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Biliary drainage using EUS-guided Cholecystostomy with lumen apposing metal stent

Echoendoscopy-guided Cholecystostomy (EUS-GBD) with deployment of a lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent throug LAMS.

EUS-GBD technique: Diagnostic EUS. Classic or free-hand with preloaded guidewire cholecystostomy with LAMS. Pneumatic dilation whithin LAMS is allowed. 'push' technique ___ ??? Deployment of a pigtail coaxial to LAMS.

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.

Decompression of the bile duct by endoscopic aproach.

Endoscopic biliary drainage

Lumen-apposing metal stent (LAMS) with coaxial double-pigtail plastic stent (DPPS) deployment:

* LAMS size: 6x8mm, 8x8mm. Consider 10x10mm or 10x15mm if abundant pathological material in gallblader.
* DPPS size: 7Fr x 3-5-7cm.

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.

Julia Escuer Turu, MD, Research fellow

Joan B Gornals Soler, PhD

Joan B Gornals, PhD

Julia Escuer Turu, MD

Maria Puigcerver Mas, MD

Sandra Maisterra, MD

Albert Garcia-Sumalla, MD

Julio G Velasquez-Rodriguez, MD

Daniel Luna-Rodriguez, MD

Carme Loras, MD, PhD

Charly Guarner Argente, MD, PhD

Juan J Vila, MD, PhD

Jose R Aparicio, MD, PhD

Jose Lariño, MD, PhD

Rafa Pedraza, MD, PhD

Antonio Rodriguez D'Jesus, MD, PhD

Alberto Alvarez, MD, PhD

Vicente Sanchiz, MD, PhD

Joan B Gornals Soler

Carme Loras

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.

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.

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

Multicenter Study of EUS-guided Gallbladder Drainage vs Choledochoduodenostomy as First Line in Malignant Distal Obstruction in Palliative Patients (CARPEGIEM Trial): an Open-label, Randomized Controlled Clinical Trial

Safety will be measured by careful and comparative evaluation of adverse effects in both groups.

Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.

Resolution of jaundice or drop in total bilirubin level by \> 50% within 2 weeks after the EUS guided drainage.

Technical success was defined as successful placement of the LAMS between the bile duct (choledoc or gallblader) and the lumen digestive system (stomach or duodenum), creating a transmural ostomy. To evaluate the correct position of the transmural stent, the deployment of the internal flap in the lumen of the bile duct must be verified by ultrasound vision and the internal flap by endoscopic vision.

Interventions needed to treat - Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.

Length of hospital stay after intervention

Evaluate the costs between the two types of strategy

Hospital Clínico Universitario de Valencia

Hospital General Universitario de Alicante

Hospital Mutua de Terrassa

Hospital Universitario Ramon y Cajal

Hospital General Universitario de Castellón

Complejo Hospitalario de Navarra

University Hospital Virgen de las Nieves

Hospital de Sant Pau

University of Salamanca

Complejo Hospitalario Universitario de Santiago

Complejo Hospitalario Universitario de Vigo

Hospital Universitari de Bellvitge

PhD and Head of Interventional Endoscopy Unit

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.

Self-expandable metallic stent (SEMS) deployment:

* Covering: Uncovered or Partially Covered. Non covered if gallbladder is present.
* Size: 10x40mm or 10x60mm or 10x80mm.

Self-expandable metallic stent (SEMS)

Maria Puigcerver-Mas, MD, Research fellow

Joan B Gornals, MD, PhD

Maria Puigcerver-Mas, MD

Julia Escuer-Turu, MD

Daniel Luna Rodriguez, MD

Albert Sumalla, MD

Berta Laquente, MD, PhD

Juli Busquets, MD, PhD

Julio Velasquez Rodriguez, MD

Charly Guarner Argente, MD, PHD

Rafael Pedraza, MD

Jose Ramon Aparicio, MD, PhD

Eduardo Redondo, MD, PhD

The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and surgery in patients with resectable distal malignant biliary obstruction.

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 resectable patients is still limited.

A recent retrospective study (Janet J et al, Ann Surg Oncol 2023) which included resectable patients, found that EUS-CDS group had significantly less delay (days) between biliary drainage and surgery 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 when compared to ERCP in MDBO in resectable patients.

EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)

Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction in Resectable Disease: An Open-label, Multicenter Randomized Controlled Trial (CARPEDIEM-1 Trial)

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

ERCP group: cannulation, cholangiogram, correct deployment of SEMS. EUS-CDS group: Correct deployment of both flaps of LAMS (and pigtail) in place, checked by ecoendoscopy/endoscopic image/floroscopy.

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

In cholangitis: stop of antibiotics without clinical recurrence or decreasing \> 50% of acute phase reactants 14 days after the endoscopic procedure.

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

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

Hospital Álvaro Cunqueiro

Maria Puigcerver-Mas, MD,

Joan B Gornals, MD,PhD

Julia Escuer, MD

VIcente Sanchiz, MD, PhD

Charly Guarner-Argente, MD, PhD

Alberto Alvarez, MD, pHD

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.

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.

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

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)

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

ERCP group: cannulation, cholangiogram, correct deployment of SEMS

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

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

Endoscopic ultrasound-guided choledochoduodenostomy with lumen-apposing metal stent . Formal indication on biliopancreatic drainage according to the instruction forms of the manufacturer.

EUSDB-LAMS (Endoscopic ultrasound guided biliary drainage with lumen-apposing metal stent)

Endoscopic ultrasound-guided choledochoduodenostomy with lumen-apposing metal stents without coaxial plastic stent. Formal indication on biliopancreatic drainage according to the instruction forms of the manufacturer.

In this arm, a double pigtail through the lumen apposing metal stent will be inserted as an axis-orienting stent.

EUSDB-LAMS-Pigtial (Endoscopic ultrasound guided biliary drainage with lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent through LAMS)

Biliary drainage guided by endoscopic ultrasound: Addition or not, of a axis-orienting plastic stent, mostly, double-pigtail stent through the lumen of a lumen-apposing metal stent

Double pigtail plastic stent through lumen-apposing metal stent

Endoscopic ultrasound-guided transmural biliary drainage is with lumen-apposing metal stent is a formal indication according to the instruction forms of the manufacturer.

Lumen-apposing metal stent without double pigtail plastic stent

The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with and without a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies (CDS) for the management of biliary obstruction.

The introduction of specific biliary lumen-apposing metal stents (LAMS) represented a great technical improvement in EUS-guided transmural Biliary drainage (BD) of distal malignant biliary obstruction Data is still limited, but recent studies and reviews have been reported with acceptable technical and clinical success. However, some concerns exist regarding its safety, as secondary adverse events

There are doubts concerning the possible benefits derived from the insertion of double-pigtail plastic stents (DPS) within the lumen-apposing metal stents (LAMS) in the EUS-guided choledochoduodenostomy (CDS). Our hypothesis is that adding a coaxial plastic stent may offer benefits in terms of safety in CDS.

LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

Multicenter, Randomized and Comparative Study of Lumen-apposing Metal Stents With or Without Coaxial Plastic Stent for Endoscopic Ultrasound-guided Transmural Biliary Drainage

Resolution of jaundice or drop in total bilirubin level by \> 50% within 2 weeks after the EUS-CD.

Technical success was defined as successful placement of the LAMS between the bile duct and the duodenal lumen, creating a transmural ostomy. To evaluate the correct position of the transmural stent, the deployment of the internal flap in the lumen of the bile duct must be verified by ultrasound vision and the internal flap by endoscopic vision.

Survival is defined as the time elapsed between biliary drainage and the end of follow-up, either due to death and cessation of follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)	NCT06375967	Malignant Bilia... Biliary Tract N... Pancreatic Canc...	Endoscopic bili... Lumen-apposing ... Lumen-apposing ...	18 Years - 100 Years	Hospital Universitari de Bellvitge
EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial)	NCT06375967	Malignant Bilia... Biliary Tract N... Pancreatic Canc...	Endoscopic bili... Lumen-apposing ... Lumen-apposing ...	18 Years - 100 Years	Hospital Universitari de Bellvitge
EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)	NCT06375928	Malignant Bilia... Pancreatic Canc... Biliary Tract N...	Endoscopic bili... Self-expandable... Lumen-apposing ...	18 Years -	Hospital Universitari de Bellvitge
EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)	NCT06375954	Malignant Bilia... Pancreatic Canc... Biliary Tract N...	Endoscopic bili... Self-expandable... Lumen-apposing ...	18 Years -	Hospital Universitari de Bellvitge
LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent	NCT04595058	Biliary Obstruc... Pancreatic Canc... Biliary Tract N...	Double pigtail ... Lumen-apposing ...	18 Years -	Hospital Universitari de Bellvitge
LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent	NCT04595058	Biliary Obstruc... Pancreatic Canc... Biliary Tract N...	Double pigtail ... Lumen-apposing ...	18 Years -	Hospital Universitari de Bellvitge
EUS-guided CDS vs ERCP as First Line in Malignant Distal Obstruction in Borderline Disease (CARPEDIEM-2 Trial)	NCT06375954	Malignant Bilia... Pancreatic Canc... Biliary Tract N...	Endoscopic bili... Self-expandable... Lumen-apposing ...	18 Years -	Hospital Universitari de Bellvitge
EUS-guided Choledochoduodenostomy vs ERCP as First Line in Malignant Distal Obstruction in Resectable Disease (CARPEDIEM-1 Trial)	NCT06375928	Malignant Bilia... Pancreatic Canc... Biliary Tract N...	Endoscopic bili... Self-expandable... Lumen-apposing ...	18 Years -	Hospital Universitari de Bellvitge

Spots Global Cancer Trial Database for lumen apposing metal stent