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

Not Applicable

Recruiting

• Conditions: Biliary Tract Neoplasms; Pancreatic Cancer Non-resectable; Malignant Biliary Obstruction

• Registration Number: NCT06375967
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief 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.

Detailed Description

Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) with a biliary lumen-apposing metal stent (LAMS) has been widely accepted as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). Recent studies (DRAMBO and ELEMENT trial) compared EUS-CDS vs ERCP as a first line treatment in MDBO in palliative patients, showing similar clinical and techinal success and adverse events rate between both techniques, demonstrating that both procedures could be options for primary biliary drainage in unresectable MDBO.

Furthermore a recent clinical trial (BAMPI trial) has proven that the addition of a coaxial double pigtail (DPS) offers benefits in terms of safey and clinical success.

In the last years there has been an increasing interest for the EUS-guided gallblader drainage (EUS-GBD) in unresectable MDBO as an alternative for EUS-CDS, and recent studies and reviews have been reported with acceptable techinal and clinical success, but no clinical trial has been performed up to date.

Our hypothesis is that EUS-GBD may offer benefits in terms of safety over EUS-CDS, maintaining similar clinical and techinal success rates.

Study Timeline

• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-19
• Status Verified: 2024-10
• Study Start: 2024-10-18
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-23
• Primary Completion: 2026-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
RELATED ADVERSE EVENTS	12 months	Safety will be measured by careful and comparative evaluation of adverse effects in both groups.
Patients with Recurrent biliary obstruction	12 months	Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.

Secondary Outcome Measures

Name	Time	Method
BILIARY REINTERVENTIONS (BRI)	12 months	Interventions needed to treat - Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.
HOSPITAL STAY	12 months	Length of hospital stay after intervention
MORTALITY	12 months	Overall mortality throughout the study
CLINICAL SUCCESS	2 weeks	Resolution of jaundice or drop in total bilirubin level by \> 50% within 2 weeks after the EUS guided drainage.
COST ANALYSIS	12 months	Evaluate the costs between the two types of strategy
TECHNICAL SUCCESS	24 hours	Technical success was defined as successful placement of the LAMS between the bile duct (choledoc or gallblader) and the lumen digestive system (stomach or duodenum), creating a transmural ostomy. To evaluate the correct position of the transmural stent, the deployment of the internal flap in the lumen of the bile duct must be verified by ultrasound vision and the internal flap by endoscopic vision.

Trial Locations

Locations (10)

Hospital General Alicante; 🇪🇸 Alicante, Valencia, Spain

Hospital Universitari de Castello; 🇪🇸 Castello, Valencia, Spain

Hospital Santa Creu I Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Virgen de Las Nieves; 🇪🇸 Granada, Spain

Complejo Hospitalario de Pamplona; 🇪🇸 Pamplona, Spain

Hospital Santiago de Compostela; 🇪🇸 Santiago De Compostela, Spain

Hospital Mutua de Terrassa; 🇪🇸 Terrassa, Spain

Hospital Clinic de Valencia; 🇪🇸 Valencia, Spain

Hospital Cunqueiro de Vigo; 🇪🇸 Vigo, Spain

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain