High Supracostal Versus Subcostal Puncture in Adult PCNL

Urolithiasis Clinical Trial

Official title:

Renal Puncture Above the Eleventh Rib (High Supracostal Approach) Versus Subcostal Puncture in Percutaneous Nephrolithotomy for Treatment of Renal Stones in Adults: A Prospective Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06350045
• Other study ID #: supra 11th puncture PCNL
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 1, 2024
• Est. completion date: April 1, 2028

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

as the supra eleventh puncture PCNL is not well investigated in the literature we will conduct that randomised trial in comparison to the subcostal one

Description:

The use of percutaneous nephrolithotomy (PCNL) was first reported by Fernström and Johansson in 1976. Percutaneous nephrolithotomy (PCNL) is the accepted treatment for staghorn stones, large renal stones, and some upper ureteric stones. Achieving suitable access to the appropriate calyx is one of the most important steps during the PCNL procedure. Effective puncture is key for the success of PCNL. An ideal percutaneous nephrolithotomy (PCNL) puncture has been described as one that provides the shortest and straightest access to all calculi, avoids major vessels, bowel and lung, lies along the axis of the calyx and causes minimal parenchymal damage. Many studies have reported that supracostal access for PCNL is advantageous over infracostal access. By creating a straight path along the kidney's long axis, the upper-pole method guarantees access to the majority of the collecting system and makes it simpler to manipulate the rigid nephroscope and other rigid devices. Therefore, supracostal puncture is perhaps the greatest method for gaining access to the upper pole calyx, where staghorn and big, complicated renal stones are most likely to be located. Although pneumothorax, hydrothorax, and lung damage (1-10%) can result after a supracostal puncture, this injury can now be handled with minimal morbidity thanks to advances in surgical technique and understanding of pleural and diaphragmatic architecture.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 162
• Est. completion date: April 1, 2028
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age = 18 years old.
• Patients amenable for PCNL with stone burden between 2 cm - 4 cm (guy score 1-2-3)

Exclusion Criteria:

• Ectopic kidney.
• Single middle calyceal stone.
• Skeletal anomalies.
• Bleeding diathesis.
• Active urinary tract infection.
• Patient refusing participation.
• Patients with active pulmonary and pleural disease.

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Combination Product:
• PCNL
percutaneous nephrolithotomy

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

Fernstrom I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. doi: 10.1080/21681805.1976.11882084. — View Citation

Galvin DJ, Pearle MS. The contemporary management of renal and ureteric calculi. BJU Int. 2006 Dec;98(6):1283-8. doi: 10.1111/j.1464-410X.2006.06514.x. No abstract available. — View Citation

He Z, Tang F, Lu Z, He Y, Wei G, Zhong F, Zeng G, Wu W, Yan L, Li Z. Comparison of Supracostal and Infracostal Access For Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Urol J. 2019 May 5;16(2):107-114. doi: 10.22037/uj.v0i0.4727. — View Citation

Mousavi-Bahar SH, Mehrabi S, Moslemi MK. The safety and efficacy of PCNL with supracostal approach in the treatment of renal stones. Int Urol Nephrol. 2011 Dec;43(4):983-7. doi: 10.1007/s11255-011-9916-y. Epub 2011 Mar 11. — View Citation

Sampaio FJ. Renal anatomy. Endourologic considerations. Urol Clin North Am. 2000 Nov;27(4):585-607, vii. doi: 10.1016/s0094-0143(05)70109-9. — View Citation

Sinha M, Krishnappa P, Subudhi SK, Krishnamoorthy V. Supracostal percutaneous nephrolithotomy: A prospective comparative study. Indian J Urol. 2016 Jan-Mar;32(1):45-9. doi: 10.4103/0970-1591.173121. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of complications	Clavien -Dindo classification.	within 3 months post operative
Primary	Stone free rate	the patient being either completely stone-free or there are residual fragments (less than 4 mm).	within 3 months post operative
Secondary	duration of Hospital stay.	post operative hospital stay	Postoperativly
Secondary	Operative time	from the puncture until withdrawal of the endoscope at the end of the operation	intraoperative