Percutaneous Nephrostomy versus Retrograde Ureteral Stent for the Treatment of Malignant Urinary Obstruction, the DECOMPRESS Trial

Status: administratively complete

This clinical trial compares percutaneous nephrostomy (PCN) versus retrograde ureteral stent in treating urinary obstruction due to cancer (malignant urinary obstruction). Cancer in the pelvic or abdominal space can often block the ducts from the kidney to the bladder (ureter). Blocking one or both ureters can lead to worsening kidney function, infection, pain, and poor cancer prognosis. Treatment options include PCN and ureteral stent placement. PCN is a surgical procedure that places a tube from the kidney that comes out of the back and drains urine into a bag. A retrograde ureteral stent is an internal drainage tube that drains urine from the kidney down to the bladder. Some studies have suggested that retrograde ureteral stents may be associated with better quality of life, however they are associated with lower urinary tract symptoms and have a 10-40% failure rate. PCN has a lower failure rate but are thought to be associated with negative quality of life and self-image due to an external drainage bag. This study may help researchers determine if patients are willing to be randomized to PCN or retrograde ureteral stent. This may help researchers design future trials to determine which procedure is better at reducing symptoms of malignant urinary obstruction.

Inclusion Criteria

Patients must have unilateral or bilateral hydronephrosis secondary to extrinsic compression by malignancy on cross sectional imaging
Age ≥ 18 years
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Anticoagulation that cannot be safely reversed in the peri-procedural time period
History of severe allergy to contrast media
Prior stent or nephrostomy in previous 6 months
Urethral or ureteric stricture disease
Lower urinary tract structural abnormalities or urinary diversion precluding retrograde ureteral stent placement
On blood pressure support or clinically unstable
Pregnant women are excluded from this study because the radiation from either procedure is known to have the potential for teratogenic or abortifacient effects
Previous renal transplant
Dialysis

PRIMARY OBJECTIVE:

I. To assess feasibility of a definitive randomized trial, specifically to quantify patient willingness to be randomly assigned treatment with retrograde ureteral stent versus percutaneous nephrostomy tube placement for malignant ureteral obstruction.

SECONDARY OBJECTIVE:

I. To understand the rates of technical success when randomizing patients to percutaneous nephrostomy or ureteral stent placement for managing malignant ureteral obstruction.

II. Assess patient reported outcomes after each procedure.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo PCN placement on study. Patients also undergo blood sample collection, computed tomography (CT) scan and magnetic resonance imaging (MRI) throughout study.

ARM II: Patients undergo ureteral stent placement on study. If surgeon is unable to place ureteral stent, patient will be referred for placement of PCN. Patients also undergo blood sample collection, CT scan and MRI throughout study.

After completion of study intervention, patients are followed for up to 52 weeks.

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Percutaneous Nephrostomy versus Retrograde Ureteral Stent for the Treatment of Malignant Urinary Obstruction, the DECOMPRESS Trial

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