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

Comparison Outcomes and Complications of Self-Propelled vs. Standard Percutaneous Endoscopic Gastrojejunostomy (PEG-J); a Randomized Single Blind Clinical Trial

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 Overview

• Status: Terminated
• Conditions: Feeding Tube
• Intervention / Treatment: Device: PEG-J placement

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-propelled PEGJ feeding tube; Patients in this arm will receive self-propelled balloon PEGJ tube.	Device: PEG-J placement; 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; PEG-J placement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 weeks
Patency of Feeding Tube	Determine tube patency which is defined as time period between tube placement and need for re-intervention.	2 years
Technical Success	Success of tube placement in the desired location as determined endoscopically.	Intra-procedural
Intervention Time	Time required from introduction of the upper endoscope until placement of the feeding tube.	Intra-procedural
Time to Repeat Endoscopy for Tube Replacement	If repeate endocopy and tube placement are needed due to clogging or retrograde migration	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.	Inra-procedural
Gastrointestinal Quality of Life Index (GIQLI) Score	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	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.	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.	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)	2 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Mouen Khashab, MD, Johns Hopkins Hospital Department of Gastroenterology

Publications and helpful links

General Publications

• Kim KJ, Victor D, Stein E, Valeshabad AK, Saxena P, Singh VK, Lennon AM, Clarke JO, Khashab MA. A novel ballooned-tip percutaneous endoscopic gastrojejunostomy tube: a pilot study. Gastrointest Endosc. 2013 Jul;78(1):154-7. doi: 10.1016/j.gie.2013.03.005. Epub 2013 Apr 24.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 1, 2013
• First Submitted That Met QC Criteria: July 3, 2013
• First Posted (Estimate): July 4, 2013

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Stroke; GERD; Gastroparesis; Respiratory failure; Acute pancreatitis; PEGJ; PEG-J; Percutaneous Endoscopic Gastrostomy; Feeding tube; Balloon; Self-propelled
• Other Study ID Numbers: NA_00079056