Evidence map›Paper›PMID 31888751›Full record

ArticleTrials2019

Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS: a randomized controlled trial protocol.

Joan B Gornals, Manuel Perez-Miranda, Enrique Vazquez-Sequeiros, Juan Vila, José M Esteban, Ferran Gonzalez-Huix, Carlos Guarner-Argente, Andres Sanchez-Yague, Alvaro Teran, Francesc Bas-Cutrina and 9 more

Registry-linked trialOpen 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 trial NCT03100578 (Randomized Multicenter Study Comparing Plastic Stents and Self-expanding Metallic Stents Used in the Eus-guided Transmural Drainage of Walled-off Pancreatic Necrosis.), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.0field-weighted citation impact, top 13% 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.

NCT03100578 nacompletednot on this map

Randomized Multicenter Study Comparing Plastic Stents and Self-expanding Metallic Stents Used in the Eus-guided Transmural Drainage of Walled-off Pancreatic Necrosis.

TypeinterventionalSponsorHospital Universitari de BellvitgeRan2017 to 2021Enrolled99ConditionsPancreas Necrosis, Pancreatic CollectionArmsWOPN TRANSMURAL DRAINAGE: PLASTIC STENT, WOPN TRANSMURAL DRAINAGE: METALLIC STENT
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
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

19 authors at 7 institutions in 1 country.

Joan B GornalsEndoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Feixa Llarga s/n, 08907 L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain. jgornals@bellvitgehospital.cat.ORCID http://orcid.org/0000-0001-8857-3556
Manuel Perez-MirandaEndoscopy Unit, Hospital Universitario Rio Hortega, Valladolid, Spain.
Enrique Vazquez-SequeirosEndoscopy Unit, Gastroenterology and Hepatology Service, Hospital Ramon y Cajal, IRYCIS, Madrid, Spain.
Juan VilaEndoscopy Unit, Complejo Hospitalario de Navarra, Pamplona, Spain.
José M EstebanEndoscopy Unit, Department of Digestive Diseases, Hospital Clínico San Carlos, Madrid, Spain.
Ferran Gonzalez-HuixEndoscopy Unit, Hospital Arnau de Vilanova, Lleida, Spain.
Carlos Guarner-ArgenteEndoscopy Unit, Hospital Sant Pau i Santa Creu, Barcelona, Spain.
Andres Sanchez-YagueEndoscopy Unit, Hospital Costa del Sol, Marbella, Spain.
Alvaro TeranDepartment of Digestive Diseases, Hospital Universitario Marqués de Valdecilla, Santander, Spain.
Francesc Bas-CutrinaEndoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Feixa Llarga s/n, 08907 L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain.
Carlos De La SernaEndoscopy Unit, Hospital Universitario Rio Hortega, Valladolid, Spain.
Ana Garcia De ParedesEndoscopy Unit, Gastroenterology and Hepatology Service, Hospital Ramon y Cajal, IRYCIS, Madrid, Spain.
Raquel BallesterEndoscopy Unit, Hospital Arnau de Vilanova, Lleida, Spain.
Julio Velasquez-RodriguezEndoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Feixa Llarga s/n, 08907 L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain.
Silvia SalordHepato-Bilio-Pancreatic Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Barcelona, Spain.
Cristian TebeBiostatistics Unit, Institute of Biomedical Research of Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.
Pilar HereuClinical Research and Clinical Trial Unit (UICEC IDIBELL), Plataforma SCRen, Clinical Pharmacology Department, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Barcelona, Catalonia, Spain.
Sebas VidelaClinical Research and Clinical Trial Unit (UICEC IDIBELL), Plataforma SCRen, Clinical Pharmacology Department, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), University of Barcelona, Barcelona, Catalonia, Spain.
Spanish Working Group on Pancreatic Collection Therapy
Bellvitge University Hospital · ESHospital Arnau de Vilanova · ESHospital Clínico San Carlos · ESHospital Costa del Sol · ESInstituto Ramón y Cajal de Investigación Sanitaria · ESComplejo Hospitalario de Navarra · ESUniversitat Oberta de Catalunya · ES

Funding

Instituto de Salud Carlos III PI1500585Sociedad Española de Endoscopia Digestiva Beca Fundacion SEED 2015Societat Catalana de Digestologia Beca d'Intensificació 2016
6 · The paper itself

Abstract

backgroundIt seems that lumen-apposing metal stents (LAMS) are displacing plastic stents in the therapy of pancreatic-fluid collection in walled-off necrosis (WON). To date, there is no quality of evidence to recommend LAMS as the standard treatment in the management of WON. The theoretical benefit of LAMS over plastic stents needs to be proven. METHODS/

designThis is a randomized controlled, multicenter, prospective clinical trial with two parallel groups, without masking. One-hundred and fourteen patients with WON will undergo endoscopic ultrasound (EUS)-guided transmural draining in nine tertiary hospitals in Spain and will be randomized to the LAMS or plastic-stent group. The primary endpoint is the short-term (4 weeks) clinical success determined by the reduction of the collection (to < 50% or < 5 cm in size), along with clinical improvement. Secondary endpoints: long-term (4 months) clinical success (total resolution or 5 cm), procedure duration, level of difficulty, safety, and recurrences. DISCUSSION: The PROMETHEUS trial has been designed to determine whether LAMS are superior to plastic stents in EUS-guided transmural drainage of WON.

trial registrationClinicalTrials.gov, ID: NCT03100578. Registered on 4 April 2017. https://clinicaltrials.gov/ct2/home.

Indexed as

DrainageEndosonographyPancreatitis, Acute NecrotizingPlasticsSelf Expandable Metallic StentsAdolescentAdultAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaleMiddle AgedMulticenter Studies as TopicProspective StudiesPlasticsEndoscopic ultrasoundLumen-apposing metal stentMetal self-expanding stentPlastic stentRandomized clinical trialTrialWalled-off necrosis, self-expanding metal stent

Identifiers

PMID31888751
PMCPMC6937819
OpenAlexW2998385465

What OpenQuestion holds

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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.