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.

Not Applicable

Terminated

• Conditions: Chronic Intestinal Failure
• Interventions: Device: Tunnelled nutritional central catheter; Device: group Piccnut

• Registration Number: NCT01840033
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-25
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• > 18 years-old
• Patients managed by CHU Nice for home parenteral nutrition
• Expected to have over 1 month of parenteral nutrition
• Signed consent
• Affiliation to Securite Social

Exclusion criteria

• Patient with nutritional catheter before inclusion
• Pregnancy or breastfeeding
• Evolutive pathology with life expectancy < 12 months

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Tunnelled nutritional central catheter	After consent, patients will be randomised to PICC Line (group A) or tunnelled nutritional central catheter with cuff (group B). Duration of inclusion will be 24 months. After randomisation, patients will have catheter inserted by a competent radiologist following an echography. Radiologist will have to answer a questionnaire and doctors will note any catheter-related complications.
Group A	group Piccnut	PICC Line (group A) : patients will have catheter inserted by a competent radiologist following an echography. Radiologist will have to answer a questionnaire and doctors will note any catheter-related complications.

Primary Outcome Measures

Name	Time	Method
major complications	12 months	Statically significative difference between rate of incidence of major complications (infection and/or thrombosis related to catheter) during the 12 months follow-up.

Secondary Outcome Measures

Name	Time	Method
Questionnaire	12 months	Questionnaire to evaluate catheter insertion by radiologist (satisfaction and complications).; Satisfaction questionnaire to patients at every visit
Delay	12 months	Delay in days between insertion and first major complications

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, Alpes-Maritimes, France