CC BY-NC-ND 4.0 · Endosc Int Open 2020; 08(10): E1291-E1301
DOI: 10.1055/a-1216-1439
Original article

Full-thickness resection device (FTRD) for treatment of upper gastrointestinal tract lesions: the first international experience

Kaveh Hajifathalian
 1   Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY
,
Yervant Ichkhanian
 2   Division of Gastroenterology, Johns Hopkins Hospital, Baltimore, Maryland, United States
,
Qais Dawod
 1   Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY
,
Alexander Meining
 3   Interventional and Experimental Endoscopy, Department of Internal Medicine I, Ulm University, Ulm, Germany
,
Arthur Schmidt
 4   Department of Medicine II, Medical Center, University of Freiburg, Faculty of Medicine, Freiburg, Germany
,
Nicholas Glaser
 4   Department of Medicine II, Medical Center, University of Freiburg, Faculty of Medicine, Freiburg, Germany
,
Kia Vosoughi
 2   Division of Gastroenterology, Johns Hopkins Hospital, Baltimore, Maryland, United States
,
David L. Diehl
 3   Interventional and Experimental Endoscopy, Department of Internal Medicine I, Ulm University, Ulm, Germany
,
Ian S. Grimm
 5   Department of Gastroenterology and Nutrition, Geisinger Medical Center, Danville, Pennsylvania, United States
,
Theodore James
 6   Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, North Carolina, United States
,
Adam W. Templeton
 7   Department of Gastroenterology, University of Washington, Seattle, Washington, United States
,
Jason B. Samarasena
 8   H. H. Chao Comprehensive Digestive Disease Center, Division of Gastroenterology and Hepatology, University of California, Irvine, Orange, California, United States
,
Nabil El Hage Chehade
 8   H. H. Chao Comprehensive Digestive Disease Center, Division of Gastroenterology and Hepatology, University of California, Irvine, Orange, California, United States
,
John G. Lee
 8   H. H. Chao Comprehensive Digestive Disease Center, Division of Gastroenterology and Hepatology, University of California, Irvine, Orange, California, United States
,
Kenneth J. Chang
 8   H. H. Chao Comprehensive Digestive Disease Center, Division of Gastroenterology and Hepatology, University of California, Irvine, Orange, California, United States
,
Meir Mizrahi
 9   Department of Internal Medicine, Division of Gastroenterology, Center for Advanced Endoscopy, University of South Alabama, Mobile, Alabama, United States
,
Mohammed Barawi
10   Division of Gastroenterology and Hepatology, Ascension St. John hospital, Detroit, Michigan, United States
,
Shayan Irani
11   Digestive Disease Institute, Virginia Mason Medical Center, Seattle, Washington, United Stats
,
Shai Friedland
12   Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, California, United States
,
Paul Korc
13   Department of Medicine, Division of Gastroenterology, Hoag Hospital, Newport Beach, California, United States
,
Abdul Aziz Aadam
14   Division of Gastroenterology, Northwestern University, Chicago, Illinois, United States
,
Mohammad Al-Haddad
15   Indiana University School of Medicine, Department of Medicine, Division of Gastroenterology, Indianapolis, Indiana, United States
,
Thomas E. Kowalski
16   Thomas Jefferson University, Philadelphia, Pennsylvania, United States
,
George Smallfield
17   Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, Virginia United States
,
Gregory G. Ginsberg
18   Gastroenterology Division, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania, United States
,
Norio Fukami
19   Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, Arizona, United States
,
Michael Lajin
20   SHARP Grossmont Hospital, La Mesa, California, United States
,
Nikhil A. Kumta
21   Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, United States
,
Shou-jiang Tang
22   Division of Digestive Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, United States
,
Yehia Naga
22   Division of Digestive Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi, United States
,
Stuart K. Amateau
23   Division of Gastroenterology, University of Minnesota, Minneapolis, Minnesota, United States
,
Franklin Kasmin
24   Division of Gastroenterology, Lenox Hill Hospital, Northwell Health, New York, New York, United States
,
Martin Goetz
25   Innere Medizin I, Universitätsklinikum Tübingen, Tuebingen, Germany
,
Stefan Seewald
26   Centre of Gastroenterology, Klinik Hirslanden, Zurich, Switzerland
,
Vivek Kumbhari
 2   Division of Gastroenterology, Johns Hopkins Hospital, Baltimore, Maryland, United States
,
Saowanee Ngamruengphong
 2   Division of Gastroenterology, Johns Hopkins Hospital, Baltimore, Maryland, United States
,
Srihari Mahdev
 1   Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY
,
Saurabh Mukewar
 1   Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY
,
Kartik Sampath
 1   Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY
,
David L. Carr-Locke
 1   Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY
,
Mouen A. Khashab
 2   Division of Gastroenterology, Johns Hopkins Hospital, Baltimore, Maryland, United States
,
Reem Z. Sharaiha
 1   Weill Cornell Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, New York, NY
› Author Affiliations

Abstract

Background and study aims The Full-Thickness Resection Device (FTRD) provides a novel treatment option for lesions not amenable to conventional endoscopic resection techniques. There are limited data on the efficacy and safety of FTRD for resection of upper gastrointestinal tract (GIT) lesions.

Patients and methods This was an international multicenter retrospective study, including patients who had an endoscopic resection of an upper GIT lesion using the FTRD between January 2017 and February 2019.

Results Fifty-six patients from 13 centers were included. The most common lesions were mesenchymal neoplasms (n = 23, 41 %), adenomas (n = 7, 13 %), and hamartomas (n = 6, 11 %). Eighty-four percent of lesions were located in the stomach, and 14 % in the duodenum. The average size of lesions was 14 mm (range 3 to 33 mm). Deployment of the FTRD was technically successful in 93 % of patients (n = 52) leading to complete and partial resection in 43 (77 %) and 9 (16 %) patients, respectively. Overall, the FTRD led to negative histological margins (R0 resection) in 38 (68 %) of patients. A total of 12 (21 %) mild or moderate adverse events (AEs) were reported. Follow-up endoscopy was performed in 31 patients (55 %), on average 88 days after the procedure (IQR 68–138 days). Of these, 30 patients (97 %) did not have any residual or recurrent lesion on endoscopic examination and biopsy, with residual adenoma in one patient (3 %).

Conclusions Our results suggest a high technical success rate and an acceptable histologically complete resection rate, with a low risk of AEs and early recurrence for FTRD resection of upper GIT lesions.



Publication History

Received: 03 March 2020

Accepted: 29 June 2020

Article published online:
22 September 2020

© 2020. 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 commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Evans JA, Chandrasekhara V, Chathadi KV. et al. The role of endoscopy in the management of premalignant and malignant conditions of the stomach. Gastrointest Endosc 2015; 82: 1-8
  • 2 Perez A, Saltzman JR, Carr-Locke DL. et al. Benign nonampullary duodenal neoplasms. J Gastrointest Surg 2003; 7: 536-541
  • 3 Chung IK, Lee JH, Lee SH. et al. Therapeutic outcomes in 1000 cases of endoscopic submucosal dissection for early gastric neoplasms: Korean ESD Study Group multicenter study. Gastrointest Endosc 2009; 69: 1228-1235
  • 4 Cao Y, Liao C, Tan A. et al. Meta-analysis of endoscopic submucosal dissection versus endoscopic mucosal resection for tumors of the gastrointestinal tract. Endoscopy 2009; 41: 751-757
  • 5 Schmidt A, Beyna T, Schumacher B. et al. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut 2018; 67: 1280-1289
  • 6 Schmidt A, Bauerfeind P, Gubler C. et al. Endoscopic full-thickness resection in the colorectum with a novel over-the-scope device: first experience. Endoscopy 2015; 47: 719-725
  • 7 Richter-Schrag HJ, Walker C, Thimme R. et al. [Full thickness resection device (FTRD). Experience and outcome for benign neoplasms of the rectum and colon]. Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen 2016; 87: 316-325
  • 8 Fahndrich M, Sandmann M. Endoscopic full-thickness resection for gastrointestinal lesions using the over-the-scope clip system: a case series. Endoscopy 2015; 47: 76-79
  • 9 Sarker S, Gutierrez JP, Council L. et al. Over-the-scope clip-assisted method for resection of full-thickness submucosal lesions of the gastrointestinal tract. Endoscopy 2014; 46: 758-761
  • 10 Bauder M, Schmidt A, Caca K. Endoscopic full-thickness resection of duodenal lesions-a retrospective analysis of 20 FTRD cases. United Europ Gastroenterol J 2018; 6: 1015-1021
  • 11 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
  • 12 Doyle DJ, Garmon EH. American Society of Anesthesiologists Classification (ASA Class). In: StatPearls. Treasure Island (FL) 2018
  • 13 Charlson ME, Pompei P, Ales KL. et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987; 40: 373-383
  • 14 Meier B, Schmidt A, Glaser N. et al. Endoscopic full-thickness resection of gastric subepithelial tumors with the gFTRD-system: a prospective pilot study (RESET trial). Surg Endosc 2019; DOI: 10.1007/s00464-019-06839-2.
  • 15 Faulx AL, Kothari S, Acosta RD. et al. The role of endoscopy in subepithelial lesions of the GI tract. Gastrointest Endosc 2017; 85: 1117-1132
  • 16 Miettinen M, Lasota J. Gastrointestinal stromal tumors: pathology and prognosis at different sites. Sem Diagn Pathology 2006; 23: 70-83
  • 17 Polkowski M. Endoscopic ultrasound and endoscopic ultrasound-guided fine-needle biopsy for the diagnosis of malignant submucosal tumors. Endoscopy 2005; 37: 635-645
  • 18 Hwang JH, Rulyak SD, Kimmey MB. American Gastroenterological Association Institute technical review on the management of gastric subepithelial masses. Gastroenterology 2006; 130: 2217-2228
  • 19 Faigel DO, Abulhawa S. Gastrointestinal stromal tumors: the role of the gastroenterologist in diagnosis and risk stratification. J Clin Gastroenterol 2012; 46: 629-636
  • 20 Lim TW, Choi CW, Kang DH. et al. Endoscopic ultrasound without tissue acquisition has poor accuracy for diagnosing gastric subepithelial tumors. Medicine 2016; 95: e5246
  • 21 Mullady DK, Tan BR. A multidisciplinary approach to the diagnosis and treatment of gastrointestinal stromal tumor. J Clin Gastroenterol 2013; 47: 578-585
  • 22 Eckardt AJ, Adler A, Gomes EM. et al. Endosonographic large-bore biopsy of gastric subepithelial tumors: a prospective multicenter study. Europ J Gastroenterol Hepatol 2012; 24: 1135-1144
  • 23 Blackstein ME, Blay JY, Corless C. et al. Gastrointestinal stromal tumours: consensus statement on diagnosis and treatment. Can J Gastroenterol 2006; 20: 157-163
  • 24 He Z, Sun C, Wang J. et al. Efficacy and safety of endoscopic submucosal dissection in treating gastric subepithelial tumors originating in the muscularis propria layer: a single-center study of 144 cases. Scand J Gastroenterol 2013; 48: 1466-1473
  • 25 Zhou PH, Yao LQ, Qin XY. et al. Endoscopic full-thickness resection without laparoscopic assistance for gastric submucosal tumors originated from the muscularis propria. Surgical endoscopy 2011; 25: 2926-2931
  • 26 Lv XH, Wang CH, Xie Y. Efficacy and safety of submucosal tunneling endoscopic resection for upper gastrointestinal submucosal tumors: a systematic review and meta-analysis. Surgical endoscopy 2017; 31: 49-63
  • 27 Tan Y, Tang X, Guo T. et al. Comparison between submucosal tunneling endoscopic resection and endoscopic full-thickness resection for gastric stromal tumors originating from the muscularis propria layer. Surg Endosc 2017; 31: 3376-3382