Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/7/2015 |
| Start Date: | July 2013 |
| End Date: | July 2015 |
| Contact: | Mouen Khashab, MD |
| Email: | mkhasha1@jhmi.edu |
| Phone: | 443-287-1960 |
Comparison Outcomes and Complications of Self-Propelled vs. Standard Percutaneous Endoscopic Gastrojejunostomy (PEG-J); a Randomized Single Blind Clinical Trial
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.
(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.
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
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