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Under Direct Vision vs Under Non Direct Vision of Insertion of UAS in RIRS

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ClinicalTrials.gov Identifier: NCT03717285
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University

Brief Summary:
Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, but can be accompanied by serious complications. In long-term clinical practice, the investigators has found that many ureteral injuries occur during UAS insertion of the ureter from ureteral orifice. And if we use rigid ureteroscopy to insert the UAS under direct vision, we can provide the placement success rate and reduce the incidence of complications. The investigator aims to perform a prospective and randomized controlled trial comparing the safety and efficacy of under direct vision and under non direct vision during the insertion of UAS.

Condition or disease Intervention/treatment Phase
Urolithiasis Procedure: Insert the UAS under direct vision Procedure: Insert the UAS under non direct vision Not Applicable

Detailed Description:

Retrograde intrarenal surgery (RIRS) has been considered as the first-line choice for the management of <20mm kidney stones. Insertion of a ureteral access sheath (UAS) before RIRS surgery is currently accepted as an effective method to improve the effectiveness of surgery, but can be accompanied by serious complications. In long-term clinical practice, the investigators has found that many ureteral injuries occur during UAS insertion of the ureter from ureteral orifice. And if we use rigid ureteroscopy to insert the UAS under direct vision, we can provide the UAS insertion success rate and reduce the incidence of complications.

Options for the UAS insertion include inserted under fluoroscopy control or inserted by the experience of the surgeon. The former is more commonly used in the United States, while the latter is more commonly used in China. But neither is perfect. Moreover, Ibrahim Karabulut et al. and Mehmet Giray Sönmez et al. reported a different technique for placement ureteral access sheath called "Endovisional technique" in which the outer sheath of UAS was worn on the semirigid endoscope and placed into the ureter under direct vision. Nevertheless, They found that complication rate was lower in the patients who had the UAS placed under "Endovisional technique" when compared to the classical technique. But the difference was not statistically significant. In addition, the investigators are concerned that failure to use sheath cores may cause new damage to the ureter.

So the investigators find a new way to insert UAS without damaging the ureter. In our new procedure, the patient is placed in the lithotomy position, and a 0.035'' flexible tip guidewire is placed into the renal pelvis using a ureteroscope. Then take out the ureteroscope and insert the ureteroscope into urinary bladder beside the guidewire. A 12 Fr/ 14 Fr ureteral access sheath (UAS) is advanced into the ureteral over the guidewire under direct vision. When the UAS successfully enters the ureteral orifice a few centimeters, the ureteroscope is removed. Continue inserting the UAS into the proximal ureter or UPJ and use the direct urinary system X-graphy (DUSG) to confirm that the UAS is inserted into the correct position. A P5 or P6 Olympus flexible ureteroscope is passed through the UAS to finish lithotripsy.

Until now, routine technique to insert ureteral access sheath during RIRS is still under discussion. The investigator aims to perform a prospective and randomized controlled trial comparing the safety and efficacy of under direct vision and under non direct vision during the insertion of UAS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Under Direct Vision Versus Under Non Direct Vision for The Efficacy and Safety Ureteral Access Sheath in RIRS for the Management of ≤20mm Size Kidney Stones: A Single-center Randomized Controlled Trial
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : September 10, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1:Under direct vision
Patients in Group 1 insert the UAS under direct vision.In this procedure,the investigators will insert the ureteroscope into urinary bladder beside the guidewire to observe the process of uas insertion into the ureter.
Procedure: Insert the UAS under direct vision
Patients in this group,we use rigid ureteroscopy to insert the UAS under direct vision.

Active Comparator: Group 2:Under non direct vision
Patients in Group 2 insert the UAS under non direct vision.In this procedure,the investigators will insert the UAS under fluoroscopy control.
Procedure: Insert the UAS under non direct vision
Patients in this group,we insert the UAS by the experience of the surgeon and under non direct vision .




Primary Outcome Measures :
  1. UAS insertion success rate [ Time Frame: intraoperatively ]
    Primary insertion of a UAS is not always possible. The ideal position of the UAS is with its distal extremity just below the ureteric-pelvic junction (UPJ). Insertion failure is defined as UAS cross the upj or do not reach the proximal ureter or the surgeon's decision to resign UAS insertion due to high resistance to the retrograde progression of the UAS along the urinary tract.


Secondary Outcome Measures :
  1. Complication rate [ Time Frame: 1 month after removing the pigtail stent ]
    Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively, including intraoperative bleeding, postoperative pain and so on.The investigator will invaluate perioperative complications by modified Clavien system

  2. Ureteral lesion grade [ Time Frame: intraoperatively ]
    Base on post-ureteroscopic lesion scale (PULS), reported byTraxer O and Thomas A in 2013.UAS related ureteral injuries were divided into 5 grades according to ureteral wall anatomy.Grade 0 means no lesion found or only mucosal petechiae. Grade 1 means ureteral mucosal erosion without smooth muscle injury. Both Grade 0 and Grade 1 are considered as low-level injuries. Grade 2 means ureteral wall injury, including mucosa and smooth muscle, with adventitial preservation (periureteral fat not seen). Grade 3 means ureteral injury indicated ureteral perforation involving the full thickness of the ureteral wall, including the adventitia.Grade 4 means injury corresponded to total ureteral avulsion with complete rupture of ureteral continuity. Grade 2, 3 and 4 are high-level injuries.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be a suitable operative candidate for RIRS
  2. Age 18 to 70 years
  3. Normal renal function 4 .ASA score Ⅰ and Ⅱ

5. Single renal stone ≤20mm or multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) up to 20 mm

Exclusion Criteria:

  1. Patients with solitary kidney
  2. Uncorrected coagulopathy and active urinary tract infection (UTI)
  3. Prior ipsilateral endourological procedure history, such as RIRS, PCNL, URS and URL
  4. Patients who underwent transplant or urinary diversion.
  5. Congenital abnormalities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717285


Contacts
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Contact: Guohua Zeng, Ph.D and M.D +86 13802916676 gzgyzgh@vip.tom.com
Contact: Guangming Chen +8613246888213 1172676107@qq.com

Locations
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China, Guangdong
epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510230
Contact: Guohua Zeng, Ph.D and M.D    +86 13802916676    gzgyzgh@vip.tom.com   
Sponsors and Collaborators
Guohua Zeng
Investigators
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Study Chair: Guohua Zeng, Ph.D and M.D The First Affiliated Hospital of Guangzhou Medical University

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Responsible Party: Guohua Zeng, Vice president, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT03717285    
Other Study ID Numbers: MRER(75)2018
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University:
RIRS
Renal stones
ureteral access sheath
ureteral injury
Additional relevant MeSH terms:
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Urolithiasis
Urologic Diseases