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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014