Percutaneous Translumbar Vs Transhepatic Permcath

Not Applicable

Not yet recruiting

• Conditions: End Stage Renal Disease

• Registration Number: NCT05666375
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-17
• Study First Submitted QC: 2022-12-17
• Last Update Submitted: 2022-12-17
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-27
• Study Start: 2023-01-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Catheter patency	Baseline	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