Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT

Study Overview
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Brief Summary
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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.

Official Title
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Comparison Outcomes and Complications of Self-Propelled vs. Standard Percutaneous Endoscopic Gastrojejunostomy (PEG-J); a Randomized Single Blind Clinical Trial

Conditions
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Feeding Tube

Intervention / Treatment
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* Device: PEG-J placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-propelled PEGJ feeding tube<br>Patients in this arm will receive self-propelled balloon PEGJ tube. | Device: PEG-J placement<br>* PEG-J placement<br>|
| Active Comparator: Standard PEGJ feeding tube<br>Patients in this arm will receive the standard commercially availabel PEGJ tube. | Device: PEG-J placement<br>* PEG-J placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, PEGJ, PEG-J, Percutaneous Endoscopic Gastrostomy, Feeding tube, Gastroparesis, Acute pancreatitis, Respiratory failure, GERD, Balloon, Self-propelled