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

This study has been terminated.
(Study was terminated prematurely as costs incurred were more than the available funds.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01892267
First Posted: July 4, 2013
Last Update Posted: May 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mouen Khashab, Johns Hopkins University
July 1, 2013
July 4, 2013
August 19, 2016
May 17, 2017
May 17, 2017
September 6, 2013
December 2014   (Final data collection date for primary outcome measure)
Number of Participants With PEG-J Tube Migration [ Time Frame: From date of placement up to 4 weeks ]
Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention.
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.
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 ]
    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 with zero being "without difficulty" and 10 being "maximum difficulty".

    The lower the score, the better the outcome.

  • Gastrointestinal Quality of Life Index (GIQLI) Score [ Time Frame: 3 month ]
    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
  • Short-term Complications [ Time Frame: One week ]
    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)
  • 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 month ]
    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)
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
 
Terminated
19
December 2014
December 2014   (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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01892267
NA_00079056
Yes
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
April 2017

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