Ultrasound Guided Port-A-Cath Isertion in Cancer Patients

NCT04103021 | Unknown FDA Device

• 1 other identifier: Ultrasound PAC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Early complications

  Early complications associated with Ultrasound guided Port-a-cath insertion periprocedural and within 24 hours

  24 hours

Secondary Outcomes (1)

• Late complications

  Up to 100 months

Study Arms (1)

Port-a-cath

EXPERIMENTAL

Ultrasound guided Port-a-cath insertion

Device: Port-A-Cath

Interventions

Port-A-Cath DEVICE

Totally implanted central venous access device

Port-a-cath

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Severe uncorrectable coagulopathy.
• Prior incidence of central vein thrombosis.
• Patients with active infection.

Sponsors & Collaborators

• Omar Mokhtar Hussein: lead

Related Publications (11)

• 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.

  PMID: 19340958 BACKGROUND

• 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.

  PMID: 25245435 BACKGROUND

• 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.

  PMID: 24886342 BACKGROUND

• 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.

  PMID: 23090255 BACKGROUND

• 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.

  PMID: 9353475 BACKGROUND

• 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.

  PMID: 11585888 BACKGROUND

• 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.

  PMID: 27216807 BACKGROUND

• 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.

  PMID: 26047398 BACKGROUND

• 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.

  PMID: 30867691 BACKGROUND

• 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.

  PMID: 30554248 BACKGROUND

• 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.

  PMID: 22425356 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Vascular Access Devices

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: September 25, 2019
• Study Start: October 30, 2019
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share