Ultrasound Guided Port-A-Cath Isertion in Cancer Patients

Effectiveness of Ultrasound Guidance for Port-A-Cath Insertion in Cancer Patients

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

Study Overview

• Status: Unknown
• Conditions: Cancer
• Intervention / Treatment: Device: Port-A-Cath

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Port-a-cath; Ultrasound guided Port-a-cath insertion	Device: Port-A-Cath; Totally implanted central venous access device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early complications	Early complications associated with Ultrasound guided Port-a-cath insertion periprocedural and within 24 hours	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late complications	complications associated with Ultrasound guided Port-a-cath insertion after 24 hours	Up to 100 months

Collaborators and Investigators

• Sponsor: Omar Mokhtar Hussein

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2019
• Primary Completion (Anticipated): October 30, 2020
• Study Completion (Anticipated): October 30, 2020

Study Registration Dates

• First Submitted: September 22, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 23, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Ultrasound PAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No