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

Johns Hopkins University

Status and phase

Terminated

Phase 2

Conditions

Feeding Tube

Treatments

Device: PEG-J placement

Study type

Interventional

Funder types

Other

Identifiers

NCT01892267

NA_00079056

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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