete removal of tumour, specimen quality, and pathological certainty.

Background: NMIBC is a common disease with a 5-year recurrence rate reported as high as 64%. The cornerstone in the treatment of NMIBC is transurethral resection (TURB) where the tumour is dissected in pieces, removed from the bladder, and pathologically examined for potential muscle invasion. As the tumour is fragmented before removal, the method violates basic oncological principles and compromises pathological examination. Hence, TURB is possibly part of the mechanism causing recurrences. En Bloc resection (EBR), where the tumour is removed in toto, can potentially overcome the flaws of conventional TURB, but large randomized trials are needed.

Methods: This project will be a multicentre randomised controlled clinical trial comparing EBR to conventional TURB. Patients with suspected NMIBC tumours with largest tumour diameter ≥1cm and ≤6cm will be randomised to either the intervention group, thus undergoing EBR, or the control group, undergoing conventional TURB. The investigators intend to include 220 patients in total, 110 patients in each group. The RCT will be initiated in 2022.

Perspectives: If EBR can be shown to remove bladder tumours with better pathological quality and certainty, this could potentially spare patients from undergoing surgeries in the future, thereby reducing costs for both patients and society.

En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

Proportion of patients with unaltered pathological T-stage following central pathology revision, reTURB, or cystectomy compared to initial T-stage description from TURB.

Prevalence of detrusor muscle in specimen by pathological examination

Proportion of patients with recurrences at 4 months follow-up cystoscopy

University of Aarhus

Novo Nordisk A/S

Jørgen Bjerggaard Jensen

Professor, DMSc

For patients undergoing bipolar transurethral standard resection, bladder tumour is resected in a piecemeal manner.

For patients undergoing bipolar transurethral en bloc resection, bladder tumour is resected and removed in one piece.

Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)

Bipolar transurethral standard resection

Bipolar transurethral en bloc resection

Jeremy YC Teoh, MBBS

Conventionally, transurethral standard resection (SR) of bladder tumour is performed in a piecemeal manner. Transurethral en bloc resection (EBR) has been described as an alternate surgical technique in bladder tumour resection. By preventing tumour fragmentation and ascertaining complete tumour resection by histological assessment of the EBR specimen, we hypothesized that EBR could reduce disease recurrence as compared to SR.

Bladder cancer is the 9th most commonly diagnosed cancer in men worldwide, with a standardized incidence rate of 9.0 per 100,000 person-years for men and 2.2 per 100,000 person-years for women. In Hong Kong, more than 400 new cases of bladder cancer are diagnosed every year. It is a common and important disease which carries a significant burden to the health medical system.

For patients who are diagnosed to have bladder tumours upon flexible cystoscopy, transurethral resection of bladder tumour (TURBT) should be offered. Being a minimally invasive procedure, it has become the standard for the initial management of bladder cancer. This operation aims to ascertain the diagnosis, to correctly stage the tumour (T-stage) and to cure the disease in the case of non-muscle-invasive bladder cancer (NMIBC). However, in a combined analysis of 2,596 patents from 7 randomised controlled trials in patients with NMIBC, it was shown that 1-year recurrence rate ranged from 15-61%, and 5-year recurrence rate ranged from 31-78%. Despite possible complete tumour resection during TURBT, the oncological control of NMIBC is far from satisfactory.

There are two main problems with the conventional standard resection (SR) procedure. First, the bladder tumour is resected in a piecemeal manner. This results in tumour fragmentation and floating tumour cells inside the bladder. The tumour cells may re-implant on to the bladder wall and lead to early disease recurrence. Second, 'complete tumour resection' is often determined by endoscopic vision only. Due to the inherited nature of piecemeal resection, it is not possible to assess the resection margin by histological means. The charring effect to the resection bed may also hinder the judgement of a 'complete tumour resection'. Routine second-look TURBT has been advocated for selected patients (Any presence of T1 disease, G3 disease, or any absence of detrusor muscle in the first TURBT specimen) even after a 'complete tumour resection' during the first TURBT. Second-look TURBT has been shown to detect residual disease in 33-55% of the patients and upstaging of disease in 4-45% of the patients. These results highlighted the limitations of TURBT in ascertaining complete tumour resection.

Transurethral en bloc resection (EBR) has been described as an alternate surgical technique in bladder tumour resection. By preventing tumour fragmentation and ascertaining complete tumour resection by histological assessment of the EBR specimen, we hypothesized that EBR could reduce disease recurrence as compared to SR.

Transurethral En Bloc Versus Standard Resection of Bladder Tumour

Transurethral En Bloc Versus Standard Resection of Bladder Tumour: A Multi-centre Randomised Controlled Trial (EB-StaR Study).

Rate of disease recurrence one year after the operation

Rate of presence of detrusor muscle in the pathological specimen

Number of participants with obturator reflex encountered by the operating surgeon during the operation

Rate of mitomycin C instillation given after the operation

Patients undergoing transurethral resection surgery have an average hospital stay of three days.

Complications which occur within 30 days after the operation

Second look transurethral resection surgery is expected to perform within six weeks after the allocated treatment and one more week is allowed for histological assessment of the second look transurethral resection specimen. Residual disease is measured by the number of participants with the presence of urothelial carcinoma in the second look transurethral resection specimen.

Second look transurethral resection surgery is expected to perform within six weeks after the allocated treatment and one more week is allowed for histological assessment of the second look transurethral resection specimen. Upstaging of disease is measured by the number of participants with upstaging of disease from non-muscle-invasive bladder cancer to muscle-invasive bladder cancer in the second look transurethral resection specimen.

Rate of disease progression one year after the operation

Kwong Wah Hospital

North District Hospital

Our Lady of Maryknoll Hospital

Pok Oi Hospital

The University of Hong Kong

Tseung Kwan O Hospital, Hong Kong

Tuen Mun Hospital

Tung Wah Hospital

United Christian Hospital

Princess Margaret Hospital, Hong Kong

Caritas Medical Centre, Hong Kong

Queen Elizabeth Hospital, Hong Kong

Chinese University of Hong Kong

Assistant Professor

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Holmium en bloc resection procedure will be done under either general or spinal anesthesia, using a Holmium laser device (Cyber Ho, Quanta device, Milano, Italy). We will use a 30-40-watt power, 1-2 joules and 20-30 MHz frequency

bipolar en bloc tumor resection of urinary bladder tumors

After obtaining informed consent, patients will be randomized with a 1:1 ratio using sealed envelopes that will be prepared by the department's ethical committee into 2 groups, group 1 represent the Holmium en bloc resection procedure while group 2 represents bipolar en bloc resection. Patients will be blinded to the type of intervention as well as the data collector and the statistician.

Intervention: all procedures will be done by an expert surgeon who performed over 50 cases of en bloc urinary bladder tumor resection with each energy source. In group A, Holmium en bloc resection procedure will be done under either general or spinal anesthesia, using a Holmium laser device (Cyber Ho, Quanta device, Milano, Italy). We will use a 30-40-watt power, 1-2 joules and 20-30 MHz frequency for Group A and bipolar en bloc resection for Group B. A 550 nm flexible laser fiber will be used in group A and a bipolar resection loop for group B.

Holmium versus Bipolar en bloc transurethral resection

AHMED M HIGAZY

En bloc resection of bladder tumors (ERBT) may improve staging quality and perioperative morbidity and influence tumour recurrence

Modern laser technology has led to new alternatives to conventional TURBT (cTURBT). The advocates of ERBT have three goals: to improve resection quality, lower perioperative complication rates, and decrease recurrence rates at resection sites. The present study is the first to compare the results of laser and electric en bloc resection of bladder cancer with respect to the aforementioned goals.

we aimTo compare the clinical outcome in the form of safety and efficacy between Holmium and bipolar transurethral en bloc resection of urinary bladder tumors.

After obtaining informed consent, patients will be randomized with a 1:1 ratio using sealed envelopes that will be prepared by the department's ethical committee into 2 groups, group 1 represent the Holmium en bloc resection procedure while group 2 represents bipolar en bloc resection. Patients will be blinded to the type of intervention as well as the data collector and the statistician.

Patients will be blinded to the type of intervention as well as the data collector and the statistician.

Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder

Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder: A Randomized Controlled Trial

conversion from the enbloc way of resection to the standard trans-urethral resection of bladder tumors

presence of muscle layer in the pathological specimen (Yes/No)

hours for the need of postoperative irrigation

recurrence of tumor in the follow up cystoscopy

recurrence of tumor in the follow up cystoscopy in the same site or in different site

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT	NCT04839029	Bladder Cancer Bladder Neoplas...	Bipolar En bloc... Monopolar En bl...	18 Years -	Benha University
En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer	NCT05223491	Non-muscle Inva...	En Bloc resecti... Conventional TU...	18 Years -	Aarhus University Hospital
Transurethral En Bloc Versus Standard Resection of Bladder Tumour	NCT02993211	Bladder Cancer	Bipolar transur... Bipolar transur...	18 Years -	Chinese University of Hong Kong
Transurethral En Bloc Versus Standard Resection of Bladder Tumour	NCT02993211	Bladder Cancer	Bipolar transur... Bipolar transur...	18 Years -	Chinese University of Hong Kong
Bipolar Versus Mono-polar Needlescopic En Bloc TUR-BT	NCT04839029	Bladder Cancer Bladder Neoplas...	Bipolar En bloc... Monopolar En bl...	18 Years -	Benha University
Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder	NCT04576286	Urinary Bladder...	Holmium versus ...	18 Years -	Ain Shams University
Holmium Versus Bipolar en Bloc Transurethral Resection of Urothelium Tumor of the Urinary Bladder	NCT04576286	Urinary Bladder...	Holmium versus ...	18 Years -	Ain Shams University

Spots Global Cancer Trial Database for en bloc resection