CompletedNot Applicable

Biliary Fistula and Late Recurrence of Liver Hydatid Cyst: Role of Cysto-biliary Communication

244 participantsStarted 2010-09

Plain-language summary

Purpose : The primary goals of this study were to determine the prevalence and risk factors of occult CBC and recurrence, as well as the relationship between occult cysto-biliary communications manifested as postoperative biliary leakage and recurrence. The secondary goal was to use chemical analysis of hydatid cyst fluid to assess excessive bilirubin and alkaline phosphatase levels as predictors of fistula and recurrence. Methods: This prospective multi-center experimental and follow-up study of six years duration was conducted at the hepato-biliary pancreatic units of our universities hospitals from September 2010 to September 2016. Initially, 292 patients were included, but only 244 patients enrolled in the final study.

Who can participate

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: * Stages CE2 * CE3b According to the WHO-IWGE classification * solitary * symptomatic or asymptomatic * superficial cyst * cases not suited for hepatic resection as the cyst wall abutting critical vascular and biliary structures as hepatic resection is harmful or excessive loss of hepatic tissue Exclusion Criteria: * stages CL, CE1, CE3a, CE4, CE5 according to WHO-IWGE classification of the hydatid cyst * preoperative total bilirubin level greater than 2.0 mg/dl and direct bilirubin level greater than 1.5 mg/dl * common bile duct dilatation greater than 10 mm , or CT, or MRI, previous percutaneous treatment * recurrent cases after any type of surgery, cases with associated extrahepatic or extra-abdominal hydatid cyst * cysts affecting an entire lobe or the main pedicles * stages Cysts that are complicated (ruptured or diseased cysts), deep cysts .Patients who refuse intervention, have a surgical contraindication, are pregnant, have hydatid cysts in both lobes of the liver, previous liver surgery, liver abscess, frank CBC, cases lost during follow-up, cases who refused to take albendazole, or cases who developed albendazole-related issues (disturbed liver function).

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

biliary leakage

Timeframe: 30 days postoperatively

recurrence

Timeframe: 5 years

Trial details

NCT IDNCT05116735

SponsorZagazig University

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Liver Surgery trials

Plain-language summary

Who can participate

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.