Clinical trial NCT01892267: Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT
Official title: Comparison Outcomes and Complications of Self-Propelled vs. Standard Percutaneous Endoscopic Gastrojejunostomy (PEG-J); a Randomized Single Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Feeding Tube
Keywords: PEGJ
PEG-J
Percutaneous Endoscopic Gastrostomy
Feeding tube
Gastroparesis
Acute pancreatitis
Stroke
Respiratory failure
GERD
Balloon
Self-propelled
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With PEG-J Tube Migration
timeFrame: From date of placement up to 4 weeks
Secondary outcomes:
measure: Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration
timeFrame: 4 weeks
measure: Patency of Feeding Tube
timeFrame: 2 years
measure: Technical Success
timeFrame: Intra-procedural
measure: Intervention Time
timeFrame: Intra-procedural
measure: Time to Repeat Endoscopy for Tube Replacement
timeFrame: 2 years
measure: Difficulty of the Procedure
timeFrame: Inra-procedural
measure: Gastrointestinal Quality of Life Index (GIQLI) Score
timeFrame: 3 month
measure: Short-term Complications
timeFrame: One week
measure: Long-term Complications
timeFrame: 2 years
measure: Direct Cost
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins Hospital Department of Gastroenterology
name: Mouen Khashab, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim KJ, Victor D, Stein E, Valeshabad AK, Saxena P, Singh VK, Lennon AM, Clarke JO, Khashab MA. A novel ballooned-tip percutaneous endoscopic gastrojejunostomy tube: a pilot study. Gastrointest Endosc. 2013 Jul;78(1):154-7. doi: 10.1016/j.gie.2013.03.005. Epub 2013 Apr 24.