Trial Title:
EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)
NCT ID:
NCT06375967
Condition:
Malignant Biliary Obstruction
Biliary Tract Neoplasms
Pancreatic Cancer Non-resectable
Conditions: Official terms:
Biliary Tract Neoplasms
Conditions: Keywords:
Choledochoduodenostomy
Gallblader drainage
Lumen apposing metal stent
Biliary drainage
Biliopancreatic malignancy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Endoscopic biliary drainage
Description:
Decompression of the bile duct by endoscopic aproach.
Arm group label:
EUS-CDS with LAMS-Pigtail
Arm group label:
EUS-GBD with LAMS-Pigtail
Other name:
Biliary drainage
Intervention type:
Device
Intervention name:
Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
Description:
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.
Arm group label:
EUS-GBD with LAMS-Pigtail
Intervention type:
Device
Intervention name:
Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
Description:
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.
Arm group label:
EUS-CDS with LAMS-Pigtail
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitari de Bellvitge
Address:
City:
L'Hospitalet de Llobregat
Zip:
08907
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Julia Escuer, MD, Research Fellow
Phone:
+34-93-2607682
Phone ext:
2624
Email:
jescuer@bellvitgehospital.cat
Contact backup:
Last name:
Joan B Gornals, PhD
Phone:
+34-932607682
Phone ext:
2433
Email:
jgornals@bellvitgehospital.cat
Investigator:
Last name:
Julia Escuer, MD
Email:
Sub-Investigator
Investigator:
Last name:
Maria Puigcerver, MD
Email:
Sub-Investigator
Investigator:
Last name:
Berta Laquente, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Carles Fabregat, MD
Email:
Sub-Investigator
Investigator:
Last name:
Joan B Gornals, PhD
Email:
Principal Investigator
Facility:
Name:
Hospital General Alicante
Address:
City:
Alicante
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
JOSE R APARICIO
Investigator:
Last name:
JOSE R APARICIO, PHD
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari de Castello
Address:
City:
Castello
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
RAFAEL PEDRAZA
Investigator:
Last name:
RAFAEL PEDRAZA
Email:
Principal Investigator
Facility:
Name:
Hospital Santa Creu I Sant Pau
Address:
City:
Barcelona
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Virgen de Las Nieves
Address:
City:
Granada
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
EDUARDO REDONDO-CEREZO
Investigator:
Last name:
EDUARDO REDONDO-CEREZO, PHD
Email:
Principal Investigator
Facility:
Name:
Complejo Hospitalario de Pamplona
Address:
City:
Pamplona
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Santiago de Compostela
Address:
City:
Santiago De Compostela
Country:
Spain
Status:
Active, not recruiting
Facility:
Name:
Hospital Mutua de Terrassa
Address:
City:
Terrassa
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
CARME LORAS, PHD
Phone:
+34-937365050
Email:
cloras@mutuaterrassa.cat
Investigator:
Last name:
Carme Loras, PhD
Email:
Principal Investigator
Investigator:
Last name:
Sonia Fernandez, MD
Email:
Sub-Investigator
Facility:
Name:
Hospital Clinic de Valencia
Address:
City:
Valencia
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
VICENTE SANCHIZ
Investigator:
Last name:
VIECNTE SANCHIZ
Email:
Principal Investigator
Facility:
Name:
Hospital Cunqueiro de Vigo
Address:
City:
Vigo
Country:
Spain
Status:
Active, not recruiting
Start date:
October 18, 2024
Completion date:
October 2027
Lead sponsor:
Agency:
Hospital Universitari de Bellvitge
Agency class:
Other
Collaborator:
Agency:
Hospital Clínico Universitario de Valencia
Agency class:
Other
Collaborator:
Agency:
Hospital General Universitario de Alicante
Agency class:
Other
Collaborator:
Agency:
Hospital Mutua de Terrassa
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario Ramon y Cajal
Agency class:
Other
Collaborator:
Agency:
Hospital General Universitario de Castellón
Agency class:
Other
Collaborator:
Agency:
Complejo Hospitalario de Navarra
Agency class:
Other
Collaborator:
Agency:
University Hospital Virgen de las Nieves
Agency class:
Other
Collaborator:
Agency:
Hospital de Sant Pau
Agency class:
Other
Collaborator:
Agency:
University of Salamanca
Agency class:
Other
Collaborator:
Agency:
Complejo Hospitalario Universitario de Santiago
Agency class:
Other
Collaborator:
Agency:
Complejo Hospitalario Universitario de Vigo
Agency class:
Other
Source:
Hospital Universitari de Bellvitge
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06375967
