Feeding TubePhase 2NCT01892267
Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT
A Phase 2 study testing PEG-J placement in people with Feeding Tube, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Feeding Tube
- What is being tested?
- PEG-J placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Feeding Tube
- Being tested
- PEG-J placement
- Keywords
- PEGJ, PEG-J, Percutaneous Endoscopic Gastrostomy, Feeding tube, Gastroparesis, Acute pancreatitis, Stroke, Respiratory failure, GERD, Balloon, Self-propelled
- Medical subject headings
- Gastroparesis, Pancreatitis, Stroke, Respiratory Insufficiency, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-J placementDevice
PEG-J placement
| Study group | Role | What they receive |
|---|---|---|
| Self-propelled PEGJ feeding tube | Experimental | Patients in this arm will receive self-propelled balloon PEGJ tube. Receives: Device: PEG-J placement |
| Standard PEGJ feeding tube | Active comparator | Patients in this arm will receive the standard commercially availabel PEGJ tube. Receives: Device: PEG-J placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With PEG-J Tube Migration
Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention.
Measured: From date of placement up to 4 weeks
Secondary outcomes (10)
Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration
Patiens who will have retrograde PEG-J tube migration will get repeat endoscopy for PEG-J tube placement
Measured: 4 weeks
Patency of Feeding Tube
Determine tube patency which is defined as time period between tube placement and need for re-intervention.
Measured: 2 years
Technical Success
Success of tube placement in the desired location as determined endoscopically.
Measured: Intra-procedural
Intervention Time
Time required from introduction of the upper endoscope until placement of the feeding tube.
Measured: Intra-procedural
Time to Repeat Endoscopy for Tube Replacement
If repeate endocopy and tube placement are needed due to clogging or retrograde migration
Measured: 2 years
Difficulty of the Procedure
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.
Measured: Inra-procedural
Gastrointestinal Quality of Life Index (GIQLI) Score
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
Measured: 3 month
Short-term Complications
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.
Measured: One week
Long-term Complications
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.
Measured: 2 years
Direct Cost
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study start6 Sep 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Study was terminated prematurely as costs incurred were more than the available funds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding TubeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mouen Khashab, Johns Hopkins University
- Investigators
- Mouen Khashab, MD, Principal investigator, Johns Hopkins Hospital Department of Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892267
- Sponsor's protocol ID
- NA_00079056
- Status last verified
- Apr 2017
- First submitted
- 1 Jul 2013
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23622977
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Outcomes and Complications of Self-Propelled vs. Standard Percutaneous Endoscopic Gastrojejunostomy (PEG-J); a Randomized Single Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01892267
- Acronym / sponsor ID
- NA_00079056
- Conditions
- Feeding Tube
- Keywords
- PEGJ, PEG-J, Percutaneous Endoscopic Gastrostomy, Feeding tube, Gastroparesis, Acute pancreatitis, Stroke, Respiratory failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated prematurely as costs incurred were more than the available funds.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 6 Sep 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-propelled PEGJ feeding tube | Experimental | Device: PEG-J placementPatients in this arm will receive self-propelled balloon PEGJ tube. |
| Standard PEGJ feeding tube | Active comparator | Device: PEG-J placementPatients in this arm will receive the standard commercially availabel PEGJ tube. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-J placementPEG-J placement | Device | Self-propelled PEGJ feeding tube, Standard PEGJ feeding tube |
Primary outcome
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.
10 secondary outcomes
Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration
Time frame: 4 weeks
Patency of Feeding Tube
Time frame: 2 years
Technical Success
Time frame: Intra-procedural
Intervention Time
Time frame: Intra-procedural
Time to Repeat Endoscopy for Tube Replacement
Time frame: 2 years
Difficulty of the Procedure
Time frame: Inra-procedural
Gastrointestinal Quality of Life Index (GIQLI) Score
Time frame: 3 month
Short-term Complications
Time frame: One week
Long-term Complications
Time frame: 2 years
Direct Cost
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23622977Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mouen Khashab, MD principal investigator
Johns Hopkins Hospital Department of Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEG-J placement in people with Feeding Tube, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With PEG-J Tube Migration (time frame: From date of placement up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01892267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.