CancerNCT04103021
Ultrasound Guided Port-A-Cath Isertion in Cancer Patients
A study testing Port-A-Cath in people with Cancer, run by Omar Mokhtar Hussein.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Port-A-Cath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2019to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- cancer patients
- Indicated for receiving long term chemotherapy
- Accepted coagulation profile.
Who cannot join
- Severe uncorrectable coagulopathy.
- Prior incidence of central vein thrombosis.
- Patients with active infection.
About this study
Official title: 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
- Conditions
- Cancer
- Being tested
- Port-A-Cath
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Port-A-CathDevice
Totally implanted central venous access device
| Study group | Role | What they receive |
|---|---|---|
| Port-a-cath | Experimental | Ultrasound guided Port-a-cath insertion Receives: Device: Port-A-Cath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early complications
Early complications associated with Ultrasound guided Port-a-cath insertion periprocedural and within 24 hours
Measured: 24 hours
Secondary outcomes (1)
Late complications
complications associated with Ultrasound guided Port-a-cath insertion after 24 hours
Measured: Up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start30 Oct 2019 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omar Mokhtar Hussein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Mokhtar Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103021
- Sponsor's protocol ID
- Ultrasound PAC
- Status last verified
- Sep 2019
- First submitted
- 22 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 19340958Mudan 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.
PubMed 25245435Granziera 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.
PubMed 24886342Capalbo 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.
PubMed 23090255Funaki 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.
PubMed 9353475Reeves 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.
PubMed 11585888Miccini 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.
PubMed 27216807LaRoy 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.
PubMed 26047398Kim 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.
PubMed 30867691Cajozzo 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.
PubMed 30554248Zaghal 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.
PubMed 22425356
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound Guidance for Port-A-Cath Insertion in Cancer Patients
- ClinicalTrials.gov ID
- NCT04103021
- Acronym / sponsor ID
- Ultrasound PAC
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Omar Mokhtar HusseinUniversity, hospital or other
- Study start
- 30 Oct 2019 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Port-a-cath | Experimental | Device: Port-A-CathUltrasound guided Port-a-cath insertion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- cancer patients
- Indicated for receiving long term chemotherapy
- Accepted coagulation profile.
Key exclusion criteria (3 listed)
- Severe uncorrectable coagulopathy.
- Prior incidence of central vein thrombosis.
- Patients with active infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Port-A-CathTotally implanted central venous access device | Device | Port-a-cath |
Primary outcome
Early complications
Time frame: 24 hours
Early complications associated with Ultrasound guided Port-a-cath insertion periprocedural and within 24 hours
1 secondary outcome
Late complications
Time frame: Up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Background: PubMed 19340958Gebauer 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.
- Background: PubMed 25245435Mudan 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.
- Background: PubMed 24886342Granziera 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.
- Background: PubMed 23090255Capalbo 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.
- Background: PubMed 9353475Funaki 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.
- Background: PubMed 11585888Reeves 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.
- Background: PubMed 27216807Miccini 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.
- Background: PubMed 26047398LaRoy 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.
- Background: PubMed 30867691Kim 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.
- Background: PubMed 30554248Cajozzo 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.
- Background: PubMed 22425356Zaghal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Port-A-Cath in people with Cancer, run by Omar Mokhtar Hussein.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early complications (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04103021, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.