Malignant Biliary ObstructionCARPEGIEMNCT06375967
EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)
A study testing Endoscopic biliary drainage and Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) in people with Malignant Biliary Obstruction and Biliary Tract Neoplasms, run by Hospital Universitari de Bellvitge at 10 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Malignant Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Cancer Non-resectable
- What is being tested?
- Endoscopic biliary drainage and Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 10 sitesSpain
- Study dates
- 18 Oct 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital General Alicante
Alicante, Valencia
Hospital Santa Creu I Sant Pau
Barcelona
Hospital Universitari de Castello
Castellon, Valencia
Hospital Virgen de Las Nieves
Granada
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, BARCELONA, 08907
Complejo Hospitalario de Pamplona
Pamplona
Hospital Santiago de Compostela
Santiago de Compostela
Hospital Mutua de Terrassa
Terrassa
Hospital Clinic de Valencia
Valencia
Hospital Cunqueiro de Vigo
Vigo
About this study
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
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.
Read the 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.
- Being tested
- Endoscopic biliary drainage, Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
- Keywords
- Choledochoduodenostomy, Gallblader drainage, Lumen apposing metal stent, Biliary drainage, Biliopancreatic malignancy
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic biliary drainageProcedure or surgery
Also called Biliary drainage
Decompression of the bile duct by endoscopic aproach.
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.
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 or 8x8mm. Consider 10x10mm if bile duct > 18mm.
- DPPS size: 7Fr x 3-7cm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Endoscopic biliary drainage; Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
RELATED ADVERSE EVENTS
Safety will be measured by careful and comparative evaluation of adverse effects in both groups.
Measured: 12 months
Patients with Recurrent biliary obstruction
Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.
Measured: 12 months
Secondary outcomes (6)
CLINICAL SUCCESS
Resolution of jaundice or drop in total bilirubin level by > 50% within 2 weeks after the EUS guided drainage.
Measured: 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.
Measured: 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.
Measured: 12 months
HOSPITAL STAY
Length of hospital stay after intervention
Measured: 12 months
MORTALITY
Overall mortality throughout the study
Measured: 12 months
COST ANALYSIS
Evaluate the costs between the two types of strategy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start18 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malignant Biliary ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valencia, Hospital General Universitario de Alicante, Hospital Mutua de Terrassa, Hospital Universitario Ramon y Cajal, Hospital General Universitario de Castellón, Complejo Hospitalario de Navarra, University Hospital Virgen de las Nieves, Hospital de Sant Pau, University of Salamanca, Complejo Hospitalario Universitario de Santiago, Complejo Hospitalario Universitario de Vigo
- Responsible party
- Principal investigator, Joan B Gornals, Hospital Universitari de Bellvitge
- Investigators
- Joan B Gornals Soler, Principal investigator, Study Principal InvestigatorCarme Loras, Principal investigator, Hospital Universitari Mutua de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375967
- Sponsor's protocol ID
- CARPEGIEM
- Acronym
- CARPEGIEM
- Status last verified
- May 2026
- First submitted
- 16 Apr 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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.
PubMed 37253185Binda 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.
PubMed 37392954Kamal 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.
PubMed 36861505Chen 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.
PubMed 31818329Garcia-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.
PubMed 35216619Teoh 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.
PubMed 37121331
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06375967
- Acronym / sponsor ID
- CARPEGIEM / CARPEGIEM
- Keywords
- Choledochoduodenostomy, Gallblader drainage, Lumen apposing metal stent, Biliary drainage, Biliopancreatic malignancy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: 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.
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valencia, Hospital General Universitario de Alicante, Hospital Mutua de Terrassa, Hospital Universitario Ramon y Cajal, Hospital General Universitario de Castellón, Complejo Hospitalario de Navarra, University Hospital Virgen de las Nieves, Hospital de Sant Pau, University of Salamanca, Complejo Hospitalario Universitario de Santiago, Complejo Hospitalario Universitario de Vigo
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-GBD with LAMS-Pigtail | Experimental | Procedure: Endoscopic biliary drainage, Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)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. |
| EUS-CDS with LAMS-Pigtail | Active comparator | Procedure: Endoscopic biliary drainage, Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic biliary drainageAlso: Biliary drainageDecompression of the bile duct by endoscopic aproach. | Procedure or surgery | EUS-CDS with LAMS-Pigtail, EUS-GBD with LAMS-Pigtail |
| 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 | EUS-GBD with LAMS-Pigtail |
| 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. | Device | EUS-CDS with LAMS-Pigtail |
Primary outcome
RELATED ADVERSE EVENTS
Time frame: 12 months
Safety will be measured by careful and comparative evaluation of adverse effects in both groups.
Patients with Recurrent biliary obstruction
Time frame: 12 months
Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.
6 secondary outcomes
CLINICAL SUCCESS
Time frame: 2 weeks
TECHNICAL SUCCESS
Time frame: 24 hours
BILIARY REINTERVENTIONS (BRI)
Time frame: 12 months
HOSPITAL STAY
Time frame: 12 months
MORTALITY
Time frame: 12 months
COST ANALYSIS
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 37253185Mangiavillano 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.
- Background: PubMed 37392954Binda 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.
- Background: PubMed 36861505Kamal 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.
- Background: PubMed 31818329Chen 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.
- Background: PubMed 35216619Garcia-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.
- Results publication: PubMed 37121331Teoh 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan B Gornals Soler principal investigator
Study Principal Investigator
Carme Loras principal investigator
Hospital Universitari Mutua de Terrassa
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic biliary drainage and Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) in people with Malignant Biliary Obstruction and Biliary Tract Neoplasms, run by Hospital Universitari de Bellvitge at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RELATED ADVERSE EVENTS (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06375967, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.