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Endoscopic retrograde cholangiopancreatography (ERCP) with deployment of a self-expandable metallic stent (SEMS). Gold standard in malignant distal biliary obstruction (MDBO) in current practice.

ERCP technique: Cannulation with papillotome (advanced cannulation techniques are allowed). Sphincterotomy. Self-expandable metallic stent (SEMS) deployment.

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.

Decompression of the bile duct by endoscopic aproach.

Endoscopic biliary drainage

Self-expandable metallic stent (SEMS) deployment:

* Covering: Uncovered or Partially Covered. Non covered if gallbladder is present.
* Size: 10x40mm or 10x60mm or 10x80mm.

Self-expandable metallic stent (SEMS)

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.

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

Maria Puigcerver-Mas, MD, Research fellow

Joan B Gornals, PhD

Joan B Gornals, MD, PhD

Maria Puigcerver-Mas, MD

Julia Escuer-Turu, MD

Daniel Luna Rodriguez, MD

Albert Sumalla, MD

Berta Laquente, MD, PhD

Juli Busquets, MD, PhD

Julio Velasquez Rodriguez, MD

Sandra Maisterra, MD

Carme Loras, MD, PhD

Charly Guarner Argente, MD, PHD

Jose Lariño, MD, PhD

Rafael Pedraza, MD

Jose Ramon Aparicio, MD, PhD

Vicente Sanchiz, MD, PhD

Eduardo Redondo, MD, PhD

Juan J Vila, MD, PhD

The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction.

Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) has been extended as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). However, there are clinical trials which have compared it with ERCP as a first line treatment for MDBO in palliative patients, showing similar clinical and technical success and adverse events (AEs) rate between both techniques. Data about the benefit of this techique in resectable patients is still limited.

A recent retrospective study (Janet J et al, Ann Surg Oncol 2023) which included resectable patients, found that EUS-CDS group had significantly less delay (days) between biliary drainage and surgery than the ERCP group, with fewer endoscopy and surgery AEs.

Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing delay between biliary drainage when compared to ERCP in MDBO in resectable patients.

EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)

Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction in Resectable Disease: An Open-label, Multicenter Randomized Controlled Trial (CARPEDIEM-1 Trial)

Number of days between intervention (T1-biliary drainage) and surgery.

ERCP group: cannulation, cholangiogram, correct deployment of SEMS. EUS-CDS group: Correct deployment of both flaps of LAMS (and pigtail) in place, checked by ecoendoscopy/endoscopic image/floroscopy.

In jaundice: decreasing \> 50% of bilirrubin or normalization of bilirrubin levels 14 days after endoscopic procedure.

In cholangitis: stop of antibiotics without clinical recurrence or decreasing \> 50% of acute phase reactants 14 days after the endoscopic procedure.

Adverse events rate related to biliary drainage according to the AGREE classification

Adverse events rate related to surgery according to the Claiven and Dindo classification.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)	NCT06375928	Malignant Bilia... Pancreatic Canc... Biliary Tract N...	Endoscopic bili... Self-expandable... Lumen-apposing ...	18 Years -	Hospital Universitari de Bellvitge
EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)	NCT06375928	Malignant Bilia... Pancreatic Canc... Biliary Tract N...	Endoscopic bili... Self-expandable... Lumen-apposing ...	18 Years -	Hospital Universitari de Bellvitge

Spots Global Cancer Trial Database for biliopancreatic maliognancy