Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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)
Sponsor:
Information provided by (Responsible Party):
Mouen Khashab, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01892267
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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • 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)
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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. Epub 2013 Apr 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
60
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01892267
NA_00079056
Yes
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