Chemotherapy EffectNCT04348487
Modified Cephalica Venous Access Port Implantation
A study testing Modified cephalica venous access in people with Chemotherapy Effect and Oncology, run by Udayana University at 1 site in Indonesia.
Trial summary
As long term totally implantable central venous access (TIVAPS) was increasingly needed in cancer patient, some modified techniques were introduced to improved the outcome and safety of the port implantation. In this modified technique, the prioritization were the safety and stability of catheter and port placement. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Chemotherapy Effect, Oncology
- What is being tested?
- Modified cephalica venous access
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2020to 1 Mar 2021
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who are planning to receive chemotherapy and need chemoports placement.
Who cannot join
- Unconsented subjects
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Putu Anda Tusta Adiputra
Denpasar, Bali, 80114
Putu Anda Tusta Adiputra, MD, 085397238798, andatusta@unud.ac.id
Putu Anda Tusta Adiputra
About this study
As long term totally implantable central venous access (TIVAPS) was increasingly needed in cancer patient, some modified techniques were introduced to improved the outcome and safety of the port implantation. In this modified technique, the prioritization were the safety and stability of catheter and port placement. Catheter was inserted to the cephalic vein in the deltopectoral groove, in which connected to the port pocket implanted in the anteromedial thorax. Connection was done by percutaenous and Seldinger technique by introducing a special trocar to ensure safety. Long term outcome was satisfactorily good by this technique without and major and minor events.
Read the detailed description
Large studies have proved that TIVAPS was effective for long term venous access with minimal risk of complication. For TIVAPS, clinicians have approach the vena cava through the subclavian, internal jugular vein, or cephalic vein regularly with various technique. The most minimal complication risk was obtained in the access through cephalic vein.In the conventional method of cephalic central venous access approach, the incision was done at clavicular regio, with the high risk of catheter being kinking. To improve the feasibility of the techique, here, the author introduced the modified technique for cephalic vein approach.
Step 1 Preparation The patient was positioned supine with the head tilted to the left. In our procedure, the head was tilted to the left in order to expose the deltopetoral groove. The procedure was done in aseptic condition with iodine tincture and sterile draping. It was carried out under local anesthesia in an operating room. A two-gram of cephazolin was inserted intravenously following the guideline standard in the local hospital.
Step 2 Landmarks There were two landmark incision in this procedure, in which the first one is in deltopectoral groove for catheter insertion and the second is in anteromedial of thorax. The deltopectoral groove is located between the insertio of pectoralis major and deltoid muscle. The cephalic vein passes through the clavipectoral (deltopectoral) triangle to join the axillary vein. Lidocaine without adrenaline was used as a local anesthetic in both incision. The procedure was done without any radiology guidance.
Step 3 Vein identification The first incision was made for the insertion of venous catheter. As long as 2 to 3 cm incision was made in the deltopectoral groove. An incision of 3 mm in length was made on the surface of the vein. The incision was then deepened to the fascia overlying the deltoid and pectoralis muscle. Subcutaneous tissue was positioned by blunt dissection to uncover the cephalic vein. The cephalic vein was identified in the adipose tissue along the deltopectoral groove. Surgical cauterization was used to control bleeding. The proximal and distal end of the vein was secured by tying and a hemostat was applied for traction. A transverse venotomy was made at the center of these 2 sutures.
Step 4 Venous catheter insertion A peel-away sheath was inserted to facilitate the catheter insertion into the venous system. The catheter was inserted into the cephalic vein for approximately 25 centimeters.
Step 5 Port pocket incision The 3-4 cm for second incision was carried out for port pocket, with the position on anteromedial of thorax for chemoport implantation. Trocar was tunneled subcutaenously and advanced to the first incision. Catheter was trimmed and ready to be connected to the reservoir.
Step 6 Port implantation The port was inserted to the port pocket and anchored to two sites of underlying muscle in chest was using permanent monofilament suture. The implanted port was flushed with 10 ml of normal saline and 5 ml of 50 IU/ml heparin.
Step 7 Ensuring position For ensuring the catheter position, plain chest radiograph (posteroanterior view) was done.
- Conditions
- Chemotherapy Effect, Oncology
- Being tested
- Modified cephalica venous access
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified cephalica venous accessOther
This modified technique prioritized the safety in TIVAPS by using several modified landmarks and techniques. The catheter was inserted through cephalic vein in deltopectoral groove regio and implanted the port in the anteromedial of thorax. Generally, the percutaneous and Seldinger technique was used to ensure safety and minimal tissue disruption. To connect the trimmed catheter to port pocket, the author anchored a special trocar from anteromedial of thorax to the deltopectoral groove for guidance.
| Study group | Role | What they receive |
|---|---|---|
| Standard procedure | Other | For the conventional TIVAPS with cephalic vein approach, incision was made either in the midline of infraclivular or supraclavicular. Cathether was introduced to the central and then connected to the laterally implanted port in the deltopectoral region. The experience in the local center experienced several pitfalls with this method such as pneumothorax, pinch-off syndrome, compression of the catheter by the clavicle, kinking of the catheter, and loss of patencty. Receives: Other: Modified cephalica venous access |
What is being measured
The primary outcome is the main question the study is designed to answer.
patency of chemoport
While flushing 10 ml of saline to chemoport, measure the velocity flow of saline injection. If the saline was complete in less than 1 minute, it was considered normal. difficulty in flushing the chemoport and pain during flushing should be considered as a failure.
Measured: 10 minutes after the insertion of chemoport
location of chemoport
appropriate location of chemoport can be found by thorax X Ray, confirmed by radiographers evaluation.
Measured: 1 hour after the insertion of chemoport.
Secondary outcomes (1)
complication of chemoport
observation any sign of infection
Measured: 1 month after the insertion of chemoport
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy EffectStudies 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
- Model description
- Introducing new approach of chemoport insertion
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Putu Anda Tusta Adiputra, Udayana University
- Investigators
- Putu Anda Tusta Adiputra, MD, Principal investigator, Division of Surgical Oncology, Department of Surgery, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348487
- Sponsor's protocol ID
- UdayanaU
- Status last verified
- Apr 2020
- First submitted
- 18 Nov 2018
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Cephalica Venous Access Port Implantation
- ClinicalTrials.gov ID
- NCT04348487
- Acronym / sponsor ID
- UdayanaU
- Conditions
- Chemotherapy Effect, Oncology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 16 Apr 2020 (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.
As long term totally implantable central venous access (TIVAPS) was increasingly needed in cancer patient, some modified techniques were introduced to improved the outcome and safety of the port implantation. In this modified technique, the prioritization were the safety and stability of catheter and port placement. Catheter was inserted to the cephalic vein in the deltopectoral groove, in which connected to the port pocket implanted in the anteromedial thorax. Connection was done by percutaenous and Seldinger technique by introducing a special trocar to ensure safety. Long term outcome was satisfactorily good by this technique without and major and minor events.
Detailed description
Large studies have proved that TIVAPS was effective for long term venous access with minimal risk of complication. For TIVAPS, clinicians have approach the vena cava through the subclavian, internal jugular vein, or cephalic vein regularly with various technique. The most minimal complication risk was obtained in the access through cephalic vein.In the conventional method of cephalic central venous access approach, the incision was done at clavicular regio, with the high risk of catheter being kinking. To improve the feasibility of the techique, here, the author introduced the modified technique for cephalic vein approach.
Step 1 Preparation The patient was positioned supine with the head tilted to the left. In our procedure, the head was tilted to the left in order to expose the deltopetoral groove. The procedure was done in aseptic condition with iodine tincture and sterile draping. It was carried out under local anesthesia in an operating room. A two-gram of cephazolin was inserted intravenously following the guideline standard in the local hospital.
Step 2 Landmarks There were two landmark incision in this procedure, in which the first one is in deltopectoral groove for catheter insertion and the second is in anteromedial of thorax. The deltopectoral groove is located between the insertio of pectoralis major and deltoid muscle. The cephalic vein passes through the clavipectoral (deltopectoral) triangle to join the axillary vein. Lidocaine without adrenaline was used as a local anesthetic in both incision. The procedure was done without any radiology guidance.
Step 3 Vein identification The first incision was made for the insertion of venous catheter. As long as 2 to 3 cm incision was made in the deltopectoral groove. An incision of 3 mm in length was made on the surface of the vein. The incision was then deepened to the fascia overlying the deltoid and pectoralis muscle. Subcutaneous tissue was positioned by blunt dissection to uncover the cephalic vein. The cephalic vein was identified in the adipose tissue along the deltopectoral groove. Surgical cauterization was used to control bleeding. The proximal and distal end of the vein was secured by tying and a hemostat was applied for traction. A transverse venotomy was made at the center of these 2 sutures.
Step 4 Venous catheter insertion A peel-away sheath was inserted to facilitate the catheter insertion into the venous system. The catheter was inserted into the cephalic vein for approximately 25 centimeters.
Step 5 Port pocket incision The 3-4 cm for second incision was carried out for port pocket, with the position on anteromedial of thorax for chemoport implantation. Trocar was tunneled subcutaenously and advanced to the first incision. Catheter was trimmed and ready to be connected to the reservoir.
Step 6 Port implantation The port was inserted to the port pocket and anchored to two sites of underlying muscle in chest was using permanent monofilament suture. The implanted port was flushed with 10 ml of normal saline and 5 ml of 50 IU/ml heparin.
Step 7 Ensuring position For ensuring the catheter position, plain chest radiograph (posteroanterior view) was done.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Introducing new approach of chemoport insertion
| Arm | Type | Receives |
|---|---|---|
| Standard procedure | Other | Other: Modified cephalica venous accessFor the conventional TIVAPS with cephalic vein approach, incision was made either in the midline of infraclivular or supraclavicular. Cathether was introduced to the central and then connected to the laterally implanted port in the deltopectoral region. The experience in the local center experienced several pitfalls with this method such as pneumothorax, pinch-off syndrome, compression of the catheter by the clavicle, kinking of the catheter, and loss of patencty. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who are planning to receive chemotherapy and need chemoports placement.
Key exclusion criteria (1 listed)
- Unconsented subjects
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 |
|---|---|---|
| Modified cephalica venous accessThis modified technique prioritized the safety in TIVAPS by using several modified landmarks and techniques. The catheter was inserted through cephalic vein in deltopectoral groove regio and implanted the port in the anteromedial of thorax. Generally, the percutaneous and Seldinger technique was used to ensure safety and minimal tissue disruption. To connect the trimmed catheter to port pocket, the author anchored a special trocar from anteromedial of thorax to the deltopectoral groove for guidance. | Other | Standard procedure |
Primary outcome
patency of chemoport
Time frame: 10 minutes after the insertion of chemoport
While flushing 10 ml of saline to chemoport, measure the velocity flow of saline injection. If the saline was complete in less than 1 minute, it was considered normal. difficulty in flushing the chemoport and pain during flushing should be considered as a failure.
location of chemoport
Time frame: 1 hour after the insertion of chemoport.
appropriate location of chemoport can be found by thorax X Ray, confirmed by radiographers evaluation.
1 secondary outcome
complication of chemoport
Time frame: 1 month after the insertion of chemoport
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
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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.
Putu Anda Tusta Adiputra, MD principal investigator
Division of Surgical Oncology, Department of Surgery, Udayana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified cephalica venous access in people with Chemotherapy Effect and Oncology, run by Udayana University at 1 site in Indonesia.
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 1 inclusion and 1 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 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Putu Anda Tusta Adiputra, MD (085397238798, andatusta@unud.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patency of chemoport (time frame: 10 minutes after the insertion of chemoport). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2020; AzTrials last refreshed its copy on 3 Nov 2026.