Endoscopic Submucosal Dissection in North America: A Large Prospective Multicenter Study.


Journal

Gastroenterology
ISSN: 1528-0012
Titre abrégé: Gastroenterology
Pays: United States
ID NLM: 0374630

Informations de publication

Date de publication:
06 2021
Historique:
received: 14 08 2020
revised: 22 01 2021
accepted: 15 02 2021
pubmed: 22 2 2021
medline: 12 1 2022
entrez: 21 2 2021
Statut: ppublish

Résumé

Endoscopic submucosal dissection (ESD) in Asia has been shown to be superior to endoscopic mucosal resection (EMR) and surgery for the management of selected early gastrointestinal cancers. We aimed to evaluate technical outcomes of ESD in North America. We conducted a multicenter prospective study on ESD across 10 centers in the United States and Canada between April 2016 and April 2020. End points included rates of en bloc resection, R0 resection, curative resection, adverse events, factors associated with failed resection, and recurrence post-R0 resection. Six hundred and ninety-two patients (median age, 66 years; 57.8% were men) underwent ESD (median lesion size, 40 mm; interquartile range, 25-52 mm) for lesions in the esophagus (n = 181), stomach (n = 101), duodenum (n = 11), colon (n = 211) and rectum (n = 188). En bloc, R0, and curative resection rates were 91.5%, 84.2%, and 78.3%, respectively. Bleeding and perforation were reported in 2.3% and 2.9% of the cases, respectively. Only 1 patient (0.14%) required surgery for adverse events. On multivariable analysis, severe submucosal fibrosis was associated with failed en bloc, R0, and curative resection and higher risk for adverse events. Overall recurrence was 5.8% (31 of 532) at a mean follow-up of 13.3 months (range, 1-60 months). In this large multicenter prospective North American experience, we demonstrate that ESD can be performed safely, effectively, and is associated with a low recurrence rate. The technical resection outcomes achieved in this study are in line with the current established consensus quality parameters and further support the implementation of ESD for the treatment of select gastrointestinal neoplasms; ClinicalTrials.gov, Number: NCT02989818.

Sections du résumé

BACKGROUND AND AIMS
Endoscopic submucosal dissection (ESD) in Asia has been shown to be superior to endoscopic mucosal resection (EMR) and surgery for the management of selected early gastrointestinal cancers. We aimed to evaluate technical outcomes of ESD in North America.
METHODS
We conducted a multicenter prospective study on ESD across 10 centers in the United States and Canada between April 2016 and April 2020. End points included rates of en bloc resection, R0 resection, curative resection, adverse events, factors associated with failed resection, and recurrence post-R0 resection.
RESULTS
Six hundred and ninety-two patients (median age, 66 years; 57.8% were men) underwent ESD (median lesion size, 40 mm; interquartile range, 25-52 mm) for lesions in the esophagus (n = 181), stomach (n = 101), duodenum (n = 11), colon (n = 211) and rectum (n = 188). En bloc, R0, and curative resection rates were 91.5%, 84.2%, and 78.3%, respectively. Bleeding and perforation were reported in 2.3% and 2.9% of the cases, respectively. Only 1 patient (0.14%) required surgery for adverse events. On multivariable analysis, severe submucosal fibrosis was associated with failed en bloc, R0, and curative resection and higher risk for adverse events. Overall recurrence was 5.8% (31 of 532) at a mean follow-up of 13.3 months (range, 1-60 months).
CONCLUSIONS
In this large multicenter prospective North American experience, we demonstrate that ESD can be performed safely, effectively, and is associated with a low recurrence rate. The technical resection outcomes achieved in this study are in line with the current established consensus quality parameters and further support the implementation of ESD for the treatment of select gastrointestinal neoplasms; ClinicalTrials.gov, Number: NCT02989818.

Identifiants

pubmed: 33610532
pii: S0016-5085(21)00424-8
doi: 10.1053/j.gastro.2021.02.036
pmc: PMC8783061
mid: NIHMS1769666
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT02989818']

Types de publication

Evaluation Study Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

2317-2327.e2

Subventions

Organisme : NIDDK NIH HHS
ID : P30 DK123704
Pays : United States

Informations de copyright

Copyright © 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.

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Auteurs

Peter V Draganov (PV)

Division of Gastroenterology and Hepatology, University of Florida, Gainesville, Florida. Electronic address: peter.draganov@medicine.ufl.edu.

Hiroyuki Aihara (H)

Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

Michael S Karasik (MS)

Division of Gastroenterology and Hepatology, Hartford Hospital, Hartford, Connecticut.

Saowanee Ngamruengphong (S)

Division of Gastroenterology and Hepatology, Johns Hopkins Medical Center, Baltimore, Maryland.

Abdul Aziz Aadam (AA)

Division of Gastroenterology and Hepatology, Northwestern Medicine Digestive Health Center, Chicago, Illinois.

Mohamed O Othman (MO)

Gastroenterology and Hepatology Section, Baylor College of Medicine, Houston, Texas.

Neil Sharma (N)

Division of Interventional Endoscopic Oncology and Surgical Endoscopy, Parkview Health, Fort Wayne, Indiana.

Ian S Grimm (IS)

Division of Gastroenterology and Hepatology, University of North Carolina Hospitals, Chapel Hill, North Carolina.

Alaa Rostom (A)

Division of Gastroenterology and Hepatology, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.

B Joseph Elmunzer (BJ)

Division of Gastroenterology and Hepatology, The Medical University of South Carolina, Charleston, South Carolina.

Salmaan A Jawaid (SA)

Gastroenterology and Hepatology Section, Baylor College of Medicine, Houston, Texas.

Donevan Westerveld (D)

Division of Gastroenterology and Hepatology New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.

Yaseen B Perbtani (YB)

Division of Gastroenterology and Hepatology, University of Florida, Gainesville, Florida.

Brenda J Hoffman (BJ)

Division of Gastroenterology and Hepatology, The Medical University of South Carolina, Charleston, South Carolina.

Alexander Schlachterman (A)

Division of Gastroenterology and Hepatology, Thomas Jefferson University Hospitals, Philadelphia, Pennsylvania.

Amanda Siegel (A)

Division of Gastroenterology and Hepatology, Northwestern Medicine Digestive Health Center, Chicago, Illinois.

Roxana M Coman (RM)

Division of Hospital Gastroenterology, Atrium/Navicent Health, Mercer University, College of Medicine, Macon, Georgia.

Andrew Y Wang (AY)

Division of Gastroenterology and Hepatology, University of Virginia, Charlottesville, Virginia.

Dennis Yang (D)

Division of Gastroenterology and Hepatology, University of Florida, Gainesville, Florida.

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