PMID- 36410447
OWN - NLM
STAT- MEDLINE
DCOM- 20230327
LR  - 20230523
IS  - 1097-6779 (Electronic)
IS  - 0016-5107 (Linking)
VI  - 97
IP  - 4
DP  - 2023 Apr
TI  - Adverse events of endoscopic full-thickness resection: results from the German 
      and Dutch nationwide colorectal FTRD registry.
PG  - 780-789.e4
LID - S0016-5107(22)02155-1 [pii]
LID - 10.1016/j.gie.2022.11.005 [doi]
AB  - BACKGROUND AND AIMS: Endoscopic full-thickness resection (eFTR) is emerging as a 
      minimally invasive alternative to surgery for complex colorectal lesions. 
      Previous studies have demonstrated favorable safety results; however, large 
      studies representing a generalizable estimation of adverse events (AEs) are 
      lacking. Our aim was to provide further insight in AEs after eFTR. METHODS: Data 
      from all registered eFTR procedures in the German and Dutch colorectal 
      full-thickness resection device registries between July 2015 and March 2021 were 
      collected. Safety outcomes included immediate and late AEs. RESULTS: Of 1892 
      procedures, the overall AE rate was 11.3% (213/1892). No AE-related mortality 
      occurred. Perforations occurred in 2.5% (47/1892) of all AEs, 57.4% (27/47) of 
      immediate AEs, and 42.6% (20/47) of delayed AEs. Successful endoscopic closure 
      was achieved in 29.8% of cases (13 immediate and 1 delayed), and antibiotic 
      treatment was sufficient in 4.3% (2 delayed). The appendicitis rate for 
      appendiceal lesions was 9.9% (13/131), and 46.2% (6/13) could be treated 
      conservatively. The severe AE rate requiring surgery was 2.2% (42/1892), 
      including delayed perforations in .9% (17/1892) and immediate perforations in .7% 
      (13/1892). Delayed perforations occurred between days 1 and 10 (median, 2) after 
      eFTR, and 58.8% (10/17) were located on the left side. Other severe AEs were 
      appendicitis (.4%, 7/1892), luminal stenosis (.1%, 2/1892), delayed bleeding 
      (.1%, 1/1892), pain after eFTR close to the dentate line (.1%, 1/1892), and 
      grasper entrapment in the clip (.1%, 1/1892). CONCLUSIONS: Colorectal eFTR is a 
      safe procedure with a low risk for severe AEs in everyday practice and without 
      AE-related mortality. These results further support the position of eFTR as an 
      established minimally invasive technique for complex colorectal lesions.
CI  - Copyright (c) 2023 American Society for Gastrointestinal Endoscopy. Published by 
      Elsevier Inc. All rights reserved.
FAU - Zwager, Liselotte W
AU  - Zwager LW
AD  - Department of Gastroenterology and Hepatology, Amsterdam University Medical 
      Centers location University of Amsterdam, Amsterdam, the Netherlands; Amsterdam 
      Gastroenterology Endocrinology Metabolism, Amsterdam, the Netherlands; Cancer 
      Center Amsterdam, Amsterdam, the Netherlands.
FAU - Mueller, Julius
AU  - Mueller J
AD  - Department of Medicine II, Medical Center, University of Freiburg, Freiburg, 
      Germany.
FAU - Stritzke, Bettina
AU  - Stritzke B
AD  - Novineon CRO, Tuebingen, Germany.
FAU - Montazeri, Nahid S M
AU  - Montazeri NSM
AD  - Biostatistics Unit, Department of Gastroenterology and Hepatology, Amsterdam 
      University Medical Centers location University of Amsterdam, Amsterdam, the 
      Netherlands.
FAU - Caca, Karel
AU  - Caca K
AD  - Department of Gastroenterology, Klinikum Ludwigsburg, Ludwigsburg, Germany.
FAU - Dekker, Evelien
AU  - Dekker E
AD  - Department of Gastroenterology and Hepatology, Amsterdam University Medical 
      Centers location University of Amsterdam, Amsterdam, the Netherlands; Amsterdam 
      Gastroenterology Endocrinology Metabolism, Amsterdam, the Netherlands; Cancer 
      Center Amsterdam, Amsterdam, the Netherlands.
FAU - Fockens, Paul
AU  - Fockens P
AD  - Department of Gastroenterology and Hepatology, Amsterdam University Medical 
      Centers location University of Amsterdam, Amsterdam, the Netherlands; Amsterdam 
      Gastroenterology Endocrinology Metabolism, Amsterdam, the Netherlands; Cancer 
      Center Amsterdam, Amsterdam, the Netherlands.
FAU - Schmidt, Arthur
AU  - Schmidt A
AD  - Department of Medicine II, Medical Center, University of Freiburg, Freiburg, 
      Germany.
FAU - Bastiaansen, Barbara A J
AU  - Bastiaansen BAJ
AD  - Department of Gastroenterology and Hepatology, Amsterdam University Medical 
      Centers location University of Amsterdam, Amsterdam, the Netherlands; Amsterdam 
      Gastroenterology Endocrinology Metabolism, Amsterdam, the Netherlands; Cancer 
      Center Amsterdam, Amsterdam, the Netherlands.
CN  - Dutch eFTR Working Group and German collaborating centers
LA  - eng
PT  - Journal Article
DEP - 20221121
PL  - United States
TA  - Gastrointest Endosc
JT  - Gastrointestinal endoscopy
JID - 0010505
SB  - IM
MH  - Humans
MH  - *Appendicitis
MH  - Treatment Outcome
MH  - Retrospective Studies
MH  - Endoscopy
MH  - *Endoscopic Mucosal Resection/methods
MH  - *Colorectal Neoplasms/surgery/pathology
FIR - Albers, D
IR  - Albers D
FIR - Beaumont, H
IR  - Beaumont H
FIR - Bekkering, F C
IR  - Bekkering FC
FIR - Bielich, A
IR  - Bielich A
FIR - Boonstra, J J
IR  - Boonstra JJ
FIR - Ter Borg, F
IR  - Ter Borg F
FIR - Bos, P R
IR  - Bos PR
FIR - Bulte, G J
IR  - Bulte GJ
FIR - Caselitz, M
IR  - Caselitz M
FIR - Denzer, U
IR  - Denzer U
FIR - Frieling, T
IR  - Frieling T
FIR - Gielisse, E A R
IR  - Gielisse EAR
FIR - Glas, A
IR  - Glas A
FIR - Glitsch, A
IR  - Glitsch A
FIR - Hasberg, S
IR  - Hasberg S
FIR - Hazen, W L
IR  - Hazen WL
FIR - Hofmann, C
IR  - Hofmann C
FIR - Houben, M H M G
IR  - Houben MHMG
FIR - Ten Hove, W R
IR  - Ten Hove WR
FIR - Hubner, G
IR  - Hubner G
FIR - Kahler, G
IR  - Kahler G
FIR - Kirchner, T
IR  - Kirchner T
FIR - Knoll, M
IR  - Knoll M
FIR - Lorenz, A
IR  - Lorenz A
FIR - Meier, B
IR  - Meier B
FIR - Mundt, M W
IR  - Mundt MW
FIR - Nagengast, W B
IR  - Nagengast WB
FIR - Perk, L E
IR  - Perk LE
FIR - Quispel, R
IR  - Quispel R
FIR - Rando Munoz, F J
IR  - Rando Munoz FJ
FIR - Repp, M
IR  - Repp M
FIR - de Ridder, R J J
IR  - de Ridder RJJ
FIR - Rietdijk, S T
IR  - Rietdijk ST
FIR - Scholz, D
IR  - Scholz D
FIR - Schreuder, R M
IR  - Schreuder RM
FIR - Schwartz, M P
IR  - Schwartz MP
FIR - Seerden, T C J
IR  - Seerden TCJ
FIR - van der Sluis, H
IR  - van der Sluis H
FIR - van der Spek, B W
IR  - van der Spek BW
FIR - Straathof, J W A
IR  - Straathof JWA
FIR - Terhaar Sive Droste, J S
IR  - Terhaar Sive Droste JS
FIR - Triller, C
IR  - Triller C
FIR - Vlug, M S
IR  - Vlug MS
FIR - van de Vrie, W
IR  - van de Vrie W
FIR - Wagner, A
IR  - Wagner A
FIR - Walter, B
IR  - Walter B
FIR - Wallstabe, I
IR  - Wallstabe I
FIR - Wannhoff, A
IR  - Wannhoff A
FIR - Weusten, B L A M
IR  - Weusten BLAM
FIR - de Wijkerslooth, T R
IR  - de Wijkerslooth TR
FIR - Wilhelm, M
IR  - Wilhelm M
FIR - Wolters, H J
IR  - Wolters HJ
FIR - Zervoulakos, P
IR  - Zervoulakos P
EDAT- 2022/11/22 06:00
MHDA- 2023/03/28 06:00
CRDT- 2022/11/21 19:33
PHST- 2022/09/05 00:00 [received]
PHST- 2022/11/03 00:00 [revised]
PHST- 2022/11/07 00:00 [accepted]
PHST- 2022/11/22 06:00 [pubmed]
PHST- 2023/03/28 06:00 [medline]
PHST- 2022/11/21 19:33 [entrez]
AID - S0016-5107(22)02155-1 [pii]
AID - 10.1016/j.gie.2022.11.005 [doi]
PST - ppublish
SO  - Gastrointest Endosc. 2023 Apr;97(4):780-789.e4. doi: 10.1016/j.gie.2022.11.005. 
      Epub 2022 Nov 21.