Evaluation of (Surgery and Endoscopy) in Management of Indeterminate Common Bile Duct Stricture (NCT05138237) | Clinical Trial Compass
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Evaluation of (Surgery and Endoscopy) in Management of Indeterminate Common Bile Duct Stricture
Egypt60 participantsStarted 2021-08-01
Plain-language summary
Evaluate the lower indeterminate CBD strictures trying to reach possible diagnosis by all available methods i.e brush cytology ,bile aspirate cytology , tissue biopsy ,imaging studies and laboratory work up then treatment of the patient either endoscopically or surgically according to the etiology.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* both sex
* above age of 20 years old
* patients presented with jaundice , pain and fever due to lower common bile duct stricture evident by abdominal imaging (Abdominal US ,MRCP) and confirmed by endoscopic retrograde cholangiopancreatography ( ERCP)
* patients presented to sohag university hospital.
Exclusion Criteria:
* Already diagnosed lower CBD strictures i.e known cause like visible pancreatic mass with visible metastasis or common bile duct stones.
* Coagulopathy INR more than 1.5 or thrombocytopenia platelet less than 50,000/ml.
* Proximal common bile duct stricture "above level of cystic duct".
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
number of patients who are successfully treated of CBD strictures by endoscopy or by surgery
Timeframe: follow up of the patient for 6 - 9 months
2
reach a proper algorithm or scheme for management of the CBD stricture
Timeframe: follow up of the patient for 6 - 9 months
Trial details
NCT IDNCT05138237
SponsorSohag University
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2022-08-01
Contact for this trial
mohamed elsayed abdel aal, master degree general surgery