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Proof of principle was achieved after inclusion of 7 patients
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| Name | Class |
|---|---|
| GI Supply | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEGJ | Experimental | Patients in this arm will receive self-propelled balloon PEGJ tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEGJ tube | Device | The self-propelled PEGJ feeding tube |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of PEGJ placement up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of PEGJ placement up to 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mouen Khashab, MD | Johns Hopkins Hospital Department of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23622977 | Derived | 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. |
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Patients were enrolled between January 2012 and May 2012 in a tertiary academic center
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| ID | Title | Description |
|---|---|---|
| FG000 | PEGJ | Patients in this arm will receive self-propelled balloon PEGJ tube. PEGJ tube: The self-propelled PEGJ feeding tube |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PEGJ | Patients in this arm will receive self-propelled balloon PEGJ tube. PEGJ tube: The self-propelled PEGJ feeding tube |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | From date of PEGJ placement up to 3 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PEGJ | Patients in this arm will receive self-propelled balloon PEGJ tube. PEGJ tube: The self-propelled PEGJ feeding tube |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders |
Small number of patients and short follow-up
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mouen Khashab | Johns Hopkins University | 443-287-1960 | mkhasha1@jhmi.edu |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D018589 | Gastroparesis |
| D010195 | Pancreatitis |
| D020521 | Stroke |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | 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. | Posted | Number | participants | From date of PEGJ placement up to 3 weeks |
|
|
|
| 0 |
| 7 |
| 1 |
| 7 |
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| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010182 | Pancreatic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |