Percutaneous Translumbar Vs Transhepatic Permcath

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Procedure: Percutaneous translumbar and transhepatic permcath


Participation Criteria
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Eligibility Criteria
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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: Patients with uncorrectable coagulopathy. Patients on long term anticoagulants Concurrent active infection. Sgnificant abdominal ascites. (transhepatic) Cirrhotic liver disease patients. (transhepatic) Morbid obesity. (translumbar)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous translumbar permcath<br>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<br>* 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<br>|
| Active Comparator: Percutaneous transhepatic permcath<br>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<br>* 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<br>|

What is the study measuring?
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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 |