LAMS Choledochoduodenostomies: With or Without Coaxial Plastic Stent

Pancreatic Cancer Clinical Trial

— BAMPI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04595058
• Other study ID #: BAMPI
• Status: Completed
• Phase: N/A
• Start date: November 17, 2020
• Est. completion date: October 17, 2023

Study information

• Verified date: December 2022
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 17, 2023
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Distal biliary strictures,
• A prior failed attempt at biliary drainage
• informed consent provided by the patient.

Patient exclusion criteria were as follows:

• younger than age 18 years,
• coagulopathy (international normalized ratio >1.5, marked thrombocytopenia with a platelet count <50,000/mL, or patient on anticoagulation therapy),
• critical illness.

Related Conditions & MeSH terms

• Biliary Obstruction
• Biliary Tract Neoplasms
• Pancreatic Cancer

Intervention

Device:
• Double pigtail plastic stent through lumen-apposing metal stent
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
• Lumen-apposing metal stent without double pigtail plastic 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.

Locations

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

Sponsors (7)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Hospital Clínico Universitario de Valencia, Hospital del Río Hortega, Hospital General Universitario de Alicante, Hospital Mutua de Terrassa, Hospital Provincial de Castellon, Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Anderloni A, Fugazza A, Troncone E, Auriemma F, Carrara S, Semeraro R, Maselli R, Di Leo M, D'Amico F, Sethi A, Repici A. Single-stage EUS-guided choledochoduodenostomy using a lumen-apposing metal stent for malignant distal biliary obstruction. Gastrointest Endosc. 2019 Jan;89(1):69-76. doi: 10.1016/j.gie.2018.08.047. Epub 2018 Sep 4. — View Citation

El Chafic AH, Shah JN, Hamerski C, Binmoeller KF, Irani S, James TW, Baron TH, Nieto J, Romero RV, Evans JA, Kahaleh M. EUS-Guided Choledochoduodenostomy for Distal Malignant Biliary Obstruction Using Electrocautery-Enhanced Lumen-Apposing Metal Stents: F — View Citation

Jacques J, Privat J, Pinard F, Fumex F, Chaput U, Valats JC, Cholet F, Jezequel J, Grandval P, Legros R, Lepetit H, Albouys J, Napoleon B. EUS-guided choledochoduodenostomy by use of electrocautery-enhanced lumen-apposing metal stents: a French multicente — View Citation

Tsuchiya T, Teoh AYB, Itoi T, Yamao K, Hara K, Nakai Y, Isayama H, Kitano M. Long-term outcomes of EUS-guided choledochoduodenostomy using a lumen-apposing metal stent for malignant distal biliary obstruction: a prospective multicenter study. Gastrointest — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Adverse events)	Safety will be measured by careful and comparative evaluation of adverse effects in both groups.	12 months
Primary	Recurrent biliary obstruction (RBO)	Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.	12 months
Secondary	Clinical success	Resolution of jaundice or drop in total bilirubin level by > 50% within 2 weeks after the EUS-CD.	2 weeks
Secondary	Technical success	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.	24 hours.
Secondary	Survival	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.	12 months