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

Pancreatic Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375954
• Other study ID #: CARPEDIEM-2
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Biliary Tract Neoplasms
• Malignant Biliary Obstruction
• Pancreatic Cancer

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