Individualized Management for Long Gap Esophageal Atresia

January 13, 2017 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Department of Pediatric Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with LGEA cured by the elongation method
Time Frame: up to 3 years
Provide the numbers of patients with LGEA cured by the method using elongation technique
up to 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Wang Jun, MD, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ANTICIPATED)

October 1, 2019

Study Completion (ANTICIPATED)

October 1, 2019

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

January 13, 2017

First Posted (ESTIMATE)

January 18, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-16-033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Share with the period of stress applied,gap distance between two esophageal segments,stress pressure.etc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Atresia

Clinical Trials on Staged stress function

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe