Cardiaplication: A Novel Antireflux Operation

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02060500
• Collaborator: Children's Healthcare of Atlanta (Other)
• Enrollment: 8
• Arm: 1
• Duration (Months): 36

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease	Procedure: Cardiaplication	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cardiaplication: A Prospective Observational Trial
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cardiaplication	Procedure: Cardiaplication

Outcome Measures

Primary Outcome Measures

1. Determine pH impedance probe results of Cardiaplication [At 3 months post-operatively]

   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.

Secondary Outcome Measures

1. Validate elongation of the intra-abdominal esophagus as a mechanism for "outgrowing" GERD in infants [1 year post-op]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 12 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Emory University
• Children's Healthcare of Atlanta

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark L. Wulkan, M.D., Principal Investigator, Emory University
• ClinicalTrials.gov Identifier: NCT02060500
• Other Study ID Numbers: IRB00056015
• First Posted: Feb 12, 2014
• Last Update Posted: Oct 24, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Mark L. Wulkan, M.D., Principal Investigator, Emory University: GERD; fundoplication; cardiaplication; reflux
• Additional relevant MeSH terms: Gastroesophageal Reflux

Study Results

No Results Posted as of Oct 24, 2017