NCT03023865

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

January 18, 2017

Status Verified

October 1, 2016

Enrollment Period

2.7 years

First QC Date

October 26, 2016

Last Update Submit

January 13, 2017

Conditions

Esophageal Atresia

Keywords

Long gap esophageal atresia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Data collection of patients with LGEA

    up to 3 years

Study Arms (1)

Staged stress function

EXPERIMENTAL

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

Interventions

Staged stress functionPROCEDURE

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

Staged stress function

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with long gap esophageal atresia（LGEA）which the gap lenth≥3.5cm；
  • with（out）tracheoesophageal fistula（TEF）

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric Surgery

Shanghai, Shanghai Municipality, 200092, China

Location

Related Publications (3)

  • 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.

    PMID: 26302063BACKGROUND

  • 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.

    PMID: 24057783BACKGROUND

  • 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.

    PMID: 26485521BACKGROUND

MeSH Terms

Conditions

Esophageal Atresia

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Wang Jun, MD

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

    STUDY DIRECTOR

Central Study Contacts

Wang Jun, MD

CONTACT

+8613651752216jwangjl@126.com

Sun Suna, bachelor

CONTACT

+8618801970307sunsuna1231@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2016

First Posted

January 18, 2017

Study Start

January 1, 2017

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

January 18, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

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

Locations

CN(1)