Esophageal AtresiaNCT03023865
Individualized Management for Long Gap Esophageal Atresia
A study testing Staged stress function in people with Esophageal Atresia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Esophageal Atresia
- What is being tested?
- Staged stress function
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with long gap esophageal atresia（LGEA）which the gap lenth≥3.5cm；
- with（out）tracheoesophageal fistula（TEF）
Who cannot join
- Patients with LGEA which can not accept the staged stress function
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pediatric Surgery
Shanghai, Shanghai Municipality, 200092
Wang Jun, MD, +8613651752216, jwangjl@126.com
About this study
Official title: 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.
Read the 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
- Being tested
- Staged stress function
- Keywords
- Long gap esophageal atresia
- Medical subject headings
- Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staged stress functionProcedure or surgery
A preoperative staged stress function procedure for elongation of the proximal and distal segments to achieve utilizing the native esophagus to establish esophageal continuity
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Staged stress function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with LGEA cured by the elongation method
Provide the numbers of patients with LGEA cured by the method using elongation technique
Measured: up to 3 years
Secondary outcomes (1)
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
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal AtresiaStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Jun, MD, Study director, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023865
- Sponsor's protocol ID
- XH-16-033
- Status last verified
- Oct 2016
- First submitted
- 26 Oct 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Share with the period of stress applied,gap distance between two esophageal segments,stress pressure.etc
Publications
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.
PubMed 26302063Spitz 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.
PubMed 24057783Rothenberg 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.
PubMed 26485521
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Diagnosis and Treatment for Long Gap Esophageal Atresia Based on the Principle of Biological Growth Under Stress
- ClinicalTrials.gov ID
- NCT03023865
- Acronym / sponsor ID
- XH-16-033
- Conditions
- Esophageal Atresia
- Keywords
- Long gap esophageal atresia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Staged stress function | Experimental | Procedure: Staged stress functionA preoperative staged stress function procedure for elongation of the proximal and distal segments to achieve utilizing the native esophagus to establish esophageal continuity |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with long gap esophageal atresia（LGEA）which the gap lenth≥3.5cm；
- with（out）tracheoesophageal fistula（TEF）
Key exclusion criteria (1 listed)
- Patients with LGEA which can not accept the staged stress function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staged stress functionA preoperative staged stress function procedure for elongation of the proximal and distal segments to achieve utilizing the native esophagus to establish esophageal continuity | Procedure or surgery | Staged stress function |
Primary outcome
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
1 secondary outcome
Data collection of patients with LGEA
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Background: PubMed 26302063von 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.
- Background: PubMed 24057783Spitz 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.
- Background: PubMed 26485521Rothenberg 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.
- Individual participant dataSharing planned: Yes. Share with the period of stress applied,gap distance between two esophageal segments,stress pressure.etc
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Jun, MD study director
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staged stress function in people with Esophageal Atresia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Jun, MD (+8613651752216, jwangjl@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with LGEA cured by the elongation method (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03023865, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.