EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)
NCT ID: NCT06375967
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
128 participants
INTERVENTIONAL
2024-10-18
2027-10-31
Brief Summary
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Detailed Description
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Furthermore a recent clinical trial (BAMPI trial) has proven that the addition of a coaxial double pigtail (DPS) offers benefits in terms of safey and clinical success.
In the last years there has been an increasing interest for the EUS-guided gallblader drainage (EUS-GBD) in unresectable MDBO as an alternative for EUS-CDS, and recent studies and reviews have been reported with acceptable techinal and clinical success, but no clinical trial has been performed up to date.
Our hypothesis is that EUS-GBD may offer benefits in terms of safety over EUS-CDS, maintaining similar clinical and techinal success rates.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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EUS-GBD with LAMS-Pigtail
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.
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, 8x8mm. Consider 10x10mm or 10x15mm if abundant pathological material in gallblader.
* DPPS size: 7Fr x 3-5-7cm.
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.
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, 8x8mm. Consider 10x10mm or 10x15mm if abundant pathological material in gallblader.
* DPPS size: 7Fr x 3-5-7cm.
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.
Other Intervention Names
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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.
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Hospital Clínico Universitario de Valencia
OTHER
Hospital General Universitario de Alicante
OTHER
Hospital Mutua de Terrassa
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Hospital General Universitario de Castellón
OTHER
Complejo Hospitalario de Navarra
OTHER
University Hospital Virgen de las Nieves
OTHER
Hospital de Sant Pau
OTHER
University of Salamanca
OTHER
Complejo Hospitalario Universitario de Santiago
OTHER
Complejo Hospitalario Universitario de Vigo
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 Soler
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Carme Loras
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Mutua de Terrassa
Locations
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Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, BARCELONA, Spain
Hospital General Alicante
Alicante, Valencia, Spain
Hospital Universitari de Castello
Castellon, Valencia, Spain
Hospital Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Virgen de Las Nieves
Granada, , Spain
Complejo Hospitalario de Pamplona
Pamplona, , Spain
Hospital Santiago de Compostela
Santiago de Compostela, , Spain
Hospital Mutua de Terrassa
Terrassa, , Spain
Hospital Clinic de Valencia
Valencia, , Spain
Hospital Cunqueiro de Vigo
Vigo, , Spain
Countries
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Central Contacts
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Facility Contacts
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JOSE R APARICIO
Role: primary
RAFAEL PEDRAZA
Role: primary
EDUARDO REDONDO-CEREZO
Role: primary
VICENTE SANCHIZ
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.
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.
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.
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.
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.
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.
Other Identifiers
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CARPEGIEM
Identifier Type: -
Identifier Source: org_study_id
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