Clinical trial: Comparative Anti-Reflux Procedures in Neurologically Impaired Children (NCT01307982)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 18 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? Contradiction