EUS-guided Choledochoduodenostomy Vs ERCP As First Line In Malignant Distal Obstruction In Resectable Disease (CARPEDIEM-1 Trial)

Study Overview

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

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.

Malignant Biliary Obstruction
Pancreatic Cancer Resectable
Biliary Tract Neoplasms

PROCEDURE: Endoscopic biliary drainage
DEVICE: Self-expandable metallic stent (SEMS)
DEVICE: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)

CARPEDIEM-1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-04-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-18
First Submitted that Met QC Criteria 2024-04-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-19
First Posted (ACTUAL) 2024-04-19	Results First Posted N/A	Last Verified 2023-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: 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 can	PROCEDURE: Endoscopic biliary drainage Decompression of the bile duct by endoscopic aproach. DEVICE: 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.
EXPERIMENTAL: 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 cho	PROCEDURE: Endoscopic biliary drainage Decompression of the bile duct by endoscopic aproach. 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.

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: 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 can

PROCEDURE: Endoscopic biliary drainage

Decompression of the bile duct by endoscopic aproach.

DEVICE: 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.

EXPERIMENTAL: 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 cho

PROCEDURE: Endoscopic biliary drainage

Decompression of the bile duct by endoscopic aproach.

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.

Primary Outcome Measures	Measure Description	Time Frame
Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP)	Number of days between intervention (T1-biliary drainage) and surgery.	1 day to 12 months

Secondary Outcome Measures	Measure Description	Time Frame
Technical success	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.	day 0
Clinical success	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.	14 days after BD
AE - biliary drainage	Adverse events rate related to biliary drainage according to the AGREE classification	0 to 30 days after BD
AE - surgery	Adverse events rate related to surgery according to the Claiven and Dindo classification.	0 to 90 days after surgery

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Maria Puigcerver-Mas, MD, Research fellow

Phone Number: +34687332007

Email: mariapuigcervermas@gmail.com

Study Contact Backup

Name: Joan B Gornals, PhD

Phone Number: +34932607682

Email: jgornals@bellvitgehospital.cat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Hospital Mutua de Terrassa
Hospital Clínico Universitario de Valencia
Hospital General Universitario de Alicante
Hospital Universitario Ramon y Cajal
Hospital General Universitario de Castellón
Hospital Álvaro Cunqueiro
Complejo Hospitalario Universitario de Santiago
University Hospital Virgen de las Nieves
Complejo Hospitalario de Navarra
Hospital de Sant Pau
University of Salamanca

Investigators

PRINCIPAL_INVESTIGATOR: Joan B Gornals, PhD, Bellvitge University Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
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. Erratum In: Am J Gastroenterol. 2018 Oct;113(10):1566. doi: 10.1038/s41395-018-0238-x.
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.

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