An interventional study of Endoscopic stenting Retrograde Cholangiopancreatography (ERCP) in Common Bile Duct Calculi, sponsored by Assiut University. Not yet recruiting at 1 site in Egypt. Open to participants aged 15 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
Gallstones are a very common problem in developed countries. Most patients with gallstones remain asymptomatic throughout their lifetime, but 10 % - 25 % of them may develop biliary pain or complications, with an annual risk of about 2 % - 3 % for symptomatic disease and 1 % - 2 % for major complications. The development of symptomatic disease and complications is mostly related to the migration of stones into the common bile duct (CBD). Common bile duct stones (CBDSs) may be treated by endoscopic retrograde cholangiopancreatography (ERCP) or surgically during cholecystectomy. Removal of common bile duct (CBD) stones can still be difficult in patients with large or multiple stones despite an adequate sphincterotomy. Procedures such as mechanical, extracorporeal, electrohydraulic or laser lithotripsy, and chemical dissolution have been introduced as effective therapeutic interventions for irretrievable CBD stones. However, these techniques have their drawbacks, are not widely available, or are still under clinical evaluation. Several studies have shown that insertion of an endoscopic biliary stent is a safe, effective, and widely available measure. An indwelling stent provides biliary drainage and fragments large stones, thereby reducing the risk of cholangitis and allowing stones to pass spontaneously or rendering them more extractable at a later procedure. Thus, this study intends to shed a light on advances in diagnosis and management in patients with biliary difficult stones.
199 studies on the registry are indexed under Gallstones; 35 are open to participants now.
This study's planned enrollment of 3 is below the median of 98 across 121 interventional studies indexed under Gallstones.
Browse Gallstones studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One session application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large \[≥ 20 mm\] or multiple \[≥ 3 sized ≥ 15 mm\] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)
Two sessions application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones.and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large \[≥ 20 mm\] or multiple \[≥ 3 sized ≥ 15 mm\] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)
Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large \[≥ 20 mm\] or multiple \[≥ 3 sized ≥ 15 mm\] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
Time of procedure.
This is measured in hours.
Time frame: On the day of determined procedure.
Rate of stone size reduction.
This is measured in millimeters.
Time frame: Baseline.
Width of CBD.
This is measured in millimeters.
Time frame: Baseline.
Degree of stone clearance and complications.
Those are determined by close monitoring of patients whether after ERCP or surgery.
Time frame: Baseline.
Postoperative morbidity and mortality.
Those are measures in percentage of patients in the study.
Time frame: Baseline.
Blood loss during the procedure.
This is measured in milliliters.
Time frame: Baseline.
Postoperative wound infection.
This is measured in percentage of patients in the study.
Time frame: Baseline.
Postoperative hospital stay.
This is measured in days.
Time frame: Baseline.
Postoperative hemorrhage.
This is measured in milliliters.
Time frame: Baseline.
Postoperative 30 day mortality rate.
This is measured in percentage of patients in the study.
Time frame: Baseline.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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