PMID- 38042207
OWN - NLM
STAT- In-Process
LR  - 20240424
IS  - 1097-6779 (Electronic)
IS  - 0016-5107 (Linking)
VI  - 99
IP  - 5
DP  - 2024 May
TI  - Endoscopic powered resection device for residual colonic lesions: the first 
      multicenter, prospective, international clinical study.
PG  - 778-786
LID - S0016-5107(23)03127-9 [pii]
LID - 10.1016/j.gie.2023.11.050 [doi]
AB  - BACKGROUND AND AIMS: Endoscopic resection is standard treatment for adenomatous 
      colorectal lesions. Depending on lesion morphology and resection technique, 
      recurrence can occur. Scarred adenomas are challenging to resect and may require 
      surgical management. This study evaluated the safety and effectiveness of an 
      endoscopic powered resection (EPR) system for scarred adenomatous colorectal 
      lesions. METHODS: This single-arm, prospective, multicenter study was conducted 
      from January 2018 to January 2021 at 12 sites. Patients with persistent flat or 
      sessile colorectal lesions were enrolled. Primary end points were technical 
      success (the ability of the device to resect the lesion[s] without use of other 
      resection devices without device-related serious adverse events [AEs]) and safety 
      (the occurrence of AEs through 90 days). Secondary end points included endoscopic 
      confirmation of resection completeness, occurrence of colon stenosis, disease 
      persistence, and diagnostic value of resected specimens. RESULTS: Sixty-five 
      patients were in the intention-to-treat/safety analysis population. Primary 
      analysis was performed on 45 per-protocol (PP) patients with 48 lesions. All PP 
      patients were solely treated by using the EPR device. Technical success was 
      achieved in 44 (98%) patients. Three (5%) serious AEs occurred: 2 delayed 
      self-limited bleeds and 1 perforation. Nonserious AEs included 4 (6%) cases of 
      mild intraprocedural bleeding. Completeness of resection and histopathologic 
      diagnosis of tissue specimens were achieved in all patients. Twenty-one (46.7%) 
      patients had disease persistence after the first treatment, and there was no 
      colon stenosis. CONCLUSIONS: EPR is safe and effective for benign, persistent, 
      large (>20 mm), scarred colorectal adenomas and should be considered as an 
      alternative treatment in lieu of surgery. A persistence rate of 46.7% indicates 
      that >1 treatment is necessary for effective endoscopic treatment. (Clinical 
      trial registration number: NCT04203667.).
CI  - Copyright (c) 2024. Published by Elsevier Inc.
FAU - Knabe, Mate
AU  - Knabe M
AD  - Centrum Gastroenterology Bethanien (CGB), Bethanien Hospital Frankfurt, Germany. 
      Electronic address: Mate.Knabe@kgu.de.
FAU - Maselli, Roberta
AU  - Maselli R
AD  - Division of Gastroenterology and Digestive Endoscopy, Department of 
      Gastroenterology Humanitas Research Hospital, Milano, Italy.
FAU - Cesbron-Metivier, Elodie
AU  - Cesbron-Metivier E
AD  - Service d'hepato-gastro-enterologie, CHU Angers, Angers, France.
FAU - Hollerbach, Stephan
AU  - Hollerbach S
AD  - Department of Gastroenterology, Allgemeines Krankenhaus Celle, Celle, Germany.
FAU - Petruzziello, Lucio
AU  - Petruzziello L
AD  - Digestive Endoscopy Unit, Universita Cattolica del Sacro Cuore, Rome, Italy, 
      Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCSS, 
      Rome, Italia.
FAU - Prat, Frederic
AU  - Prat F
AD  - Endoscopy Unit, Beaujon Hospital, Publique des Hopitaux de Paris, Clichy, France.
FAU - Khara, Harshit S
AU  - Khara HS
AD  - Department of Gastroenterology and Hepatology, Geisinger Medical Center, 
      Danville, Pennsylvania, USA.
FAU - Pioche, Mathieu
AU  - Pioche M
AD  - Endoscopy and Gastroenterology Unit, Edouard Herriot Hospital, Hospices Civils de 
      Lyon, Lyon, France.
FAU - Hartmann, Dirk
AU  - Hartmann D
AD  - Department of General Internal Medicine, Diabetology, Gastroenterology and 
      Oncology, Katholisches Klinikum Mainz, Mainz, Germany.
FAU - Cesaro, Paola
AU  - Cesaro P
AD  - Digestive Endoscopy Unit and Gastroenterology, Fondazione Poliambulanza, Brescia, 
      Italy.
FAU - Barbaro, Federico
AU  - Barbaro F
AD  - Digestive Endoscopy Unit, Universita Cattolica del Sacro Cuore, Rome, Italy, 
      Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCSS, 
      Rome, Italia.
FAU - Berger, Arthur
AU  - Berger A
AD  - CHU Bordeaux, Department of Gastroenterology and Digestive Endoscopy, Univ. 
      Bordeaux, Bordeaux, France.
FAU - Spada, Cristiano
AU  - Spada C
AD  - Digestive Endoscopy Unit and Gastroenterology, Fondazione Poliambulanza, Brescia, 
      Italy; Digestive Endoscopy Unit, Universita Cattolica del Sacro Cuore, Rome, 
      Italy, Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli 
      IRCSS, Rome, Italia.
FAU - Diehl, David L
AU  - Diehl DL
AD  - Department of Gastroenterology and Hepatology, Geisinger Medical Center, 
      Danville, Pennsylvania, USA.
FAU - May, Andrea
AU  - May A
AD  - Department of Gastroenterology, Oncology and Pneumology, Asklepios Paulinen 
      Klinik, Wiesbaden, Germany.
FAU - Ponchon, Thierry
AU  - Ponchon T
AD  - Endoscopy and Gastroenterology Unit, Edouard Herriot Hospital, Hospices Civils de 
      Lyon, Lyon, France.
FAU - Repici, Alessandro
AU  - Repici A
AD  - Division of Gastroenterology and Digestive Endoscopy, Department of 
      Gastroenterology Humanitas Research Hospital, Milano, Italy.
FAU - Costamagna, Guido
AU  - Costamagna G
AD  - Digestive Endoscopy Unit, Universita Cattolica del Sacro Cuore, Rome, Italy, 
      Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCSS, 
      Rome, Italia.
LA  - eng
SI  - ClinicalTrials.gov/NCT04203667
PT  - Journal Article
DEP - 20231201
PL  - United States
TA  - Gastrointest Endosc
JT  - Gastrointestinal endoscopy
JID - 0010505
SB  - IM
COIS- Disclosure G. Costamagna: Research grants from Cook Medical, Olympus, and Boston 
      Scientific. L. Petruzziello: Research grants from Cook Medical, Olympus, and 
      Boston Scientific. D. L. Diehl: Consultant for Boston Scientific, Olympus, 
      Pentax, Microtech, Steris, Castle Biosciences, Laborie, Actuated Medical, 
      Lumendi, Merit Medical, and One Pass Medical. A. May: Study support from 
      Interscope. A. Repici: Consultant for Boston Scientific, Fujifilm, and ERBE. R. 
      Maselli, Consultant for Boston Scientific, Fujifilm, ERBE, 3D Matrix, and Apollo 
      Endosurgery. All other authors disclosed no financial relationships. The study 
      was sponsored by Interscope, Inc.
EDAT- 2023/12/03 00:42
MHDA- 2023/12/03 00:42
CRDT- 2023/12/02 19:25
PHST- 2023/08/15 00:00 [received]
PHST- 2023/11/27 00:00 [revised]
PHST- 2023/11/28 00:00 [accepted]
PHST- 2023/12/03 00:42 [pubmed]
PHST- 2023/12/03 00:42 [medline]
PHST- 2023/12/02 19:25 [entrez]
AID - S0016-5107(23)03127-9 [pii]
AID - 10.1016/j.gie.2023.11.050 [doi]
PST - ppublish
SO  - Gastrointest Endosc. 2024 May;99(5):778-786. doi: 10.1016/j.gie.2023.11.050. Epub 
      2023 Dec 1.