Individualized Management for Long Gap Esophageal Atresia

NCT ID: NCT03023865

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-10-31

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.

Conditions

Esophageal Atresia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Staged stress function

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wang Jun, MD

Role: STUDY_DIRECTOR

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Locations

Department of Pediatric Surgery

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Wang Jun, MD

Role: CONTACT

jwangjl@126.com

+8613651752216

Sun Suna, bachelor

Role: CONTACT

sunsuna1231@163.com

+8618801970307

Facility Contacts

Wang Jun, MD

Role: primary

jwangjl@126.com

+8613651752216

References

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. Epub 2015 Aug 24.

Reference Type: BACKGROUND

PMID: 26302063 (View on PubMed)

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. Epub 2013 Sep 21.

Reference Type: BACKGROUND

PMID: 24057783 (View on PubMed)

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. Epub 2015 Oct 20.

Reference Type: BACKGROUND

PMID: 26485521 (View on PubMed)

Other Identifiers

XH-16-033

Identifier Type: -

Identifier Source: org_study_id