Evaluation of Two Different Treatments for Lower Pore Renal Stone: Microperc Vs FURS

November 16, 2017 updated by: Li Fang, Ningbo No. 1 Hospital
This is a prospect, randomized control trial to evaluate merits between microperc and FURS for lower pole renal stone

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To evaluate the merits of Microperc and RIRS for the treatment for lower pole renal stone between 10-20 mm. Investigators will do a multi-centers randomized controlled trial(RCT). A total of 200 (three hundred) patients, aging between 18 and 60 years are being planned to be enrolled into the study; By simple random sampling technique, patients will be prospectively randomized into group A and group B with a 1:1 ratio. Group A will receive the microperc surgery and group B will undergo FURS.

All the patients will be diagnosed definitely before operations with non-contrast CT+IVP or CTU, lower pole Infundibular length, Infundibular width and Lower pole infundibulopelvic angle were recorded. A double J stent will be inserted in two the relevant ureter two weeks before surgery to guarantee the successful of operations. Patience will receive either microperic or FURS respectively, The operation time , hemoglobin change, renal function, post-operation pain, complications and hospital stay will be recorded. Patience will have follow-up visits at one month and three months, CT and KUB will be taken to evaluate the clearance of renal stone.

Surgical technique Microperc surgery: After the satisfaction of anesthesia, Patient is turned into prone position and the desired calyx is punctured by 4.8F microperc under fluoroscopic or sonographic guidance. No tract dilation is needed. A 200um holmium laser fiber will be used to break stone into less than 2mm. Pull out microperc without drainage tube left; RIRS: After the satisfaction of anesthesia, the patient is placed in the lithotomy position, pull out the pre-inserted double J stent, and place guidewire into the renal pelvis. A 12/14 Fr ureteral access sheath (UAS) is advanced into the proximal ureter over the guidewire, and flexible ureteroscope is passed through the UAS. The stones are fragmented smeller than 2mm using a 200um holmium laser fiber. Fragments are removed using a stone basket for stone analysis if necessary, a double J stent is placed at the conclusion of the procedure and removed post-operative 2 weeks.

Data collection Data for the 2 groups-demographic characteristics, hemoglobin(HB) decrease, white blood cell(WBC) increase, postoperative pain, duration of postoperative hospital stay, complications (modified Clavien system), stone clearance (SFR) and the need for auxiliary treatment are compared.

Mean study endpoint: Final SFR (3 months after procedure) Secondary endpoint: Complications, duration of postoperative hospital stay. re-microperc, ureteroscopy and SWL are considered as auxiliary treatments.

The stone size is defined as the maximum diameter as determined by CT scans. Degree of hydronephrosis are assigned as follow: none (no calyx or pelvic dilation), mild (pelvic dilatation alone), moderate (mild calyx dilation), or severe (severe calyx dilation or calyx dilation accompanied by renal parenchyma atrophy).

Definition of operation time:

For microperc: recorded from the time of the first percutaneous renal puncture to pulling out the microperc.

For RIRS: recorded from insertion of an endoscope into the urethra to the completion of stent placement.

Hospital stay are rounded to the nearest whole day and calculated from the day of surgery to the day of discharge.

Postoperative pain (visual analogue scale(VAS), use of analgesics) will be recorded.

The rate of hemoglobin decrease is assessed by comparing the preoperative Hb level with 24-hour postoperative Hb level.

Non-contrast CT and KUB is obtained for all patients at 3 month after the operation to evaluate the final SFR, allowing time for the spontaneous passage of stone fragments.

Stone-free status are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the kidney which were defined as ≤4mm, asymptomatic, non-obstructive and non-infectious stone particles.

Complications of all patients are recorded according to modified Clavien classification system.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • Ningbo NO.1 hospital
        • Contact:
          • Liemin Ruan, MD
          • Phone Number: 0086057487085111
        • Contact:
          • Zhongze Lou, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 10-20mm lower pole renal stone measured by KUB or CT;
  2. Age between 18-60 years, no gender limitation;
  3. Participators can understand the research and sign the consent form without mental illness nor language disorder;
  4. Low pole renal stone left after lithotripsy;
  5. Lower pole infundibulopelvic angle which measured by IVP or CTU will less than 30 degree;
  6. Asymptomatic patients with positive urine white blood cells and negative preoperative urine culture should be treated with antibiotics for 3days before operation;
  7. Patients with symptoms of urinary infections, positive urine withe blood cells and positive preoperative urine culture should be treated with suitable antibiotics based on the culture sensitivity result for at least 7days before operation.

Exclusion Criteria:

  1. Transplant kidney stone;
  2. Renal malformations, such as UPJO, medullary sponge kidney, polycystic kidney, horseshoe kidney, etc.;
  3. Combine other part of urinary stones need to be handle at the same procedure, for example ureteral stone, renal pelvic stone, middle or upper pole renal stone;
  4. Hematological Disease or Coagulation disorders;
  5. Withdraw anticoagulant medicine less than two weeks;
  6. Fever or urinary infections without treatment according to the inclusion criteria;
  7. Sevier renal dysfunction(endogenous creatinine clearance rate≤50ml/min)
  8. Middle or severe hydronephrosis(dilatation of the renal pelvis ≥20mm by ultrasound);
  9. Women in menstrual period or pregnancy;
  10. Patients have severe disease, such as heart disease, lung dysfunction, and multiple organ failure that cannot tolerate anesthesia or operation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microperc surgery
Patient is turned into prone position and the desired calyx is punctured by 4.8F microperc under fluoroscopic or sonographic guidance. No tract dilation is needed. A 200um holmium laser fiber will be used to break stone into less than 2mm. Pull out microperc without drainage tube left.
Procedure: Microperc surgery
Parents are treated by Microperc Percutaneous Nephrolithotomy
Active Comparator: FURS
Patient is placed in the lithotomy position, pull out the pre-inserted double J, and place guidewire into the renal pelvis. A 12/14 Fr ureteral access sheath (UAS) is advanced into the proximal ureter over the guidewire, and flexible ureteroscope is passed through the UAS. The stones are fragmented smeller than 2mm using a 200um holmium laser fiber. Fragments are removed using a stone basket for stone analysis if necessary, a double J stent is placed at the conclusion of the procedure and removed post-operative 4 weeks.
Procedure: FURS
Parents are treated by FURS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SFR
Time Frame: 3 month
Stone free Rate
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 3 month
Complications after surgery
3 month
Duration of postoperative hospital stay
Time Frame: 7 days
Duration of postoperative hospital stay
7 days
Postoperative pain
Time Frame: 3 month
Postoperative pain,visual analogue scale(VAS)
3 month
The rate of hemoglobin decrease
Time Frame: 7 days
The rate of hemoglobin decrease
7 days
Operation time
Time Frame: 12 hours
Operation time of surgery
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ningbo No. 1 Hospital

Collaborators

The First Affiliated Hospital with Nanjing Medical University
General Hospital of Shenyang Military Region
Jiangsu Province Hospital of Traditional Chinese Medicine
Beijing Friendship Hospital
West China Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Affiliated Hospital of Hebei University
Renmin Hospital of Wuhan University
Zhejiang Provincial People's Hospital
First Affiliated Hospital of Xinjiang Medical University
People's Hospital of Anshun City of Guizhou Province

Investigators

  • Principal Investigator: Yue Cheng, Dr., Ningbo No. 1 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 17, 2017

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

September 30, 2017

First Submitted That Met QC Criteria

October 10, 2017

First Posted (Actual)

October 11, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBDYYY2017003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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