EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial) (NCT06375967) | Clinical Trial Compass
SuspendedNot Applicable
EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)
Stopped: Class I Recall (Feb 2026): Boston Scientific issued a global recall for specific lots of AXIOS 6x8mm and 8x8mm due to reports of deployment and expansion failure during the procedure.
Spain128 participantsStarted 2024-10-18
Plain-language summary
The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients.
Who can participate
Age range18 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Malignant distal biliary obstruction diagnosed in patient considered PALIATIVE with biliary drainage indication.
* 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.
* Previous cholecistectomy or gallblader perforation.
* Tumoral obstruction of cystic duct.
* Multiple liver metastases affecting more than 30% of the liver parenchyma
* Distal malignant biliary strictures in patients considered resectable or borderline.
* 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).
* Gastric outlet obstruction.
* 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, …