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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorNational Cancer Institute (NCI)

About this trial

Background:

Bladder cancer is the sixth most common cancer in the United States. The way that doctors remove tumors in bladder surgeries may leave some cancer . Also, many people have their tumors return or progress after surgery. Researchers want to test a modified device. It might tell doctors more about bladder tumors.

Objective:

To see if using a modified standard device with bladder surgery can provide better information about tumors in bladder specimens.

Eligibility:

People ages 18 and older who need to have their bladder removed at the NIH.

Design:

Participants will be screened with:

Medical and prior surgical history

Review of existing MRI, x-ray, or CT scans

Review of existing specimens and reports

Pregnancy test for women of childbearing age

CT or MRI: Participants will lie in a machine. The machine will take pictures of their body.

Participants will have bladder surgery. This will occur in the same way as if they did not take part in this study. A member of the research team will cut the removed bladder using the modified device. This will most likely be done on a separate back table in the operating room. The bladder and samples after cutting will be sent out for review. The will occur just as it would if the participants were not in this study. The only difference is the way that the specimen is prepared for review.

Participants follow-up care will occur per standard of care. Or it will occur as part of any other study in which they might also be enrolled.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients requiring surgical removal of the bladder at the NIH Clinical Center.

Men and women

Age greater than or less than 18 years

Deemed clinically appropriate for the planned surgical procedure.

Disqualifiers

None

Trial population

Bladder Cancer Patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • modified resectoscope

    Device

    The modified resectoscope will be used post cystectomy (En-bloc TURBT) to resect areas of the tumor from the cystectomy specimen. These resected tumors will be sent for histopathology to assess the size of resection, depth of resection, and ability to ascertain tumor orientation and compared to the remainder of the cystectomy specimens to see if the modified resectoscope can provide improved pathologic standards for the TURBT procedure.

  • TURBT

    Procedure/Surgery

    All patients will receive routine surgical transurethral resection of bladder tumors (TURBT).

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: 1/ Cohort 12 interventions

Trial outcomes

Primary outcomes

1

Assessment of resectoscope device modification on pathologic standards for the TURBT procedure

-Presence of three tissue layers with in 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.

Time frame
Time of surgery/pathologic assessment (7-10 days)

Secondary outcomes

1

Assessment for possible bladder perforation in bladder specimens

The rate of occurrence will be described/tabulated.

Time frame
Time of surgery/pathologic assessment (7-10 days)

Other outcomes

Sponsors and contacts

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