Chronic Intestinal Failure Clinical Trial
Official title:
A Monocenter Prospective Study to Evaluate the Efficacy of Peripherally Inserted Central Catheter to Tunnelled Central Catheter With Cuff in Home Parenteral Nutrition for Long-term Used: the PICCnut Study.
Home parenteral nutrition (HPN) is the reference treatment for anatomic or fonctionnal
chronic intestinal failure. Nutritionnal catheter must follow two rules: low infection rate
and be able to preserve the permeability of the central vein. Today, in europeen guidelines,
two types of central devices are recommended: tunnelled central catheter with cuff and
implanted ports. However, their insertion is not without risk. Since many years, we have seen
a new generation of catheter - peripherally inserted central catheter (PICC line)- which have
many advantage over other central catheter. ESPEN guidelines accept the use of PICC line in
short and moderate-term for HPN, but no prospective study have look for long-term used in
HPN.
The objective of our study is to evaluate in a prospective randomised monocenter study the
no-inferiority of PICC line to tunnelled central catheter with cuff for serious catheter
related-complications such as infection and thrombophlebitis for patient on HPN over 1 month
of duration. The secondary objectives are to: evaluate the number of patients with at least
one serious complications related in 1000 days of used, the rate of minors and majors
complications, number of catheter inserted, the satisfaction of patients and doctors.
The study is held in CHU Nice and will be proposed to hospitalized patients who will need
HPN. After consent, patients will be randomized to receive PICC Line (group A) of nutritional
central catheter with cuff (group B). Echography of vessels will be held at the beginning, 3
months and 12 months. Follow-up will be conduct at regular interval (month 0-1-3-6-9-12). The
duration of follow-up will be of 12 months and the global duration of the study will be 36
months. One major complication will conduct to withdrawal of the study. There will be 55
patients in each group.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT04390633 -
Perception of Needs of Patients With Chronic Intestinal Failure and Their Practitioners: a Qualitative Study
|
||
| Completed |
NCT05857254 -
Treatment Adherence of Home Parenteral Nutrition in Patients With Chronic Intestinal Failure. (QANPIC)
|