TerminatedPhase 2

Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT

Stopped: Study was terminated prematurely as costs incurred were more than the available funds.

United States19 participantsStarted 2013-09-06

Plain-language summary

Our main hypothesis is that self-propelled Percutaneous Endoscopic Gastrojejunostomy tube (PEG-J) that has a balloon on it's tip is associated with lower J-tube retrograde migration rate, and lower rates of short- and long-term complications when compared to standard PEGJ feeding tubes.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consecutive adult patients (18-80 years of age) with need for post-pyloric feeding (patients unable to eat due to stroke, intubated patients with respiratory failure, patients with acute pancreatitis, etc). * Ability to give informed consent. Exclusion Criteria: * Unable to give informed consent * Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing) * Acute gastrointestinal bleeding * Coagulopathy defined by prothrombin time \< 50% of control; PTT \> 50 sec, or INR \> 1.5), on chronic anticoagulation, or platelet count \<50,000 * Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy * Cirrhosis with portal hypertension, varices, and/or ascites * Allergy to egg

What they're measuring

Number of Participants With PEG-J Tube Migration

Timeframe: From date of placement up to 4 weeks

Trial details

NCT IDNCT01892267

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

Results submitted2016-08-19

View on ClinicalTrials.gov More Feeding Tube trials