Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
- Conditions
- Tracheoesophageal FistulaEsophageal Atresia
- Interventions
- Device: Transanastomotic Tube (5FR)Other: No Transanastomotic Tube
- Registration Number
- NCT03730454
- Lead Sponsor
- Phoenix Children's Hospital
- Brief Summary
This trial will compare the effectiveness of two common surgical practices for Type C esophageal atresia repair: esophageal atresia (EA) with distal tracheoesophageal fistula (TEF). Infants with EA/TEF requiring surgical intervention will be recruited. Subjects will be randomized to either repair with or without transanstomotic tube (TT) during esophageal anastomosis creation. Primary outcome is symptomatic anastomotic stricture development requiring dilation within 12 months.
- Detailed Description
Esophageal atresia is a congenital condition requiring surgical intervention. The most common configuration is Gross type C, proximal EA with distal TEF (EA/TEF). The operation for type C includes tracheoesophageal fistula closure and esophageal anastomosis creation. Although mortality has markedly decreased since the operation was first described, overall complication rate remains at 62%, with the most common complication being anastomotic stricture, 43%.
During the creation of esophageal anastomosis, two common practices are to either use or not use a transanastomtic tube (TT) across the anastomosis. However the utility and benefits of TT have not been validated. A recent retrospective analysis by the Midwestern Pediatric Surgical Research Consortium identified anastomotic stricture to be the most common postoperative complications (43%). On univariate analysis, only utilization of a TT was significantly associated with strictures (p=0.013). On multivariate analysis after adjusting for both pre and perioperative variables, TT use remained significant with an odd ratio (OR) of 1.91 (p=0.04).
Given the inherent limitations and biases of retrospective analysis, there is a critical need for a prospective multi-institutional study to validate this finding. The Western Pediatric Surgical Research Consortium (WPSRC) consists of 10 children's hospitals including Phoenix Children's Hospital, Doernbecher Children's Hospital, Primary Children's Hospital, Lucile Packard Children's Hospital, Seattle Children's Hospital, Colorado Children's Hospital, Children's Hospital of Los Angeles, Rady Children's Hospital, Benioff Children's Hospital, and Children's Medical Center Dallas. The WPSRC will conduct a prospective randomized control trial comparing the effects of TT use. Target enrollment is 150. One group of patients will receive TTs and another group of patients will not receive TTs. We hypothesize that the use of TT will result in increased anastomotic stricture formation. Primary outcome is symptomatic anastomotic stricture requiring dilation within 12 months.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Infants diagnosed with type C esophageal atresia: proximal esophageal atresia and distal tracheoesophageal fistula
- Primary repair of the esophageal atresia within the first six months of life
- Minimum follow up of 1 year (12 months)
- Other types of esophageal atresia without esophageal anastomosis creation
- Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A. Transanastomotic Tube Transanastomotic Tube (5FR) Group A. Transanastomotic Tube: Standard repair of EA/TEF will be performed. TT will be used during the esophageal anastomosis creation. Group B. No Transanastomotic Tube No Transanastomotic Tube Group B. No Transanastomotic tube group: Standard repair of EA/TEF will be performed. TT will NOT be used during the esophageal anastomosis creation.
- Primary Outcome Measures
Name Time Method Anastomotic stricture 12 months Symptomatic anastomotic stricture requiring dilation
- Secondary Outcome Measures
Name Time Method Unplanned return to OR 12 months Any unplanned return to opearting room
Anastomotic Leak 12 months Anastomotic leak seen radiographically or in the operating room
Duration of perenteral nutrition 12 months Days requrining TPN
Length of Stay 12 months Length of stay during hospitalization for primary repair
Recurrent Fistula 12 months Recurrent fistula seen radiographically or in the operating room
Vocal cord injury 12 months vocal cord injury seen radiographically or in the operating room
Trial Locations
- Locations (10)
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Benioff Children's Hospital
🇺🇸San Francisco, California, United States
Lucile Packard Children's Hospital
🇺🇸Stanford, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Doernbecher Children's Hospital
🇺🇸Portland, Oregon, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Children's Medical Center
🇺🇸Dallas, Texas, United States