Trial Title:
EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)
NCT ID:
NCT06375954
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
Other name:
Biliary drainage
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 temporal delay (days) between biliary
drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with
borderline 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 borderline patients is still limited.
A recent retrospective study (Janet J et al, Ann Surg Oncol 2023) which included
borderline patients, found that EUS-CDS group had significantly less delay (days) between
biliary drainage and neoadjuvant chemotherapy start than the ERCP group with fewer
endoscopy and surgery AEs.
Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing delay between
biliary drainage and neoadjuvant chemotherapy start when compared to ERCP in MDBO in
borderline patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Malignant distal biliary obstruction diagnosed in patient considered 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 Universitari de Bellvitge
Address:
City:
L'Hospitalet de Llobregat
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 Garcia-Sumalla, 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
Investigator:
Last name:
Carme Loras, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Juan J Vila, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Jose Lariño, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
VIcente Sanchiz, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Jose R Aparicio, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Eduardo Redondo, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Charly Guarner-Argente, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Antonio Rodriguez D'Jesus, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Alberto Alvarez, MD, pHD
Email:
Principal Investigator
Start date:
May 1, 2024
Completion date:
May 1, 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 Universitario Ramon y Cajal
Agency class:
Other
Collaborator:
Agency:
Hospital General Universitario de Castellón
Agency class:
Other
Collaborator:
Agency:
Hospital Álvaro Cunqueiro
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/NCT06375954
