EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Oct 22, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help patients with a specific type of bile duct blockage caused by cancer, known as distal malignant biliary obstruction. The study is testing a procedure called EUS-guided choledochoduodenostomy, which aims to provide a safer and more effective way to drain bile from the blocked area using a special type of stent. This could help prevent the stent from failing, which is a common issue in patients with this condition.

To participate in this trial, you must be between the ages of 65 and 74 and have a confirmed diagnosis of cancer that is causing a blockage in your bile duct. Additionally, you should require drainage of the bile duct, and you need to provide written consent to take part in the study. Participants will undergo the procedure at a medical center and will be monitored for safety and effectiveness. This trial is currently recruiting, so if you or a loved one are facing this health challenge, it may be worth discussing with your doctor.

Gender

ALL

Eligibility 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.