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Not yet recruitingNCT06375954Updated Apr 19, 2024

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

An interventional study of Endoscopic biliary drainage and Self-expandable metallic stent (SEMS) in Malignant Biliary Obstruction, Pancreatic Cancer and Biliary Tract Neoplasms, sponsored by Hospital Universitari de Bellvitge. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by Hospital Universitari de Bellvitge · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Malignant Biliary Obstruction
  • Pancreatic Cancer
  • Biliary Tract Neoplasms

Keywords

  • Choledochoduodenostomy
  • Therapeutic endoscopy
  • Biliary Drainage
  • Lumen apposing metal stent
  • ERCP
  • Biliopancreatic malignancy
03

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's planned enrollment of 96 is above the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Hospital Universitari de Bellvitge is the lead sponsor of 120 studies on the registry; 30 are open to participants now.

Browse Hospital Universitari de Bellvitge studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (estimated)

Study arms

  • 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 · Device: Self-expandable metallic stent (SEMS)

  • 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 · Device: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)

Interventions

  • ProcedureEndoscopic biliary drainage

    Decompression of the bile duct by endoscopic aproach.

    Also known as: Biliary drainage

  • DeviceSelf-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.

  • DeviceLumen-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.

06

What researchers measure

Primary outcomes

  1. Delay in days between endoscopic biliary drainage and chemotherapy treatment start

    Number of days between intervention (T1-biliary drainage) and chemotherapy treatment start.

    Time frame: 1 day to 12 months

Secondary outcomes

  1. Technical success

    ERCP group: cannulation, cholangiogram, correct deployment of SEMS

    Time frame: day 0

  2. Clinical success

    In jaundice: decreasing \> 50% of bilirrubin or normalization of bilirrubin levels 14 days after endoscopic procedure.

    Time frame: 14 days after BD

  3. AE - biliary drainage

    Adverse events rate related to biliary drainage according to the AGREE classification

    Time frame: 0 to 30 days after BD

  4. AE - surgery

    Adverse events rate related to surgery according to the Claiven and Dindo classification.

    Time frame: 0 to 90 days after surgery

  5. Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP)

    Number of days between intervention (T1-biliary drainage) and surgery

    Time frame: 6 to 12 months

07

Study locations

1 site
  • Hospital Universitari de Bellvitge
    L'Hospitalet de Llobregat, Barcelona 08907, Spain
    • Joan B Gornals, MD, PhD · Contact · jgornals@bellvitgehospital.cat · + 34 93 260 7682
    • Maria Puigcerver-Mas, MD · Contact · mariapuigcervermas@gmail.com · +34 687332007
    • Julia Escuer, MD · Sub investigator
    • Sandra Maisterra, MD · Sub investigator
    • Julio G Velasquez-Rodriguez, MD · Sub investigator
    • Albert Garcia-Sumalla, MD · Sub investigator
    • Daniel Luna-Rodriguez, MD · Sub investigator
    • Berta Laquente, MD, PhD · Sub investigator
    • Juli Busquets, MD, PhD · Sub investigator
    • Carme Loras, MD, PhD · Principal investigator
    • Juan J Vila, MD, PhD · Principal investigator
    • Jose Lariño, MD, PhD · Principal investigator
    • VIcente Sanchiz, MD, PhD · Principal investigator
    • Jose R Aparicio, MD, PhD · Principal investigator
    • Eduardo Redondo, MD, PhD · Principal investigator
    • Charly Guarner-Argente, MD, PhD · Principal investigator
    • Antonio Rodriguez D'Jesus, MD, PhD · Principal investigator
    • Alberto Alvarez, MD, pHD · Principal investigator
08

References and documents

Publications

  • Teoh 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 ↗
  • Janet J, Albouys J, Napoleon B, Jacques J, Mathonnet M, Magne J, Fontaine M, de Ponthaud C, Durand Fontanier S, Bardet SSM, Bourdariat R, Sulpice L, Lesurtel M, Legros R, Truant S, Robin F, Prat F, Palazzo M, Schwarz L, Buc E, Sauvanet A, Gaujoux S, Taibi A. Pancreatoduodenectomy Following Preoperative Biliary Drainage Using Endoscopic Ultrasound-Guided Choledochoduodenostomy Versus a Transpapillary Stent: A Multicenter Comparative Cohort Study of the ACHBT-FRENCH-SFED Intergroup. Ann Surg Oncol. 2023 Aug;30(8):5036-5046. doi: 10.1245/s10434-023-13466-8. Epub 2023 Apr 17. PubMed 37069476 ↗
  • Paik WH, Lee TH, Park DH, Choi JH, Kim SO, Jang S, Kim DU, Shim JH, Song TJ, Lee SS, Seo DW, Lee SK, Kim MH. EUS-Guided Biliary Drainage Versus ERCP for the Primary Palliation of Malignant Biliary Obstruction: A Multicenter Randomized Clinical Trial. Am J Gastroenterol. 2018 Jul;113(7):987-997. doi: 10.1038/s41395-018-0122-8. Epub 2018 Jul 2. PubMed 29961772 ↗
  • Bang JY, Hawes R, Varadarajulu S. Endoscopic biliary drainage for malignant distal biliary obstruction: Which is better - endoscopic retrograde cholangiopancreatography or endoscopic ultrasound? Dig Endosc. 2022 Jan;34(2):317-324. doi: 10.1111/den.14186. Epub 2021 Nov 29. PubMed 34748675 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06375954
Lead sponsor
Hospital Universitari de Bellvitge
Collaborators
Hospital Mutua de Terrassa, Hospital Clínico Universitario de Valencia, Hospital General Universitario de Alicante, Hospital Universitario Ramon y Cajal, Hospital General Universitario de Castellón, Hospital Álvaro Cunqueiro, Complejo Hospitalario Universitario de Santiago, University Hospital Virgen de las Nieves, Complejo Hospitalario de Navarra, Hospital de Sant Pau, University of Salamanca
Responsible party
Joan B Gornals (PhD and Head of Interventional Endoscopy Unit, Hospital Universitari de Bellvitge) — Principal investigator
First posted
Apr 19, 2024
Start date
May 1, 2024 (estimated)
Primary completion
Jun 1, 2026 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Apr 19, 2024

Study contacts

Maria Puigcerver-Mas, MD,
Contact
mariapuigcervermas@gmail.com
+34 687332007
Joan B Gornals, MD,PhD
Contact
jgornals@bellvitgehospital.cat
+34 932607682 ext. 2624
Joan B Gornals, PhD
principal investigator · Hospital Universitari de Bellvitge, SEED

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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