EUS-guided procedure for draining bile in patients with malignant obstructions
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction: a Pilot Study Using FCSEMS Through LAMS
This study is testing a new way to drain bile for patients with cancer-related blockages in their bile ducts to see if it helps relieve their symptoms safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05595122 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the feasibility and safety of using endoscopic ultrasound (EUS)-guided choledochoduodenostomy as a primary drainage method for patients suffering from distal malignant biliary obstruction. The approach utilizes a fully covered self-expanding metal stent (FCSEMS) through a lumen-apposing metal stent (LAMS) to minimize stent dysfunction. The study aims to evaluate the effectiveness of this technique in providing relief from biliary obstruction caused by malignancies such as distal cholangiocarcinoma and pancreatic neoplasms.
Who should consider this trial
Good fit: Ideal candidates include adults with confirmed distal malignant bile duct obstruction requiring biliary drainage.
Not a fit: Patients with extensive liver metastases or those with a WHO performance score of 4 may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could offer a safer and more effective drainage option for patients with malignant biliary obstructions.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using EUS-guided techniques for biliary drainage.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Radiographically (CT or EUS) distal malignant bile duct obstruction * Histology or cytology proven malignancy of the primary tumour or metastasis; onsite cytology evaluation after EUS guided fine-needle sampling that is highly suspected of a malignancy suffices * Indication for biliary drainage; in case of a resectable tumour this should be discussed during a clinical multidisciplinary meeting * Written informed consent Exclusion Criteria: * Age \< 18 year * Surgically altered anatomy after previous gastric, periampullary or duodenal resection * Cancer extending into the antrum or proximal duodenum * Extensive liver metastases * WHO performance score of 4 (in bed 100% of time) * Uncorrectable coagulopathy, defined by INR\>1.5 or platelets \< 50 x 10\^9/L\* * Clinically relevant gastric-outlet obstruction * Unable to complete sign informed consent * Inclusion is allowed after corrective treatment measures are taken, according to local protocol and treating physician.
Where this trial is running
Amsterdam
- Amsterdam UMC location VUmc — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Jeska Fritzsche
- Email: j.a.fritzsche@amsterdamumc.nl
- Phone: +3120440613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.