Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J): A Pilot Study|
- Safety: Number of Participants With Adverse Events [ Time Frame: From date of PEGJ placement up to 3 weeks ] [ Designated as safety issue: Yes ]Complications as a result of the PEGJ will be assessed (pain, vomiting, nausea)
- Migration of PEGJ Feeding Tube [ Time Frame: From date of PEGJ placement up to 3 weeks ] [ Designated as safety issue: No ]Risk of retrograde migration within 3 weeks of placement
|Study Start Date:||January 2012|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Patients in this arm will receive self-propelled balloon PEGJ tube.
Device: PEGJ tube
The self-propelled PEGJ feeding tube
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551095
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Mouen Khashab, MD||Johns Hopkins Hospital Department of Gastroenterology|