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

Phase 2

Terminated

Conditions: Feeding Tube

Interventions: Device: PEG-J placement

Registration Number: NCT01892267

Lead Sponsor: Johns Hopkins University

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 19

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-propelled PEGJ feeding tube	PEG-J placement	Patients in this arm will receive self-propelled balloon PEGJ tube.
Standard PEGJ feeding tube	PEG-J placement	Patients in this arm will receive the standard commercially availabel PEGJ tube.

Primary Outcome Measures

Name	Time	Method
Number of Participants With PEG-J Tube Migration	From date of placement up to 4 weeks	Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention.

Secondary Outcome Measures

Name	Time	Method
Patency of Feeding Tube	2 years	Determine tube patency which is defined as time period between tube placement and need for re-intervention.
Technical Success	Intra-procedural	Success of tube placement in the desired location as determined endoscopically.
Intervention Time	Intra-procedural	Time required from introduction of the upper endoscope until placement of the feeding tube.
Time to Repeat Endoscopy for Tube Replacement	2 years	If repeate endocopy and tube placement are needed due to clogging or retrograde migration
Long-term Complications	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.
Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration	4 weeks	Patiens who will have retrograde PEG-J tube migration will get repeat endoscopy for PEG-J tube placement
Difficulty of the Procedure	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	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	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.
Direct Cost	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)