Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03730454 |
| Other study ID # |
17-136 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 11, 2018 |
| Est. completion date |
February 14, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Phoenix Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
