Cardiaplication: A Novel Antireflux Operation

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Cardiaplication: A Prospective Observational Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060500
• Other study ID #: IRB00056015
• Status: Completed
• Phase: N/A
• First received: December 20, 2013
• Last updated: October 20, 2017
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: October 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gastro-Esophageal Reflux is a commonly encountered problem in infants. After failure of medical therapy, many children are referred for surgical intervention. Techniques have evolved over the last 50 years; however, benefits in children remain the center of debate in many surgical forums. This is primarily owing to the high incidence of recurrence of reflux and need for revisions later in life. Some clinicians theorize that the pathophysiology of reflux in infants is different from that of the population at large, and that the traditional operation may not be the best suited for this patient population. We propose a study to test an alternative plication technique for modifying the gastro-esophageal junction at the Angle of Hiss. By plicating the cardia of the stomach, we hypothesize that we will create a valve which will limit reflux without disrupting the diaphragmatic crura, thus reducing the incidence of recurrent hiatal hernia and limiting the incidence of fundoplications which are too tight.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• Patients under 12 months old who are scheduled to undergo an operative intervention for medically refractory GERD.

Exclusion Criteria:

• Inability to obtain consent

• Surgeon preference

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Procedure:
• Cardiaplication

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Children's Healthcare of Atlanta

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine pH impedance probe results of Cardiaplication	We will perform a pH impedance probe on all patients at 3 months post-op (+/- 30 days). We are looking for a statistically significant improvement in per-cent time the pH is <= 4.	At 3 months post-operatively
Secondary	Validate elongation of the intra-abdominal esophagus as a mechanism for "outgrowing" GERD in infants	Radiographs at 1 year will be compared to post-op chest x-ray to determine vertical length between clips placed intra-operatively at the GE junction and on the diaphragmatic crus.	1 year post-op