CompletedNot Applicable

EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice

Romania539 participantsStarted 2018-03-27

Plain-language summary

The main objective of the study is to evaluate the size of the common bile duct (CBD) in a large cohort of patients with jaundice secondary to pancreatic head or distal bile duct malignancy undergoing diagnostic EUS for tissue acquisition or evaluation of resectability and to establish factors associated with a dilation of the CBD greater than 15mm.

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: * Patients with jaundice and a pancreatic head mass lesion referred for EUS-guided tissue acquisition or staging * Patients with jaundice and a distal CBD lesion suggestive of cholangiocarcinoma or a carcinoma of the ampulla of Vater referred for EUS-guided tissue acquisition or staging * Serum bilirubin level ≥3 mg/dL * Age ≥18 years * Written informed consent Exclusion Criteria: * Presence of altered anatomy from previous gastric surgery (Billroth II or Roux-en-Y anastomosis) * Previously performed sphincterotomy, biliary plastic stent or metal stent placement * Previous percutaneous drainage of the bile duct * Pregnancy * Inability to sign the informed consent

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

Common bile duct diameter

Timeframe: Enrollment over 6 months

Trial details

NCT IDNCT03494023

SponsorClinical Hospital Colentina

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12-31

View on ClinicalTrials.gov More Pancreatic Cancer trials