EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)

April 18, 2024 updated by: Joan B Gornals, Hospital Universitari de Bellvitge

Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction in Borderline Disease: An Open-label, Multicenter Randomized Trial (CARPEDIEM-2 Trial)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge
        • Sub-Investigator:
          • Sandra Maisterra, MD
        • Sub-Investigator:
          • Albert Garcia-Sumalla, MD
        • Sub-Investigator:
          • Julio G Velasquez-Rodriguez, MD
        • Sub-Investigator:
          • Daniel Luna-Rodriguez, MD
        • Principal Investigator:
          • Carme Loras, MD, PhD
        • Principal Investigator:
          • Juan J Vila, MD, PhD
        • Principal Investigator:
          • Jose R Aparicio, MD, PhD
        • Principal Investigator:
          • Jose Lariño, MD, PhD
        • Principal Investigator:
          • Antonio Rodriguez D'Jesus, MD, PhD
        • Principal Investigator:
          • Alberto Alvarez, MD, pHD
        • Principal Investigator:
          • Vicente Sanchiz, MD, PhD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Julia Escuer, MD
        • Sub-Investigator:
          • Berta Laquente, MD, PhD
        • Sub-Investigator:
          • Juli Busquets, MD, PhD
        • Principal Investigator:
          • Eduardo Redondo, MD, PhD
        • Principal Investigator:
          • Charly Guarner-Argente, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ERCP with SEMS

Endoscopic retrograde cholangiopancreatography (ERCP) with deployment of a self-expandable metallic stent (SEMS). Gold standard in malignant distal biliary obstruction (MDBO) in current practice.

ERCP technique: Cannulation with papillotome (advanced cannulation techniques are allowed). Sphincterotomy. Self-expandable metallic stent (SEMS) deployment.
Procedure: Endoscopic biliary drainage
Decompression of the bile duct by endoscopic aproach.
Other Names:
  • Biliary drainage
Device: Self-expandable metallic stent (SEMS)

Self-expandable metallic stent (SEMS) deployment:

  • Covering: Uncovered or Partially Covered. Non covered if gallbladder is present.
  • Size: 10x40mm or 10x60mm or 10x80mm.
Experimental: EUS-CDS with LAMS-Pigtail

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.
Procedure: Endoscopic biliary drainage
Decompression of the bile duct by endoscopic aproach.
Other Names:
  • Biliary drainage
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay in days between endoscopic biliary drainage and chemotherapy treatment start
Time Frame: 1 day to 12 months
Number of days between intervention (T1-biliary drainage) and chemotherapy treatment start.
1 day to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: day 0
ERCP group: cannulation, cholangiogram, correct deployment of SEMS
day 0
Clinical success
Time Frame: 14 days after BD
In jaundice: decreasing > 50% of bilirrubin or normalization of bilirrubin levels 14 days after endoscopic procedure.
14 days after BD
AE - biliary drainage
Time Frame: 0 to 30 days after BD
Adverse events rate related to biliary drainage according to the AGREE classification
0 to 30 days after BD
AE - surgery
Time Frame: 0 to 90 days after surgery
Adverse events rate related to surgery according to the Claiven and Dindo classification.
0 to 90 days after surgery
Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP)
Time Frame: 6 to 12 months
Number of days between intervention (T1-biliary drainage) and surgery
6 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari de Bellvitge

Collaborators

Hospital Universitario Ramon y Cajal
Complejo Hospitalario de Navarra
University of Salamanca
Hospital Mutua de Terrassa
Hospital General Universitario de Alicante
Complejo Hospitalario Universitario de Santiago
Hospital de Sant Pau
Hospital Álvaro Cunqueiro
University Hospital Virgen de las Nieves
Hospital General Universitario de Castellón
Hospital Clínico Universitario de Valencia

Investigators

  • Principal Investigator: Joan B Gornals, PhD, Hospital Universitari de Bellvitge, SEED

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARPEDIEM-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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