EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)

NCT06375967 | Suspended DMC FDA Device

• 1 other identifier: CARPEGIEM
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 10

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.

Conditions

Malignant Biliary Obstruction; Biliary Tract Neoplasms; Pancreatic Cancer Non-resectable

Keywords

Choledochoduodenostomy; Gallblader drainage; Lumen apposing metal stent; Biliary drainage; Biliopancreatic malignancy

Outcome Measures

Primary Outcomes (2)

• RELATED ADVERSE EVENTS

  Safety will be measured by careful and comparative evaluation of adverse effects in both groups.

  12 months

• Patients with Recurrent biliary obstruction

  Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.

  12 months

Secondary Outcomes (6)

• CLINICAL SUCCESS

  2 weeks

• TECHNICAL SUCCESS

  24 hours

• BILIARY REINTERVENTIONS (BRI)

  12 months

• HOSPITAL STAY

  12 months

• MORTALITY

  12 months

Study Arms (2)

EUS-GBD with LAMS-Pigtail

EXPERIMENTAL

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.

Procedure: Endoscopic biliary drainage; Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)

EUS-CDS with LAMS-Pigtail

ACTIVE COMPARATOR

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.

Procedure: Endoscopic biliary drainage; Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)

Interventions

Endoscopic biliary drainage PROCEDURE

Decompression of the bile duct by endoscopic aproach.

Also known as: Biliary drainage

EUS-CDS with LAMS-Pigtail; EUS-GBD with LAMS-Pigtail

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

Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment: * LAMS size: 6x8mm, 8x8mm. Consider 10x10mm or 10x15mm if abundant pathological material in gallblader. * DPPS size: 7Fr x 3-5-7cm.

EUS-GBD with LAMS-Pigtail

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Hospital Clínico Universitario de Valencia: collaborator
• Hospital General Universitario de Alicante: collaborator
• Hospital Mutua de Terrassa: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital General Universitario de Castellón: collaborator
• Complejo Hospitalario de Navarra: collaborator
• University Hospital Virgen de las Nieves: collaborator
• Hospital de Sant Pau: collaborator
• University of Salamanca: collaborator
• Complejo Hospitalario Universitario de Santiago: collaborator
• Complejo Hospitalario Universitario de Vigo: collaborator

Study Sites (10)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, BARCELONA, 08907, Spain

Location

Hospital General Alicante

Alicante, Valencia, Spain

Location

Hospital Universitari de Castello

Castellon, Valencia, Spain

Location

Hospital Santa Creu I Sant Pau

Barcelona, Spain

Location

Hospital Virgen de Las Nieves

Granada, Spain

Location

Complejo Hospitalario de Pamplona

Pamplona, Spain

Location

Hospital Santiago de Compostela

Santiago de Compostela, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Spain

Location

Hospital Clinic de Valencia

Valencia, Spain

Location

Hospital Cunqueiro de Vigo

Vigo, Spain

Location

Related Publications (6)

• Mangiavillano B, Moon JH, Facciorusso A, Vargas-Madrigal J, Di Matteo F, Rizzatti G, De Luca L, Forti E, Mutignani M, Al-Lehibi A, Paduano D, Bulajic M, Decembrino F, Auriemma F, Franchellucci G, De Marco A, Gentile C, Shin IS, Rea R, Massidda M, Calabrese F, Mirante VG, Ofosu A, Crino SF, Hassan C, Repici A, Larghi A. Endoscopic ultrasound-guided gallbladder drainage as a first approach for jaundice palliation in unresectable malignant distal biliary obstruction: Prospective study. Dig Endosc. 2024 Mar;36(3):351-358. doi: 10.1111/den.14606. Epub 2023 Jul 3.

  PMID: 37253185 BACKGROUND

• Binda C, Anderloni A, Fugazza A, Amato A, de Nucci G, Redaelli A, Di Mitri R, Cugia L, Pollino V, Macchiarelli R, Mangiavillano B, Forti E, Brancaccio ML, Badas R, Maida M, Sinagra E, Repici A, Fabbri C, Tarantino I. EUS-guided gallbladder drainage using a lumen-apposing metal stent as rescue treatment for malignant distal biliary obstruction: a large multicenter experience. Gastrointest Endosc. 2023 Nov;98(5):765-773. doi: 10.1016/j.gie.2023.06.054. Epub 2023 Jun 29.

  PMID: 37392954 BACKGROUND

• Kamal F, Khan MA, Lee-Smith W, Sharma S, Acharya A, Farooq U, Aziz M, Kouanda A, Dai SC, Munroe CA, Arain M, Adler DG. Efficacy and safety of EUS-guided gallbladder drainage for rescue treatment of malignant biliary obstruction: A systematic review and meta-analysis. Endosc Ultrasound. 2023 Jan-Feb;12(1):8-15. doi: 10.4103/EUS-D-21-00206.

  PMID: 36861505 BACKGROUND

• Chen YI, Callichurn K, Chatterjee A, Desilets E, Fergal D, Forbes N, Gan I, Kenshil S, Khashab MA, Kunda R, Lam E, May G, Mohamed R, Mosko J, Paquin SC, Sahai A, Sandha G, Teshima C, Barkun A, Barkun J, Bessissow A, Candido K, Martel M, Miller C, Waschke K, Zogopoulos G, Wong C; ELEMENT trial and for the Canadian Endoscopic Research Collaborative (CERC). ELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangio-pancreatography in the management of malignant distal biliary obstruction. Trials. 2019 Dec 9;20(1):696. doi: 10.1186/s13063-019-3918-y.

  PMID: 31818329 BACKGROUND

• Garcia-Sumalla A, Loras C, Sanchiz V, Sanz RP, Vazquez-Sequeiros E, Aparicio JR, de la Serna-Higuera C, Luna-Rodriguez D, Andujar X, Capilla M, Barbera T, Foruny-Olcina JR, Martinez B, Dura M, Salord S, Laquente B, Tebe C, Videla S, Perez-Miranda M, Gornals JB; Spanish Working Group on Endoscopic Ultrasound Guided Biliary Drainage. Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction-BAMPI TRIAL: an open-label, randomized controlled trial protocol. Trials. 2022 Feb 25;23(1):181. doi: 10.1186/s13063-022-06106-1.

  PMID: 35216619 BACKGROUND

• 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.

  PMID: 37121331 RESULT

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Joan B Gornals Soler

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

• Carme Loras

  Hospital Universitari Mutua de Terrassa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD and Head of Interventional Endoscopy Unit

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: October 18, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

ES (10)