Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-02-08 @ 8:11 AM
Study NCT ID:
NCT02519634
Status:
COMPLETED
Last Update Posted:
2020-04-01
First Post:
2015-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMP vs RIRS for Symptomatic Lower Pole Renal Calculi of 10-20 mm Size: a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '2015-08-03', 'studyFirstSubmitQcDate': '2015-08-06', 'lastUpdatePostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone free rate (SFR)', 'timeFrame': 'The primary endpoint was the SFR at 3-months after surgery.', 'description': '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 ≦ 3mm, asymptomatic, non-obstructive and non-infectious stone particles.'}], 'secondaryOutcomes': [{'measure': 'Perioperative complications', 'timeFrame': 'intraoperatively or ≤ 3 month postoperatively', 'description': 'Complication is defined as any adverse event occurred intraoperatively or ≤3 month postoperatively.'}, {'measure': 'Operation time', 'timeFrame': 'intraoperatively', 'description': 'The operating time for SMP was recorded from the time of the first percutaneous renal puncture to wound closure;For RIRS,The operating time was recorded from insertion of an endoscope into the urethra to the completion of stent placement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Super-Mini Percutaneous Nephrolithotomy', 'SMP', 'Retrograde Intrarenal Surgery', 'RIRS', 'Randomized Controlled Trial', 'RCT'], 'conditions': ['Renal Calculi']}, 'referencesModule': {'references': [{'pmid': '29873874', 'type': 'DERIVED', 'citation': 'Zeng G, Zhang T, Agrawal M, He X, Zhang W, Xiao K, Li H, Li X, Xu C, Yang S, de la Rosette JJ, Fan J, Zhu W, Sarica K. Super-mini percutaneous nephrolithotomy (SMP) vs retrograde intrarenal surgery for the treatment of 1-2 cm lower-pole renal calculi: an international multicentre randomised controlled trial. BJU Int. 2018 Dec;122(6):1034-1040. doi: 10.1111/bju.14427. Epub 2018 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'Shock wave lithotripsy (SWL) is recommended for kidney stones \\< 20 mm. However, the stone clearance of lower pole calculi after SWL is limited, thus leading to an extended indication for mini-percutaneous nephrolithotripsy (PCNL) even for stones between 10 and 20 mm in many centers. This trend is further promoted by introduction of super-mini PCNL (SMP), which is postulated to be less invasive compared to mini-PCNL due to the miniaturized instruments. However, this issue remains controversial.\n\nOn the other hand, improvements in endoscopy technology have made retrograde stone removal more attractive. This has led to an increasing use of RIRS as a primary treatment although it is recommended only as 2nd-line option by current guidelines. However, the treatment of symptomatic lower pole calculi is a challenge for RIRS because of lower clearance rates.\n\nThe purpose of this study is to evaluate the efficacy and safety of SMP and RIRS for the treatment for symptomatic lower pole calculi renal calculi measuring 10-20 mm.', 'detailedDescription': "To evaluate the efficacy and safety of SMP and RIRS for the treatment for symptomatic lower pole calculi renal calculi measuring 10-20 mm.Investigators will do a multi-centers international randomized controlled trial(RCT)，and investigators plan to perform this study in 10 hospitals，which are the First Affiliated Hospital of Guangzhou Medical University of China, Department of Urology, Renmin Hospital, Wuhan University of China, Shenzhen People's Hospital of China, The Second Affiliated Hospital of Zhengzhou University of China, The Second Affiliated Hospital of Harbin Medical University of China, Zhujiang Hospital of Southern Medical University of China, Jiangsu Province hospital, The First Affiliated Hospital With Nanjing Medical University of China, Zhejiang provincial people's hospital of china, Dr. Lutfi Kirdar Training and Research Hospital of Turkey and Global Rainbow Healthcare of India respectively.\n\nInvestigators plan to beginning their study at August in 2015 and end at July in 2017.One hundred and sixty patients with symptomatic lower pole calculi renal calculi measuring 10-20 mm will be enrolled in this study. By simple random sampling technique, patients will be assigned to two 80-patient groups.All the patients will be diagnosed definitely before operations with non-contrast CT.Patients with positive preoperative urine culture should be treated with suitable antibiotics based on the culture sensitivity result for at least 72h before SMP/RIRS. Patients who have negative urine culture should receive a single dose of broad spectrum antibiotic prophylaxis just prior to the procedure.\n\nSurgical technique\n\nSMP\n\nAll the biochemistry tests and preoperative preparations are referenced to the mini-PCNL. Under general anesthesia a 6 French(Fr).Open end ureteral catheter is first inserted in to the relevant ureter. Patient is then turned into prone position and the desired calyx is punctured under fluoroscopic or sonographic guidance. Nephrostomy tract dilation is carried out using fascial dilators up to 12-14 Fr. as indicated. Corresponding size of suction-evacuation sheath was placed. The sheath is connected to the specimen collection bottle and the bottle then onto the aspirator. A rubber cap with a center aperture was placed at the proximal end of the sheath. The negative pressure aspirator was adjusted to a setting of 150-200 mm Hg. The miniature endoscope is inserted into the sheath through the cap. Stone is visualized and lithotripsy is performed using either Holmium-yttrium aluminum garnet(YAG) laser or pneumatic lithotripsy. At the end of procedure fluoroscopic images are obtained to assess stone clearance status. Double J ureteral stent is placed only in the presence of ureteral inflammatory polyp; evidence of ureteropelvic obstruction; presence of significant pyelocalyceal blood clots following lithotripsy; significant residual stones. Indications for nephrostomy tube placement included: significant residual stone fragments which would require a second look procedure; significant pyelocalyceal blood clots or bleeding after lithotripsy (because the nephrostomy tube could tamponade the access tract and drain the urine and clots).\n\nRIRS\n\nThe patient is placed in the lithotomy position, Cystoscopy and retrograde pyelogram were preformed, and a 0.035'' flexible tip guidewire is placed into the renal pelvis. A 12 Fr/ 14 Fr ureteral access sheath (UAS) is advanced into the proximal ureter over the guidewire, and a P5 or P6 Olympus flexible ureteroscope is passed through the UAS. The stones are fragmented using a 200um holmium laser fibre at a 8-25 weeks energy setting. Some fragments are removed using a stone basket for stone analysis, and the remaining stone fragments smaller than 2 mm were left for spontaneous passage. A 5 Fr or 6Fr pigtail stent is placed at the conclusion of the procedure. Double J stents were removed post-operative 2 weeks.\n\nData collection\n\nData for the 2 groups-demographic characteristics,hemoglobin(HB) decrease, postoperative pain, duration of postoperative, hospital stay, complications (modified Clavien system), stone clearance (SFR after day 1 and final SFR) and the need for auxiliary treatment are compared.\n\nMean study endpoint: The primary endpoint was the SFR at 3-months after surgery.\n\nSecondary endpoint: Complications, duration of postoperative and hospital stay. re-SMP, ureteroscopy and SWL are considered as auxiliary treatments. Demographic characteristics include age, sex, BMI, stone size and location, etc…\n\nThe stone size is defined as the maximum diameter as determined by CT scans.\n\nDegree 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).\n\nDefinition of operation time:\n\nFor SMP: recorded from the time of the first percutaneous renal puncture to the completion of the stone removal.\n\nFor RIRS: recorded from insertion of an endoscope into the urethra to the completion of stent placement.\n\nHospital stay are rounded to the nearest whole day and calculated from the day of surgery to the day of discharge.\n\nPostoperative pain (visual analogue scale(VAS), use of analgesics) and Postoperative comfort scores (Bruggrmann comfort scale，BCS) will be recorded.\n\nThe rate of hemoglobin decrease is assessed by comparing the preoperative Hb level with 24-hour postoperative Hb level.\n\nSFR is assessed by KUB and ultrasound at 1-day after operation.\n\nNon-contrast CT 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.\n\nStone-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 ≦ 3mm, asymptomatic, non-obstructive and non-infectious stone particles.\n\nIf the procedure is considered as successful, the pigtail stent is removed as outpatient after 2 weeks. Follow-up including non-contrast CT will be generally scheduled in 3 month.\n\nBleeding severity is judged by the treating physician, and transfusions are administered according to local practice guideline.\n\nComplications of all patients are recorded according to modified Clavien classification system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 to 70 years\n2. Normal renal function\n3. Anesthesia rating(ASA) score 1 and 2\n4. Absence of congenital abnormalities\n5. Symptomatic lower pole calculi and diameter 10-20 mm\n\nExclusion Criteria:\n\n1. Patients with solitary kidney\n2. Patients with congenital anomalies, e.g. ectopic kidney, polycystic horseshoe, or mal-rotated kidney\n3. Patients who underwent transplant or urinary diversion\n4. Uncorrected coagulopathy and active urinary tract infection(UTI)\n5. Patient undergoing any other surgical procedure during the same admission. (e.g. ureteroscopy)\n6. If patients undergoing RIRS/SMP have purulent urine, we will place D-J stent (for RIRS) or nephrostomy tube (for SMP) and postpone the procedure and excluded the patients from the study'}, 'identificationModule': {'nctId': 'NCT02519634', 'briefTitle': 'SMP vs RIRS for Symptomatic Lower Pole Renal Calculi of 10-20 mm Size: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Super-Mini Percutaneous Nephrolithotomy (SMP) Versus Retrograde Intrarenal Surgery (RIRS) for Symptomatic Lower Pole Renal Calculi of 10-20 mm Size: a Randomized Controlled Trial (IAU-01)', 'orgStudyIdInfo': {'id': 'MRER(45)2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1', 'description': 'Patients in Group 1 undergo Super-Mini Percutaneous Nephrolithotomy', 'interventionNames': ['Procedure: Super-Mini Percutaneous Nephrolithotomy']}, {'type': 'OTHER', 'label': 'Group 2', 'description': 'Patients in Group 2 undergo Retrograde Intrarenal Surgery', 'interventionNames': ['Procedure: Retrograde Intrarenal Surgery']}], 'interventions': [{'name': 'Super-Mini Percutaneous Nephrolithotomy', 'type': 'PROCEDURE', 'description': 'Patients undergo Super-Mini Percutaneous Nephrolithotomy', 'armGroupLabels': ['Group 1']}, {'name': 'Retrograde Intrarenal Surgery', 'type': 'PROCEDURE', 'description': 'Patients undergo Retrograde Intrarenal Surgery', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510230', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Guohua Zeng, PH.D and M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President of the Hospital', 'investigatorFullName': 'Guohua Zeng', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}