Esophageal Stenosis in ChildrenNCT07373522
Biliary Stent For Management Of Esophageal Stricture In Children
A study testing endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent in people with Esophageal Stenosis in Children, run by Zagazig University at 1 site in Egypt.
Trial summary
All patients will subjected to the followings: patients were selected by randomization method, full history taking, Complete physical examination, laboratory investigations (complete blood picture, liver and kidney functions, coagulation profile, tumor marker tests, serum electrolytes), patients were assessed… Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Esophageal Stenosis in Children
- What is being tested?
- endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 15 Jan 2026
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with Esophageal Stricture In Children.
- recurrent fistula.
- failed conservative measures .
- patient with good general condition (ASA I\&II).
Who cannot join
- bad general condition (ASAIII\&IV\&V).
- respond to conservative measures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biliary Stent For Management Of Esophageal Stricture In Children: A Randomized Controlled Trial.
All patients will subjected to the followings:
patients were selected by randomization method, full history taking, Complete physical examination, laboratory investigations (complete blood picture, liver and kidney functions, coagulation profile, tumor marker tests, serum electrolytes), patients were assessed radio-logically by abdominal x- ray , abdominal ultrasound, pelvic and abdominal CT.
For patients in EG, we began with assessment of the site \& lenght of stricture . In this study, we used fully covered self expanded metallic biliary stent.
For patients in SG, we usually did gastrotomy feeding tube, excision and re-anastomosis, or did esophageal replacement surgery
Read the detailed description
Technical design:
A- Site of the study: The investigators included all patients who were presented to General Surgery Department with Esophgeal Stricuture In Children at Zagazig University hospital between (December 2024 to December 2025).
B- Sample size:
c- Sample selection: Included patients were randomized at a 1:1 ratio to "Endoscopic Group, EG" or "Surgical Group , SG" via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention.(simple random sample).
D- Subjects: Patients will be divided into 2 groups in accordance type of preoperative
Therapy :
Group 1: "Endoscopic Group, EG" included patients. Group 2: "Surgical Group , SG" included patients.
Inclusion criteria:
Patients with Esophgeal Stricuture In Children , recurrent fistula , failued conservative meaures .patient with good general condition (ASA I\&II).
Exclusion criteria:
We excluded patients who bad general condition (ASAIII\&IV\&V), respond to conservative measures.
E- Data collection (tools): All patients will subjected to the followings:
patients were selected by randomization method, full history taking, Complete physical examination, laboratory investigations (complete blood picture, liver and kidney functions, coagulation profile, tumor marker tests, serum electrolytes), patients were assessed radio-logically by abdominal x- ray , abdominal ultrasound, pelvic and abdominal CT.
Study design (operational study):
- Type of the study : A randomized Controlled Trial.
- Steps of performance:
- Complete history taking.
- Clinical and laboratory results.
- Radiological results.
- Endoscopic management of Esophgeal Stricuture In Children.
- Analysis of the results.
- Preparing conclusion and recommendation.
C-Study techniques (procedure):
For patients in EG, we began with assessment of the site \& lenght of stricture . In this study, we used fully covered self expanded metallic biliary stent.
For patients in SG, we usually did gastrotomy feeding tube, excision and re-anastomosis, or did esophageal replacement surgery.
D-Outcomes:
Primary and secondary outcomes were incidence of postoperative hospital stay and complications in each group during the 3-months follow-up period, respectively.
- Conditions
- Esophageal Stenosis in Children
- Being tested
- endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic stenting of esophageal stricture by fully covered self expanding metallic stentProcedure or surgery
endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Group | Active comparator | endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent. Receives: Procedure: endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent |
| surgical group | No intervention | resection and reconstruction of stenosed esophageal segemt |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of recurrence of stenosis
incidence of recurrence of stenosis
Measured: within one week after the endoscopy
Secondary outcomes (1)
incidence of side effects of endoscopy
incidence of side effects of endoscopy
Measured: within one month after the endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Nov 2024
- Primary completion1 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Stenosis in ChildrenStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study included children who were admitted to investigators' center to repair esophageal stricture. Cases were collected in the period from December 2025 to January 2026. the sample size was 40 patients divided into two equal groups. Group (1) included 20 patients managed by surgical intervention , group (2) included 15 patients managed by endoscopic intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Said Negm, Principal investigator, Zagazig University Faculty Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373522
- Sponsor's protocol ID
- Ahmed Farag
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biliary Stent For Management Of Esophageal Stricture In Children: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07373522
- Acronym / sponsor ID
- Ahmed Farag
- Conditions
- Esophageal Stenosis in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 28 Jan 2026 (actual)
- 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.
All patients will subjected to the followings:
patients were selected by randomization method, full history taking, Complete physical examination, laboratory investigations (complete blood picture, liver and kidney functions, coagulation profile, tumor marker tests, serum electrolytes), patients were assessed radio-logically by abdominal x- ray , abdominal ultrasound, pelvic and abdominal CT.
For patients in EG, we began with assessment of the site \& lenght of stricture . In this study, we used fully covered self expanded metallic biliary stent.
For patients in SG, we usually did gastrotomy feeding tube, excision and re-anastomosis, or did esophageal replacement surgery
Detailed description
Technical design:
A- Site of the study: The investigators included all patients who were presented to General Surgery Department with Esophgeal Stricuture In Children at Zagazig University hospital between (December 2024 to December 2025).
B- Sample size:
c- Sample selection: Included patients were randomized at a 1:1 ratio to "Endoscopic Group, EG" or "Surgical Group , SG" via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention.(simple random sample).
D- Subjects: Patients will be divided into 2 groups in accordance type of preoperative
Therapy :
Group 1: "Endoscopic Group, EG" included patients. Group 2: "Surgical Group , SG" included patients.
Inclusion criteria:
Patients with Esophgeal Stricuture In Children , recurrent fistula , failued conservative meaures .patient with good general condition (ASA I\&II).
Exclusion criteria:
We excluded patients who bad general condition (ASAIII\&IV\&V), respond to conservative measures.
E- Data collection (tools): All patients will subjected to the followings:
patients were selected by randomization method, full history taking, Complete physical examination, laboratory investigations (complete blood picture, liver and kidney functions, coagulation profile, tumor marker tests, serum electrolytes), patients were assessed radio-logically by abdominal x- ray , abdominal ultrasound, pelvic and abdominal CT.
Study design (operational study):
- Type of the study : A randomized Controlled Trial.
- Steps of performance:
- Complete history taking.
- Clinical and laboratory results.
- Radiological results.
- Endoscopic management of Esophgeal Stricuture In Children.
- Analysis of the results.
- Preparing conclusion and recommendation.
C-Study techniques (procedure):
For patients in EG, we began with assessment of the site \& lenght of stricture . In this study, we used fully covered self expanded metallic biliary stent.
For patients in SG, we usually did gastrotomy feeding tube, excision and re-anastomosis, or did esophageal replacement surgery.
D-Outcomes:
Primary and secondary outcomes were incidence of postoperative hospital stay and complications in each group during the 3-months follow-up period, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study included children who were admitted to investigators' center to repair esophageal stricture. Cases were collected in the period from December 2025 to January 2026. the sample size was 40 patients divided into two equal groups. Group (1) included 20 patients managed by surgical intervention , group (2) included 15 patients managed by endoscopic intervention.
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Group | Active comparator | Procedure: endoscopic stenting of esophageal stricture by fully covered self expanding metallic stentendoscopic stenting of esophageal stricture by fully covered self expanding metallic stent. |
| surgical group | No intervention | –resection and reconstruction of stenosed esophageal segemt |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients with Esophageal Stricture In Children.
- recurrent fistula.
- failed conservative measures .
- patient with good general condition (ASA I\&II).
Key exclusion criteria (2 listed)
- bad general condition (ASAIII\&IV\&V).
- respond to conservative measures.
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 |
|---|---|---|
| endoscopic stenting of esophageal stricture by fully covered self expanding metallic stentendoscopic stenting of esophageal stricture by fully covered self expanding metallic stent | Procedure or surgery | Endoscopic Group |
Primary outcome
incidence of recurrence of stenosis
Time frame: within one week after the endoscopy
incidence of recurrence of stenosis
1 secondary outcome
incidence of side effects of endoscopy
Time frame: within one month after the endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Esophageal Stenosis in Children
Not yet recruiting
Budesonide Following Endoscopic Dilatation of Esophageal Strictures in Children.
Esophageal Stricture
Recruiting
An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children
Esophageal Stenosis, Esophageal Dilation
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.
Said Negm principal investigator
Zagazig University Faculty 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 endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent in people with Esophageal Stenosis in Children, run by Zagazig University at 1 site in Egypt.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 28 Jan 2026. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of recurrence of stenosis (time frame: within one week after the endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026.