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

NCT ID: NCT06375928

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-05-01

Brief Summary

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.

Detailed Description

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.

Conditions

Malignant Biliary Obstruction; Pancreatic Cancer Resectable; Biliary Tract Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Endoscopic biliary drainage

Intervention Type: PROCEDURE

Decompression of the bile duct by endoscopic aproach.

Self-expandable metallic stent (SEMS)

Intervention Type: DEVICE

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.

Group Type: EXPERIMENTAL

Endoscopic biliary drainage

Intervention Type: PROCEDURE

Decompression of the bile duct by endoscopic aproach.

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

Intervention Type: DEVICE

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

Endoscopic biliary drainage

Decompression of the bile duct by endoscopic aproach.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Biliary drainage

Eligibility Criteria

Inclusion Criteria

• Malignant distal biliary obstruction diagnosed in patient considered RESECTABLE with biliary drainage indication: i) impaired hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of retrograde dilatation, of at least 12-mm axial diameter.
• 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.
• Distal malignant biliary strictures in patients considered borderline, 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Mutua de Terrassa

OTHER

Sponsor Role: collaborator

Hospital Clínico Universitario de Valencia

OTHER

Sponsor Role: collaborator

Hospital General Universitario de Alicante

OTHER

Sponsor Role: collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: collaborator

Hospital General Universitario de Castellón

OTHER

Sponsor Role: collaborator

Hospital Álvaro Cunqueiro

OTHER

Sponsor Role: collaborator

Complejo Hospitalario Universitario de Santiago

OTHER

Sponsor Role: collaborator

University Hospital Virgen de las Nieves

OTHER

Sponsor Role: collaborator

Complejo Hospitalario de Navarra

OTHER

Sponsor Role: collaborator

Hospital de Sant Pau

OTHER

Sponsor Role: collaborator

University of Salamanca

OTHER

Sponsor Role: collaborator

Hospital Universitari de Bellvitge

OTHER

Sponsor Role: lead

Responsible Party

Joan B Gornals

PhD and Head of Interventional Endoscopy Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joan B Gornals, PhD

Role: PRINCIPAL_INVESTIGATOR

Bellvitge University Hospital

Locations

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain

Countries

Spain

Central Contacts

Maria Puigcerver-Mas, MD, Research fellow

Role: CONTACT

mariapuigcervermas@gmail.com

+34687332007

Joan B Gornals, PhD

Role: CONTACT

jgornals@bellvitgehospital.cat

+34932607682 ext. 2624

Facility Contacts

Joan B Gornals, MD, PhD

Role: primary

jgornals@bellvitgehospital.cat

+34 93 260 76 82 ext. 2624

Maria Puigcerver-Mas, MD

Role: backup

mariapuigcervermas@gmail.com

+34 687332007

References

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.

Reference Type: RESULT

PMID: 37121331 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37069476 (View on PubMed)

Paik WH, Lee TH, Park DH, Choi JH, Kim SO, Jang S, Kim DU, Shim JH, Song TJ, Lee SS, Seo DW, Lee SK, Kim MH. EUS-Guided Biliary Drainage Versus ERCP for the Primary Palliation of Malignant Biliary Obstruction: A Multicenter Randomized Clinical Trial. Am J Gastroenterol. 2018 Jul;113(7):987-997. doi: 10.1038/s41395-018-0122-8. Epub 2018 Jul 2.

Reference Type: RESULT

PMID: 29961772 (View on PubMed)

Bang JY, Hawes R, Varadarajulu S. Endoscopic biliary drainage for malignant distal biliary obstruction: Which is better - endoscopic retrograde cholangiopancreatography or endoscopic ultrasound? Dig Endosc. 2022 Jan;34(2):317-324. doi: 10.1111/den.14186. Epub 2021 Nov 29.

Reference Type: RESULT

PMID: 34748675 (View on PubMed)

Other Identifiers

CARPEDIEM-1

Identifier Type: -

Identifier Source: org_study_id