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

This study has suspended participant recruitment.
(We had problems with the PEG-J tube being studied)
Information provided by (Responsible Party):
Mouen Khashab, Johns Hopkins University Identifier:
First received: July 1, 2013
Last updated: January 22, 2015
Last verified: January 2015

July 1, 2013
January 22, 2015
July 2013
July 2015   (Final data collection date for primary outcome measure)
PEG-J Tube migration rate [ Time Frame: From date of placement up to 4 weeks ]
Tube migration will be assessed by X-ray at 4 weeks post-intervention.
Same as current
Complete list of historical versions of study NCT01892267 on Archive Site
  • 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)
  • Gastrointestinal Quality of Life Index (GIQLI) score [ Time Frame: 3 months ]
    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 ]
    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)
Same as current
Not Provided
Not Provided
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Feeding Tube
Device: PEG-J placement
PEG-J placement
  • Experimental: Self-propelled PEGJ feeding tube
    Patients in this arm will receive self-propelled balloon PEGJ tube.
    Intervention: Device: PEG-J placement
  • Active Comparator: Standard PEGJ feeding tube
    Patients in this arm will receive the standard commercially availabel PEGJ tube.
    Intervention: Device: PEG-J placement
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2015
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Mouen Khashab, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Mouen Khashab, MD Johns Hopkins Hospital Department of Gastroenterology
Johns Hopkins University
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP