Individualized Management for Long Gap Esophageal Atresia

Esophageal Atresia Clinical Trial

Official title:

Individualized Diagnosis and Treatment for Long Gap Esophageal Atresia Based on the Principle of Biological Growth Under Stress

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03023865
• Other study ID #: XH-16-033
• Status: Not yet recruiting
• Phase: N/A
• First received: October 26, 2016
• Last updated: January 13, 2017
• Start date: January 2017
• Est. completion date: October 2019

Study information

• Verified date: October 2016
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Wang Jun, MD
• Phone: +8613651752216
• Email: jwangjl[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with long gap esophageal atresia(LGEA)which the gap lenth=3.5cm;

• with(out)tracheoesophageal fistula(TEF)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Esophageal Atresia

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
China	Department of Pediatric Surgery	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (3)

Rothenberg SS, Flake AW. Experience with Thoracoscopic Repair of Long Gap Esophageal Atresia in Neonates. J Laparoendosc Adv Surg Tech A. 2015 Nov;25(11):932-5. doi: 10.1089/lap.2015.0124. — View Citation

Spitz L, Kiely EM, Drake DP, Pierro A. Long-gap oesophageal atresia. Pediatr Surg Int. 1996 Aug;11(7):462-5. doi: 10.1007/BF00180083. — View Citation

von Allmen D, Wijnen RM. Bridging the Gap in the Repair of Long-Gap Esophageal Atresia: Still Questions on Diagnostics and Treatment. Eur J Pediatr Surg. 2015 Aug;25(4):312-7. doi: 10.1055/s-0035-1562926. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with LGEA cured by the elongation method	Provide the numbers of patients with LGEA cured by the method using elongation technique	up to 3 years
Secondary	Data collection of patients with LGEA	Circumstances of diagnosis,gap length in centimetre between esophageal pouches ,operation method,modalities in percent of follow-up clinical management	up to 3 years