Comparison between Internal Jugular Vein versus Axilar Vein for implantable ports

Internal Jugular vein versus Axilar Vein with single-incision for Implantable Ports: a prospective and randomized study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-8p484w

Enrollment

Unknown

Registered

2017-12-14

Start date

2017-04-17

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant neoplasm, postoperative complications.

Interventions

Comparison between internal jugular vein versus via axilar vein with single-incision for placement of implantable ports in cancer patients. We are recruiting 240 patients and randomizing 120 for each

Procedure/surgery

E02.148.167

Eligibility

Inclusion criteria

Inclusion criteria: Minimum age 18; cancer patients; only catheter for chemotherapy; ECOG (performance status) from 0 to 2; signed informed consent form.

Exclusion criteria

Exclusion criteria: Non compliance; anticoagulant therapy; coagulopathy (platelet count below 50,000 and/or protrombin time above 18s); death within 30 days after the procedure; another catheter in superior vena cava; previous long term catheter in superior vena cava; obesity (IBM>40 Kg/m2).

Design outcomes

Primary

Measure	Time frame
Early complications in 30 days during clinical assessment and the presence of one of the follow complications: intra-operative complications, such as pneumothorax, hemothorax, vascular injury, cardiac arrhythmia, hematoma.;Post-operative until 30 days complications identified through clinical assessment such as wound infections, catheter related bacteremia, catheter disfunction, catheter related deep venous thrombosis, reservoir extrusion and skin erosion.	—

Measure

Time frame

Early complications in 30 days during clinical assessment and the presence of one of the follow complications: intra-operative complications, such as pneumothorax, hemothorax, vascular injury, cardiac arrhythmia, hematoma.;Post-operative until 30 days complications identified through clinical assessment such as wound infections, catheter related bacteremia, catheter disfunction, catheter related deep venous thrombosis, reservoir extrusion and skin erosion.

—

Secondary

Measure	Time frame
Late complications, the same complications used in primary outcome, but within 30 days and 6 months identified during clinical assessment.;Quality of life questionnaire to evaluate quality of life. Measured by the presence of statistically significant diference between both arms.	—

Countries

Brazil

Contacts

Public ContactBruno Pignataro

AC Camargo Cancer Center

brunosoriano86@yahoo.com.br551121895000

Outcome results

None listed

Source: REBEC (via WHO ICTRP)