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Kidney CalculiNCT04690010

Ambulatory Versus Inpatient Percutaneous Nephrolithotomy

A study testing Ambulatory tubeless PCNL and Inpatient PCNL with nephrostomy tube in people with Kidney Calculi, run by University of California, San Francisco at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The goal of the study is to determine if ambulatory tubeless PCNL is safe and effective compared to inpatient PCNL with a nephrostomy tube. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Calculi
What is being tested?
Ambulatory tubeless PCNL and Inpatient PCNL with nephrostomy tube
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
20 Oct 2022to 10 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled for PCNL who agree to be included in the study
  • Age 18 years or more
  • Absence of renal anatomic abnormalities
  • Patients undergoing bilateral procedures or those with pre-operative indwelling ureteral stents or nephrostomy tubes will be included

Who cannot join

  • Pre-operative:
  • Age <18
  • Pregnancy
  • Positive urine culture within 3 weeks
  • Bleeding disorder
  • Presence of renal anatomic abnormalities
Show all 18Show fewer
  • Solitary kidney
  • Need for admission based on comorbidities determined by anesthesiologist
  • Intra-operative:
  • Significant ureteral or pelvicalyceal injury
  • Significant intraoperative hemorrhage
  • Post-operative:
  • Temperature >100.4 Fahrenheit
  • Hemodynamic instability (defined as 2 of 3: heart rate >90 beats per minute, respiratory rate >20 breaths per minute, systolic blood pressure <90mmHg, or drop in systolic blood pressure >40mmHg)
  • Hemoglobin drop of > 3 g/dL compared to pre-operative bloodwork
  • Transfusion of blood products
  • Pneumothorax or hemothorax on chest X ray
  • Uncontrolled nausea, vomiting, or pain

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: A Randomized Controlled Trial of Ambulatory Versus Inpatient Percutaneous Nephrolithotomy

The goal of the study is to determine if ambulatory tubeless PCNL is safe and effective compared to inpatient PCNL with a nephrostomy tube.

Read the detailed description

One in eight human beings will develop kidney stones during their lifetime. Of these, roughly 20% require surgery. Percutaneous nephrolithotomy (PCNL) is the standard minimally invasive surgical procedure for removal of large kidney stones. In the standard PCNL technique, a drainage tube connecting the kidney to a bag on the outside of the body (nephrostomy tube) is left in place after surgery. Patients are admitted to hospital for one to two days for observation at which time the nephrostomy tube is removed before discharge. The presence of the nephrostomy tube is associated with pain, increased use of opioids, and slower recovery after surgery.

Ambulatory PCNL has been proposed as a way to potentially speed recovery, reduce pain, decrease time in hospital, and decrease cost. Initial studies of ambulatory tubeless PCNL have shown favourable results. However, these studies were performed in a small subset of healthy patients with favourable stones that do not represent the majority of patients who undergo PCNL. In this technique, patients are discharged home the same day as surgery usually with a small drainage tube on the inside of the body called a stent that is removed 1-2 weeks later and no nephrostomy tube (tubeless). The stent itself can be painful and may require a second procedure for removal. There is increasing evidence for the safety of totally tubeless PCNL (in which no nephrostomy tube or ureteric stent is placed) or placement of a stent on a string for a short period of time. Given that current recommendations for stone management in the times of COVID-19 include minimizing use of stents, the investigators believe it is an optimal time to evaluate safety and efficacy of using a minimal stenting technique (either no stent at all or stent on string) in ambulatory PCNL patients.

The goal of the study is to determine if ambulatory tubeless PCNL is safe and effective compared to inpatient PCNL with a nephrostomy tube in a more representative patient population including obese patients, patients with moderate medical comorbidities, and patients with large kidney stones. A secondary aim is to determine if a minimal stent technique (stent on a string for 5 days or less or no stent) is safe and effective as an exit strategy in ambulatory PCNL patients. The study hypothesis is that ambulatory tubeless PCNL will have similar complication and stone free rates as inpatient PCNL with benefits over inpatient PCNL including improved patient quality of life, decreased use of opioid pain medications, shortened hospital admission, faster return to work, and lower cost.

Conditions
Kidney Calculi
Being tested
Ambulatory tubeless PCNL, Inpatient PCNL with nephrostomy tube
Medical subject headings
Kidney Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ambulatory tubeless PCNLProcedure or surgery

    Patients will be discharged the same day of surgery. No nephrostomy tube will be left in place. A ureteral stent on a string may be left for up to 5 days.

  • Inpatient PCNL with nephrostomy tubeProcedure or surgery

    Patients will be admitted to hospital for 1-3 days. A nephrostomy tube will be placed at the time of surgery that will be removed prior to discharge.

Study groups in NCT04690010
Study groupRoleWhat they receive
Ambulatory tubeless PCNLActive comparatorPatients will be discharged home on the same day as surgery. No nephrostomy tube will be placed (tubeless).
Receives: Procedure: Ambulatory tubeless PCNL
Inpatient PCNL with nephrostomy tubeActive comparatorPatients will be admitted to hospital for 1-3 days with a nephrostomy tube placed at the time of surgery that will then be removed prior to discharge.
Receives: Procedure: Inpatient PCNL with nephrostomy tube

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total number of complications

    Any of: Emergency department visits related to procedure, unplanned provider visits, re-admission related to the procedure, blood transfusion, and need for secondary procedures. Patients with an emergency department or provider visit leading to re-admission will be classified once in the primary outcome as re-admission.

    Measured: 4 weeks after surgery

Secondary outcomes (5)
  1. Stone free status

    Stone free status will be defined as no residual stones with maximum diameter >3 mm on low dose non-contrast CT scan at 4 weeks post-surgery.

    Measured: 4 weeks after surgery

  2. Change in Wisconsin Stone Quality of Life Questionnaire by 10 points or more from baseline to 4 weeks after surgery.

    The Wisconsin Stone Quality of Life Questionnaire is a validated, disease specific quality-of-life instrument that has been used in the acute, chronic, and post-operative setting and is currently the most commonly used questionnaire for kidney stone disease.The survey is a 28-item instrument with a 5-point Likert scale for each item. There is a total of 140 points, and a difference of 10 points is considered clinically significant.

    Measured: This will be completed at the initial visit (baseline) and at the follow-up visit 4 weeks later.

  3. Cumulative opiate morphine equivalent dosing

    This will be the calculated as the morphine equivalent dosage of all opioid medications taken by patients from time of surgery to follow-up at 4 weeks above their baseline opioid needs.

    Measured: 4 weeks after surgery

  4. Return to work

    Mean time to return to work (in days) and percent who have returned to work at 1 week will be determined at the time of the 4-week follow-up visit.

    Measured: 4 weeks after surgery

  5. Time in hospital

    Duration spent in hospital (in hours) will be determined

    Measured: 1 week after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2020
  2. Study start20 Oct 2022 (estimated)
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion10 Nov 2024

Why it stopped: No funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04690010
Sponsor's protocol ID
20-33137
Status last verified
Sep 2026
First submitted
28 Dec 2020
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ambulatory tubeless PCNL and Inpatient PCNL with nephrostomy tube in people with Kidney Calculi, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total number of complications (time frame: 4 weeks after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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