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Individualized Management for Long Gap Esophageal Atresia

Primary Purpose

Esophageal Atresia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Staged stress function
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Atresia focused on measuring Long gap esophageal atresia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Pediatric Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Staged stress function

Arm Description

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

Outcomes

Primary Outcome Measures

Number of patients with LGEA cured by the elongation method
Provide the numbers of patients with LGEA cured by the method using elongation technique

Secondary Outcome Measures

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

Full Information

First Posted
October 26, 2016
Last Updated
January 13, 2017
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03023865
Brief Title
Individualized Management for Long Gap Esophageal Atresia
Official Title
Individualized Diagnosis and Treatment for Long Gap Esophageal Atresia Based on the Principle of Biological Growth Under Stress
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Atresia
Keywords
Long gap esophageal atresia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Staged stress function
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Staged stress function
Intervention Description
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 Measure Information:
Title
Number of patients with LGEA cured by the elongation method
Description
Provide the numbers of patients with LGEA cured by the method using elongation technique
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Data collection of patients with LGEA
Description
Circumstances of diagnosis,gap length in centimetre between esophageal pouches ,operation method,modalities in percent of follow-up clinical management
Time Frame
up to 3 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Jun, MD
Phone
+8613651752216
Email
jwangjl@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sun Suna, bachelor
Phone
+8618801970307
Email
sunsuna1231@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Jun, MD
Organizational Affiliation
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Department of Pediatric Surgery
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Jun, MD
Phone
+8613651752216
Email
jwangjl@126.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Share with the period of stress applied,gap distance between two esophageal segments,stress pressure.etc
Citations:
PubMed Identifier
26302063
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. Epub 2015 Aug 24.
Results Reference
background
PubMed Identifier
24057783
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. Epub 2013 Sep 21.
Results Reference
background
PubMed Identifier
26485521
Citation
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.
Results Reference
background

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Individualized Management for Long Gap Esophageal Atresia

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