Clinical trial NCT03299868: Comparison Between Initial Routine PICC and General IV Access in Terminally Ill Cancer Patients
Official title: Comparison of Safety, Efficacy, and Patient-perceived Satisfaction Between Initial Routine Peripherally Inserted Central Catheters Insertion and General Intravenous Access in Terminally Ill Cancer Patients: A Randomized Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripherally Inserted Central Catheter
Intravenous Access
Keywords: Peripherally inserted central catheter
Terminally ill cancer patients
Palliative care
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Single institution, Open-label, Randomized, Phase 2
Primary purpose: TREATMENT

Brief summary: To establish the IV access strategy for terminally ill cancer patients, using comparisons of the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC insertion group (routine PICC group) and general IV access group (optional PICC group).

Detailed description: Reliable intravenous (IV) access is an important issue in terminally ill cancer patients, however, they have limited or no peripheral venous access due to edema or long period of IV therapy. Thus, intravenous access has been provided by Central venous catheter (CVC).

There are some options for applying CVC in cancer patients; subclavian venous catheter (SVC), chemo-port (CP), and the peripherally inserted central catheter (PICC).

When considering the characteristics of terminally ill cancer patients, such as poor general condition and a limited period of survival, PICC could be a safe and effective method for intravenous access.

There are two previous studies concerned about PICC study in terminally ill cancer patients. They showed that PICC might be overall safe and efficient in terminally ill cancer patients. However, these studies did not evaluate superiority of PICC insertion compared to no insertion and the appropriate time for PICC insertion due to limitation of their design, such as retrospective or single-arm observational study. Thus, strategies of PICC insertion for IV access in terminally ill cancer patients have not been determined until now.

Considering the favorable results of PICC insertion in previous studies and limited survival time of terminally ill cancer patients, the investigator postulated that routine PICC insertion at the time of admission for terminal care would be effective for IV access.

Thus, the investigator assumed that initially routine PICC insertion would be non-inferior in maintenance success rate / and complication rate compared to general IV access. In addition, it would be superior in patient-perceived satisfaction. The inveistigator will undertake a randomized phase II study to confirm the hypothesis.

Eligibility criteria: Inclusion Criteria:

1. Cancer patients with histologically or cytologically confirmed malignancy and fulfilled all of the following conditions
2. Patients with expected survival time of 3 months or less due to a progressive disease without additional anticancer treatment. (However, palliative radiation treatment for symptom control is allowed.)
3. Patients who need the IV access route continuously for hydration or medication.
4. Age18 or older
5. Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed about all pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

1. Patients who showed severe coagulopathy such as thrombocytopenia (Platelet count ≤ 20,000/mm2) or international normalized ratio (INR) prolongation (≥2.0 ) in spite of treatment
2. Patients who have an evidence of current sepsis (bacteremia or fungemia)

   1. 'current' means bacteremia/fungemia without eradication on follow-up peripheral blood culture
   2. patients with persistent fever (bacteremia or fungemia cannot be ruled out)
3. Patients who is impracticable to PICC insertion due to uncontrolled behavioral disorders

Primary outcomes:
measure: IV access maintenance success rate
timeFrame: From date of enrollment until death or discharge/transfer, assess up to 2 years
Secondary outcomes:
measure: PICC related complication rate
timeFrame: From date of enrollment until death or discharge/transfer, assess up to 2 years
measure: PICC premature removal rate
timeFrame: From date of enrollment until date of PICC removal, assess up to 2 years
measure: PICC life span
timeFrame: From date of enrollment until death or discharge/transfer, assess up to 2 years
measure: patient perceived procedure-related distress
timeFrame: 5th day after procedure
measure: patient perceived comfort and convenience assessed by a newly developed question in this study
timeFrame: 3th to 7th day after enrollment
measure: colonization of microbiology in PICC
timeFrame: at the time of PICC removal, assess up to 2 years
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Kwonoh Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Park K, Jun HJ, Oh SY. Safety, efficacy, and patient-perceived satisfaction of peripherally inserted central catheters in terminally ill cancer patients: a prospective multicenter observational study. Support Care Cancer. 2016 Dec;24(12):4987-4992. doi: 10.1007/s00520-016-3360-6. Epub 2016 Jul 26.