GERD
Conditions
Keywords
PEGJ, PEG-J, percutaneous endoscopic gastrostomy, feeding tube, gastroparesis, acute pancreatitis, stroke, respiratory failure, GERD, balloon, self-propelled
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.
Interventions
DEVICEPEGJ tube
The self-propelled PEGJ feeding tube
Sponsors
GI Supply
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number of Participants With Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Retrograde Migration of PEGJ Feeding Tube Within 3 Weeks of Placement | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled between January 2012 and May 2012 in a tertiary academic center
Participants by arm
| Arm | Count |
|---|---|
| PEGJ Patients in this arm will receive self-propelled balloon PEGJ tube.
PEGJ tube: The self-propelled PEGJ feeding tube | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | PEGJ |
|---|---|
| Age, Customized | 38.3 years |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Safety: Number of Participants With Adverse Events
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.
Time frame: From date of PEGJ placement up to 3 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEGJ | Safety: Number of Participants With Adverse Events | Nausea | 0 participants |
| PEGJ | Safety: Number of Participants With Adverse Events | Vomiting | 0 participants |
| PEGJ | Safety: Number of Participants With Adverse Events | Abdominal Pain | 1 participants |
Secondary
Number of Participants With Retrograde Migration of PEGJ Feeding Tube Within 3 Weeks of Placement
An Abdominal X-ray was obtained 3 weeks after the procedure to check whether or not there was any PEGJ feeding tube migration.
Time frame: From date of PEGJ placement up to 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEGJ | Number of Participants With Retrograde Migration of PEGJ Feeding Tube Within 3 Weeks of Placement | 0 participants |