Clinical trial · Interventional
EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)
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
NCT06375967CI-TRIAL-00110572CARPEGIEMsuspendedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Class I Recall (Feb 2026): Boston Scientific issued a global recall for specific lots of AXIOS 6x8mm and 8x8mm due to reports of deployment and expansion failure during the procedure.
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Malignant Biliary Obstruction | — | UNRESOLVED | — |
| Pancreatic Cancer Non-resectable | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic biliary drainage | Procedure | — | UNRESOLVED |
| Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EUS-GBD with LAMS-Pigtail
- description
- 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.
- interventionNames
- Procedure: Endoscopic biliary drainage
- Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
- type
- ACTIVE_COMPARATOR
- label
- EUS-CDS with LAMS-Pigtail
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDMangiavillano 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
- BACKGROUNDBinda 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
- BACKGROUNDKamal 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
- BACKGROUNDChen 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
- 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.