PMID- 38500708
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240320
IS  - 2364-3722 (Print)
IS  - 2196-9736 (Electronic)
IS  - 2196-9736 (Linking)
VI  - 11
IP  - 11
DP  - 2023 Nov
TI  - Plastic versus metal stents for transmural drainage of walled-off necrosis with 
      significant solid debris: a randomized controlled trial.
PG  - E1069-E1077
LID - 10.1055/a-2185-6318 [doi]
AB  - Background and study aims Recently, larger-caliber metal stents have been 
      increasingly used, resulting in higher efficacy in walled-off necrosis (WON) with 
      more solid debris. However, none of the trials have included WON with significant 
      solid debris. The aim of this study was to compare plastic stents and metal 
      stents for drainage of symptomatic WON with significant solid debris (>/=20%). 
      Patients and methods We conducted a single-center, open-label, noninferiority 
      trial including 48 patients. The primary endpoint was treatment success. 
      Secondary outcomes were technical success, total number of procedures, adverse 
      events (AEs), duration of procedure, and treatment failure. All the outcomes were 
      assessed at 3 weeks after drainage. Patients were followed up for 3 months to 
      assess recurrence. Results Treatment succeeded in 21 of 24 patients (87.5%) and 
      20 of 24 patients (83.3%) in the metal and plastic stent groups, respectively 
      with P =1.05 (95% confidence interval 0.81-1.39). Assuming 10% non-inferiority 
      margin, P <0.001 for non-inferiority, suggesting that plastic stents are 
      non-inferior to metal stents. The technical success rate was 100%. Procedure 
      duration was significantly shorter in the metal stent group (12.95+/-5.3 minutes 
      versus 29.77+/-6.6 minutes, P <0.001). The number of total procedures was 
      comparable (2.8+/-1 vs 2.2+/-1, P =0.097). There were more minor AEs in plastic stent 
      arm but no significant difference between the two groups. A single asymptomatic 
      recurrence was observed in the metal stent arm. Conclusions Plastic stents are 
      not inferior to metal stents for WON drainage with significant solid debris. 
      However, larger sample-size studies are needed to make definite conclusions.
CI  - The Author(s). This is an open access article published by Thieme under the terms 
      of the Creative Commons Attribution-NonDerivative-NonCommercial-License, 
      permitting copying and reproduction so long as the original work is given 
      appropriate credit. Contents may not be used for commercial purposes, or adapted, 
      remixed, transformed or built upon. 
      (https://creativecommons.org/licenses/by-nc-nd/4.0/).
FAU - Kakadiya, Rinkal
AU  - Kakadiya R
AD  - Gastroenterology, Post Graduate Institute of Medical Education and Research, 
      Chandigarh, India. RINGGOLD: 29751
FAU - Muktesh, Gaurav
AU  - Muktesh G
AD  - Gastroenterology, Post Graduate Institute of Medical Education and Research, 
      Chandigarh, India. RINGGOLD: 29751
FAU - Samanta, Jayanta
AU  - Samanta J
AUID- ORCID: 0000-0002-9277-5086
AD  - Gastroenterology, Post Graduate Institute of Medical Education and Research, 
      Chandigarh, India. RINGGOLD: 29751
FAU - Mandavdhare, Harshal S
AU  - Mandavdhare HS
AUID- ORCID: 0000-0001-8020-9848
AD  - Gastroenterology, Post Graduate Institute of Medical Education and Research, 
      Chandigarh, India. RINGGOLD: 29751
FAU - Gupta, Pankaj
AU  - Gupta P
AD  - Radiodiagnosis, Post Graduate Institute of Medical Education and Research, 
      Chandigarh, India.
FAU - Shah, Jimil
AU  - Shah J
AD  - Gastroenterology, Post Graduate Institute of Medical Education and Research, 
      Chandigarh, India. RINGGOLD: 29751
FAU - Sarma, Phulen
AU  - Sarma P
AD  - Pharmacology, Post Graduate Institute of Medical Education and Research, 
      Chandigarh, India. RINGGOLD: 29751
FAU - Gupta, Vikas
AU  - Gupta V
AD  - General Surgery, Post Graduate Institute of Medical Education and Research, 
      Chandigarh, India. RINGGOLD: 29751
FAU - Yadav, Thakur Deen
AU  - Yadav TD
AD  - General Surgery, Post Graduate Institute of Medical Education and Research, 
      Chandigarh, India. RINGGOLD: 29751
FAU - Jena, Anuraag
AU  - Jena A
AD  - Gastroenterology, Post Graduate Institute of Medical Education and Research, 
      Chandigarh, India. RINGGOLD: 29751
FAU - Sharma, Vishal
AU  - Sharma V
AD  - Gastroenterology, Post Graduate Institute of Medical Education and Research, 
      Chandigarh, India. RINGGOLD: 29751
FAU - Kochhar, Rakesh
AU  - Kochhar R
AD  - Gastroenterology, Post Graduate Institute of Medical Education and Research, 
      Chandigarh, India. RINGGOLD: 29751
LA  - eng
PT  - Journal Article
DEP - 20231110
PL  - Germany
TA  - Endosc Int Open
JT  - Endoscopy international open
JID - 101639919
PMC - PMC10946060
OTO - NOTNLM
OT  - Endoscopic ultrasonography
OT  - Intervention EUS
OT  - Pancreas
COIS- Conflict of Interest The authors declare that they have no conflict of interest.
EDAT- 2024/03/19 06:43
MHDA- 2024/03/19 06:44
PMCR- 2023/11/01
CRDT- 2024/03/19 03:39
PHST- 2023/07/05 00:00 [received]
PHST- 2023/09/25 00:00 [accepted]
PHST- 2024/03/19 06:44 [medline]
PHST- 2024/03/19 06:43 [pubmed]
PHST- 2024/03/19 03:39 [entrez]
PHST- 2023/11/01 00:00 [pmc-release]
AID - EIO-2023-07-3061-OA [pii]
AID - 10.1055/a-2185-6318 [doi]
PST - epublish
SO  - Endosc Int Open. 2023 Nov 10;11(11):E1069-E1077. doi: 10.1055/a-2185-6318. 
      eCollection 2023 Nov.