EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)
- Conditions
- Biliary Tract NeoplasmsPancreatic Cancer Non-resectableMalignant Biliary Obstruction
- Interventions
- Procedure: Endoscopic biliary drainageDevice: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 128
- 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
- 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
- Arm && Interventions
Group Intervention Description EUS-CDS with LAMS-Pigtail Endoscopic biliary drainage Echoendoscopy-guided Choledochoduodenostomy (EUS-CDS) with deployment of a lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent throug LAMS. EUS-CDS technique: Diagnostic EUS. Classic or free-hand with preloaded guidewire choledochoduodenostomy with LAMS. Pneumatic dilation whithin LAMS is allowed. In case of bile duct \< 15mm is mandatory the 'push' technique. Deployment of a pigtail coaxial to LAMS. EUS-GBD with LAMS-Pigtail Endoscopic biliary drainage Biliary drainage using EUS-guided Cholecystostomy with lumen apposing metal stent Echoendoscopy-guided Cholecystostomy (EUS-GBD) with deployment of a lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent throug LAMS. EUS-GBD technique: Diagnostic EUS. Classic or free-hand with preloaded guidewire cholecystostomy with LAMS. Pneumatic dilation whithin LAMS is allowed. 'push' technique ___ ??? Deployment of a pigtail coaxial to LAMS. EUS-GBD with LAMS-Pigtail Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) Biliary drainage using EUS-guided Cholecystostomy with lumen apposing metal stent Echoendoscopy-guided Cholecystostomy (EUS-GBD) with deployment of a lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent throug LAMS. EUS-GBD technique: Diagnostic EUS. Classic or free-hand with preloaded guidewire cholecystostomy with LAMS. Pneumatic dilation whithin LAMS is allowed. 'push' technique ___ ??? Deployment of a pigtail coaxial to LAMS. EUS-CDS with LAMS-Pigtail Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) Echoendoscopy-guided Choledochoduodenostomy (EUS-CDS) with deployment of a lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent throug LAMS. EUS-CDS technique: Diagnostic EUS. Classic or free-hand with preloaded guidewire choledochoduodenostomy with LAMS. Pneumatic dilation whithin LAMS is allowed. In case of bile duct \< 15mm is mandatory the 'push' technique. Deployment of a pigtail coaxial to LAMS.
- 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 MORTALITY 12 months Overall mortality throughout the study
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
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