Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair



Status:Recruiting
Conditions:Hospital, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:Any
Updated:11/7/2018
Start Date:May 11, 2018
End Date:May 2020

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A Multi-Center Randomized Trial of Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

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.

Esophageal atresia 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 9 children's hospitals including Phoenix
Children's Hospital, Doerbnercher Children's Hospital, Primary Children's Hospital, Lucille
Packard Children's Hospital, Seattle Children's Hospital, Colorado Children's Hospital,
Children's Hospital of Los Angeles, Rady Children's Hospital, and Benioff Children's
Hospital. 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.

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
We found this trial at
9
sites
Stanford, California 94305
Principal Investigator: Claudia Mueller, MD, PhD
Phone: 650-723-6439
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Lorriane Kelley-Quon, MD
Phone: 323-361-1628
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Rony Marwan, MD
Phone: 720-777-6549
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phone: 602-933-7007
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Portland, Oregon 97239
Principal Investigator: Elizabeth Fialkowski, MD
Phone: 503-494-7764
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Salt Lake City, Utah 84143
Principal Investigator: Katie Russell, MD
Phone: 801-662-2956
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San Diego, California 92123
Principal Investigator: David Lazar, MD
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San Francisco, California 94158
Principal Investigator: Benjamin Padilla, MD
Phone: 415-476-4086
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Caitlin Smith, MD
Phone: 206-987-7419
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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