Comparative Anti-Reflux Procedures in Neurologically Impaired Children (CARPNIC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raj Srivastava, University of Utah
ClinicalTrials.gov Identifier:
NCT01307982
First received: February 18, 2011
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Gastroesophageal Reflux
Nervous System Diseases
Fundoplication
Enteral Nutrition
Procedure: Fundoplication
Procedure: Gastrojejunal (GJ) feeding tube

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Anti-Reflux Procedures in Neurologically Impaired Children

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • GERD-related hospitalization and ED visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Health Related Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    These are a series of surveys about the child and caregiver's health related quality of life.

  • Total length of stay [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    This is the length of stay for each hospitalization and ED visit.

  • Complications from treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    This will be monitored with hospitalizations (primary outcome)

  • Complications from failure of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Mortality [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Any cause captured at 28 days and 12 months post procedure. Procedure related deaths will also be captured.

  • Costs related to hospital, ED, outpatient, and home-health care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    This will be abstracted from hospital administrative database.

  • Nutritional outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Nutritional outcomes will be measured through anthropomorphic measurements including:

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

  • Other outpatient health care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    This will include primary care provider, neurology, gastroenterology, surgery, physiotherapy, etc.

  • Symptom control [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We will ask parents/caregivers to evaluate their childs symptoms and severity.

  • Parental Goals of either treatment for GERD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We will ask parents/caregivers their goals for treatment and evaluate if they have been met.

  • Physician Goals of either treatment for GERD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We will ask physicians their goals for treatment and evaluate if they have been met.


Enrollment: 3
Study Start Date: January 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Procedure: 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.
Other Name: Nissen Fundoplication
Active Comparator: Gastrojejunal (GJ) feeding 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).
Procedure: Gastrojejunal (GJ) feeding 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).
Other Name: GJ tube

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307982

Locations
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Raj Srivastava, MD, MPH University of Utah
  More Information

No publications provided

Responsible Party: Raj Srivastava, Dr. Raj Srivastava, MD, MPH, University of Utah
ClinicalTrials.gov Identifier: NCT01307982     History of Changes
Other Study ID Numbers: 00043616
Study First Received: February 18, 2011
Last Updated: October 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Gastroesophageal Reflux
Nervous System Diseases
Fundoplication
Enteral Nutrition

Additional relevant MeSH terms:
Gastroesophageal Reflux
Nervous System Diseases
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 22, 2014