Comparison of the complications between the papillary and infundibular access to the cacyceal system of the kidney during percutaneous nephtrolithotomy.

• Register: ISRCTN
• Last refreshed on: 19 November 2018
• Main ID: ISRCTN14679893
• Date of registration: 23/07/2016
• Prospective Registration: No
• Primary sponsor: Evangelos Liatsikos
• Public title: Comparison of the complications between the papillary and infundibular access to the cacyceal system of the kidney during percutaneous nephtrolithotomy.
• Scientific title: Randomized trial comparing the surgical outcome and morbidity of the accesses to fornix- papilla to the accesses to the infundibulum of the calyx of the kidney during percutaneous nephtrolithotomy.
• Date of first enrolment: 17/06/2015
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN14679893
• Study type: Interventional
• Study design: Randomised controlled trial; (Treatment)

Countries of recruitment

Greece

Contacts

• Name: Evangelos Liatsikos

Key inclusion & exclusion criteria

Inclusion criteria: Renal stones >2cm in maximal diameter with indication for percutaneous nephrolithotomy.
Exclusion criteria: 1. Single kidney
2. Ureteral stone in the same system
3. Stone in diverticulum
4. Concomitant urinary infection
5. Congenital anomalies of the urinary tract
6. Skeletal anomalies

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Lithiasis of the urinary tract. Large stone in the renal pelvicalyceal system.
Urological and Genital Diseases

Intervention(s)

Participants are randomly allocated to one of two groups:

Group 1: Undergo percutaneous nephtrolithotomy with access and tract dilation to the papilla of the desired calyx (control)
Group 2: Undergo percutaneous nephtrolithotomy with access and tract dilation to the infudibulum of the desired calyx (intervention)

The intervention performed in all patients is the percutaneous nephrolithotomy (PCNL) which is performed for the management of large renal stones. PCNL is performed with the patient in prone position after the patient is intubated and a ureteral catheter has been inserted to pelvicalcyceal system of the kindey that is going to be treated. Under fluoroscopic guidance the desired renal calyx puncture is made with the use of a 18G needle. The common practice is to puncture the fornix-papilla of the desired calyx (control arm). The procedure can also be performed by puncturing the infundibulum of the desired renal calyx (intervention). The rest of the procedure is performed by inserting appropriate guidewires and dilating the tract to the pelvicalyceal system at a diameter of 30Fr with the use of Amplatz dilators or Balloon dilator. A nephroscope is inserted and the stones to be treated and are detected and removed with the use of clamp or ultrasound lithotripter. At the end of the procedure a Malecot nephrostomy tube is left in place.

The patients are discharged on the 2-3 postoperative day based on the presence of clear urine in the Malecot tube. An KUB x-ray or KUB CT scan are performed for the confirmation of the stone free status on the discharge day after the removal of the Malecot catheter. Blood and serum examinations take place during the hospitalization of the patients.

Primary Outcome(s)

1. The hemoglobin drop on the first postoperative day and discharge day
2. Need for transfusion during the first postoperative month

Secondary Outcome(s)

1. Operative time
2. Number of accesses performed
3. Stone free rate (at discharge and 3 months)
4. Complications rate (during the 4 weeks and 3 months postoperatively)
5. Hospitalization

Secondary ID(s)

11393/16-6-2015

Source(s) of Monetary Support

University of Patras

Ethics review

Status:
Approval date:
Contact:

Scientific Board of the University Hospital of Patras, 6th Hygeonomic Region of Greece, 27/05/2015, ref: 11393/16-6-2015

Results

• Results available: Yes
• Date Completed: 16/06/2017