Clinical trial · Interventional
Comparison Between Initial Routine PICC and General IV Access in Terminally Ill Cancer Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intravenous Access | — | UNRESOLVED | — |
| Peripherally Inserted Central Catheter | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| peripherally inserted central catheter (PICC) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Routine PICC group
- description
- PICC is initially routine insertion at the time of admission of hospice-palliative care unit
- interventionNames
- Device: peripherally inserted central catheter (PICC)
- type
- ACTIVE_COMPARATOR
- label
- General IV group
- description
- PICC is inserted if 3 or more times of IV insertion trial per day is required for IV access
- interventionNames
- Device: peripherally inserted central catheter (PICC)
Primary outcomes (1)
- measure
- IV access maintenance success rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- RESULTCleeland CS. Cancer-related symptoms. Semin Radiat Oncol. 2000 Jul;10(3):175-90. doi: 10.1053/srao.2000.6590. PMID 11034629
- RESULTBruera E, Sala R, Rico MA, Moyano J, Centeno C, Willey J, Palmer JL. Effects of parenteral hydration in terminally ill cancer patients: a preliminary study. J Clin Oncol. 2005 Apr 1;23(10):2366-71. doi: 10.1200/JCO.2005.04.069. PMID 15800328
- RESULTMercadante S, Ferrera P, Girelli D, Casuccio A. Patients' and relatives' perceptions about intravenous and subcutaneous hydration. J Pain Symptom Manage. 2005 Oct;30(4):354-8. doi: 10.1016/j.jpainsymman.2005.04.004. PMID 16256899
- RESULTLam S, Scannell R, Roessler D, Smith MA. Peripherally inserted central catheters in an acute-care hospital. Arch Intern Med. 1994 Aug 22;154(16):1833-7. PMID 8053751
- RESULTNg PK, Ault MJ, Ellrodt AG, Maldonado L. Peripherally inserted central catheters in general medicine. Mayo Clin Proc. 1997 Mar;72(3):225-33. doi: 10.4065/72.3.225. PMID 9070197
- RESULTRaad I, Davis S, Becker M, Hohn D, Houston D, Umphrey J, Bodey GP. Low infection rate and long durability of nontunneled silastic catheters. A safe and cost-effective alternative for long-term venous access. Arch Intern Med. 1993 Aug 9;153(15):1791-6. PMID 8392831
- RESULTSmith JR, Friedell ML, Cheatham ML, Martin SP, Cohen MJ, Horowitz JD. Peripherally inserted central catheters revisited. Am J Surg. 1998 Aug;176(2):208-11. doi: 10.1016/s0002-9610(98)00121-4. PMID 9737634
- RESULTPark 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.