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Biliary Stent For Management Of Esophageal Stricture In Children

Z

Zagazig University

Status

Completed

Conditions

Esophageal Stenosis in Children

Treatments

Procedure: endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent

Study type

Interventional

Funder types

Other

Identifiers

NCT07373522
Ahmed Farag

Details and patient eligibility

About

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

Full 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):

A. Type of the study : A randomized Controlled Trial.

B. Steps of performance:

  1. Complete history taking.
  2. Clinical and laboratory results.
  3. Radiological results.
  4. Endoscopic management of Esophgeal Stricuture In Children.
  5. Analysis of the results.
  6. 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.

Enrollment

40 patients

Sex

All

Ages

1 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with Esophageal Stricture In Children.
  • recurrent fistula.
  • failed conservative measures .
  • patient with good general condition (ASA I&II).

Exclusion criteria

  • bad general condition (ASAIII&IV&V).
  • respond to conservative measures.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Endoscopic Group
Active Comparator group
Description:
endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent.
Treatment:
Procedure: endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent
surgical group
No Intervention group
Description:
resection and reconstruction of stenosed esophageal segemt

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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