Comparative Anti-Reflux Procedures in Neurologically Impaired Children

NCT ID: NCT01307982

Last Updated: 2013-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-09-30

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.

Conditions

Gastroesophageal Reflux; Nervous System Diseases; Fundoplication; Enteral Nutrition

Keywords

Gastroesophageal Reflux; Nervous System Diseases; Fundoplication; Enteral Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Fundoplication

Intervention Type: PROCEDURE

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 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).

Group Type: ACTIVE_COMPARATOR

Gastrojejunal (GJ) feeding tube

Intervention Type: PROCEDURE

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: PROCEDURE

Other Intervention Names

Nissen Fundoplication; GJ tube

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Raj Srivastava

Dr. Raj Srivastava, MD, MPH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raj Srivastava, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Primary Children's Medical Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

00043616

Identifier Type: -

Identifier Source: org_study_id