Transanastomotic Tube (5FR)
Device5FR tube left in place for 5 days after completion of esophageal anastomosis.
NCT Number: NCT03730454
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.
This study is active but is not currently recruiting participants.
Notify MeUp to 6 month
All sexes
Interventional
Not applicable
Phoenix Children's Hospital, Phoenix, Arizona, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5FR tube left in place for 5 days after completion of esophageal anastomosis.
No transanastomotic tube used during repair
Time frame: 12 months
Symptomatic anastomotic stricture requiring dilation
Time frame: 12 months
Anastomotic leak seen radiographically or in the operating room
Time frame: 12 months
Recurrent fistula seen radiographically or in the operating room
Time frame: 12 months
vocal cord injury seen radiographically or in the operating room
Time frame: 12 months
Any unplanned return to opearting room
Time frame: 12 months
Days requrining TPN
Time frame: 12 months
Length of stay during hospitalization for primary repair
Phoenix Children's Hospital
Other
A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair
Acronym: TEF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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