Percutaneous Translumbar Vs Transhepatic Permcath

NCT05666375 | Unknown

• 1 other identifier: Unconventional permcath
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Percutaneous translumbar permcath

ACTIVE COMPARATOR

* 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

Percutaneous transhepatic permcath

ACTIVE COMPARATOR

* 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

Interventions

Percutaneous translumbar and transhepatic permcath PROCEDURE

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

Percutaneous transhepatic permcath; Percutaneous translumbar permcath

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (5)

• 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.

  PMID: 24190069 BACKGROUND

• Lorenz JM. Unconventional venous access techniques. Semin Intervent Radiol. 2006 Sep;23(3):279-86. doi: 10.1055/s-2006-948767.

  PMID: 21326774 BACKGROUND

• 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.

  PMID: 24131509 BACKGROUND

• 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.

  PMID: 35919518 BACKGROUND

• 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.

  PMID: 29970738 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Abdallah Morsy

CONTACT

+2001093744274; Abdallahmorsynah96@gmail.com

Hany Seif

CONTACT

+2001005618665; Hanyseifrad@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 17, 2022
• First Posted: December 27, 2022
• Study Start: January 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 27, 2022

Record last verified: 2022-12