PMID- 36302047
OWN - NLM
STAT- MEDLINE
DCOM- 20221108
LR  - 20221108
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 17
IP  - 10
DP  - 2022
TI  - Percutaneous transhepatic or endoscopic ultrasound-guided biliary drainage in 
      malignant distal bile duct obstruction using a self-expanding metal stent: Study 
      protocol for a prospective European multicenter trial (PUMa trial).
PG  - e0275029
LID - 10.1371/journal.pone.0275029 [doi]
LID - e0275029
AB  - BACKGROUND: Endoscopic ultrasound-guided biliary drainage (EUS-BD) was associated 
      with better clinical success and a lower rate of adverse events (AEs) than 
      fluoroscopy-guided percutaneous transhepatic biliary drainage (PTBD) in recent 
      single center studies with mainly retrospective design and small case numbers (< 
      50). The aim of this prospective European multicenter study is to compare both 
      drainage procedures using ultrasound-guidance and primary metal stent 
      implantation in patients with malignant distal bile duct obstruction (PUMa 
      Trial). METHODS: The study is designed as a non-randomized, controlled, parallel 
      group, non-inferiority trial. Each of the 16 study centers performs the procedure 
      with the best local expertise (PTBD or EUS-BD). In PTBD, bile duct access is 
      performed by ultrasound guidance. EUS-BD is performed as an endoscopic ultrasound 
      (EUS)-guided hepaticogastrostomy (EUS-HGS), EUS-guided choledochoduodenostomy 
      (EUS-CDS) or EUS-guided antegrade stenting (EUS-AGS). Insertion of a metal stent 
      is intended in both procedures in the first session. Primary end point is 
      technical success. Secondary end points are clinical success, duration pf 
      procedure, AEs graded by severity, length of hospital stay, re-intervention rate 
      and survival within 6 months. The target case number is 212 patients (12 
      calculated dropouts included). DISCUSSION: This study might help to clarify 
      whether PTBD is non-inferior to EUS-BD concerning technical success, and whether 
      one of both interventions is superior in terms of efficacy and safety in one or 
      more secondary endpoints. Randomization is not provided as both procedures are 
      rarely used after failed endoscopic biliary drainage and study centers usually 
      prefer one of both procedures that they can perform best. TRIAL REGISTRATION: 
      ClinicalTrials.gov ID: NCT03546049 (22.05.2018).
FAU - Schmitz, Daniel
AU  - Schmitz D
AUID- ORCID: 0000-0002-3273-8435
AD  - Department of Gastroenterology, Oncology and Diabetology, Theresienkrankenhaus 
      und St. Hedwig-Klinik, Lehrkrankenhaus der Universitat Heidelberg, Mannheim, 
      Germany.
AD  - Department of Gastroenterology and Infectiology, Helios Kliniken Schwerin, 
      Schwerin, Germany.
FAU - Valiente, Carlos T
AU  - Valiente CT
AD  - Department of Gastroenterology, Oncology and Diabetology, Theresienkrankenhaus 
      und St. Hedwig-Klinik, Lehrkrankenhaus der Universitat Heidelberg, Mannheim, 
      Germany.
FAU - Dollhopf, Markus
AU  - Dollhopf M
AD  - Department of Gastroenterology and Hepatology, Munchen Klinik Neuperlach, 
      Munchen, Germany.
FAU - Perez-Miranda, Manuel
AU  - Perez-Miranda M
AUID- ORCID: 0000-0003-0744-220X
AD  - Department of Gastrointestinal Endoscopy, Hospital Universitario Rio Hortega, 
      Valladolid, Spain.
FAU - Kullmer, Armin
AU  - Kullmer A
AD  - Department of Medicine II: Gastroenterology, Hepatology, Endocrinology, and 
      Infectious Diseases, Universitatsklinikum Freiburg, Freiburg, Germany.
FAU - Gornals, Joan
AU  - Gornals J
AD  - Department of Digestive Diseases, Hospital Universitari de Bellvitge, Barcelona, 
      Spain.
FAU - Vila, Juan
AU  - Vila J
AD  - Endoscopy Unit, Complejo Hospitalario de Navarra, Pamplona, Spain.
FAU - Weigt, Jochen
AU  - Weigt J
AD  - Department of Gastroenterology, Hepatology and Infectiology, Universitatsklinikum 
      Magdeburg, Magdeburg, Germany.
FAU - Voigtlander, Torsten
AU  - Voigtlander T
AD  - Department of Gastroenterology, Hepatology and Endocrinology, Medizinische 
      Hochschule Hannover, Hannover, Germany.
FAU - Redondo-Cerezo, Eduardo
AU  - Redondo-Cerezo E
AD  - Department of Gastrointestinal Endoscopy, Hospital universitario Virgen de las 
      Nieves, Granada, Spain.
FAU - von Hahn, Thomas
AU  - von Hahn T
AD  - Department of Gastroenterology, Hepatology, and Interventional Endoscopy, 
      Asklepios Klinik Barmbek, Hamburg, Germany.
FAU - Albert, Jorg
AU  - Albert J
AD  - Department of Gastroenterology, Hepatology and Endocrinology, 
      Robert-Bosch-Krankenhaus, Stuttgart, Germany.
FAU - Vom Dahl, Stephan
AU  - Vom Dahl S
AUID- ORCID: 0000-0003-0481-0601
AD  - Department of Gastroenterology, Hepatology and Infectiology, Universitatsklinikum 
      Dusseldorf, Dusseldorf, Germany.
FAU - Beyna, Torsten
AU  - Beyna T
AD  - Department of Internal Medicine, Gastroenterology and Interventional Endoscopy 
      Evangelisches Krankenhaus Dusseldorf, Dusseldorf, Germany.
FAU - Hartmann, Dirk
AU  - Hartmann D
AD  - Department of General Internal Medicine, Diabetology, Gastroenterology and 
      Oncology, Katholisches Klinikum Mainz, Mainz, Germany.
FAU - Franck, Franziska
AU  - Franck F
AD  - Department of Gastroenterology and Hepatology, Munchen Klinik Neuperlach, 
      Munchen, Germany.
FAU - Garcia-Alonso, Francisco Javier
AU  - Garcia-Alonso FJ
AD  - Department of Gastrointestinal Endoscopy, Hospital Universitario Rio Hortega, 
      Valladolid, Spain.
FAU - Schmidt, Arthur
AU  - Schmidt A
AD  - Department of Medicine II: Gastroenterology, Hepatology, Endocrinology, and 
      Infectious Diseases, Universitatsklinikum Freiburg, Freiburg, Germany.
FAU - Garcia-Sumalla, Albert
AU  - Garcia-Sumalla A
AD  - Department of Digestive Diseases, Hospital Universitari de Bellvitge, Barcelona, 
      Spain.
FAU - Arrubla, Amaia
AU  - Arrubla A
AUID- ORCID: 0000-0002-9646-009X
AD  - Endoscopy Unit, Complejo Hospitalario de Navarra, Pamplona, Spain.
FAU - Joerdens, Markus
AU  - Joerdens M
AD  - Department of Gastroenterology, Hepatology and Infectiology, Universitatsklinikum 
      Dusseldorf, Dusseldorf, Germany.
FAU - Kleemann, Tobias
AU  - Kleemann T
AUID- ORCID: 0000-0003-3913-6821
AD  - Department of Gastroenterology and Rheumatology, Carl-Thiem-Klinikum Cottbus, 
      Cottbus, Germany.
FAU - Tomo, Jose Ramon Aparicio
AU  - Tomo JRA
AD  - Department of Digestive Diseases, Hospital General Universitario de Alicante, 
      Alicante, Spain.
FAU - Grassmann, Felix
AU  - Grassmann F
AD  - Institute for Medical Statistics and Epidemiology, Medical School Hamburg, 
      Hamburg, Germany.
FAU - Rudi, Jochen
AU  - Rudi J
AD  - Department of Gastroenterology, Oncology and Diabetology, Theresienkrankenhaus 
      und St. Hedwig-Klinik, Lehrkrankenhaus der Universitat Heidelberg, Mannheim, 
      Germany.
LA  - eng
SI  - ClinicalTrials.gov/NCT03546049
PT  - Controlled Clinical Trial
PT  - Equivalence Trial
PT  - Journal Article
DEP - 20221027
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
SB  - IM
MH  - Humans
MH  - Cholangiopancreatography, Endoscopic Retrograde/adverse effects
MH  - *Cholestasis/diagnostic imaging/surgery
MH  - Drainage/adverse effects/methods
MH  - Endosonography/methods
MH  - Multicenter Studies as Topic
MH  - Prospective Studies
MH  - Retrospective Studies
MH  - Stents/adverse effects
MH  - Ultrasonography, Interventional
PMC - PMC9612485
COIS- The authors have declared that no competing interests exist.
EDAT- 2022/10/28 06:00
MHDA- 2022/11/01 06:00
PMCR- 2022/10/27
CRDT- 2022/10/27 14:05
PHST- 2021/12/17 00:00 [received]
PHST- 2022/09/07 00:00 [accepted]
PHST- 2022/10/27 14:05 [entrez]
PHST- 2022/10/28 06:00 [pubmed]
PHST- 2022/11/01 06:00 [medline]
PHST- 2022/10/27 00:00 [pmc-release]
AID - PONE-D-21-38739 [pii]
AID - 10.1371/journal.pone.0275029 [doi]
PST - epublish
SO  - PLoS One. 2022 Oct 27;17(10):e0275029. doi: 10.1371/journal.pone.0275029. 
      eCollection 2022.