Clinical trial NCT06375967: EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)
Official title: Multicenter Study of EUS-guided Gallbladder Drainage vs Choledochoduodenostomy as First Line in Malignant Distal Obstruction in Palliative Patients (CARPEGIEM Trial): an Open-label, Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Biliary Obstruction
Biliary Tract Neoplasms
Pancreatic Cancer Non-resectable
Keywords: Choledochoduodenostomy
Gallblader drainage
Lumen apposing metal stent
Biliary drainage
Biliopancreatic malignancy
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Hospital Clínico Universitario de Valencia
name: Hospital General Universitario de Alicante
name: Hospital Mutua de Terrassa
name: Hospital Universitario Ramon y Cajal
name: Hospital General Universitario de Castellón
name: Complejo Hospitalario de Navarra
name: University Hospital Virgen de las Nieves
name: Hospital de Sant Pau
name: University of Salamanca
name: Complejo Hospitalario Universitario de Santiago
name: Complejo Hospitalario Universitario de Vigo
First posted: 2024-04-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) with a biliary lumen-apposing metal stent (LAMS) has been widely accepted as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). Recent studies (DRAMBO and ELEMENT trial) compared EUS-CDS vs ERCP as a first line treatment in MDBO in palliative patients, showing similar clinical and techinal success and adverse events rate between both techniques, demonstrating that both procedures could be options for primary biliary drainage in unresectable MDBO.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: RELATED ADVERSE EVENTS
timeFrame: 12 months
measure: Patients with Recurrent biliary obstruction
timeFrame: 12 months
Secondary outcomes:
measure: CLINICAL SUCCESS
timeFrame: 2 weeks
measure: TECHNICAL SUCCESS
timeFrame: 24 hours
measure: BILIARY REINTERVENTIONS (BRI)
timeFrame: 12 months
measure: HOSPITAL STAY
timeFrame: 12 months
measure: MORTALITY
timeFrame: 12 months
measure: COST ANALYSIS
timeFrame: 12 months
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Alicante
country: Spain
facility: Hospital General Alicante
state: Valencia
city: Castello
country: Spain
facility: Hospital Universitari de Castello
state: Valencia
city: Barcelona
country: Spain
facility: Hospital Santa Creu I Sant Pau
city: Granada
country: Spain
facility: Hospital Virgen de Las Nieves
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Pamplona
city: Santiago De Compostela
country: Spain
facility: Hospital Santiago de Compostela
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
city: Valencia
country: Spain
facility: Hospital Clinic de Valencia
city: Vigo
country: Spain
facility: Hospital Cunqueiro de Vigo
Study officials:
affiliation: Study Principal Investigator
name: Joan B Gornals Soler
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Mutua de Terrassa
name: Carme Loras
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.