Trial Title:
EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction (CARPEDIEM Trial)
NCT ID:
NCT06653192
Condition:
Malignant Biliary Obstruction
Pancreatic Cancer
Biliary Tract Neoplasms
Conditions: Official terms:
Biliary Tract Neoplasms
Conditions: Keywords:
Choledochoduodenostomy
Therapeutic endoscopy
Biliary Drainage
Lumen apposing metal stent
ERCP
Biliopancreatic malignancy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet 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:
ERCP with SEMS
Arm group label:
EUS-CDS with LAMS-Pigtail
Intervention type:
Device
Intervention name:
Self-expandable metallic stent (SEMS)
Description:
Self-expandable metallic stent (SEMS) deployment:
Covering: Uncovered or Partially Covered. Non covered if gallbladder is present.
Size: 10x40mm or 10x60mm or 10x80mm.
Arm group label:
ERCP with SEMS
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 this clinical trial is to evaluate the biliary drainage technical failure rate
and/or the postprocedure acute pancreatitis rate between EUS-CDS vs ERCP procedures in
patients with distal malignant biliary obstruction.
Detailed description:
Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) has been extended as a second line
treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO).
However, there are clinical trials which have compared it with ERCP as a first line
treatment for MDBO in palliative patients, showing similar clinical and technical success
and adverse events (AEs) rate between both techniques. Data about the benefit of this
techique in potentially surgical patients is still limited.
Recent retrospective study (Janet J et al, Ann Surg Oncol 2023) and two recent
meta-analysis (Barbosa E et al, GIE 2024; Gopakumar H et al, AM J Gastr 2024; both with >
500 cases) found that EUS-CDS group had significantly less technical failure rate and
less postprocedure pancreatitis rate.
Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing those rates
(technical failure, postprocedure pancreatitis) when compared to ERCP in MDBO in
potentially surgical patients with resectable and borderline disease.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Malignant distal biliary obstruction diagnosed in patient considered RESECTABLE or
POTENTIALLY RESECTABLE/BORDERLINE with biliary drainage indication: i) impaired
hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal
value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of
retrograde dilatation, of at least 12-mm axial diameter.
- 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.
- Distal malignant biliary strictures in patients considered directly resectable,
non-surgical, unresectable, or palliative
- 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).
- Stenosis in the antral or duodenal region that prevents access to the duodenum and
reaching the papilla.
- 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:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital General Universitario de Castellón
Address:
City:
Castelló de la Plana
Zip:
12004
Country:
Spain
Contact:
Last name:
Rafael Pedraza, MD, PhD
Facility:
Name:
Hospital de Sant Pau i de la Santa Creu
Address:
City:
Barcelona
Zip:
08041
Country:
Spain
Facility:
Name:
Hospital Universitari de Bellvitge
Address:
City:
Hospitalet de Llobregat, BARCELONA
Zip:
08907
Country:
Spain
Contact:
Last name:
Joan B Gornals, MD,PhD
Phone:
+ 34 93 260 7682
Phone ext:
2624
Email:
jgornals@bellvitgehospital.cat
Contact backup:
Last name:
Maria Puigcerver-Mas, MD
Phone:
+34 687332007
Email:
mariapuigcervermas@gmail.com
Investigator:
Last name:
Julia Escuer, MD
Email:
Sub-Investigator
Investigator:
Last name:
Sandra Maisterra, MD
Email:
Sub-Investigator
Investigator:
Last name:
Julio G Velasquez-Rodriguez, MD
Email:
Sub-Investigator
Investigator:
Last name:
Albert Sumalla-Garcia, MD
Email:
Sub-Investigator
Investigator:
Last name:
Daniel Luna-Rodriguez, MD
Email:
Sub-Investigator
Investigator:
Last name:
Berta Laquente, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Juli Busquets, MD, PhD
Email:
Sub-Investigator
Facility:
Name:
Hospital Mútua de Terrassa
Address:
City:
Terrassa
Zip:
08221
Country:
Spain
Contact:
Last name:
Carme Loras, MD, PhD
Facility:
Name:
Hospital Clínico Universitario de Santiago
Address:
City:
Santiago De Compostela
Zip:
15706
Country:
Spain
Contact:
Last name:
Jose Lariño, MD, PhD
Facility:
Name:
Complejo Hospitalario de Navarra
Address:
City:
Pamplona
Zip:
31006
Country:
Spain
Contact:
Last name:
Juan J Vila, MD, PhD
Facility:
Name:
Hospital General Universitario Dr. Balmis
Address:
City:
Alicante
Zip:
03010
Country:
Spain
Contact:
Last name:
Jose R Aparicio, MD, PhD
Facility:
Name:
Hospital Universitario Virgen de las Nieves
Address:
City:
Granada
Zip:
18014
Country:
Spain
Contact:
Last name:
Eduardo Redondo, MD, PhD
Facility:
Name:
Hospital Clínico Universitario de Salamanca
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Contact:
Last name:
Alberto Álvarez, MD, PhD
Facility:
Name:
Hospital Clínico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Contact:
Last name:
Vicente Sanchiz, MD, PhD
Start date:
October 15, 2024
Completion date:
October 15, 2027
Lead sponsor:
Agency:
Hospital Universitari de Bellvitge
Agency class:
Other
Collaborator:
Agency:
Hospital Mutua de Terrassa
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 General Universitario de Castellón
Agency class:
Other
Collaborator:
Agency:
Complejo Hospitalario Universitario de Santiago
Agency class:
Other
Collaborator:
Agency:
University Hospital Virgen de las Nieves
Agency class:
Other
Collaborator:
Agency:
Complejo Hospitalario de Navarra
Agency class:
Other
Collaborator:
Agency:
Hospital de Sant Pau
Agency class:
Other
Collaborator:
Agency:
University of Salamanca
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/NCT06653192
