Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT
|ClinicalTrials.gov Identifier: NCT01892267|
Recruitment Status : Terminated (Study was terminated prematurely as costs incurred were more than the available funds.)
First Posted : July 4, 2013
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Feeding Tube||Device: PEG-J placement||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||September 6, 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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
- Number of Participants With PEG-J Tube Migration [ Time Frame: From date of placement up to 4 weeks ]Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention.
- Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration [ Time Frame: 4 weeks ]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 ]Determine tube patency which is defined as time period between tube placement and need for re-intervention.
- Technical Success [ Time Frame: Intra-procedural ]Success of tube placement in the desired location as determined endoscopically.
- Intervention Time [ Time Frame: Intra-procedural ]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 ]If repeate endocopy and tube placement are needed due to clogging or retrograde migration
- Difficulty of the Procedure [ Time Frame: 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.
- Gastrointestinal Quality of Life Index (GIQLI) Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892267
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Mouen Khashab, MD||Johns Hopkins Hospital Department of Gastroenterology|