Recruiting
Phase 3

Surgical Techniques

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06703476

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Stent placement

Alvimopan

Study Details

Brief summary:

The purpose of this study is to look at two standard surgical techniques used during a radical cystectomy and see whether they influence outcomes such as length of stay in the hospital and infections after surgery. This trial will evaluate whether the following surgical methods influence outcomes:

A ureteral stent is a thin tube that is placed in the ureter to drain urine from the kidney. Ureteral stents are often used to promote urine drainage after radical cystectomy, but may come at risk of urinary tract infection.

Alvimopan is a standard drug used to promote return of bowel function following surgery. Doctors do not know whether alvimopan is beneficial in current clinical practice.

The surgeon will decide whether participants will receive a stent and/or alvimopan, but if they are unsure what the best approach is, a surgical technique has been assigned by chance to them.

Conditions

Bladder Cancer

Study ID

NCT06703476

Start date

Nov 21, 2024

Status verified date

Jul, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Stent vs. no stent

  • Patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons Alvimopan vs. no alvimopan
  • Patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons

Exclusion Criteria:

Stent vs. no stent

  • No exclusion criteria

Alvimopan vs. no alvimopan

  • Patients on chronic opioid therapy are ineligible to receive alvimopan and will be excluded from this cohort of the trial

Study Design

Enrollment

530 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stent vs No Stent

For patients treated by a surgeon randomized to use ureteral stents, the operating surgeon may choose to use a single or double J ureteral stent (6- to 8.5-fr in size) or an alternative ureteral stent of the surgeon's choice to be placed across the ureteroenteric anastomosis intraoperatively. Because there is no standard ureteral stent size or type, the surgeon will select a stent type and size according to their experience and will document the stent size and type used. This is already routinely recorded as part of the standard of care at MSK.

experimental: Alvimopan vs No Alvimopan

For patients randomized to receive alvimopan, the patient will receive alvimopan as a fixed 12-mg dose, with the first dose administered 0.5 to 5 h before the start of surgery; administration will be continued with twice daily oral doses postoperatively until hospital discharge or a maximum of 7 days (15 in-hospital doses), as indicated on the medication's FDA label. This is the current standard of care for most cases at MSK.

Interventions

Stent placement

Surgeon may choose to use a single or double J ureteral stent (6- to 8.5-fr in size) or an alternative ureteral stent of the surgeon's choice.

Alvimopan

Patient will receive alvimopan as a fixed 12-mg dose, with the first dose administered 0.5 to 5 h before the start of surgery; administration will be continued with twice daily oral doses postoperatively until hospital discharge or a maximum of 7 days (15 in-hospital doses).

Primary outcome measure

  • Length of hospital stay (Alvimopan) [ Time Frame: greater than 6 days ]
  • Symptomatic urinary tract infections (Stents) [ Time Frame: within 30 days of surgery ]

Central Contacts and Locations

Central contacts

Alvin Goh, MD

646-422-4667goha@mskcc.org

Bernard Bochner, MD

646-422-4387

Locations

Memorial Sloan Kettering at Basking Ridge (Consent Only)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Alvin Goh, MD

646-422-4667

Memorial Sloan Kettering Monmouth (Consent Only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Alvin Goh, MD

646-422-4667

Memorial Sloan Kettering Bergen (Consent Only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Alvin Goh, MD

646-422-4667

Memorial Sloan Kettering Suffolk-Commack (Consent Only)

Recruiting

Commack, New York, United States, 11725

Contacts

Alvin Goh, MD

646-422-4667

Memorial Sloan Kettering Westchester (Consent Only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Alvin Goh, MD

646-422-4667

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

Recruiting

New York, New York, United States, 10065

Contacts

Alvin Goh, MD

646-422-4667

Memorial Sloan Kettering Nassau (Consent Only)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Alvin Goh, MD

646-422-4667

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Cystectomy
  • Ureteral stents
  • Alvimopan
  • 24-361

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-13.