NCT07373522

Biliary Stent For Management Of Esophageal Stricture In Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

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 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): 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.

Conditions

• Esophageal Stenosis in Children

Interventions

Type	Name	Description
PROCEDURE	endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent	endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-01-01
• Completion: 2026-01-15
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: Egypt