Clinical trialNACompleted
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
- Outcome
- Finished, no results posted
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- 17 November 2020
- Expected end
- 17 October 2023
- Enrollment
- 123 participants
- Sites
- 2
- Primary outcomes
- Safety (Adverse events); Recurrent biliary obstruction (RBO)
- Sponsor
- Other
- Results posted
- No
- Last update
- 18 April 2024
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.
Papers 5
- Registry-listed results paperEUS-guided choledochoduodenostomy by use of electrocautery-enhanced lumen-apposing metal stents: a French multicenter s… DOI 10.1016/j.gie.2020.01.055↗
- Builds on itLumen-Apposing Stents With or Without Pigtail in Endosonography-Guided Biliary Drainage for Malignant Distal Biliary Ob… DOI 10.1016/j.cgh.2025.05.025↗
- Builds on itMulticenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary draina… DOI 10.1186/s13063-022-06106-1↗
- BackgroundEUS-Guided Choledochoduodenostomy for Distal Malignant Biliary Obstruction Using Electrocautery-Enhanced Lumen-Apposing… DOI 10.1007/s10620-019-05688-2↗
- BackgroundLong-term outcomes of EUS-guided choledochoduodenostomy using a lumen-apposing metal stent for malignant distal biliary… DOI 10.1016/j.gie.2017.08.017↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.