Percutaneous Translumbar Vs Transhepatic Permcath

Percutaneous Translumbar Vs Transhepatic Insertion of Long Term Hemodialysis Catheters (Permcath) After Failure of Classic Accesses

The aim of the study is to emphasize the technique , success rate , efficacy of translumbar and transhepatic approaches and shed light on the complications of both methods and through comparison we can give recommendations to either of these methods.

Study Overview

• Status: Not yet recruiting
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Procedure: Percutaneous translumbar and transhepatic permcath

Detailed Description

For selected ESRD patients who have exhausted all conventional access routes , translumbar and transhepatic permcath provide additional sites for access. This study will compare the two methods in terms of technical success (position of catheter tip), patency (primary defined as the number of catheter days from initial placement until removal & secondary defined as the number of catheter days after device replacement using the same access site) , mean cumulative duration of catheter in situ defined as the cumulative catheter days divided by the number of patients, function (adequacy of dialysis based on Urea Reduction Ratio URR & Simplified Daugirdas Formula Kt/V) and complications (infectious; exit site infection & sepsis and non-infectious; thrombosis, catheter migration, hematoma, intraperitoneal hemorrhage.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdallah Morsy; Phone Number: +2001093744274; Email: Abdallahmorsynah96@gmail.com
• Study Contact Backup: Name: Hany Seif; Phone Number: +2001005618665; Email: Hanyseifrad@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Chronic dialysis patients with failed classic routes of catheterization ( internal jugular, subclavian and femoral veins bilaterally ) as well as non-functioning a-v fistulas.

Exclusion Criteria:

1. Patients with uncorrectable coagulopathy.
2. Patients on long term anticoagulants
3. Concurrent active infection.
4. Sgnificant abdominal ascites. (transhepatic)
5. Cirrhotic liver disease patients. (transhepatic)
6. Morbid obesity. (translumbar)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percutaneous translumbar permcath; Local anesthesia in adults and general anesthesia in pediatrics.; The patient under fasting condition is placed prone on angiography table.; Skin preparation and a sterile draping of the operating field.; Puncture site is chosen 1.5 cm above right iliac crest 10 cm lateral to the posterior median line.; Puncture into inferior vena cava is made using 21 gauge 15 cm long needle, inserted at 45 degree angle from the horizontal and advanced medially and superiorly under us then fluoroscopic guidance.; Entry into the IVC is made below the level of the renal veins, immediately anterior to the 3rd lumber vertebra.; Intravascular position of the needle is confirmed by free aspiration of blood and injection of contrast media under fluoroscopy.; A guide wire is introduced through the needle and advanced well into the IVC.; The needle is replaced with a dilator. A catheter of appropriate length is tunneled subcutaneously from the right flank and advanced to the IVC	Procedure: Percutaneous translumbar and transhepatic permcath; For selected ESRD patients who have exhausted all conventional access routes , translumbar and transhepatic insertion of long term hemodialysis catheters provide additional sites for access
Active Comparator: Percutaneous transhepatic permcath; The patient lies in supine position.; The procedure is done under local anesthesia.; Under ultrasound guidance; access by a 21 gauge angiocatheter (15cm) to right or middle hepatic vein through intercostal or subcostal approach.; Entrance of the hepatic veins is confirmed by injection of diluted contrast media (iopromide) under fluoroscopy.; A 0.018-inch guidewire is advanced through the needle and into the right atrium. Intravascular catheter length is measured and selected in standard fashion.; The initial access needle is exchanged over the guidewire for a coaxial transitional sheath, which permits replacement of the 0.018-inch guidewire with a 0.035-inch guidewire.; The tunneled catheter is inserted over the wire through a peel-away sheath	Procedure: Percutaneous translumbar and transhepatic permcath; For selected ESRD patients who have exhausted all conventional access routes , translumbar and transhepatic insertion of long term hemodialysis catheters provide additional sites for access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter patency	patency (primary defined as the number of catheter days from initial placement until removal & secondary defined as the number of catheter days after device replacement using the same access site) , mean cumulative duration of catheter in situ defined as the cumulative catheter days divided by the number of patients	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Kade G, Les J, Buczkowska M, Labus M, Niemczyk S, Wankowicz Z. Percutaneous translumbar catheterization of the inferior vena cava as an emergency access for hemodialysis - 5 years of experience. J Vasc Access. 2014 Jul-Aug;15(4):306-10. doi: 10.5301/jva.5000185. Epub 2013 Nov 4.
• Lorenz JM. Unconventional venous access techniques. Semin Intervent Radiol. 2006 Sep;23(3):279-86. doi: 10.1055/s-2006-948767.
• Napalkov P, Felici DM, Chu LK, Jacobs JR, Begelman SM. Incidence of catheter-related complications in patients with central venous or hemodialysis catheters: a health care claims database analysis. BMC Cardiovasc Disord. 2013 Oct 16;13:86. doi: 10.1186/1471-2261-13-86.
• Farag YMK, El-Sayed E. Global Dialysis Perspective: Egypt. Kidney360. 2022 Apr 20;3(7):1263-1268. doi: 10.34067/KID.0007482021. eCollection 2022 Jul 28. No abstract available.
• Zouaghi MK, Lammouchi MA, Hassan M, Rais L, Krid M, Smaoui W, Jebali H, Kheder R, Hamida FB, Moussa FB, Fatma LB, Beji S. Determinants of patency of arteriovenous fistula in hemodialysis patients. Saudi J Kidney Dis Transpl. 2018 May-Jun;29(3):615-622. doi: 10.4103/1319-2442.235183.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: December 17, 2022
• First Submitted That Met QC Criteria: December 17, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 17, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: Unconventional permcath

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No