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Study was terminated prematurely as costs incurred were more than the available funds.
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Our main hypothesis is that self-propelled Percutaneous Endoscopic Gastrojejunostomy tube (PEG-J) that has a balloon on it's tip is associated with lower J-tube retrograde migration rate, and lower rates of short- and long-term complications when compared to standard PEGJ feeding tubes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-propelled PEGJ feeding tube | Experimental | Patients in this arm will receive self-propelled balloon PEGJ tube. |
|
| Standard PEGJ feeding tube | Active Comparator | Patients in this arm will receive the standard commercially availabel PEGJ tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-J placement | Device | PEG-J placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With PEG-J Tube Migration | Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention. | From date of placement up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration | Patiens who will have retrograde PEG-J tube migration will get repeat endoscopy for PEG-J tube placement | 4 weeks |
| Patency of Feeding Tube |
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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 | Background | 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 7/1/13 and 4/14/14 in an academic tertiary center
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| ID | Title | Description |
|---|---|---|
| FG000 | Self-propelled PEGJ Feeding Tube | Patients in this arm will receive self-propelled balloon PEGJ tube. PEG-J placement: PEG-J placement |
| FG001 | Standard PEGJ Feeding Tube | Patients in this arm will receive the standard commercially availabel PEGJ tube. PEG-J placement: PEG-J placement |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Self-propelled PEGJ Feeding Tube | Patients in this arm will receive self-propelled balloon PEGJ tube. PEG-J placement: PEG-J placement |
| BG001 | Standard PEGJ Feeding Tube | Patients in this arm will receive the standard commercially availabel PEGJ tube. PEG-J placement: PEG-J placement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Number of Participants With PEG-J Tube Migration | Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention. | Posted | Number | participants | From date of placement up to 4 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 | Self-propelled PEGJ Feeding Tube | Patients in this arm will receive self-propelled balloon PEGJ tube. PEG-J placement: PEG-J placement |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea after tube placement | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mouen Khashab | Johns Hopkins Hospital | 443-287-1960 | mkhasha1@jhmi.edu |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D010195 | Pancreatitis |
| D020521 | Stroke |
| D012131 | Respiratory Insufficiency |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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Determine tube patency which is defined as time period between tube placement and need for re-intervention.
| 2 years |
| Technical Success | Success of tube placement in the desired location as determined endoscopically. | Intra-procedural |
| Intervention Time | Time required from introduction of the upper endoscope until placement of the feeding tube. | Intra-procedural |
| Time to Repeat Endoscopy for Tube Replacement | If repeate endocopy and tube placement are needed due to clogging or retrograde migration | 2 years |
| Difficulty of the Procedure | Scored by the endoscopist on a 10-point Visual Analogue Scale with zero being "without difficulty" and 10 being "maximum difficulty". The lower the score, the better the outcome. | Inra-procedural |
| Gastrointestinal Quality of Life Index (GIQLI) Score | Gastrointestinal Quality of Life Index (GIQLI) score ranging from 0 (worst quality of life possible with severe digestive symptoms) to 144 (optimal quality of life without symptoms | 3 month |
| Short-term Complications | Short-term complications will include stomal (Infection, erythema, bleeding, pain and secretion, etc) and tube (Clotting, dislocation, defect, aspiration, etc) complications detected in the first week. | One week |
| Long-term Complications | Long-term complications will include stomal (Infection, erythema, bleeding, pain, secretion, abscess, etc) and tube (Clotting, dislocation, defect and aspiration, etc) complications detected more than one week after intervention. | 2 years |
| Direct Cost | Cost will be determined according to Medicare reimbursement of billed CPT codes. The cost of all related follow-up procedures will be included (e.g. cost of standard PEGJ in case of failed Self-propelled PEGJ feeding tube, cost of managing complications, cost of re-intervention in case of tube dysfunction, etc) | 2 years |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Gastrointestinal Quality of Life Index (GIQLI) score | Gastrointestinal Quality of Life Index (GIQLI) score ranging from 0 (worst quality of life possible with severe digestive symptoms) to 144 (optimal quality of life without symptoms | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration | Patiens who will have retrograde PEG-J tube migration will get repeat endoscopy for PEG-J tube placement | Posted | Number | participants | 4 weeks |
|
|
|
| Secondary | Patency of Feeding Tube | Determine tube patency which is defined as time period between tube placement and need for re-intervention. | Study terminated prematurely, so that the appropriate follow-up data was not collected. | Posted | 2 years |
|
|
| Secondary | Technical Success | Success of tube placement in the desired location as determined endoscopically. | Posted | Number | procedure | Intra-procedural |
|
|
|
| Secondary | Intervention Time | Time required from introduction of the upper endoscope until placement of the feeding tube. | Posted | Mean | Standard Deviation | minute | Intra-procedural |
|
|
|
| Secondary | Time to Repeat Endoscopy for Tube Replacement | If repeate endocopy and tube placement are needed due to clogging or retrograde migration | Study terminated prematurely, so that the appropriate follow-up data was not collected. | Posted | 2 years |
|
|
| Secondary | Difficulty of the Procedure | Scored by the endoscopist on a 10-point Visual Analogue Scale with zero being "without difficulty" and 10 being "maximum difficulty". The lower the score, the better the outcome. | Posted | Mean | Standard Deviation | units on a scale | Inra-procedural |
|
|
|
| Secondary | Gastrointestinal Quality of Life Index (GIQLI) Score | Gastrointestinal Quality of Life Index (GIQLI) score ranging from 0 (worst quality of life possible with severe digestive symptoms) to 144 (optimal quality of life without symptoms | The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that only 5 patients had a completed GIQLI questionnaire at 3-month follow-up. | Posted | Median | Full Range | units on a scale | 3 month |
|
|
|
| Secondary | Short-term Complications | Short-term complications will include stomal (Infection, erythema, bleeding, pain and secretion, etc) and tube (Clotting, dislocation, defect, aspiration, etc) complications detected in the first week. | Posted | Number | participants | One week |
|
|
|
| Secondary | Long-term Complications | Long-term complications will include stomal (Infection, erythema, bleeding, pain, secretion, abscess, etc) and tube (Clotting, dislocation, defect and aspiration, etc) complications detected more than one week after intervention. | Study terminated prematurely, so that the appropriate follow-up data was not collected. | Posted | 2 years |
|
|
| Secondary | Direct Cost | Cost will be determined according to Medicare reimbursement of billed CPT codes. The cost of all related follow-up procedures will be included (e.g. cost of standard PEGJ in case of failed Self-propelled PEGJ feeding tube, cost of managing complications, cost of re-intervention in case of tube dysfunction, etc) | Study terminated prematurely, so that the appropriate follow-up data was not collected. | Posted | 2 years |
|
|
| 0 |
| 9 |
| 5 |
| 9 |
| EG001 | Standard PEGJ Feeding Tube | Patients in this arm will receive the standard commercially availabel PEGJ tube. PEG-J placement: PEG-J placement | 0 | 10 | 3 | 10 |
| vomiting after tube placement | Gastrointestinal disorders | Systematic Assessment |
|
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| 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 |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |