En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

Summary

Participation Requirements

Description

Background: Bladder cancer is the sixth most common cancer in the United States, disproportionately affecting more men than women. The gold standard for the surgical treatment and diagnosis of non-muscle invasive bladder cancer is transurethral resection of bladder tumors (TURBT). TURBT requires the...

Background: Bladder cancer is the sixth most common cancer in the United States, disproportionately affecting more men than women. The gold standard for the surgical treatment and diagnosis of non-muscle invasive bladder cancer is transurethral resection of bladder tumors (TURBT). TURBT requires the fragmentation of bladder tumors and piecemeal removal of these tumors. TURBT leads to loss of histopathologic information - including tumor orientation, size, and margin status - which may compromise outcomes and risk tumor seeding within the bladder. Given these multiple problems with TURBT we are testing some modifications to the current resectoscope device and the effect of these modifications on the quality of TURBT specimens produced. The redesigned resectoscope device will be tested ex-vivo on cystectomy specimens to avoid risks to patient safety. Objectives: The primary objective of this study is to determine if resectoscope device modification can provide improved pathologic standards for the TURBT procedure. An improvement in any of the parameters outlined below will constitute a device improvement in the current resectoscope: Presence of three tissue layers within the tumor specimens containing bladder mucosa, lamina propria, and portions of the muscularis. Information regarding tumor margin, assessed as the ability to ascertain if tumor is present at the margin of the resection. Eligibility: Medical condition requiring surgical removal of the bladder Men and women, age >= 18 years Design: Preclinical tissue acquisition trial, ex vivo, proof-of-concept. Following cystectomy, a modified resectoscope/redesigned resectoscope will be used to resect areas of tumor from the cystectomy specimens. These resected tumors will be sent with the cystectomy specimen for histopathology to assess the size of resection, depth of resection, and ability to ascertain tumor orientation. The remainder of the cystectomy specimens will undergo traditional histopathology. Histopathologic information from both specimens will be included in the final histopathologic diagnosis to ensure accurate oncology staging. This study will allow for about 2 years of accrual and the accrual ceiling will be set at 25 subjects.

Tracking Information