EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)

Last updated: October 19, 2024
Sponsor: Hospital Universitari de Bellvitge
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Cancer

Digestive System Neoplasms

Treatment

Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)

Endoscopic biliary drainage

Clinical Study ID

NCT06375967
CARPEGIEM
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Malignant distal biliary obstruction diagnosed in patient considered PALIATIVE withbiliary drainage indication.

  • Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histologicalconfirmation 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 teststhroughout its duration

Exclusion

Exclusion Criteria:

  • Pregnancy or lactation.

  • Severe coagulation disorder: INR > 1.5 non correctable with plasma administrationand/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 proximallyor 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 papillaryaccess ______________ (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., esophagealstricture).

  • Patients with functional diversity, who lack the capacity to understand the natureand potential consequences of the study, except when a legal representative isavailable.

  • Patients incapable of maintaining follow-up appointments (lack of adherence).

  • Lack of informed consent.

Study Design

Total Participants: 128
Treatment Group(s): 2
Primary Treatment: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
Phase:
Study Start date:
October 18, 2024
Estimated Completion Date:
October 31, 2027

Study 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.

Connect with a study center

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Active - Recruiting

  • Hospital Universitari de Bellvitge

    L'Hospitalet De Llobregat, Barcelona, Catalonia 08907
    Spain

    Site Not Available

  • Hospital General Alicante

    Alicante, Valencia
    Spain

    Site Not Available

  • Hospital Universitari de Castello

    Castello, Valencia
    Spain

    Site Not Available

  • Hospital Santa Creu I Sant Pau

    Barcelona,
    Spain

    Site Not Available

  • Hospital Virgen de Las Nieves

    Granada,
    Spain

    Site Not Available

  • Complejo Hospitalario de Pamplona

    Pamplona,
    Spain

    Site Not Available

  • Hospital Santiago de Compostela

    Santiago De Compostela,
    Spain

    Site Not Available

  • Hospital Mutua de Terrassa

    Terrassa,
    Spain

    Site Not Available

  • Hospital Clinic de Valencia

    Valencia,
    Spain

    Site Not Available

  • Hospital Cunqueiro de Vigo

    Vigo,
    Spain

    Site Not Available

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