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Gastroesophageal RefluxCARPNICNCT01307982

Comparative Anti-Reflux Procedures in Neurologically Impaired Children

A study testing Fundoplication and Gastrojejunal (GJ) feeding tube in people with Gastroesophageal Reflux and Nervous System Diseases, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is a randomized controlled trial of two standard anti-reflux procedures, Nissen fundoplication versus gastrojejunal feeding tubes (GJ tubes), in children and adolescents with functional and intellectual impairment who have gastrostomy feeding tubes and medically refractory or severe gastroesophageal reflux… Read more about this study

Who is it for?
Ages 6 months to 18 years
What is being tested?
Fundoplication and Gastrojejunal (GJ) feeding tube
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Jan 2011to Sep 2013
Phase
Interventional
Are there results?
None posted in the registry

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 6 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • patient is between 6 months and 18 years of age; AND
  • patient has functional impairment classified by either gross motor functional classification of 3, 4 or 5 OR impaired function in walking, crawling/standing, rolling/sitting, arm use, hand use, ability to hold head up; AND
  • patient has a gastrostomy; AND
  • patient has intolerance of feedings or other complications attributed to GERD as defined below; AND
  • patient has a positive GERD diagnostic evaluation as define below:
  • GERD diagnostic evaluation will include the following investigations;
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  • endoscopy and biopsy for visual assessment and histology of the esophageal mucosa
  • pH study and/or multichannel intraluminal impedance (MII) probe to detect and quantify gastroesophageal reflux
  • GER demonstrated by:
  • Reflux Esophagitis: Endoscopic appearance of mucosal breaks in the distal esophagus with or without pathologist diagnosis based on one or more biopsy histologic features of: inflammatory cellular infiltrate, basal cell hyperplasia, elongation of the vascular papillae AND no infectious microorganisms and < 15 eosinophils per high power field; OR
  • pH OR pH/multichannel intraluminal impedance(MII) probe evidence of pathologic GER:
  • pH probe: acid reflux index > 7 % OR
  • pH/MII reflux symptom-associated acid or non-acid volume associated reflux events;
  • Upper GI will only be used to determine normal anatomy; AND
  • patient has either medically refractory GERD or severe GERD as defined below:
  • Medically refractory GERD - GERD that has not responded to 12 weeks of treatment with a proton pump inhibitor (PPI) (and verified gastric pH > 4) and/or trial of continuous intragastric feedings and has one of the following complications:
  • Esophagitis: Endoscopic appearance of mucosal breaks in the distal esophagus with or without pathologist diagnosis based on one or more biopsy histologic features of: inflammatory cellular infiltrate, basal cell hyperplasia, elongation of the vascular papillae
  • Failure to thrive: diminishing weight percentile for age or weight for age z-score sustained over 6 months.
  • Pneumonia consistent with aspiration,
  • Acute life threatening event,
  • Severe GERD - at least one severe complication of GERD and patient cannot safely tolerate a trial of medical management due to one of the following life-threatening complications:
  • aspiration pneumonia,
  • acute life threatening event (ALTE),
  • complete loss of airway protection (absent cough/gag) AND,
  • Upper GI barium contrast study for anatomy; AND
  • Barium pharyngeal swallow study or modified barium swallow study or Flexible Endoscopic Evaluation of Swallowing (FEES) in past year; AND
  • the parent or legal guardian speaks English or Spanish (the only two languages in which the instruments are standardized)

Who cannot join

  • Upper GI findings that would mandate a fundoplication including: hiatal hernia, esophageal stricture, Barret's esophagus; OR
  • Upper GI findings show uncorrected distal gastrointestinal obstruction including: gastric outlet obstruction, duodenal obstruction, malrotation; OR
  • Upper GI demonstrates structural foregut abnormalities that preclude a fundoplication including: microgastria, short esophagus, high anesthetic risk; OR
  • Diagnosis or history of congenital diaphragmatic hernia, esophageal atresia, chronic intestinal pseudoobstruction; OR
  • Endoscopy and biopsy demonstrates esophagitis from causes other than GER including: eosinophilic esophagitis, candida esophagitis, viral esophagitis); OR
  • Rapidly changing or indeterminate neurological including either a deteriorating neurological condition such as rapid loss of developmental milestones or improving, such as rapid recovery following severe neurological insult; OR
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  • Patient has unacceptable general anesthetic risk; OR
  • A previous Nissen fundoplication; OR
  • Feeds delivered by GJ/NJ at the time of enrollment occurring for greater than 3 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Primary Children's Medical Center

    Salt Lake City, Utah, 84113

Other trials in United States

About this study

This trial is a randomized controlled trial of two standard anti-reflux procedures, Nissen fundoplication versus gastrojejunal feeding tubes (GJ tubes), in children and adolescents with functional and intellectual impairment who have gastrostomy feeding tubes and medically refractory or severe gastroesophageal reflux disease (GERD). This is a pilot study to establish feasibility before initiating a multi-centered study.

Being tested
Fundoplication, Gastrojejunal (GJ) feeding tube
Keywords
Gastroesophageal Reflux, Nervous System Diseases, Fundoplication, Enteral Nutrition
Medical subject headings
Gastroesophageal Reflux, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FundoplicationProcedure or surgery

    Also called Nissen Fundoplication

    During fundoplication surgery, the upper curve of the stomach (the fundus) is wrapped around the esophagus and sewn into place so that the lower portion of the esophagus passes through a small tunnel of stomach muscle. This surgery strengthens the valve between the esophagus and stomach (lower esophageal sphincter), which stops acid from backing up into the esophagus as easily.

  • Gastrojejunal (GJ) feeding tubeProcedure or surgery

    Also called GJ tube

    Gastrojejunal (GJ) tube placement is an image guided technique in which a special soft feeding catheter is placed through an existing hole in the stomach (gastrostomy) into the small bowel (jejunum).

Study groups in NCT01307982
Study groupRoleWhat they receive
FundoplicationActive comparatorDuring fundoplication surgery, the upper curve of the stomach (the fundus) is wrapped around the esophagus and sewn into place so that the lower portion of the esophagus passes through a small tunnel of stomach muscle. This surgery strengthens the valve between the esophagus and stomach (lower esophageal sphincter), which stops acid from backing up into the esophagus as easily.
Receives: Procedure: Fundoplication
Gastrojejunal (GJ) feeding tubeActive comparatorGastrojejunal (GJ) tube placement is an image guided technique in which a special soft feeding catheter is placed through an existing hole in the stomach (gastrostomy) into the small bowel (jejunum).
Receives: Procedure: Gastrojejunal (GJ) feeding tube

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. GERD-related hospitalization and ED visits

    Parental interviews and chart reviews will be used to record all health care encounters. Each encounter will be classified as either GERD-related or not. GERD-related hospitalizations and ED visits will be further classified as; diagnostic testing, procedural problems, likely aspiration pneumonia (AP or bacterial pneumonia), respiratory distress of other etiology, or death from any cause.

    Measured: 12 months

Secondary outcomes (11)

  1. Health Related Quality of Life

    These are a series of surveys about the child and caregiver's health related quality of life.

    Measured: 12 months

  2. Total length of stay

    This is the length of stay for each hospitalization and ED visit.

    Measured: 12 months

  3. Complications from treatment

    This will be monitored with hospitalizations (primary outcome)

    Measured: 12 months

  4. Complications from failure of treatment

    This will be monitored with hospitalizations (primary outcome), and will include things such as repeat procedure for fundoplication arm, ongoing need for GERD medications, and treatment cross-over.

    Measured: 12 months

  5. Mortality

    Any cause captured at 28 days and 12 months post procedure. Procedure related deaths will also be captured.

    Measured: 12 months

  6. Costs related to hospital, ED, outpatient, and home-health care

    This will be abstracted from hospital administrative database.

    Measured: 12 months

  7. Nutritional outcomes

    Nutritional outcomes will be measured through anthropomorphic measurements including:

    • weight for age z-score
    • tibial length
    • triceps and subscapular skinfold thickness

    Measured: 12 months

  8. Other outpatient health care

    This will include primary care provider, neurology, gastroenterology, surgery, physiotherapy, etc.

    Measured: 12 months

  9. Symptom control

    We will ask parents/caregivers to evaluate their childs symptoms and severity.

    Measured: 12 months

  10. Parental Goals of either treatment for GERD

    We will ask parents/caregivers their goals for treatment and evaluate if they have been met.

    Measured: 12 months

  11. Physician Goals of either treatment for GERD

    We will ask physicians their goals for treatment and evaluate if they have been met.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01307982
Sponsor's protocol ID
00043616
Acronym
CARPNIC
Status last verified
Oct 2013
First submitted
18 Feb 2011
Last updated
21 Oct 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Fundoplication and Gastrojejunal (GJ) feeding tube in people with Gastroesophageal Reflux and Nervous System Diseases, run by University of Utah 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 27 inclusion and 9 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: finished, as of the sponsor's last update on 21 Oct 2013. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

GERD-related hospitalization and ED visits (time frame: 12 months). 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 NCT01307982.

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 21 Oct 2013.

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