Clinical trial NCT03730454: Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
Official title: A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Esophageal Atresia
Tracheoesophageal Fistula
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 142
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multisite randomized control trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Other types of esophageal atresia without esophageal anastomosis creation
* Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations

Primary outcomes:
measure: Anastomotic stricture
timeFrame: 12 months
Secondary outcomes:
measure: Anastomotic Leak
timeFrame: 12 months
measure: Recurrent Fistula
timeFrame: 12 months
measure: Vocal cord injury
timeFrame: 12 months
measure: Unplanned return to OR
timeFrame: 12 months
measure: Duration of perenteral nutrition
timeFrame: 12 months
measure: Length of Stay
timeFrame: 12 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: San Francisco
country: United States
facility: Benioff Children's Hospital
state: California
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Portland
country: United States
facility: Doernbecher Children's Hospital
state: Oregon
city: Dallas
country: United States
facility: Children's Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Phoenix Children's Hospital
name: Justin Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: