EUS-Guided Choledochoduodenostomy Versus ERCP for Primary Biliary Decompression in Distal Maligna… (NCT04898777) | Clinical Trial Compass
CompletedNot Applicable
EUS-Guided Choledochoduodenostomy Versus ERCP for Primary Biliary Decompression in Distal Malignant Biliary Obstruction
Egypt100 participantsStarted 2021-07-01
Plain-language summary
Malignant biliary obstruction commonly caused by pancreatic adenocarcinoma, cholangiocarcinoma and other etiologies like gallbladder carcinoma, hepatocellular carcinoma, lymphoma, and metastasis to regional solid organs and lymph nodes.
Pancreatobiliary cancers generally present with jaundice, weight loss, and anorexia with significant impact on quality of life, morbidity, and mortality.
The primary goal of diagnosis and management is curative resection but it's difficult due to local invasion and distant metastases at the time of clinical presentation. Biliary decompression helps to reduce symptoms and improve quality of life in patients with malignant biliary obstruction.
Endoscopically placed stents have become the standard of care for non-surgical biliary drainage due to their minimal invasiveness compared to percutaneous drainage.
The standard treatment of obstructive jaundice has been ERCP with biliary stent placement with high success rate in expert hands and low frequency of adverse events.
Endoscopic ultrasound-guided biliary drainage (EUS-BD) has been increasingly used in patients who underwent failed ERCP. EUS-BD can be performed in several ways, choledochoduodenostomy (CDS), hepaticogastrostomy (HGS), antegrade (AG) procedure, and rendezvous (RV) technique.
Who can participate
Age range
18 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:
* Age: 18 years and older.
* Presence of locally advanced or metastatic pancreatic head mass on CT or magnetic resonance imaging of the abdomen
* Absence of duodenal obstruction.
* Elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
* Histologic or cytologic diagnosis of malignancy.
* Accept sharing in the study.
Exclusion Criteria:
* Age younger than 18 years.
* Pregnancy.
* Hilar biliary obstruction (as the main lesion or coexisting with distal obstruction).
* Presence of duodenal obstruction.
* Histologic or cytologic diagnosis of malignancy.
* Patients underwent previous intervention for biliary drainage.
* Previously failed biliary cannulation at ERCP.
* Prior biliary sphincterotomy or stent placement.
* Surgically altered anatomy or inability to access the major duodenal papilla.
* Patients unfit for anesthesia.
* Patients having uncorrectable coagulopathy or thrombocytopenia.
* History of allergy to radiocontrast agents.
* Refuse sharing in the study.
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.