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New treatment option for Malignant Hilar Stricture
Official title ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
ClinicalTrials.gov ID: NCT06613945
What this study is testing
- What it's testing
- A prospective randomized clinical trial to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced malignant hilar biliary obstruction. The primary outcome will be technical success, clinical success, procedural duration, and re-interventions.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Presence of inoperable malignant hilar biliary obstruction on magnetic resonance cholangiography, computed tomography and/or direct cholangiography...
- Histologically confirmed malignant hilar biliary obstruction.
- Elevated serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
- Absence of duodenal narrowing/obstruction.
- Accept sharing in the study
You likely can't join if
- Pregnancy.
- Distal biliary obstruction as the main lesion.
- Benign biliary stenosis.
- Malignant hilar biliary obstruction bismuth type I and II.
- Presence of duodenal obstruction.
- Surgically altered anatomy or inability to access the major duodenal papilla.
See the full eligibility criteria
- Presence of inoperable malignant hilar biliary obstruction on magnetic resonance cholangiography, computed tomography and/or direct cholangiography bismuth type III \& IV only.
- Histologically confirmed malignant hilar biliary obstruction.
- Elevated serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
- Absence of duodenal narrowing/obstruction.
- Accept sharing in the study
- Pregnancy.
- Distal biliary obstruction as the main lesion.
- Benign biliary stenosis.
- Malignant hilar biliary obstruction bismuth type I and II.
- Presence of duodenal obstruction.
- Surgically altered anatomy or inability to access the major duodenal papilla.
- Patients underwent previous intervention for biliary drainage.
- Previously failed biliary cannulation at ERCP.
- Large volume ascites.
- Patients unfit for anesthesia.
- Patients having uncorrectable coagulopathy or thrombocytopenia.
- History of allergy to radiocontrast agents.
- Refuse sharing in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Al Mansurah, Dakahlia Governorate, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Al Mansurah, Dakahlia Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.