Feeding Tube
Conditions
Keywords
PEGJ, PEG-J, Percutaneous Endoscopic Gastrostomy, Feeding tube, Gastroparesis, Acute pancreatitis, Stroke, Respiratory failure, GERD, Balloon, Self-propelled
Brief summary
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.
Interventions
DEVICEPEG-J placement
PEG-J placement
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive adult patients (18-80 years of age) with 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.
Exclusion criteria
* Unable to give informed consent * Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing) * Acute gastrointestinal bleeding * Coagulopathy defined by prothrombin time \< 50% of control; PTT \> 50 sec, or INR \> 1.5), on chronic anticoagulation, or platelet count \<50,000 * Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy * Cirrhosis with portal hypertension, varices, and/or ascites * Allergy to egg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With PEG-J Tube Migration | From date of placement up to 4 weeks | Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patency of Feeding Tube | 2 years | Determine tube patency which is defined as time period between tube placement and need for re-intervention. |
| Technical Success | Intra-procedural | Success of tube placement in the desired location as determined endoscopically. |
| Intervention Time | Intra-procedural | Time required from introduction of the upper endoscope until placement of the feeding tube. |
| Time to Repeat Endoscopy for Tube Replacement | 2 years | If repeate endocopy and tube placement are needed due to clogging or retrograde migration |
| Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration | 4 weeks | Patiens who will have retrograde PEG-J tube migration will get repeat endoscopy for PEG-J tube placement |
| Gastrointestinal Quality of Life Index (GIQLI) Score | 3 month | 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 |
| Short-term Complications | One week | 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. |
| Long-term Complications | 2 years | 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. |
| Direct Cost | 2 years | 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) |
| Difficulty of the Procedure | Inra-procedural | 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. |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled between 7/1/13 and 4/14/14 in an academic tertiary center
Participants by arm
| Arm | Count |
|---|---|
| Self-propelled PEGJ Feeding Tube Patients in this arm will receive self-propelled balloon PEGJ tube.
PEG-J placement: PEG-J placement | 9 |
| Standard PEGJ Feeding Tube Patients in this arm will receive the standard commercially availabel PEGJ tube.
PEG-J placement: PEG-J placement | 10 |
| Total | 19 |
Baseline characteristics
| Characteristic | Self-propelled PEGJ Feeding Tube | Standard PEGJ Feeding Tube | Total |
|---|---|---|---|
| Age, Continuous | 62.22 years STANDARD_DEVIATION 13.3 | 52 years STANDARD_DEVIATION 10.68 | 56.84 years STANDARD_DEVIATION 12.77 |
| Gastrointestinal Quality of Life Index (GIQLI) score | 78.2 units on a scale STANDARD_DEVIATION 27.1 | 69.1 units on a scale STANDARD_DEVIATION 11.9 | 73.4 units on a scale STANDARD_DEVIATION 20.5 |
| Sex/Gender, Customized Female | 4 participants | 8 participants | 12 participants |
| Sex/Gender, Customized Male | 5 participants | 2 participants | 7 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 9 | 3 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 |
Outcome results
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.
Time frame: From date of placement up to 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self-propelled PEGJ Feeding Tube | Number of Participants With PEG-J Tube Migration | 3 participants |
| Standard PEGJ Feeding Tube | Number of Participants With PEG-J Tube Migration | 3 participants |
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.
Time frame: Inra-procedural
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-propelled PEGJ Feeding Tube | Difficulty of the Procedure | 6.2 units on a scale | Standard Deviation 3.8 |
| Standard PEGJ Feeding Tube | Difficulty of the Procedure | 7 units on a scale | Standard Deviation 2.2 |
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)
Time frame: 2 years
Population: Study terminated prematurely, so that the appropriate follow-up data was not collected.
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
Time frame: 3 month
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Self-propelled PEGJ Feeding Tube | Gastrointestinal Quality of Life Index (GIQLI) Score | 106 units on a scale |
| Standard PEGJ Feeding Tube | Gastrointestinal Quality of Life Index (GIQLI) Score | 75 units on a scale |
Secondary
Intervention Time
Time required from introduction of the upper endoscope until placement of the feeding tube.
Time frame: Intra-procedural
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self-propelled PEGJ Feeding Tube | Intervention Time | 17.2 minute | Standard Deviation 12.3 |
| Standard PEGJ Feeding Tube | Intervention Time | 28.7 minute | Standard Deviation 13.6 |
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.
Time frame: 2 years
Population: Study terminated prematurely, so that the appropriate follow-up data was not collected.
Secondary
Patency of Feeding Tube
Determine tube patency which is defined as time period between tube placement and need for re-intervention.
Time frame: 2 years
Population: Study terminated prematurely, so that the appropriate follow-up data was not collected.
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
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self-propelled PEGJ Feeding Tube | Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration | 3 participants |
| Standard PEGJ Feeding Tube | Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration | 3 participants |
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.
Time frame: One week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self-propelled PEGJ Feeding Tube | Short-term Complications | 2 participants |
| Standard PEGJ Feeding Tube | Short-term Complications | 3 participants |
Secondary
Technical Success
Success of tube placement in the desired location as determined endoscopically.
Time frame: Intra-procedural
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Self-propelled PEGJ Feeding Tube | Technical Success | 8 procedure |
| Standard PEGJ Feeding Tube | Technical Success | 10 procedure |
Secondary
Time to Repeat Endoscopy for Tube Replacement
If repeate endocopy and tube placement are needed due to clogging or retrograde migration
Time frame: 2 years
Population: Study terminated prematurely, so that the appropriate follow-up data was not collected.