Ultrasound Guided Port-A-Cath Isertion in Cancer Patients

NCT ID: NCT04103021

Last Updated: 2019-09-25

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2020-10-30

Brief Summary

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Port-A-Cath is a totally implanted central venous access system and one of the most frequently used systems for administration of chemotherapies in oncological patients .

The currently used techniques for placement of totally implantable venous access devices involve the open insertion by cut down technique, or percutaneous puncture of the central vein either by anatomical landmarks or image guided approach by using ultrasound guidance which is increasingly being preferred over the traditional anatomical landmark due to its low complication rate and high technical success rate; as this technique enables the direct visualization of needle entrance and advancement into the target vein

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Port-a-cath

Ultrasound guided Port-a-cath insertion

Group Type EXPERIMENTAL

Port-A-Cath

Intervention Type DEVICE

Totally implanted central venous access device

Interventions

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Port-A-Cath

Totally implanted central venous access device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* cancer patients
* Indicated for receiving long term chemotherapy
* Accepted coagulation profile.

Exclusion Criteria

* Severe uncorrectable coagulopathy.
* Prior incidence of central vein thrombosis.
* Patients with active infection.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Omar Mokhtar Hussein

OTHER

Sponsor Role lead

Responsible Party

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Omar Mokhtar Hussein

Resident

Responsibility Role SPONSOR_INVESTIGATOR

References

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Gebauer B, El-Sheik M, Vogt M, Wagner HJ. Combined ultrasound and fluoroscopy guided port catheter implantation--high success and low complication rate. Eur J Radiol. 2009 Mar;69(3):517-22. doi: 10.1016/j.ejrad.2007.10.018.

Reference Type BACKGROUND
PMID: 19340958 (View on PubMed)

Mudan S, Giakoustidis A, Morrison D, Iosifidou S, Raobaikady R, Neofytou K, Stebbing J. 1000 Port-A-Cath (R) placements by subclavian vein approach: single surgeon experience. World J Surg. 2015 Feb;39(2):328-34. doi: 10.1007/s00268-014-2802-x.

Reference Type BACKGROUND
PMID: 25245435 (View on PubMed)

Granziera E, Scarpa M, Ciccarese A, Filip B, Cagol M, Manfredi V, Alfieri R, Celentano C, Cappellato S, Castoro C, Meroni M. Totally implantable venous access devices: retrospective analysis of different insertion techniques and predictors of complications in 796 devices implanted in a single institution. BMC Surg. 2014 May 8;14:27. doi: 10.1186/1471-2482-14-27.

Reference Type BACKGROUND
PMID: 24886342 (View on PubMed)

Capalbo E, Peli M, Lovisatti M, Cosentino M, Ticha V, Cariati M, Cornalba G. Placement of port-a-cath through the right internal jugular vein under ultrasound guidance. Radiol Med. 2013 Jun;118(4):608-15. doi: 10.1007/s11547-012-0894-6. Epub 2012 Oct 22.

Reference Type BACKGROUND
PMID: 23090255 (View on PubMed)

Funaki B, Szymski GX, Hackworth CA, Rosenblum JD, Burke R, Chang T, Leef JA. Radiologic placement of subcutaneous infusion chest ports for long-term central venous access. AJR Am J Roentgenol. 1997 Nov;169(5):1431-4. doi: 10.2214/ajr.169.5.9353475.

Reference Type BACKGROUND
PMID: 9353475 (View on PubMed)

Reeves AR, Seshadri R, Trerotola SO. Recent trends in central venous catheter placement: a comparison of interventional radiology with other specialties. J Vasc Interv Radiol. 2001 Oct;12(10):1211-4. doi: 10.1016/s1051-0443(07)61681-9.

Reference Type BACKGROUND
PMID: 11585888 (View on PubMed)

Miccini M, Cassini D, Gregori M, Gazzanelli S, Cassibba S, Biacchi D. Ultrasound-Guided Placement of Central Venous Port Systems via the Right Internal Jugular Vein: Are Chest X-Ray and/or Fluoroscopy Needed to Confirm the Correct Placement of the Device? World J Surg. 2016 Oct;40(10):2353-8. doi: 10.1007/s00268-016-3574-2.

Reference Type BACKGROUND
PMID: 27216807 (View on PubMed)

LaRoy JR, White SB, Jayakrishnan T, Dybul S, Ungerer D, Turaga K, Patel PJ. Cost and Morbidity Analysis of Chest Port Insertion: Interventional Radiology Suite Versus Operating Room. J Am Coll Radiol. 2015 Jun;12(6):563-71. doi: 10.1016/j.jacr.2015.01.012.

Reference Type BACKGROUND
PMID: 26047398 (View on PubMed)

Kim DH, Ryu DY, Jung HJ, Lee SS. Evaluation of complications of totally implantable central venous port system insertion. Exp Ther Med. 2019 Mar;17(3):2013-2018. doi: 10.3892/etm.2019.7185. Epub 2019 Jan 18.

Reference Type BACKGROUND
PMID: 30867691 (View on PubMed)

Cajozzo M, Palumbo VD, Mannino V, Geraci G, Lo Monte AI, Caronia FP, Fatica F, Romano G, Puzhlyakov V, D'Anna R, Cocchiara G. Ultrasound-guided port-a-cath positioning with the new one-shoot technique: thoracic complications. Clin Ter. 2018 Nov-Dec;169(6):e277-e280. doi: 10.7417/CT.2018.2093.

Reference Type BACKGROUND
PMID: 30554248 (View on PubMed)

Zaghal A, Khalife M, Mukherji D, El Majzoub N, Shamseddine A, Hoballah J, Marangoni G, Faraj W. Update on totally implantable venous access devices. Surg Oncol. 2012 Sep;21(3):207-15. doi: 10.1016/j.suronc.2012.02.003. Epub 2012 Mar 17.

Reference Type BACKGROUND
PMID: 22425356 (View on PubMed)

Other Identifiers

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Ultrasound PAC

Identifier Type: -

Identifier Source: org_study_id

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