Percutaneous Translumbar Vs Transhepatic Permcath

NCT ID: NCT05666375

Last Updated: 2022-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-01-01

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.

Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Percutaneous translumbar and transhepatic permcath

Intervention Type 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

* 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

Group Type ACTIVE_COMPARATOR

Percutaneous translumbar and transhepatic permcath

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

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

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)
Minimum Eligible Age

5 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abdallah Morsy Mohamed Khalil

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Abdallah Morsy

Role: CONTACT

Phone: +2001093744274

Email: [email protected]

Hany Seif

Role: CONTACT

Phone: +2001005618665

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 24190069 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 21326774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24131509 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35919518 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29970738 (View on PubMed)

Other Identifiers

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Unconventional permcath

Identifier Type: -

Identifier Source: org_study_id