En-Bloc Resection of Bladder Tumors

En-Bloc Resection of Bladder Tumors: a Multicentric Safety and Feasibility Trial (IDEAL Phase II) vs Conventional Resection of Bladder Tumors?

Observational data shows that "en bloc" resection of bladder tumor (EBR-BT) may entail advantages when compared with conventional transurethral bladder tumor resection (TURBT). EBR-BT has the potential to increase the rate of correct staging and accurate assignment of risk-classification in non-muscle-invasive bladder cancer (NMIBC) and to avoid re-TURBT in a considerable number of high-grade NMIBC by demonstrating total macro and microscopic eradication of the primary tumor and to provide the basis for a correct treatment based on a correct stage.

Following the rules of the IDEAL collaboration evaluation and stages of surgical innovation and considering EBR-BT as a surgical technical innovation, the investigators designed a multi-institutional, stage 2a/b study on feasibility (procedural success), safety (including pathology features), and short-term efficacy of EBR-BT and as proof of concept on the reliability of NMIBC staging.

Main objective: to prospectively assess the pathological efficacy of EBR-BT in the staging of bladder cancer and the clinical efficacy at short-term recurrence-free survival.

Secondary objectives: To assess the clinical efficacy at short-term (3-months) of EBR-BT, and to compare efficacy in the staging of the EBR-BT with the conventional TURBT.

Study Overview

• Status: Recruiting
• Conditions: Bladder Neoplasm
• Intervention / Treatment: Procedure: En Bloc Resection; Procedure: Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)

Detailed Description

En-bloc resection of bladder tumors (EBR-BT) has been showing certain advantages over conventional transurethral resection technique (TURBT) in non-muscle-invasive bladder cancer. These advantages consist mainly in the reduction of obturator nerve reflex and obtention of surgical samples according to oncological principles. Advantages in terms of tumor recurrence in the short-term, when compared with TURBT, remain uncertain. Herein several randomized control trials aim to assess comparative outcomes in the short and long term.

A higher rate of detrusor muscle is found in the EBR-BT samples than in the conventional samples resulting in a better staging and at least theoretically the need for fewer re-TURBT indications. However, a detailed and scrupulous description of the histopathological samples is lacking and, it is assumed that the presence of detrusor in the sample without solution of continuity with submucosa and tumor is sufficient to stage. As in surgical samples of other organs, the objective of EBR-RT is not only to obtain detrusor, but also clean margins that ensure the radicality of the tumor.

The hypothesis of the investigators' is that EBR-BT will results in an increased rate of pathological specimen with the presence of detrusor muscle and free-tumor margins, hence a more accurate stage than TURBT and a decrease in 3-months recurrence at short-term (3 months)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rahim Horuz; Phone Number: +90533 934 38 50; Email: rhoruz@medipol.edu.tr
• Study Contact Backup: Name: Betul Kartal; Email: bbkartal@medipol.edu.tr

Study Locations

• Turkey
  • Bagcilar
    • Istanbul, Bagcilar, Turkey, 34200
      • Recruiting
      • Bagcilar Education and Research Hospital
      • Contact: Bagcilar; Phone Number: (0212) 440 40 00
    • Istanbul, Bagcilar, Turkey, 34214
      • Recruiting
      • Medipol Mega University Hospital
      • Contact: Medipol; Phone Number: 444 7 044

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: 18 years old and older (adult, older adult) Sexes: All Accepts healthy volunteers: No

Inclusion criteria:

• Patients aged 18 and older presenting with suspicion of primary or recurrent Non-muscle invasive bladder cancer (NMIBC)
• Tumor size estimated by cystoscopy ≤ 3 cm
• Solitary or multiple tumors (up to 3 in number)

Exclusion Criteria:

• Tumor size > 3 cm of maximum dimeter
• Patient with severe systemic disease (ASA III+)
• Location on the anterior bladder wall and/ or anterior bladder neck (relative contraindication depending on accessibility)
• Pregnancy
• Histological diagnosis other than NMIBC urothelial bladder cancer
• Presence or history of previous upper-tract urinary cancer (UTUC)
• Presence of positive cytology without macroscopic identifiable bladder tumor
• Life expectancy < 1 year
• Non-reversible coagulopathy
• Bladder tumor detected during intravesical BCG therapy
• Tumor multiplicity (> 3 tumors)

Contacts and locations:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: En Bloc Resection Bladder Tumor (Any energy source); Patients with suspicion of NMIBC (primary or recurrent) that underwent en bloc resection (EBRT	Procedure: En Bloc Resection; En bloc transurethral resection of bladder tumor (EBR-BT) using any energy source (laser and bipolar or monopolar energy)
Active Comparator: Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar); Patients with suspicion of NMIBC (primary or recurrent) that underwent conventional TURBT	Procedure: Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar); Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Staging	Staging of NMIBC is defined by the presence of sufficient detrusor in the EBR-BT specimens, the status of the margins, presence of a tumor and /or CIS in the mucosal margins, the status of the detrusor margin, and suspicion of instability in mucosa free of tumor.	Immediately after the intervention
Recurrence at 3 months	Recurrence free survival at 3-months (absence of visible tumors at the site of the previous resection	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Complications	Rate of operative complications (estimated bleeding, bladder perforation, obturatory reflex, tumor fragmentation, conversion to conventional TURBT)	intraoperative
Perioperative Complications	Postoperative complications according to Clavien-Dindo classification	Up to 90 days

Collaborators and Investigators

• Sponsor: Betul Kartal
• Collaborators: Bağcılar Eğitim ve Araştırma Hastanesi

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Urinary Bladder Neoplasms; Urogenital Neoplasms; Urologic Neoplasms
• Additional Relevant MeSH Terms: Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Neoplasms; Urinary Bladder Neoplasms
• Other Study ID Numbers: 10840098-604.01.01-E.55105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be provided by request according to the primary objectives of the IPD study and according to the availability in the present trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No