Modified Cephalica Venous Access Port Implantation

Oncology Clinical Trial

Official title:

Modified Cephalica Venous Access Port Implantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04348487
• Other study ID #: UdayanaU
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2020
• Source: Udayana University
• Contact: Putu Anda Tusta Adiputra, MD
• Phone: 085397238798
• Email: andatusta[@]unud.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3
• Est. completion date: March 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects who are planning to receive chemotherapy and need chemoports placement.

Exclusion Criteria:

• Unconsented subjects

Related Conditions & MeSH terms

• Chemotherapy Effect
• Neoplasms
• Oncology

Intervention

Other:
• Modified cephalica venous access
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.

Locations

Country	Name	City	State
Indonesia	Putu Anda Tusta Adiputra	Denpasar	Bali

Sponsors (1)

Lead Sponsor	Collaborator
Udayana University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes after the insertion of chemoport
Primary	location of chemoport	appropriate location of chemoport can be found by thorax X Ray, confirmed by radiographers evaluation.	1 hour after the insertion of chemoport.
Secondary	complication of chemoport	observation any sign of infection	1 month after the insertion of chemoport