RecruitingNot ApplicableNCT06375967

EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)

Multicenter Study of EUS-guided Gallbladder Drainage vs Choledochoduodenostomy as First Line in Malignant Distal Obstruction in Palliative Patients (CARPEGIEM Trial): an Open-label, Randomized Controlled Clinical Trial

Sponsor

Hospital Universitari de Bellvitge

Enrollment

128 participants

Start Date

Oct 18, 2024

Study Type

INTERVENTIONAL

Conditions

Biliary Tract Neoplasms Pancreatic Cancer Non-resectable Malignant Biliary Obstruction

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria4

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 Criteria14

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, except when a legal representative is available.
Patients incapable of maintaining follow-up appointments (lack of adherence).
Lack of informed consent.

Interventions

PROCEDUREEndoscopic biliary drainage

Decompression of the bile duct by endoscopic aproach.

DEVICELumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)

Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment: * LAMS size: 6x8mm, 8x8mm. Consider 10x10mm or 10x15mm if abundant pathological material in gallblader. * DPPS size: 7Fr x 3-5-7cm.

DEVICELumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)

Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment: * LAMS size: 6x8mm or 8x8mm. Consider 10x10mm if bile duct \> 18mm. * DPPS size: 7Fr x 3-7cm.