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Ureteral Stents with or without Alvimopan for the Improvement in Recovery after Surgery in Patients with Bladder Cancer Undergoing Radical Cystectomy
Trial Status: active
This phase III trial compares the effect of ureteral stents with or without alvimopan in improving surgical recovery in patients undergoing surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy) for the treatment of bladder cancer. Although radical cystectomy is the standard of care treatment for muscle-invasive localized bladder cancer, there is significant variation in outcomes between surgeons and hospitals. Different standard surgical techniques used during a radical cystectomy influence outcomes such as length of stay in the hospital and infections after surgery. A ureteral stent is a thin tube that is placed in a patient's ureter to drain urine from the kidney. Ureteral stents are often used to promote urine drainage after radical cystectomy. Alvimopan is known as a peripherally acting mu-opioid antagonist and is currently used as part of the standard of care to promote return of bowel function following surgery and reduce hospital stay. This trial may help doctors determine which technique, or combination of techniques, work best for patients undergoing radical cystectomy for the treatment of bladder cancer.
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 at Memorial Sloan Kettering (MSK)
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 at MSK
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
Additional locations may be listed on ClinicalTrials.gov for NCT06703476.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Alvin Goh
Phone: 646-422-4667
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Alvin Goh
Phone: 646-422-4667
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Alvin Goh
Phone: 646-422-4667
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Alvin Goh
Phone: 646-422-4667
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Alvin Goh
Phone: 646-422-4667
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Alvin Goh
Phone: 646-422-4667
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Alvin Goh
Phone: 646-422-4667
PRIMARY OBJECTIVES:
I. Determine the effect of ureteral stents at the time of surgery on urinary tract infections. (Stent Study)
II. Evaluate whether the use of alvimopan, a peripherally acting mu-opioid antagonist, decreases hospital length of stay. (Alvimopan Study)
SECONDARY OBJECTIVES:
I. Evaluate whether the use of ureteral stents at the time of surgery affects readmissions, extended postoperative ileus, or ureteroenteric anastomosis–related complications.
II. Evaluate whether the use of alvimopan decreases extended postoperative ileus or the need for a nasogastric tube.
OUTLINE: Surgeons are randomized to 1 of 4 arms. Patients receive treatment based on which arm their treating surgeon is randomized.
ARM I: For the initial 3 months, surgeons perform ureteral stent placement during standard of care (SOC) radical cystectomy for their patients, and patients receive alvimopan before the start of surgery and then orally (PO) twice daily (BID) until hospital discharge or up to 7 days on study. For the subsequent 3 months, surgeons do not perform ureteral stent placements during SOC radical cystectomy for their patients, and patients do not receive alvimopan.
ARM II: For the initial 3 months, surgeons do not perform ureteral stent placements during SOC radical cystectomy for their patients, and patients receive alvimopan before the start of surgery and then PO BID until hospital discharge or up to 7 days on study. For the subsequent 3 months, surgeons perform ureteral stent placement during SOC radical cystectomy for their patients, and patients do not receive alvimopan.
ARM III: For the initial 3 months, surgeons perform ureteral stent placement during SOC radical cystectomy for their patients, and patients do not receive alvimopan. For the subsequent 3 months, surgeons do not perform ureteral stent placements during SOC radical cystectomy for their patients, and patients receive alvimopan before the start of surgery and then PO BID until hospital discharge or up to 7 days on study.
ARM IV: For the initial 3 months, surgeons do not perform ureteral stent placements during SOC radical cystectomy for their patients, and patients do not receive alvimopan. For the subsequent 3 months, surgeons perform ureteral stent placements during SOC radical cystectomy for their patients, and patients receive alvimopan before the start of surgery and then PO BID until hospital discharge or up to 7 days on study.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
