Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A. Transanastomotic Tube | Experimental | 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 | Experimental | Group B. No Transanastomotic tube group: Standard repair of EA/TEF will be performed. TT will NOT be used during the esophageal anastomosis creation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transanastomotic Tube (5FR) | Device | 5FR tube left in place for 5 days after completion of esophageal anastomosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic stricture | Symptomatic anastomotic stricture requiring dilation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Anastomotic Leak | Anastomotic leak seen radiographically or in the operating room | 12 months |
| Recurrent Fistula | Recurrent fistula seen radiographically or in the operating room |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Justin Lee, MD | Phoenix Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States | ||
| Children's Hospital Los Angeles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 19, 2023 |
Not provided
Multisite randomized control trial.
Not provided
Not provided
Not provided
Not provided
| No Transanastomotic Tube | Other | No transanastomotic tube used during repair |
|
| 12 months |
| Vocal cord injury | vocal cord injury seen radiographically or in the operating room | 12 months |
| Unplanned return to OR | Any unplanned return to opearting room | 12 months |
| Duration of perenteral nutrition | Days requrining TPN | 12 months |
| Length of Stay | Length of stay during hospitalization for primary repair | 12 months |
| Los Angeles |
| California |
| 90027 |
| United States |
| Rady Children's Hospital | San Diego | California | 92123 | United States |
| Benioff Children's Hospital | San Francisco | California | 94158 | United States |
| Lucile Packard Children's Hospital | Stanford | California | 94305 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Doernbecher Children's Hospital | Portland | Oregon | 97239 | United States |
| Children's Medical Center | Dallas | Texas | 75235 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Apr 3, 2024 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D004933 | Esophageal Atresia |
| D014138 | Tracheoesophageal Fistula |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004937 | Esophageal Fistula |
| D016154 | Digestive System Fistula |
| D016156 | Respiratory Tract Fistula |
| D012140 | Respiratory Tract Diseases |
| D014133 | Tracheal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided