Evidence map›Paper›PMID 35216619›Full record

ArticleTrials2022

Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction-BAMPI TRIAL: an open-label, randomized controlled trial protocol.

Albert Garcia-Sumalla, Carme Loras, Vicente Sanchiz, Rafael Pedraza Sanz, Enrique Vazquez-Sequeiros, Jose Ramon Aparicio, Carlos de la Serna-Higuera, Daniel Luna-Rodriguez, Xavier Andujar, María Capilla and 11 more

Erratum issued 2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
4.1field-weighted citation impact, top 5% 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.

NCT04595058 nacompletednot on this map

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

TypeinterventionalSponsorHospital Universitari de BellvitgeRan2020 to 2023Enrolled123ConditionsBiliary Obstruction, Pancreatic Cancer, Biliary Tract NeoplasmsArmsDouble pigtail plastic stent through lumen-apposing metal stent, Lumen-apposing metal stent without double pigtail plastic stent
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

19 citing papers in PubMed, 28 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 9 institutions in 1 country.

Albert Garcia-SumallaEndoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain.
Carme LorasEndoscopy Unit, Department of Digestive Diseases, Hospital Universitari Mútua Terrassa, Fundació per la Recerca Mútua Terrassa, CIBERehd, Terrassa, Spain.
Vicente SanchizEndoscopy Unit, Department of Digestive Diseases, Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain.
Rafael Pedraza SanzEndoscopy Unit, Department of Digestive Diseases Endoscopy Unit, Hospital General Universitario de Castellón, Castelló de la Plana, Spain.
Enrique Vazquez-SequeirosEndoscopy Unit, Gastroenterology and Hepatology Service, Hospital Ramon y Cajal, IRYCIS, Madrid, Spain.
Jose Ramon AparicioEndoscopy Unit, Department of Digestive Diseases, Hospital General Universitario de Alicante; Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain.
Carlos de la Serna-HigueraEndoscopy Unit, Department of Digestive Diseases, Hospital Universitario Rio Hortega, Valladolid, Spain.
Daniel Luna-RodriguezEndoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain.
Xavier AndujarEndoscopy Unit, Department of Digestive Diseases, Hospital Universitari Mútua Terrassa, Fundació per la Recerca Mútua Terrassa, CIBERehd, Terrassa, Spain.
María CapillaEndoscopy Unit, Department of Digestive Diseases, Hospital Clínico Universitario de Valencia, Instituto de Investigación Sanitaria INCLIVA, Valencia, Spain.
Tatiana BarberáEndoscopy Unit, Department of Digestive Diseases Endoscopy Unit, Hospital General Universitario de Castellón, Castelló de la Plana, Spain.
Jose Ramon Foruny-OlcinaEndoscopy Unit, Gastroenterology and Hepatology Service, Hospital Ramon y Cajal, IRYCIS, Madrid, Spain.
Belen MartínezEndoscopy Unit, Department of Digestive Diseases, Hospital General Universitario de Alicante; Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain.
Miguel DuraEndoscopy Unit, Department of Digestive Diseases, Hospital Universitario Rio Hortega, Valladolid, Spain.
Silvia SalordHepato-Bilio-Pancreatic Unit, Digestive Diseases Department, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain.
Berta LaquenteClinical Oncology Department, Hospital Duran y Reynalds, Institu Oncologic de Catalunya, Barcelona, Catalonia, Spain.
Cristian TebeBellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain.
Sebastia VidelaEndoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain.
Manuel Perez-MirandaEndoscopy Unit, Department of Digestive Diseases, Hospital General Universitario de Alicante; Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Alicante, Spain.
Joan B GornalsEndoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Catalonia, Spain. jgornals@bellvitgehospital.cat.ORCID http://orcid.org/0000-0001-8857-3556
Spanish Working Group on Endoscopic Ultrasound Guided Biliary Drainage
Bellvitge University Hospital · ESHospital General Universitario de Alicante Doctor Balmis · ESHospital Clínico Universitario de Valencia · ESHospital General Universitari de Castelló · ESHospital Universitario Río Hortega · ESInstituto Ramón y Cajal de Investigación Sanitaria · ESUniversitat Oberta de Catalunya · ESCentro de Investigación Biomédica en Red · ESDuran i Reynals Hospital · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIt is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing meal stent (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency. The aim of this study is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (BD) for the management of distal malignant biliary obstruction. METHODS/

designThis is a multicenter open-label, randomized controlled trial with two parallel groups. Eighty-four patients with malignant biliary obstruction will undergo EUS-BD (CDS type) using LAMS in 7 tertiary hospitals in Spain and will be randomized to the LAMS and LAMS plus DPS groups. The primary endpoint is the rate of recurrent biliary obstruction, as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin > 50% within 14 days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate). DISCUSSION: The BAMPI trial has been designed to determine whether the addition of a coaxial axis-orienting DPS through LAMS is superior to LAMS alone to prevent stent dysfunction.

trial registrationClinicalTrials.gov NCT04595058 . Registered on October 14, 2020.

Indexed as

CholestasisEndosonographyDrainageHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicStentsUltrasonography, InterventionalBiliary drainageCholedochoduodenostomyEndoscopic ultrasoundLumen-apposing metal stentMalignant biliary obstructionPlastic stentTrial

Identifiers

PMID35216619
PMCPMC8874735
OpenAlexW4214753952

What OpenQuestion holds

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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.