Clinical trial NCT01307982: Comparative Anti-Reflux Procedures in Neurologically Impaired Children
Official title: Comparative Anti-Reflux Procedures in Neurologically Impaired Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Nervous System Diseases
Fundoplication
Enteral Nutrition
Keywords: Gastroesophageal Reflux
Nervous System Diseases
Fundoplication
Enteral Nutrition
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-03-03
Enrollment: 3
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 disease (GERD). This is a pilot study to establish feasibility before initiating a multi-centered study.


Eligibility criteria: Inclusion Criteria:

* 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;

    * 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)

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: GERD-related hospitalization and ED visits
timeFrame: 12 months
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: 12 months
measure: Total length of stay
timeFrame: 12 months
measure: Complications from treatment
timeFrame: 12 months
measure: Complications from failure of treatment
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Costs related to hospital, ED, outpatient, and home-health care
timeFrame: 12 months
measure: Nutritional outcomes
timeFrame: 12 months
measure: Other outpatient health care
timeFrame: 12 months
measure: Symptom control
timeFrame: 12 months
measure: Parental Goals of either treatment for GERD
timeFrame: 12 months
measure: Physician Goals of either treatment for GERD
timeFrame: 12 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
Study officials:
affiliation: University of Utah
name: Raj Srivastava, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: