UMIN-CTR Clinical Trial

Public title

Prospective observational study on infecitious adverse events in patients with central venous catheter and port system.

Acronym

Prospective observational study on infection of CV ports.

Scientific Title

Prospective observational study on infecitious adverse events in patients with central venous catheter and port system.

Scientific Title:Acronym

Prospective observational study on infection of CV ports.

Region

Japan

Condition

Malignant tumor

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine the incidence of central-venous-port-related infection and the relevant factors in patients with malignant tumors.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Incidence of the CV-port-related infection at 3 months after implantation of the system.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Indication for implantation of central venous port for the treatment of malignant tumor.
(2) Age 18 or older.
(3) Follow-up is available at our institution.
(4) Written informed consent.

Key exclusion criteria

(1) Preexisting central venous port.
(2) Active inflammatory disease.
(3) Uncontrollable comorbid diseases.
(4) Contraindication judged by responsible physicians.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Miyuki Sone

Organization

Iwate Medical University

Division name

Department of Radiology

Zip code

Address

19-1, Uchimaru, Morioka 020-8505, Japan

TEL

03-3542-2511

Email

Name of contact person

1st name
Middle name
Last name	Akio Akahane

Organization

Iwate Medical Univerisity

Division name

Department of Radiology

Zip code

Address

19-1, Uchimaru, Morioka 020-8505, Japan

TEL

Homepage URL

Email

Institute

Iwate Medical University

Institute

Department

Personal name

Organization

Iwate Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2010

Year

05

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Fifty-nine patients were enrolled in this study and 60 central venous ports (CVPs) were implanted. Thirty-six (61%) patients had head and neck malignancies. Access route was subclavian vein in 43 (71.7%) CVPs and forearm vein in 17 (28.3%). CVP-related infection was observed in three (5.1%) patients: port-pocket infection in one and probable CVP-related infection in two patients, respectively. No definitive CVP-related blood-stream infection was observed. Before the placement of CVP, colonization at the insertion site was observed in 10 subclavian CVP patients while no colonization was observed in the forearm CVP patients. At 1 and 4 weeks, detection rates of colonization were also higher in subclavian CVP patients. No definitive relationship was demonstrated between skin colonization and clinical development of CVP-related infection.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2010

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2010

Year

03

Month

01

Day

Last follow-up date

2010

Year

10

Month

01

Day

Date of closure to data entry

2010

Year

11

Month

01

Day

Date trial data considered complete

2010

Year

11

Month

01

Day

Date analysis concluded

2010

Year

11

Month

01

Day

Other related information

Outcome measurement and criteria (1w, 1mo, 2mo, 3mo)
All patients are to be evaluated and reported when the following adverse events are observed. All AEs are to be graded according to CTCAE v3.0. Removal of the catheter is also reported regarding the time and the reason of the removal.

(1) Blood-stream infection
Defined as clinical symptoms of infection with positive blood culture without other obvious infectious focus.
(2) Port-pocket infection
Defined as suppuration within the port-pocket, spontaneous rupture of the abscess, or necrosis of overlying skin. Ports should be removed and the observation will be terminated.
(3) Clinical catheter-related infection
Defined as clinical symptoms of infection with negative blood culture and improvement of the symptoms following the removal of catheter and port systems.
(4) Local inflammatory process
Defined as redness, swelling, and tenderness in the region of port-pockets.

Registered date

2010

Year

05

Month

25

Day

Last modified on

2011

Year

05

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003629