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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
19
PEG-J placement
Johns Hopkins Hospital
Baltimore, Maryland, United States
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
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
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
Technical Success
Success of tube placement in the desired location as determined endoscopically.
Time frame: Intra-procedural
Intervention Time
Time required from introduction of the upper endoscope until placement of the feeding tube.
Time frame: Intra-procedural
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
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
Gastrointestinal Quality of Life Index (GIQLI) Score
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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
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
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
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