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

This study is currently recruiting participants.
Verified September 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Mouen Khashab, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01892267
First received: July 1, 2013
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Feeding Tube
Device: PEG-J placement
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 60
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01892267

Contacts
Contact: Mouen Khashab, MD 443-287-1960 mkhasha1@jhmi.edu
Contact: Ahmed Messallam, MD 443-287-1960 amessal1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Mouen Khashab, MD    443-287-1960    mkhasha1@jhmi.edu   
Contact: Ahmed Messallam, MD    443-287-1960    amessal1@jhmi.edu   
Principal Investigator: Mouen Khashab, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Mouen Khashab, MD Johns Hopkins Hospital Department of Gastroenterology
  More Information

Publications:
Responsible Party: Mouen Khashab, Assistant Professor of Medicine; Director of Therapeutic Endoscopy, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01892267     History of Changes
Other Study ID Numbers: NA_00079056
Study First Received: July 1, 2013
Last Updated: September 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
PEGJ
PEG-J
Percutaneous Endoscopic Gastrostomy
Feeding tube
Gastroparesis
Acute pancreatitis
Stroke
Respiratory failure
GERD
Balloon
Self-propelled

ClinicalTrials.gov processed this record on April 17, 2014