Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J)
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|ClinicalTrials.gov Identifier: NCT01551095|
Recruitment Status : Terminated (Proof of principle was achieved after inclusion of 7 patients)
First Posted : March 12, 2012
Results First Posted : October 12, 2016
Last Update Posted : March 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|GERD||Device: PEGJ tube||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J): A Pilot Study|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Patients in this arm will receive self-propelled balloon PEGJ tube.
Device: PEGJ tube
The self-propelled PEGJ feeding tube
- Safety: Number of Participants With Adverse Events [ Time Frame: From date of PEGJ placement up to 3 weeks ]One week after the procedure patients were called by one of the study investigators and were asked whether or not they had Abdominal pain, Nausea or Vomiting after the procedure.
- Number of Participants With Retrograde Migration of PEGJ Feeding Tube Within 3 Weeks of Placement [ Time Frame: From date of PEGJ placement up to 3 weeks ]An Abdominal X-ray was obtained 3 weeks after the procedure to check whether or not there was any PEGJ feeding tube migration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551095
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Mouen Khashab, MD||Johns Hopkins Hospital Department of Gastroenterology|