Clinical trial NCT01551095: Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J)
Official title: Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J): A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: GERD
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
Collaborators: name: GI Supply
First posted: 2012-03-12
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research is being done to study the safety of an investigational percutaneous endoscopic gastrojejunostomy (PEGJ) tube and whether the addition of a balloon on the end of the J tube prevents it from slipping back into the stomach.

Detailed description: The word "investigational" means the PEGJ feeding tube used in this study is not approved by the U. S. Food and Drug Administration (FDA) and is still being tested in research studies. Currently commercially available PEGJ tubes are long tubes which are placed into the part of the small intestine that connects to the stomach (duodenum) under endoscopic guidance. The tip of these PEGJ tubes usually have some built-in extra weight (several grams), which theoretically should prevent slippage of the tube back into the stomach. However, these tubes usually cannot be placed very far into the duodenum and the build-in weight is usually not sufficient to keep the tube in place.

The tip of the currently commercially available PEGJ tubes often (usually within 1-2 weeks) migrates back into the stomach and at that point the tube needs to be replaced. The investigational PEGJ feeding tube used in this study is self-propelled and has a balloon on its tip. The tip of this tube is directed endoscopically through the part of the stomach that connects to the duodenum (pylorus), then the balloon is filled with 5 cc of water and the endoscope is removed. The water filled balloon then is carried by the movement of the intestinal muscles through the duodenum into the middle section of the small intestine (jejunum). It is hoped that such a deep position of the tip of the self-propelled PEGJ tube and presence of the water-filled balloon on its tip will prevent migration of the tube back into the stomach and therefore eliminates the need for tube replacement.

The only difference between the currently approved PEGJ feeding tube and the investigational one being used in this study is the addition of the balloon to the tip of the J port. People who come to Johns Hopkins Hospital for PEGJ placement as part of standard clinical care and who are not pregnant may join the study.

Eligibility criteria: Inclusion Criteria:

* age 18-90 years
* 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 for the study

Exclusion Criteria:

* patients with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000)
* inability to get informed consent for the study from patients or their families
* pregnancy (all women of child-bearing age will undergo urine pregnancy testing)

Primary outcomes:
measure: Safety: Number of Participants With Adverse Events
timeFrame: From date of PEGJ placement up to 3 weeks
Secondary outcomes:
measure: Number of Participants With Retrograde Migration of PEGJ Feeding Tube Within 3 Weeks of Placement
timeFrame: From date of PEGJ placement up to 3 weeks
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.