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Completed

NCT Number: NCT07373522

Biliary Stent For Management Of Esophageal Stricture In Children

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

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Key information

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University

Zagazig, Sharquia, 7120730, Egypt

About this study

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:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. incidence of recurrence of stenosis

    Time frame: within one week after the endoscopy

    incidence of recurrence of stenosis

Secondary outcomes

  1. incidence of side effects of endoscopy

    Time frame: within one month after the endoscopy

    incidence of side effects of endoscopy

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Biliary Stent For Management Of Esophageal Stricture In Children: A Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.