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Transanastomotic Tube Use and Anastomotic Stricture: A Multicenter Randomized Controlled Trial in Neonates Undergoing Repair of Type C EA/TEF
*Justin Lee^1,2, *Katie W. Russell³, *Caitlin Smith⁴, *Claudia Mueller⁵, *Zachary Kastenberg³, *Anastasia Kahan³, *David Rothstein⁴, *Stephanie Chao⁵, *Shannon Acker⁶, *Jose Diaz-Miron⁶, *Aimee Kim⁸, *Lorraine Kelley-Quon⁸, *Benjamin Keller¹⁰, *David Lazar¹⁰, *Sarah Cairo¹¹, *Natasha Corbitt¹², *Benjamin Carr¹³, *Elizabeth Fialkowski¹³, *Paul Kang¹⁴, *Jason Fraser¹, *Eric Scaife³, *Aaron Jensen¹¹, Steven Lee⁴, *Samir Pandya¹², Romeo Ignacio¹⁰, Thomas Inge⁷, Kenneth Azarow¹³, Kasper Wang⁹, *Ben Padilla¹, Daniel Ostlie^2
1Pediatric Surgery, Phoenix Children's Hospital, Phoenix, Arizona; ²Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; ³Pediatric Surgery, University of Utah, Primary Children's, Salt Lake City, Utah; ⁴Pediatric Surgery, Seattle Children's, Seattle, Washington; ⁵Pediatric Surgery, Lucile Packard Children's Hospital, Palo Alto, California; ⁶Pediatric Surgery, Children's Hospital Colorado, Aurora, Colorado; ⁷Pediatric Surgery, Lurie Children's Hospital of Chicago, Chicago, Illinois; ⁸Pediatric Surgery, Children's Hospital Los Angeles, Los Angeles, California; ⁹Pediatric Surgery, The Hospital for Sick Children, Toronto, Ontario; ¹⁰Pediatric Surgery, Rady Children's, San Diego, California; ¹¹Pediatric Surgery, UCSF Benioff Children's Hospital, San Francisco, California; ¹²Pediatric Surgery, Children's Medical Center, Dallas, Texas; ¹³Pediatric Surgery, Doernbecher Children's, Portland, Oregon; ¹⁴Creighton University School of Medicine, Omaha, Nebraska

Objective:
Anastomotic stricture (AS) is the most common complication after proximal esophageal atresia with distal tracheoesophageal fistula (type C EA/TEF) repair and the leading cause of unplanned return to the operating room, contributing to significant morbidity. Two large multicenter retrospective studies identified transanastomotic tube (TT) use as a major factor associated with increased AS risk. However, these findings remain controversial given the limitations of retrospective design and insufficient data granularity to determine causality. We conducted a multicenter prospective randomized controlled trial of type C EA/TEF repair with or without TT, with AS as the primary outcome.

Methods:
Type C EA/TEF cases were randomized to repair with or without TT across 10 children's hospitals. The required sample size was 136, and 141 patients were ultimately enrolled. Prospective collection of >400 variables included prenatal, preoperative, and intraoperative factors such as gap length and surgeon-assessed anastomotic tension. The primary outcome was AS requiring dilation within 12 months postoperatively. Secondary outcomes included early and long-term metrics such as anastomotic leak, enteral feeding, infection, and unplanned ED visits and readmissions.

Results:
A total of 141 cases were enrolled between 2019 and 2025: 74 (52.5%) without TT and 67 (47.5%) with TT. There were no significant differences in prenatal, demographic, preoperative, or intraoperative variables, including ventilation settings, pressor requirements, associated congenital anomalies, thoracoscopic approach, suture characteristics, gap length, surgeon-assessed tension, or operative time. The primary outcome"”stricture rate"”was similar between groups (35 [47.3%] without vs 36 [53.7%] with, p=0.45). However, time to stricture was significantly longer in those without TT (median 110 vs 67 days, p=0.014). Early outcomes, including anastomotic leak, enteral feeding, infection, and reoperation, were similar. Long-term outcomes, including reflux, recurrent fistula, tracheomalacia, ED visits, and readmissions, were also similar. On multivariate regression adjusting for weight, thoracoscopic repair, anastomotic tension, leak, and acid suppression at discharge, TT use was not independently associated with stricture (OR 1.18, p=0.64, CI 0.58-2.45). The only significant predictor of stricture development was surgeon-assessed moderate/severe anastomotic tension (OR 2.45, p=0.026, CI 1.11-5.40).

Conclusions:
This is the largest and only multicenter prospective randomized controlled trial evaluating outcomes of EA/TEF repair. Contrary to prior retrospective studies, TT use was not associated with AS. Instead, intraoperative surgeon-assessed anastomotic tension emerged as the strongest predictor of stricture development, underscoring the critical role of surgical judgment. These findings highlight the value of multicenter prospective randomized trials in improving neonatal surgical outcomes.
Multivariate Regression Analysis for Developing Anastomotic Stricture

	OR	p	CI
Weight, < 2 kg	1.49	0.35	0.65-2.37
Transanastomotic Tube	1.18	0.64	0.58-2.45
Thoracoscopic Repair	1.93	0.10	0.88-4.24
Surgeon Assessment: Mod/Severe Tension	2.45	0.026	1.11-5.40
Anastomotic Leak	1.37	0.49	0.54-3.50
Acid Suppression at Discharge	0.76	0.65	0.23-2.49

Kaplan-Meier Estimates of Time to Anastomotic Stricture

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