Comparison of Two Endoscopically Placed Nasojejunal Probes

Not Applicable

• Conditions: Investigation Time
• Interventions: Device: Freka®-Trilumina versus Freka®-EasyIn

• Registration Number: NCT02705027
• Lead Sponsor: Ruhr University of Bochum

Brief Summary

A direct application of jejunal tube feeding is necessary especially in patients with gastroparesis due of existing diabetes mellitus, postoperative or severe underlying disease. Since the jejunal tube feedings, the secretion of gastric juice can be increased, the use of probes that allow both: jejunal nutrition, as well as a gastric outflow of secretions are beneficial.

While in a randomized trial of Schwab et al. it could be shown that the use of Freka-Trilumina® compared to Dobbhoff probe by so-called drag technique is significantly faster there are currently no comparative data to use the Easy-In® probe subsequently developed , which is directly introduced through the working channel of the endoscope, and thus shortening the procedure time.

Detailed Description

The use of probes nasojejunal has increasingly become important especially in critically ill patients because of the beneficial effect in patients e.g. with necrotizing pancreatitis, according trauma or major surgical procedures.

A direct application of jejunal tube feeding is necessary especially in patients with gastroparesis due of existing diabetes mellitus, postoperative or severe underlying disease. Since the jejunal tube feedings, the secretion of gastric juice can be increased, the use of probes that allow both: jejunal nutrition, as well as a gastric outflow of secretions are beneficial.

While in a randomized trial of Schwab et al. it could be shown that the use of Freka-Trilumina® compared to Dobbhoff probe by so-called drag technique is significantly faster there are currently no comparative data to use the Easy-In® probe subsequently developed , which is directly introduced through the working channel of the endoscope, and thus shortening the procedure time.

In the presented study should be investigated to what extent the use of imported directly via the working channel Easy-Inn® probe, application time and thus the investigation period may be shortened compared to the usual nasojenunal probes.

Study Timeline

• Study Start: 2012-08
• Status Verified: 2016-02
• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-03-05
• Last Update Submitted: 2016-03-05
• Study First Posted: 2016-03-10
• Last Update Posted: 2016-03-10
• Primary Completion: 2016-07
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Age ≥ 18 years
• Clinical indication for enteral feeding via naso-jejunal probe

Exclusion Criteria

• Lack of consent of the patient or their relatives (in intubated and mechanically ventilated patients in intensive care)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Freka®-Trilumina versus Freka®-EasyIn	After randomization one half of the patients receive a Freka®-Trilumina probe, which is inserted in nasogastric route an then "pushed " using a small forceps which is inserted through the endoscope into the small intestine.
Freka®-EasyIn	Freka®-Trilumina versus Freka®-EasyIn	The other half of the patients will receive a Freka®-EasyIn probe which is directly placed in the small intestine inserted over the endoscope, after endoscopy was initially pushed - as far as possible - into the small intestine.

Primary Outcome Measures

Name	Time	Method
Examination time for the probe system	Through study completion, an average of 1 year

Trial Locations

Locations (2)

PD Dr. Andrea Riphaus; 🇩🇪 Hannover, Germany

Klinikum Agness Karll Laatzen; 🇩🇪 Laatzen, Germany