NCT06375954

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
May 2024May 2027

First Submitted

Initial submission to the registry

April 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 19, 2024

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

April 16, 2024

Last Update Submit

April 18, 2024

Conditions

Malignant Biliary ObstructionPancreatic CancerBiliary Tract Neoplasms

Keywords

CholedochoduodenostomyTherapeutic endoscopyBiliary DrainageLumen apposing metal stentERCPBiliopancreatic malignancy

Outcome Measures

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.

    1 day to 12 months

Secondary Outcomes (5)

  • Technical success

    day 0

  • Clinical success

    14 days after BD

  • AE - biliary drainage

    0 to 30 days after BD

  • AE - surgery

    0 to 90 days after surgery

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

    6 to 12 months

Study Arms (2)

ERCP with SEMS

ACTIVE COMPARATOR

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 drainageDevice: Self-expandable metallic stent (SEMS)

EUS-CDS with LAMS-Pigtail

EXPERIMENTAL

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

Interventions

Endoscopic biliary drainagePROCEDURE

Decompression of the bile duct by endoscopic aproach.

Also known as: Biliary drainage
ERCP with SEMSEUS-CDS with LAMS-Pigtail
Self-expandable metallic stent (SEMS)DEVICE

Self-expandable metallic stent (SEMS) deployment: * Covering: Uncovered or Partially Covered. Non covered if gallbladder is present. * Size: 10x40mm or 10x60mm or 10x80mm.

ERCP with SEMS
Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)DEVICE

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.

EUS-CDS with LAMS-Pigtail

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (4)

  • 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.

    PMID: 37121331RESULT

  • 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.

    PMID: 37069476RESULT

  • 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.

    PMID: 29961772RESULT

  • 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.

    PMID: 34748675RESULT

MeSH Terms

Conditions

Pancreatic NeoplasmsBiliary Tract Neoplasms

Interventions

Self Expandable Metallic Stents

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBiliary Tract Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Joan B Gornals, PhD

    Hospital Universitari de Bellvitge, SEED

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Puigcerver-Mas, MD,

CONTACT

+34 687332007mariapuigcervermas@gmail.com

Joan B Gornals, MD,PhD

CONTACT

+34 932607682jgornals@bellvitgehospital.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD and Head of Interventional Endoscopy Unit

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 19, 2024

Study Start

May 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

April 19, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)