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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06375954
Other study ID # CARPEDIEM-2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date May 1, 2027

Study information

Verified date September 2023
Source Hospital Universitari de Bellvitge
Contact Maria Puigcerver-Mas, MD,
Phone +34 687332007
Email mariapuigcervermas@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 96
Est. completion date May 1, 2027
Est. primary completion date June 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Endoscopic biliary drainage
Decompression of the bile duct by endoscopic aproach.
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.
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.

Locations

Country Name City State
Spain Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona

Sponsors (12)

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

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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 — View Citation

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 — View Citation

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 Choledo — View Citation

Outcome

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