ClinicalTrials.gg
Status unknownNCT03259594Updated Apr 29, 2020

Measurement of Renal Functional Reserve Change In Patients With SRC Before and After Laparoscopic Deroofing

An interventional study of Laparoscopic deroofing and 100 g of amino acids supplementation in Simple Renal Cyst, sponsored by ou tongwen. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-04-29.

Sponsored by ou tongwen · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Renal functional reserve may be improved in patients with simple renal cysts after laparoscopic deroofing.

Read the detailed description

Simple renal cysts (SRC) are the most frequent type of cystic renal disease. The prevalence rate of SRCs is about 10% and increases with age. Hypertension and decreased renal functions have been reported to occur more commonly among these patients with SRC and there are no clear guidelines for managing asymptomatic SRCs.Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase glomerular filtration rate(GFR) from baseline in response to stimuli (e.g., protein load).The investigators hypothesized that RFR may be improved in some patients with simple renal cysts after laparoscopic deroofing despite identical resting glomerular filtration rate (rGFR).The aim of this study is to examine whether there is improvement of RFR in patients with simple renal cysts after laparoscopic deroofing.

02

Conditions studied

  • Simple Renal Cyst

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Keywords

  • Renal functional reserve
  • Simple renal cysts
  • Laparoscopic deroofing
03

In context

Cysts

67 studies on the registry are indexed under Cysts; 16 are open to participants now.

This study's planned enrollment of 200 is above the median of 48 across 40 interventional studies indexed under Cysts.

Browse Cysts studies →

Lead sponsor

This is the only study on the registry with ou tongwen as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18
  2. Estimated >30 mL/min/1.73m2
  3. Subjects who signed forms

Exclusion criteria

Exclusion Criteria:

  1. Allergy to iothalamate, shellfish or iodine
  2. Use of metformin or amiodarone
  3. Inability to maintain a stable regimen of medications which affect for > one week prior to participation (e.g. non-steroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, angiotensin receptor blockers)
  4. Use of medications which directly affect elimination of creatinine (e.g. cimetidine and trimethoprim)
  5. Acute exacerbation of asthma or within 3 months requiring hospitalization or oral therapy
  6. Inadequate intravenous access
  7. Severe anemia (Hct \<21%)
  8. Acute kidney injury (rise in creatinine to ≥1.5 times the previous baseline or by ≥ 0.3 mg/dL on most recent labs prior to enrollment)
  9. History of contrast-induced nephropathy
  10. Hyperthyroidism
  11. Pheochromocytoma
  12. Sickle cell disease
  13. Urinary retention or incontinence
  14. Status post organ transplant
  15. Pregnancy or active breast feeding
  16. Cognitive impairment with inability to give consent
  17. Institutionalized status
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    endophytic group

    participants are with endophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.

    Procedure: Laparoscopic deroofing · Drug: 100 g of amino acids supplementation

  • Sham comparator
    exophytic group

    participants are with exophytic renal cyst and undergo laparoscopic deroofing.2 day before laparoscopic deroofing, they were given intravenous 100 g of amino acids supplementation.

    Procedure: Laparoscopic deroofing · Drug: 100 g of amino acids supplementation

Interventions

  • ProcedureLaparoscopic deroofing

    The classic treatment of patients with simple renal cysts is deroofing, which can be performed by open surgery or laparoscopy. Laparoscopic deroofing is an effective minimally invasive approach and has gained popularity.

  • Drug100 g of amino acids supplementation

    intravenous supplementation with 100 g of amino acids 2 day before laparoscopic deroofing.

    Also known as: Compound Amino Acids Injection(18AA-Ⅶ)

06

What researchers measure

Primary outcomes

  1. Change in renal functional reserve after laparoscopic deroofing

    1 month after surgery, repeated glomerular filtration rate measurements are to be performed to calculate change in renal functional reserve.

    Time frame: 1 month after surgery.

07

Study locations

1 of 1 sites recruiting
  • Xuanwu Hospital Capital Medical University
    Beijing, Beijing 100053, China
    Recruiting
    • Zhenhua Shang, MD. · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03259594
Lead sponsor
ou tongwen
Responsible party
ou tongwen (Head of Urology, Xuanwu Hospital, Beijing) — Sponsor-investigator
First posted
Aug 23, 2017
Start date
Mar 1, 2018
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Apr 29, 2020

Study contacts

Zhenhua Shang, MD.
Contact
shangzhenhua16@126.com
+8617801117318
Hao Yan, MD.
Contact
+8683198448
Tongwen Ou, MD.
study chair · Xuanwu Hospital, Beijing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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