Evidence map›Paper›PMID 31818329›Full record

ArticleTrials2019

ELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangio-pancreatography in the management of malignant distal biliary obstruction.

Yen-I Chen, Kashi Callichurn, Avijit Chatterjee, Etienne Desilets, Donnellan Fergal, Nauzer Forbes, Ian Gan, Sana Kenshil, Mouen A Khashab, Rastislav Kunda and 18 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.4field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03870386 nacompletednot on this map

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

TypeinterventionalSponsorMcGill University Health Centre/Research Institute of the McGill University Health CentreRan2019 to 2023Enrolled144ConditionsBiliary ObstructionArmsEUS-BD with LAMS, ERCP
NCT06375967 nasuspendednot on this mapstarted 2024, after this paper: background citation

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

TypeinterventionalSponsorHospital Universitari de BellvitgeRan2024 to 2027Enrolled128ConditionsMalignant Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Cancer Non-resectableArmsEndoscopic biliary drainage, Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS)
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 22 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors at 11 institutions in 3 countries.

Yen-I ChenDivision of Gastroenterology and Hepatology, McGill University Health Centre, McGill University, Montreal, QC, Canada. yen-i.chen@mcgill.ca.ORCID http://orcid.org/0000-0001-5704-2226
Kashi CallichurnDivision of Gastroenterology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
Avijit ChatterjeeDivision of Gastroenterology and Hepatology, Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada.
Etienne DesiletsDivision of Gastroenterology, Hôpital Charles-Le Moyne, University of Sherbrooke, Greenfield Park, QC, Canada.
Donnellan FergalDivision of Gastroenterology and Hepatology, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada.
Nauzer ForbesDivision of Gastroenterology and Hepatology, University of Calgary, Calgary, AB, Canada.
Ian GanDivision of Gastroenterology and Hepatology, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada.
Sana KenshilDivision of Gastroenterology and Hepatology, Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada.
Mouen A KhashabDivision of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, MD, USA.
Rastislav KundaDepartment of Surgery, Department of Gastroenterology and Hepatology, Department of Advanced Interventional Endoscopy, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
Eric LamDivision of Gastroenterology and Hepatology, St-Paul's Hospital, University of British Columbia, Vancouver, BC, Canada.
Gary MayDivision of Gastroenterology and Hepatology, St-Michael's Hospital, University of Toronto, Toronto, ON, Canada.
Rachid MohamedDivision of Gastroenterology and Hepatology, University of Calgary, Calgary, AB, Canada.
Jeff MoskoDivision of Gastroenterology and Hepatology, St-Michael's Hospital, University of Toronto, Toronto, ON, Canada.
Sarto C PaquinDivision of Gastroenterology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
Anand SahaiDivision of Gastroenterology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.
Gurpal SandhaDivision of Gastroenterology and Hepatology, University of Alberta Hospital, University of Alberta, Edmonton, AB, Canada.
Christopher TeshimaDivision of Gastroenterology and Hepatology, St-Michael's Hospital, University of Toronto, Toronto, ON, Canada.
Alan BarkunDivision of Gastroenterology and Hepatology, McGill University Health Centre, McGill University, Montreal, QC, Canada.
Jeffrey BarkunDepartment of Surgery, McGill University Health Centre, McGill University, Montreal, QC, Canada.
Ali BessissowDepartment of Radiology, McGill University Health Centre, McGill University, Montreal, QC, Canada.
Kristina CandidoDivision of Gastroenterology and Hepatology, McGill University Health Centre, McGill University, Montreal, QC, Canada.
Myriam MartelDivision of Gastroenterology and Hepatology, McGill University Health Centre, McGill University, Montreal, QC, Canada.
Corey MillerDivision of Gastroenterology and Hepatology, McGill University Health Centre, McGill University, Montreal, QC, Canada.
Kevin WaschkeDivision of Gastroenterology and Hepatology, McGill University Health Centre, McGill University, Montreal, QC, Canada.
George ZogopoulosDepartment of Surgery, McGill University Health Centre, McGill University, Montreal, QC, Canada.
Clarence WongDivision of Gastroenterology and Hepatology, Royal Alexandra Hospital, University of Alberta, Edmonton, AB, Canada.
ELEMENT trial and for the Canadian Endoscopic Research Collaborative (CERC)
McGill University Health Centre · CACentre Hospitalier de l’Université de Montréal · CASt. Michael's Hospital · CAUniversity of British Columbia · CAUniversity of Calgary · CAUniversity of Ottawa · CAHôpital Charles-Le Moyne · CAJohns Hopkins Hospital · USUniversity of Alberta · CAUniversity of Alberta Hospital · CAVrije Universiteit Brussel · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND &

aimsEndoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); however, its growth has been limited by a lack of multicenter randomized controlled trials (RCT) and dedicated devices. A dedicated EUS-BD lumen- apposing metal stent (LAMS) has recently been developed with the potential to greatly facilitate the technique and safety of the procedure. We aim to compare a first intent approach with EUS-guided choledochoduodenostomy with a dedicated biliary LAMS vs. standard ERCP in the management of malignant distal biliary obstruction.

methodsThe ELEMENT trial is a multicenter single-blinded RCT involving 130 patients in nine Canadian centers. Patients with unresectable, locally advanced, or borderline resectable malignant distal biliary obstruction meeting the inclusion and exclusion criteria will be randomized to EUS-choledochoduodenostomy using a LAMS or ERCP with traditional metal stent insertion in a 1:1 proportion in blocks of four. Patients with hilar obstruction, resectable cancer, or benign disease are excluded. The primary endpoint is the rate of stent dysfunction needing re-intervention. Secondary outcomes include technical and clinical success, interruptions in chemotherapy, rate of surgical resection, time to stent dysfunction, and adverse events. DISCUSSION: The ELEMENT trial is designed to assess whether EUS-guided choledochoduodenostomy using a dedicated LAMS is superior to conventional ERCP as a first-line endoscopic drainage approach in malignant distal biliary obstruction, which is an important and timely question that has not been addressed using an RCT study design.

trial registrationRegistry name: ClinicalTrials.gov. Registration number: NCT03870386. Date of registration: 03/12/2019.

Indexed as

Bile Duct NeoplasmsCholangiopancreatography, Endoscopic RetrogradeCholestasisDrainageEndosonographyStentsUltrasonography, InterventionalHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicSingle-Blind MethodCholangiopancreatography (ERCP)Endoscopic retrogradeEndoscopic ultrasound guided-biliary drainage (EUS-BD)EndoscopyMalignant distal obstructionTreatmentTrial

Identifiers

PMID31818329
PMCPMC6902519
OpenAlexW2995085185

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.