PMID- 36646148
OWN - NLM
STAT- MEDLINE
DCOM- 20230522
LR  - 20230524
IS  - 1097-6779 (Electronic)
IS  - 0016-5107 (Linking)
VI  - 97
IP  - 6
DP  - 2023 Jun
TI  - EUS-guided transluminal drainage using lumen-apposing metal stents with or 
      without coaxial plastic stents for treatment of walled-off necrotizing 
      pancreatitis: a prospective bicentric randomized controlled trial.
PG  - 1070-1080
LID - S0016-5107(23)00012-3 [pii]
LID - 10.1016/j.gie.2022.12.026 [doi]
AB  - BACKGROUND AND AIMS: Lumen-apposing metal stents (LAMSs) have proven to be 
      effective for drainage of pancreatic walled-off necrosis (WON), although 
      associated adverse events (AEs) have been reported. Anchoring coaxial 
      double-pigtail plastic stents (DPSs) within LAMSs have been proposed to prevent 
      LAMS-related AEs but have not been assessed in prospective studies. We aimed to 
      evaluate the utility of such measures with a randomized controlled trial. 
      METHODS: We randomly assigned consecutive patients with WON indications for 
      drainage to EUS-guided transluminal drainage using LAMSs with (group A) or 
      without (group B) DPSs. All LAMSs were to be removed after 3 weeks had elapsed 
      from the index procedure with a preceding CT to decide whether additional steps 
      needed to be taken (eg, transluminal necrosectomy or placing transluminal plastic 
      stents in patients with incomplete resolution of WON). The main outcomes were 
      failure of the index method, defined as necessity of reintervention (endoscopic, 
      percutaneous, or surgical) before LAMS removal because of LAMS-related AEs and/or 
      clinical deterioration; AE rates; and mortality with the LAMS in place. Variables 
      were evaluated using the Mann-Whitney U test, chi(2) test, or Fisher exact test as 
      appropriate. P < .05 was considered significant. RESULTS: Sixty-seven patients 
      (37.3% women; mean age, 54 +/- 14.4 years) underwent LAMS placement with (n = 34) 
      or without (n = 33) DPS placement in 2 tertiary centers. Baseline characteristics 
      including demographics, etiology, comorbidity, and clinical presentation (sterile 
      vs infected necrosis) were comparable between both groups. The technical success 
      rate in placing LAMSs and DPSs was 100%. The global rate of AEs was significantly 
      lower in group A versus group B (20.7% vs 51.5%, respectively; P = .008). Stent 
      occlusion was the most frequently observed AE (14.7% vs 36.3%, P = .042). Failure 
      of the index method was lower in group A versus group B (29.4% vs 48.5%, 
      respectively; P = .109); however, the difference did not achieve statistical 
      significance. The same applied to the mortality rate with LAMSs in place (2.9% vs 
      12.1%, P = .197). CONCLUSIONS: The addition of a coaxial DPS within a LAMS was 
      associated with a significantly lower global rate of AEs and stent occlusion rate 
      in EUS-guided drainage of WON. (Clinical trial registration number: 
      NCT03923686.).
CI  - Copyright (c) 2023 American Society for Gastrointestinal Endoscopy. Published by 
      Elsevier Inc. All rights reserved.
FAU - Vanek, Petr
AU  - Vanek P
AD  - Department of Internal Medicine II-Gastroenterology and Geriatrics, Faculty of 
      Medicine and Dentistry, Palacky University Olomouc and University Hospital 
      Olomouc, Olomouc, Czech Republic.
FAU - Falt, Premysl
AU  - Falt P
AD  - Department of Internal Medicine II-Gastroenterology and Geriatrics, Faculty of 
      Medicine and Dentistry, Palacky University Olomouc and University Hospital 
      Olomouc, Olomouc, Czech Republic.
FAU - Vitek, Petr
AU  - Vitek P
AD  - Beskydske Gastrocentrum, Frydek-Mistek Hospital, Frydek-Mistek, Czech Republic; 
      Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
FAU - Zoundjiekpon, Vincent
AU  - Zoundjiekpon V
AD  - Department of Internal Medicine II-Gastroenterology and Geriatrics, Faculty of 
      Medicine and Dentistry, Palacky University Olomouc and University Hospital 
      Olomouc, Olomouc, Czech Republic.
FAU - Horinkova, Monika
AU  - Horinkova M
AD  - Department of Internal Medicine II-Gastroenterology and Geriatrics, Faculty of 
      Medicine and Dentistry, Palacky University Olomouc and University Hospital 
      Olomouc, Olomouc, Czech Republic.
FAU - Zapletalova, Jana
AU  - Zapletalova J
AD  - Department of Medical Biophysics, Faculty of Medicine and Dentistry, Palacky 
      University Olomouc, Olomouc, Czech Republic.
FAU - Lovecek, Martin
AU  - Lovecek M
AD  - Department of Surgery I, Faculty of Medicine and Dentistry, Palacky University 
      Olomouc and University Hospital Olomouc, Olomouc, Czech Republic.
FAU - Urban, Ondrej
AU  - Urban O
AD  - Department of Internal Medicine II-Gastroenterology and Geriatrics, Faculty of 
      Medicine and Dentistry, Palacky University Olomouc and University Hospital 
      Olomouc, Olomouc, Czech Republic.
LA  - eng
SI  - ClinicalTrials.gov/NCT03923686
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20230113
PL  - United States
TA  - Gastrointest Endosc
JT  - Gastrointestinal endoscopy
JID - 0010505
RN  - 0 (Plastics)
SB  - IM
CIN - Gastrointest Endosc. 2023 Jun;97(6):1081-1082. PMID: 37208041
MH  - Humans
MH  - Female
MH  - Adult
MH  - Middle Aged
MH  - Aged
MH  - Male
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Retrospective Studies
MH  - *Stents/adverse effects
MH  - *Pancreatitis, Acute Necrotizing/surgery
MH  - Drainage/methods
MH  - Plastics
MH  - Necrosis/etiology
MH  - Endosonography
EDAT- 2023/01/17 06:00
MHDA- 2023/05/22 06:42
CRDT- 2023/01/16 19:23
PHST- 2022/10/24 00:00 [received]
PHST- 2022/12/16 00:00 [revised]
PHST- 2022/12/31 00:00 [accepted]
PHST- 2023/05/22 06:42 [medline]
PHST- 2023/01/17 06:00 [pubmed]
PHST- 2023/01/16 19:23 [entrez]
AID - S0016-5107(23)00012-3 [pii]
AID - 10.1016/j.gie.2022.12.026 [doi]
PST - ppublish
SO  - Gastrointest Endosc. 2023 Jun;97(6):1070-1080. doi: 10.1016/j.gie.2022.12.026. 
      Epub 2023 Jan 13.