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

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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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

19 participants in 2 patient groups

Self-propelled PEGJ feeding tube
Experimental group
Description:
Patients in this arm will receive self-propelled balloon PEGJ tube.
Treatment:
Device: PEG-J placement
Standard PEGJ feeding tube
Active Comparator group
Description:
Patients in this arm will receive the standard commercially availabel PEGJ tube.
Treatment:
Device: PEG-J placement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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