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

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

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.

Study Overview

• Status: Suspended
• Conditions: Biliary Tract Neoplasms; Malignant Biliary Obstruction; Pancreatic Cancer Non-resectable
• Intervention / Treatment: Procedure: Endoscopic biliary drainage; Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS); Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Hospital Santa Creu i Sant Pau
  • Granada, Spain
    • Hospital Virgen de las Nieves
  • Pamplona, Spain
    • Complejo Hospitalario de Pamplona
  • Santiago de Compostela, Spain
    • Hospital Santiago de Compostela
  • Terrassa, Spain
    • Hospital Mútua de Terrassa
  • Valencia, Spain
    • Hospital Clinic de Valencia
  • Vigo, Spain
    • Hospital Cunqueiro de Vigo
  • BARCELONA
    • L'Hospitalet de Llobregat, BARCELONA, Spain, 08907
      • Hospital Universitari de Bellvitge
  • Valencia
    • Alicante, Valencia, Spain
      • Hospital General Alicante
    • Castellon, Valencia, Spain
      • Hospital Universitari de Castello

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Endoscopic biliary drainage; Decompression of the bile duct by endoscopic aproach.; Other Names: Biliary drainage; 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, 8x8mm. Consider 10x10mm or 10x15mm if abundant pathological material in gallblader.; DPPS size: 7Fr x 3-5-7cm.; 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.
Experimental: 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.	Procedure: Endoscopic biliary drainage; Decompression of the bile duct by endoscopic aproach.; Other Names: Biliary drainage; 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, 8x8mm. Consider 10x10mm or 10x15mm if abundant pathological material in gallblader.; DPPS size: 7Fr x 3-5-7cm.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
CLINICAL SUCCESS	Resolution of jaundice or drop in total bilirubin level by > 50% within 2 weeks after the EUS guided drainage.	2 weeks
TECHNICAL SUCCESS	Technical success was defined as successful placement of the LAMS between the bile duct (choledoc or gallblader) and the lumen digestive system (stomach or duodenum), creating a transmural ostomy. To evaluate the correct position of the transmural stent, the deployment of the internal flap in the lumen of the bile duct must be verified by ultrasound vision and the internal flap by endoscopic vision.	24 hours
BILIARY REINTERVENTIONS (BRI)	Interventions needed to treat - Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.	12 months
HOSPITAL STAY	Length of hospital stay after intervention	12 months
MORTALITY	Overall mortality throughout the study	12 months
COST ANALYSIS	Evaluate the costs between the two types of strategy	12 months

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Collaborators: Hospital Universitario Ramon y Cajal; Complejo Hospitalario de Navarra; University of Salamanca; Hospital Mutua de Terrassa; Hospital General Universitario de Alicante; Complejo Hospitalario Universitario de Vigo; Complejo Hospitalario Universitario de Santiago; Hospital de Sant Pau; University Hospital Virgen de las Nieves; Hospital General Universitario de Castellón; Hospital Clínico Universitario de Valencia
• Investigators: Principal Investigator: Joan B Gornals Soler, Study Principal Investigator; Principal Investigator: Carme Loras, Hospital Universitari Mutua de Terrassa

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Biliary drainage; Lumen apposing metal stent; Choledochoduodenostomy; Gallblader drainage; Biliopancreatic malignancy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: CARPEGIEM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes