Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT
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|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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|