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

Stopped early · Phase 2

Conditions studied: Feeding Tube

In brief

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.

Key facts

Study ID

NCT01892267

Run by

Johns Hopkins University

People needed

19

Starts

2013-09-06

Expected to finish

2014-12-01

Last updated by the study team

2017-05-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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