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.
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
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 group | Role | What they receive |
|---|---|---|
| Ambulatory tubeless PCNL | Active comparator | Patients 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 tube | Active comparator | Patients 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.
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)
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
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.
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
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
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.
- First posted30 Dec 2020
- Study start20 Oct 2022 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion10 Nov 2024
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University
- Responsible party
- Sponsor
- Investigators
- Thomas Chi, MD, Principal investigator, University of California, San Francisco
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Ambulatory Versus Inpatient Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT04690010
- Acronym / sponsor ID
- 20-33137
- Conditions
- Kidney Calculi
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Queen's University
- Study start
- 20 Oct 2022 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to determine if ambulatory tubeless PCNL is safe and effective compared to inpatient PCNL with a nephrostomy tube.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulatory tubeless PCNL | Active comparator | Procedure: Ambulatory tubeless PCNLPatients will be discharged home on the same day as surgery. No nephrostomy tube will be placed (tubeless). |
| Inpatient PCNL with nephrostomy tube | Active comparator | Procedure: Inpatient PCNL with nephrostomy tubePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- Age <18
- Pregnancy
- Positive urine culture within 3 weeks
- Bleeding disorder
- Presence of renal anatomic abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory tubeless PCNLPatients 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. | Procedure or surgery | Ambulatory tubeless PCNL |
| Inpatient PCNL with nephrostomy tubePatients 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. | Procedure or surgery | Inpatient PCNL with nephrostomy tube |
Primary outcome
Total number of complications
Time frame: 4 weeks after surgery
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.
5 secondary outcomes
Stone free status
Time frame: 4 weeks after surgery
Change in Wisconsin Stone Quality of Life Questionnaire by 10 points or more from baseline to 4 weeks after surgery.
Time frame: This will be completed at the initial visit (baseline) and at the follow-up visit 4 weeks later.
Cumulative opiate morphine equivalent dosing
Time frame: 4 weeks after surgery
Return to work
Time frame: 4 weeks after surgery
Time in hospital
Time frame: 1 week after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Chi, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
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.