Individualized Management for Long Gap Esophageal Atresia

Not Applicable

• Conditions: Esophageal Atresia
• Interventions: Procedure: Staged stress function

• Registration Number: NCT03023865
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

The treatment of long gap esophageal atresia (LGEA) in neonates is one of the most challenging congenital malformations in neonatal surgery. Usually the proximal and distal segments of the esophagus are too far apart, which leads to primary anastomosis abandoned. Thus various techniques have been used including Circular and spiral myotomies、Foker and Kimura elongation and gastrointestinal replacement. They are being widely used but bring more complications and less effectiveness. And considering about the absence of definite guideline for the diagnosis and treatment of LGEA worldwide, We prepare to use a preoperative staged stress function procedure for elongation of the proximal and distal segments, then to obtain an exact evaluation of the pouch status to achieve an individualized protocol of diagnosis and treatment utilizing the native esophagus to establish esophageal continuity for patients with LGEA.

Detailed Description

Patients with diagnosis of LGEA(gap distance\>3.5cm) will be accepted to the program.

After accepted to our center, the patients will feed by gastrostomy tube to keep nutritional status remain well controlled. Continuous suction in the upper pouch will be applied to avoid aspiration pneumonia.

We will design a bouginage with baroreceptor. Then the stress function will be performed as following steps. The designed bouginage will be inserted into the upper esophagus pouch through oral cavity with a certain downward longitudinal force to increase esophageal length by tissue stretch and growth, it will be performed 10-15 minutes each time once/twice a day. While the elongation of distal pouch will be achieved via the gastrostomy using the same bouginage to give upward pressure, the program will be operated under X-ray firstly to avoid injury or false passage formation,it can be performed in the ward thereafter. The gap length and the diameter of the pouch will be evaluated every 1-2 weeks. During the elongation period, continuous upper pouch suctioning and nutritional support were maintained.

When the gap distance is short enough，the method of surgery will be decided，including end-to-end anastomosis、Livadites、flip-flap and choice of thoracoscopy use. The purpose of the program is to achieve the exact management and treatment for patients with LGEA and help promoting the use of the new technology.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-26
• Study Start: 2017-01
• Study First Submitted QC: 2017-01-13
• Last Update Submitted: 2017-01-13
• Study First Posted: 2017-01-18
• Last Update Posted: 2017-01-18
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients with LGEA which can not accept the staged stress function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Staged stress function	Staged stress function	A preoperative staged stress function procedure for elongation of the proximal and distal segments to achieve utilizing the native esophagus to establish esophageal continuity

Primary Outcome Measures

Name	Time	Method
Number of patients with LGEA cured by the elongation method	up to 3 years	Provide the numbers of patients with LGEA cured by the method using elongation technique

Secondary Outcome Measures

Name	Time	Method
Data collection of patients with LGEA	up to 3 years	Circumstances of diagnosis，gap length in centimetre between esophageal pouches ，operation method，modalities in percent of follow-up clinical management

Trial Locations

Locations (1)

Department of Pediatric Surgery; 🇨🇳 Shanghai, Shanghai, China