Modified Cephalica Venous Access Port Implantation

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.

Study Overview

• Status: Unknown
• Conditions: Chemotherapy Effect; Oncology
• Intervention / Treatment: Other: Modified cephalica venous access

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 Type: Interventional
• Enrollment (Anticipated): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Putu Anda Tusta Adiputra, MD; Phone Number: 085397238798; Email: andatusta@unud.ac.id

Study Locations

• Indonesia
  • Bali
    • Denpasar, Bali, Indonesia, 80114
      • Putu Anda Tusta Adiputra
      • Contact: Putu Anda Tusta Adiputra, MD; Phone Number: 085397238798; Email: andatusta@unud.ac.id
      • Principal Investigator: Putu Anda Tusta Adiputra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unconsented subjects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Standard procedure; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
complication of chemoport	observation any sign of infection	1 month after the insertion of chemoport

Collaborators and Investigators

• Sponsor: Udayana University
• Investigators: Principal Investigator: Putu Anda Tusta Adiputra, MD, Division of Surgical Oncology, Department of Surgery, Udayana University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): March 1, 2021

Study Registration Dates

• First Submitted: November 18, 2018
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (ACTUAL): April 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: UdayanaU

Drug and device information, study documents

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