Comparative Anti-Reflux Procedures in Neurologically Impaired Children

NCT01307982 | Completed DMC

• 1 other identifier: 00043616
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (11)

• Health Related Quality of Life

  12 months

• Total length of stay

  12 months

• Complications from treatment

  12 months

• Complications from failure of treatment

  12 months

• Mortality

  12 months

Study Arms (2)

Fundoplication

ACTIVE COMPARATOR

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

Gastrojejunal (GJ) feeding tube

ACTIVE COMPARATOR

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

Interventions

Fundoplication 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.

Also known as: Nissen Fundoplication

Fundoplication

Gastrojejunal (GJ) feeding tube 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).

Also known as: GJ tube

Gastrojejunal (GJ) feeding tube

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Nervous System Diseases

Interventions

Fundoplication; Enteral Nutrition

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Raj Srivastava, MD, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Raj Srivastava, MD, MPH

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: March 3, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 21, 2013

Record last verified: 2013-10

Locations

US (1)