EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)
NCT ID: NCT06653192
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-05-06
2028-05-06
Brief Summary
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Detailed Description
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Recent retrospective study (Janet J et al, Ann Surg Oncol 2023) and two recent meta-analysis (Barbosa E et al, GIE 2024; Gopakumar H et al, AM J Gastr 2024; both with \> 500 cases) found that EUS-CDS group had significantly less technical failure rate and less postprocedure pancreatitis rate.
Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing those rates (technical failure, postprocedure pancreatitis) when compared to ERCP in MDBO in potentially surgical patients with resectable and borderline disease.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ERCP with SEMS
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.
Endoscopic biliary drainage
Decompression of the bile duct by endoscopic aproach.
Self-expandable metallic stent (SEMS)
Self-expandable metallic stent (SEMS) deployment:
Covering: Uncovered or Partially Covered. Non covered if gallbladder is present.
Size: 10x40mm or 10x60mm or 10x80mm.
EUS-CDS with LAMS-Pigtail
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.
Endoscopic biliary drainage
Decompression of the bile duct by endoscopic aproach.
Lumen-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.
Interventions
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Endoscopic biliary drainage
Decompression of the bile duct by endoscopic aproach.
Self-expandable metallic stent (SEMS)
Self-expandable metallic stent (SEMS) deployment:
Covering: Uncovered or Partially Covered. Non covered if gallbladder is present.
Size: 10x40mm or 10x60mm or 10x80mm.
Lumen-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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe coagulation disorder: INR \> 1.5 non correctable with plasma administration and/or platelet count \< 50.000/mm3.
* Distal malignant biliary strictures in patients considered directly resectable, non-surgical, unresectable, or palliative
* 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).
* Stenosis in the antral or duodenal region that prevents access to the duodenum and reaching the papilla.
* 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.
18 Years
ALL
No
Sponsors
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Hospital Mutua de Terrassa
OTHER
Hospital Clínico Universitario de Valencia
OTHER
Hospital General Universitario de Alicante
OTHER
Hospital General Universitario de Castellón
OTHER
Complejo Hospitalario Universitario de Santiago
OTHER
University Hospital Virgen de las Nieves
OTHER
Complejo Hospitalario de Navarra
OTHER
Hospital de Sant Pau
OTHER
University of Salamanca
OTHER
Hospital Universitari de Bellvitge
OTHER
Responsible Party
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Joan B Gornals
PhD and Head of Interventional Endoscopy Unit
Principal Investigators
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Joan B Gornals, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari de Bellvitge, SEED
Locations
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Hospital General Universitario Dr. Balmis
Alicante, Alicante, Spain
Hospital General Universitario de Castellón
Castellon, Castellón, Spain
Hospital de Sant Pau i de la Santa Creu
Barcelona, Catalonia, Spain
Hospital Universitari de Bellvitge
Hospitalet de Llobregat, Barcelona, Catalonia, Spain
Hospital Mútua de Terrassa
Terrassa, Catalonia, Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Galicia, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Salamanca, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Countries
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Central Contacts
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Facility Contacts
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Jose R Aparicio, MD, PhD
Role: primary
Rafael Pedraza, MD, PhD
Role: primary
Carles Guarner-Argente, MD, PhD
Role: primary
Carme Loras, MD, PhD
Role: primary
Jose Lariño, MD, PhD
Role: primary
Eduardo Redondo, MD, PhD
Role: primary
Juan J Vila, MD, PhD
Role: primary
Alberto Álvarez, MD, PhD
Role: primary
Vicente Sanchiz, MD, PhD
Role: primary
References
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Teoh AYB, Napoleon B, Kunda R, Arcidiacono PG, Kongkam P, Larghi A, Van der Merwe S, Jacques J, Legros R, Thawee RE, Saxena P, Aerts M, Archibugi L, Chan SM, Fumex F, Kaffes AJ, Ma MTW, Messaoudi N, Rizzatti G, Ng KKC, Ng EKW, Chiu PWY. EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial). Gastroenterology. 2023 Aug;165(2):473-482.e2. doi: 10.1053/j.gastro.2023.04.016. Epub 2023 Apr 28.
Janet J, Albouys J, Napoleon B, Jacques J, Mathonnet M, Magne J, Fontaine M, de Ponthaud C, Durand Fontanier S, Bardet SSM, Bourdariat R, Sulpice L, Lesurtel M, Legros R, Truant S, Robin F, Prat F, Palazzo M, Schwarz L, Buc E, Sauvanet A, Gaujoux S, Taibi A. Pancreatoduodenectomy Following Preoperative Biliary Drainage Using Endoscopic Ultrasound-Guided Choledochoduodenostomy Versus a Transpapillary Stent: A Multicenter Comparative Cohort Study of the ACHBT-FRENCH-SFED Intergroup. Ann Surg Oncol. 2023 Aug;30(8):5036-5046. doi: 10.1245/s10434-023-13466-8. Epub 2023 Apr 17.
Chen YI, Sahai A, Donatelli G, Lam E, Forbes N, Mosko J, Paquin SC, Donnellan F, Chatterjee A, Telford J, Miller C, Desilets E, Sandha G, Kenshil S, Mohamed R, May G, Gan I, Barkun J, Calo N, Nawawi A, Friedman G, Cohen A, Maniere T, Chaudhury P, Metrakos P, Zogopoulos G, Bessissow A, Khalil JA, Baffis V, Waschke K, Parent J, Soulellis C, Khashab M, Kunda R, Geraci O, Martel M, Schwartzman K, Fiore JF Jr, Rahme E, Barkun A. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6.
Barbosa EC, Santo PADE, Baraldo S, Nau AL, Meine GC. EUS- versus ERCP-guided biliary drainage for malignant biliary obstruction: a systematic review and meta-analysis of randomized controlled trials. Gastrointest Endosc. 2024 Sep;100(3):395-405.e8. doi: 10.1016/j.gie.2024.04.019. Epub 2024 Apr 20.
Gopakumar H, Singh RR, Revanur V, Kandula R, Puli SR. Endoscopic Ultrasound-Guided vs Endoscopic Retrograde Cholangiopancreatography-Guided Biliary Drainage as Primary Approach to Malignant Distal Biliary Obstruction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Am J Gastroenterol. 2024 Aug 1;119(8):1607-1615. doi: 10.14309/ajg.0000000000002736. Epub 2024 Feb 29.
Other Identifiers
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CARPEDIEM
Identifier Type: -
Identifier Source: org_study_id
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