Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|Official Title:||Comparison Outcomes and Complications of Self-Propelled vs. Standard Percutaneous Endoscopic Gastrojejunostomy (PEG-J); a Randomized Single Blind Clinical Trial|
- PEG-J Tube migration rate [ Time Frame: From date of placement up to 4 weeks ] [ Designated as safety issue: No ]Tube migration will be assessed by X-ray at 4 weeks post-intervention.
- Repeat endoscopy for feeding tube placement due to retrograde tube migration [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Patiens who will have retrograde PEG-J tube migration will get repeat endoscopy for PEG-J tube placement
- Patency of feeding tube [ Time Frame: 2 years ] [ Designated as safety issue: No ]Determine tube patency which is defined as time period between tube placement and need for re-intervention.
- Technical success [ Time Frame: Intra-procedural ] [ Designated as safety issue: No ]Success of tube placement in the desired location as determined endoscopically.
- Intervention time [ Time Frame: Intra-procedural ] [ Designated as safety issue: No ]Time required from introduction of the upper endoscope until placement of the feeding tube.
- Time to repeat endoscopy for tube replacement [ Time Frame: 2 years ] [ Designated as safety issue: No ]If repeate endocopy and tube placement are needed due to clogging or retrograde migration
- Difficulty of the procedure [ Time Frame: Inra-procedural ] [ Designated as safety issue: No ]Scored by the endoscopist on a 10-point Visual Analogue Scale)
- Gastrointestinal Quality of Life Index (GIQLI) score [ Time Frame: 3 months ] [ Designated as safety issue: No ]Patients` quality of life will be assessed using a specific scoring system for digestive diseases.4 The score is based on the results of a self-administered questionnaire using 36 items related to digestive symptoms and quality of life, including nausea, bloating, abdominal pain, regurgitation and appetite. Each item is rated from 0 to 4 (0=extremely severe, 1=severe, 2=moderate, 3=mild and 4=absent). The overall GIQLI score is calculated by adding the scores for each item and varies from 0 (worst quality of life possible with severe digestive symptoms) to 144 (optimal quality of life without symptoms). Patients will fill GIQLI at baseline and 1, 2 and 3 months after procedure.
- Short-term complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 Start Date:||July 2013|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: Self-propelled PEGJ feeding tube
Patients in this arm will receive self-propelled balloon PEGJ tube.
Device: PEG-J placement
Active Comparator: Standard PEGJ feeding tube
Patients in this arm will receive the standard commercially availabel PEGJ tube.
Device: PEG-J placement
Please refer to this study by its ClinicalTrials.gov identifier: NCT01892267
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Mouen Khashab, MD||Johns Hopkins Hospital Department of Gastroenterology|