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This study aims to find out whether taking antibiotics to prevent a urinary tract infection after a medical procedure called percutaneous nephrostomy (placement of a catheter directly into the kidney to keep it working after the urinary tract has been blocked by a malignant tumour) actually prevents a urinary tract infection, compared to not taking antibiotic prophylaxis.
The medical records of cancer patients who underwent percutaneous nephrostomy between January 2013 and July 2020 were reviewed. Procedures were excluded if the nephrostomy was used for other procedures (e.g. double-J passage) or for non-malignant urinary tract obstruction (e.g. kidney stones). The association between antibiotic prophylaxis and UTI was assessed using association tests such as Pearson's chi-squared or Fisher's exact test. A significant level of 5% was adopted.
Definitions:
Urinary tract infection - occurs when there are signs and symptoms consistent with a local infection (fever, chills, dysuria, lower back pain, and costovertebral angle tenderness), such as cystitis (bladder or lower UTI) or pyelonephritis (kidney or upper UTI), combined with a positive urine culture (more than 104 colony-forming units of microorganisms per millilitre of urine with a catheter present or more than 105 colony-forming units of microorganisms per millilitre of urine without a catheter present).
UTI related to percutaneous nephrostomy procedure - occurs until seven days after the percutaneous nephrostomy procedure, both for first placement and/or catheter replacement.
UTI related to the nephrostomy catheter - occurs at another time, usually within 90 days of the procedure, in the presence of the nephrostomy catheter, and in the absence of another focus that would justify the infection.
Antibiotic prophylaxis was administered before percutaneous nephrostomy. If there was no record of antibiotics in the cost centre of the institution's database, it was considered that antibiotic prophylaxis was not given.
For the first percutaneous nephrostomy catheter placement, antibiotic prophylaxis was given empirically.
For catheter replacement, antibiotic prophylaxis was both empirical and targeted, based on the result of a pre-procedure urine culture to guide the antibiotic choice.
Percutaneous nephrostomies (first placement and/or catheter replacement) were excluded from analysis if patients were treated for UTI up to 7 days before or during the procedure. However, they were included in analysis outside the period of antibiotic prophylaxis for future UTIs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No antibiotic prophylaxis (NAP) - Group | No antibiotic prophylaxis before percutaneous nephrostomy | ||
| Antibiotic prophylaxis (AP) - Group | With antibiotic prophylaxis before percutaneous nephrostomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antibiotic prophylaxis | Drug | Antibiotic prophylaxis before percutaneous nephrostomy |
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| Measure | Description | Time Frame |
|---|---|---|
| Urinary Tract Infection After Percutaneous Nephrostomy Procedure | Proportion of urinary tract infection after each percutaneous nephrostomy | Up to 7 days after percutaneous nephrostomy |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated for cancer who required percutaneous nephrostomies
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo RD Reis | Barretos Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jales Cancer Hospital | Jales | São Paulo | 15706-396 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42238679 | Derived | Zanon JR, Santos TM, Durante H, Hirai WY, Mimica MJ, Fregnani JHTG, Dos Reis R. Antibiotic prophylaxis in percutaneous nephrostomy placements and replacements for malignant urinary tract obstruction. Retrospective cohort study with systematic review and meta-analysis. Front Radiol. 2026 May 19;6:1787168. doi: 10.3389/fradi.2026.1787168. eCollection 2026. |
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Publication in a peer-reviewed journal and release of data upon plausible justification
For an indefinite period
Justification sent by e-mail
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As the same participant can undergo more than one percutaneous nephrostomy procedure, be it placement or replacement, and the aim of the study is to assess the rate of urinary tract infection after percutaneous nephrostomy, this becomes the sampling unit and not the participant. Therefore, the number of participants is 320 and the number of procedures studied is 734, of which 214 (29.2%) were excluded from the analysis due to prior antibiotic use.
Data were collected on age, sex, skin colour, number of percutaneous nephrostomies performed, including first placements and catheter replacements. The time spent ill and using the nephrostomy catheter was calculated.
| ID | Title | Description |
|---|---|---|
| FG000 | No Antibiotic Prophylaxis (NAP) - Group | No antibiotic prophylaxis before percutaneous nephrostomy |
| FG001 | Antibiotic Prophylaxis (AP) - Group | With antibiotic prophylaxis before percutaneous nephrostomy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 11, 2021 | Apr 4, 2025 |
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| COMPLETED |
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| NOT COMPLETED |
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The use of antibiotic prophylaxis is generally recommended by institutional protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | No Antibiotic Prophylaxis (NAP) - Group | No antibiotic prophylaxis before percutaneous nephrostomy |
| BG001 | Antibiotic Prophylaxis (AP) - Group | With antibiotic prophylaxis before percutaneous nephrostomy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | As the sampling unit is the percutaneous nephrostomy procedure, it is possible for a single participant to have undergone the procedure more than once throughout the study period. Consequently, there are 133 procedures in the NAP group and 287 in the AP group. | Median | Inter-Quartile Range | year-old |
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| Sex: Female, Male | Sample unit: percutaneous nephrostomy | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Four missing data Sample unit: percutaneous nephrostomy | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urinary Tract Infection After Percutaneous Nephrostomy Procedure | Proportion of urinary tract infection after each percutaneous nephrostomy | The sampling unit for the analyses was the percutaneous nephrostomy procedure, not the patient, since the same patient may have undergone more than one percutaneous nephrostomy procedure, especially for catheter replacement, during cancer treatment. | Posted | Count of Units | Percutaneous nephrostomy procedure | Up to 7 days after percutaneous nephrostomy | Percutaneous nephrostomy procedure | Percutaneous nephrostomy procedure |
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From enrollment until end of follow-up, an average of 1 week.
Mortality and adverse events were described on a per patient basis, while urinary tract infection was assessed on a per percutaneous nephrostomy procedure basis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Antibiotic Prophylaxis (NAP) - Group | No antibiotic prophylaxis before percutaneous nephrostomy | 53 | 66 | 0 | 66 | 0 | 66 |
| EG001 | Antibiotic Prophylaxis (AP) - Group | With antibiotic prophylaxis before percutaneous nephrostomy | 127 | 153 | 0 | 153 | 0 | 153 |
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Our main limitation is the observational design, which, despite all the precautions taken, still carries a high risk of selection bias in the population
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeferson Rodrigo Zanon | Barretos Cancer Hospital | +551736243900 | 4041 | jrzanon@hotmail.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2021 | Apr 4, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014517 | Ureteral Obstruction |
| D009369 | Neoplasms |
| D058186 | Acute Kidney Injury |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019072 | Antibiotic Prophylaxis |
| ID | Term |
|---|---|
| D018890 | Chemoprevention |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011292 | Premedication |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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