Clinical trialNACompleted
EUS Biliary Drainage vs. ERCP
EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction: a Randomized Controlled Trial
- Outcome
- Finished, no results posted
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- 8 March 2019
- Expected end
- 1 July 2023
- Enrollment
- 144 participants
- Sites
- 11
- Primary outcomes
- Rate of re-intervention
- Sponsor
- Other
- Results posted
- No
- Last update
- 14 August 2023
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Brief summary public domain (ClinicalTrials.gov)
Endoscopic ultrasound guided biliary drainage (EUS-BD) is an evolving field that has grown in popularity in the management of malignant biliary obstruction. Although Endoscopic retrograde cholangio-pancreatography (ERCP) with stent insertion has been the mainstay therapy throughout several decades, the transpapillary approach through tumor tissue is associated with significant risk for adverse events such as post-ERCP pancreatitis and stent dysfunction from tumor tissue overgrowth and ingrowth. EUS-BD, through the creation of a choledochoduodenostomy with a stent, has the potential advantage of avoiding the papilla and its associated complications while potentially improving stent patency with lower risks for tumor tissue ingrowth and/or overgrowth.
Papers 8
- Builds on itEndoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograd… DOI 10.1053/j.gastro.2023.07.024↗
- Builds on itELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of fir… DOI 10.1186/s13063-019-3918-y↗
- BackgroundEUS-Guided Biliary Drainage Versus ERCP for the Primary Palliation of Malignant Biliary Obstruction: A Multicenter Rand… DOI 10.1038/s41395-018-0122-8↗
- BackgroundStent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos). DOI 10.1016/j.gie.2018.03.012↗
- BackgroundValidation of the American Joint Commission on Cancer (AJCC) 8th Edition Staging System for Patients with Pancreatic Ad… DOI 10.1245/s10434-017-5810-x↗
- BackgroundCost-effectiveness and clinical efficacy of biliary stents in patients undergoing neoadjuvant therapy for pancreatic ad… DOI 10.1016/j.gie.2016.02.047↗
- BackgroundAdjuvant treatments for resected pancreatic adenocarcinoma: a systematic review and network meta-analysis. DOI 10.1016/s1470-2045(13)70388-7↗
- BackgroundA lexicon for endoscopic adverse events: report of an ASGE workshop. DOI 10.1016/j.gie.2009.10.027↗