EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)

Launched by HOSPITAL UNIVERSITARI DE BELLVITGE · Apr 18, 2024

Keywords

ClinConnect Summary

The CARPEDIEM-2 Trial is a clinical study that aims to compare two treatments for patients with a specific type of cancer-related blockage in the bile ducts caused by conditions like pancreatic cancer. The trial will look at how quickly patients can start chemotherapy after receiving one of two different drainage techniques: EUS-guided cystic duct stenting (EUS-CDS) or endoscopic retrograde cholangiopancreatography (ERCP). These treatments help relieve the blockage and allow bile to flow, which is important for starting cancer treatment.

To be eligible for this trial, patients need to have a diagnosed malignant blockage in the bile ducts and meet certain health criteria, such as having elevated liver enzymes and specific imaging results. Participants must also be able to understand the study and provide consent. The trial is not yet recruiting participants, but once it begins, those who join can expect regular follow-ups to monitor their health and response to treatment. It's important to note that certain patients, such as those with severe bleeding disorders or previous biliary treatments, will not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Malignant distal biliary obstruction diagnosed in patient considered BORDERLINE with biliary drainage indication: i) impaired hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of retrograde dilatation, of at least 12-mm axial diameter.
• • Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histological confirmation is not mandatory)
• • Patient capable of understanding and/or singning the informed consent.
• • Patient who understands the type of study and will comply with all follow-up tests throughout its duration
• Exclusion Criteria:
• • Pregnancy or lactation.
• • Severe coagulation disorder: INR \> 1.5 non correctable with plasma administration and/or platelet count \< 50.000/mm3.
• • Distal malignant biliary strictures in patients considered directly resectable, non-surgical, unresectable, or palliative
• • Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum.
• • Patients with prior biliary stents or other biliary drainages (e.g., PTCD).
• • Altered intestinal anatomy due to prior surgery that prevents or hinders papillary access (e.g., gastric bypass, Billroth II, duodenal switch, Roux-en-Y).
• • Stenosis in the antral or duodenal region that prevents access to the duodenum and reaching the papilla.
• • Situations that do not allow for upper gastrointestinal endoscopy (e.g., esophageal stricture).
• • Patients with functional diversity, who lack the capacity to understand the nature and potential consequences of the study, except when a legal representative is available.
• • Patients incapable of maintaining follow-up appointments (lack of adherence).
• • Lack of informed consent.