Zagazig University
Zagazig, Sharquia, 7120730, Egypt
NCT Number: NCT07373522
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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Notify Me1 year–12 year
All sexes
Interventional
Not applicable
Zagazig, Sharquia, 7120730, Egypt
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent
Time frame: within one week after the endoscopy
incidence of recurrence of stenosis
Time frame: within one month after the endoscopy
incidence of side effects of endoscopy
Zagazig University
Other Gov
Biliary Stent For Management Of Esophageal Stricture In Children: A Randomized Controlled Trial.
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