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Ureteral Stent Versus Percutaneous Nephrostomy in Acutely Obstructed Infected Kidney

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ClinicalTrials.gov Identifier: NCT03498794
Recruitment Status : Not yet recruiting
First Posted : April 17, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
MMMohammed, Assiut University

Brief Summary:

Non-malignant causes of ureter obstruction can be intrinsic such as stone disease, ureter stricture or congenital ureteropelvic junction obstruction, or extrinsic such as idiopathic retro peritoneal fibrosis. Nearly all clinicians agree that obstructing stones, with a concern for sepsis require immediate decompression of the urinary system.

Though large epidemiologic studies of the management of obstructed infected nephrolithiasis demonstrate higher rates of sepsis and mortality associated with PCN placement relative to ureteral stenting, the observational nature of the analysis highlights the need for prospective analyses of PCN vs stenting for obstructive nephrolithiasis.

Despite this obvious need, there are few studies comparing the efficacy of ureteral stenting vs PCN in the setting of obstructive urolithiasis. The choice between PCN and stenting is often made by the urologist at initial presentation and can be influenced by factors including disease severity, stone size, location of stone, eventual modality of definitive stone management, or even availability of in-house interventional radiology services.

Retrospective studies reveal that both procedures have high success rates. In the setting of unsuccessful stenting, PCN is often successful, but the contrary is not always true. Furthermore, patients are often selected for PCN over ureteral stenting in the setting of larger stones and if they are more severely ill.

Goldsmith et al studied 130 patients who underwent decompression for obstructing ureteral stone with PCN or stent placement. Although patients who underwent PCN placement had longer hospital stay, other outcomes such as time to definitive stone management, rates of spontaneous stone passage, and initiation of stone metabolic workup were not statistically different. The authors noted that the method of initial decompression correlated with eventual approach selected for definitive stone management. Patients treated with PCN were more likely to undergo percutaneous definitive management, while patients managed with ureteral stenting were more likely to be treatked with a ureteroscopic approach.

Two prospective studies comparing PCN vs stent management of obstructing ureteral stones have conflicting outcomes. Mokhmalji et al 6 in 2001 prospectively randomized 40 patients to receive either PCN or stent. Sixteen out of twenty stents were successfully placed while all twenty PCNs were successfully placed initially. All unsuccessful stents were successfully managed by PCN. Their results demonstrated that stent utilization was less successful as compared to PCN and there was a trend for longer antibiotic therapy due to persistent signs of urinary tract infection in patients who underwent stent placement.

In contrast, Pearle et al randomized 42 patients to receive PCN vs stents. This study failed to demonstrate one procedure to be more successful than the other. All 21stents and 20 out of 21 PCNs were successfully placed. One failed PCN successfully underwent stent placement. Their results demonstrated an increased incidence of bacterial urinary colonization post-procedure in the PCN group as compared to the stent group, but overall no differences in time to clinical improvement or length of stay were noted.


Condition or disease Intervention/treatment Phase
Management of Obstructed Infected Kidney Procedure: Ureteral stent Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Comparison Between Ureteral Stent versus Percutaneous Nephrostomy in Obstructed infected kidney due to Ureteric calculi
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internal Ureteral Stent Versus Percutaneous Nephrostomy Tube in Management of Acutely Obstructed Infected Kidney in the Presence Upper Urinary Tract Stones: A Prospective, Randomized Study
Estimated Study Start Date : May 5, 2020
Estimated Primary Completion Date : May 10, 2020
Estimated Study Completion Date : June 1, 2020

Arm Intervention/treatment
Active Comparator: Ureteral stent

Technique of ureteral stent insertion:

All patients will be in lithotomy position, and an endoscopy operating table with fluoroscopic imaging capability will be used. Before the procedures, all patients will have retrograde ureteropyelography. Then, a 0.035-inch hydrophilic guide wire will be placed into the renal pelvis under the guidance of flexible cystoscope.

The ureteral stent will be inserted retrograde by using flexible cystoscope, under mild sedation or local anesthesia by instilling 2% xylocain gel per urethra. Patients will be covered by specific antimicrobial therapy according to urine and/or blood culture. This treatment will be continued until there was no fever and any evidence of infection disappeared. A Foley's catheter will be left in the bladder for 2 hours in all patients. In each case the type of stent will be that of 5 or 6 F, with side-holes and remain in place until definitive treatment of stone.

Procedure: Ureteral stent

Patients will be randomized into 2 groups:

Group (A): 75 patients with the use of ureteral stent. Group (B): 75 patients with the use of PCN.

How the technique will be applied?

Technique of ureteral stent insertion:

The ureteral stent will be inserted retrograde by using flexible cystoscope.

Technique of PCN insertion:

Percutaneous nephrostomy will be performed in the angiography suite by a urologist with the patient under local anesthesia. All the patients will be given non-nephrotoxic antibiotics pre-operatively.

Other Name: Percutanous nephrostomy tube

Active Comparator: Percutaneous nephrostomy tube

Technique of PCN insertion:

Percutaneous nephrostomy will be performed in the angiography suite by a urologist with the patient under local anesthesia. All the patients will be given non-nephrotoxic antibiotics pre-operatively. The patients will be placed on the ultrasound table with fluoroscopic imaging capability in prone position and a pillow placed under the abdomen on the affected side to support the kidney. Then the initial puncture site will be chosen, cleaned and draped. Local anesthesia was injected and a stab incision was given at the puncture site. The 18-gauge Chiba needle will be inserted at the renal angle or at the posterior axillary line under ultrasound guidance into dilated pelvicalyceal system. Urine or pus drained out spontaneously or will be sucked with a disposable syringe and sample was sent to the laboratory for culture and sensitively.

Procedure: Ureteral stent

Patients will be randomized into 2 groups:

Group (A): 75 patients with the use of ureteral stent. Group (B): 75 patients with the use of PCN.

How the technique will be applied?

Technique of ureteral stent insertion:

The ureteral stent will be inserted retrograde by using flexible cystoscope.

Technique of PCN insertion:

Percutaneous nephrostomy will be performed in the angiography suite by a urologist with the patient under local anesthesia. All the patients will be given non-nephrotoxic antibiotics pre-operatively.

Other Name: Percutanous nephrostomy tube




Primary Outcome Measures :
  1. Ureteral stent vs percutaneous nephrostomy (PCN) for drainage obstructed infected kidney [ Time Frame: 2 years from April 2018 to may 2020 ]
    To compare between Ureteral stent versus Percutaneous Nephrostomy tube (PCN) in management of obstructed infected kidney by Improvement of infection clinically by decreasing high body temperature.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult Patients with infected hydronephrosis.
  2. Infected hydronephrosis due to ureteric stone or ureteric stricture.
  3. Uremic and non uremic patients.

Exclusion Criteria:

  • Patients with a contraindication to either form of drainage (uncorrected coagulopathy, urethral stricture disease, bladder outlet obstruction, pregnancy, ureteral stone greater than 15 mm., or Steinstrasse).

Publications:

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Responsible Party: MMMohammed, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03498794     History of Changes
Other Study ID Numbers: US VS PCN
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No