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A large multicenter cohort on the use of full-thickness resection device for difficult colonic lesions

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Abstract

Background

Introduction of the full-thickness resection device (FTRD) has allowed endoscopic resection of difficult lesions such as those with deep wall origin/infiltration or those located in difficult anatomic locations. The aim of this study is to assess the outcomes of the FTRD among its early users in the USA.

Methods

Patients who underwent endoscopic full-thickness resection (EFTR) for lower gastrointestinal tract lesions using the FTRD at 26 US tertiary care centers between 10/2017 and 12/2018 were included. Primary outcome was R0 resection rate. Secondary outcomes included rate of technical success (en bloc resection), achievement of histologic full-thickness resection (FTR), and adverse events (AE).

Results

A total of 95 patients (mean age 65.5 ± 12.6 year, 38.9% F) were included. The most common indication, for use of FTRD, was resection of difficult adenomas (non-lifting, recurrent, residual, or involving appendiceal orifice/diverticular opening) (66.3%), followed by adenocarcinomas (22.1%), and subepithelial tumors (SET) (11.6%). Lesions were located in the proximal colon (61.1%), distal colon (18.9%), or rectum (20%). Mean lesion diameter was 15.5 ± 6.4 mm and 61.1% had a prior resection attempt. The mean total procedure time was 59.7 ± 31.8 min. R0 resection was achieved in 82.7% while technical success was achieved in 84.2%. Histologically FTR was demonstrated in 88.1% of patients. There were five clinical AE (5.3%) with 2 (2.1%) requiring surgical intervention.

Conclusions

Results from this first US multicenter study suggest that EFTR with the FTRD is a technically feasible, safe, and effective technique for resecting difficult colonic lesions.

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Abbreviations

AE:

Adverse event

APC:

Argon plasma coagulation

EFTR:

Endoscopic full-thickness resection

EMR:

Endoscopic mucosal resection

ESD:

Endoscopic submucosal dissection

FTRD:

Full-thickness resection device

HF:

High-frequency

OTSC:

Over-the-scope clip

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Author information

Author notes

  1. Y. Ichkhanian and K. Vosoughi contributed equally to this article

Authors and Affiliations

  1. Division of Gastroenterology, Johns Hopkins Hospital, Baltimore, MD, USA

    Y. Ichkhanian, K. Vosoughi, G. O. I. Brewer, V. Kumbhari & Mouen A. Khashab

  2. Department of Gastroenterology and Nutrition, Geisinger Medical Center, Danville, PA, USA

    D. L. Diehl

  3. Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC, USA

    I. S. Grimm & T. W. James

  4. Department of Gastroenterology, University of Washington, Seattle, WA, USA

    A. W. Templeton

  5. Division of Gastroenterology and Hepatology, Department of Medicine, Weill Cornell Medicine, New York, NY, USA

    K. Hajifathalian & R. Sharaiha

  6. Fox Chase Cancer Center, Philadelphia, PA, USA

    J. L. Tokar

  7. H. H. Chao Comprehensive Digestive Disease Center, Division of Gastroenterology and Hepatology, University of California, Irvine, Orange, CA, USA

    J. B. Samarasena, N. El Hage Chehade, J. Lee & K. Chang

  8. Department of Internal Medicine, Division of Gastroenterology, Center for Advanced Endoscopy, University of South Alabama, Mobile, AL, USA

    M. Mizrahi

  9. Division of Gastroenterology and Hepatology, St. John Hospital and Medical Center, Detroit, MI, USA

    M. Barawi

  10. Digestive Disease Institute, Virginia Mason Medical Center, Seattle, WA, USA

    S. Irani

  11. Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, CA, USA

    S. Friedland

  12. Department of Medicine, Division of Gastroenterology, Hoag Hospital, Newport Beach, CA, USA

    P. Korc

  13. Division of Gastroenterology, Department of Medicine, Rush University Medical Center, Chicago, IL, USA

    A. A. Aadam

  14. Division of Gastroenterology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA

    M. A. Al-Haddad

  15. Thomas Jefferson University, Philadelphia, PA, USA

    T. E. Kowalski & A. Novikov

  16. Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA, USA

    G. Smallfield

  17. Gastroenterology Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

    G. G. Ginsberg

  18. McLeod Regional Medical Center, Florence, SC, USA

    D. Panuu

  19. Division of Gastroenterology and Hepatology, Mayo Clinic Arizona, Scottsdale, AZ, USA

    N. Fukami

  20. VA White River Junction, White River Junction, VT, USA

    H. Pohl

  21. SHARP Grossmont Hospital, La Mesa, CA, USA

    Michael Lajin

  22. Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA

    N. A. Kumta

  23. Division of Digestive Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA

    S. J. Tang & Y. M. Naga

  24. Division of Gastroenterology, University of Minnesota, Minneapolis, MN, USA

    S. K. Amateau

  25. Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Sheikh Zayed Bldg, 1800 Orleans Street, Suite 7125G, Baltimore, MD, 21287, USA

    Mouen A. Khashab

  26. Division of Gastroenterology and Hepatology, University of South Carolina, Greenville, SC, USA

    V. M. Oza

Authors
  1. Y. Ichkhanian
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  2. K. Vosoughi
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  3. D. L. Diehl
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  4. I. S. Grimm
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  5. T. W. James
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  10. N. El Hage Chehade
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  11. J. Lee
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  12. K. Chang
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  13. M. Mizrahi
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  14. M. Barawi
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  15. S. Irani
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  19. M. A. Al-Haddad
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  20. T. E. Kowalski
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  33. G. O. I. Brewer
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  34. V. Kumbhari
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  35. R. Sharaiha
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  36. Mouen A. Khashab
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Contributions

MK, YI, and KV were involved in the study planning, interpretation of the data, and development of the manuscript. DD, GI, JT, and TA were involved in critically revising the manuscript for important intellectual content. All remaining authors involved in performing the procedure and data extraction. All authors approved the final submitted draft of this manuscript.

Corresponding author

Correspondence to Mouen A. Khashab.

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Disclosures

Dr. Khashab is consultant for Boston Scientific, Medtronic, and Olympus. Dr. Ian Grimm is a consultant for Boston Scientific. Dr. Irani is a consultant for Boston Scientific. Dr. Kumbhari is a consultant for ReShape Life Sciences, Apollo Endosurgery, Medtronic, and Boston Scientific. Dr. Nikhil is a consultant for Apollo Endosurgery, Boston scientific, and Olympus. Dr. Amateau is a consultant for Merit Endoscopy, Boston Scientific, US Endoscopy, and Neurotronic and the recipient of research support from Cook Medical. Dr. Smallfield has research funding from CSA medical and C2 therapeutics. Dr. Aadam AA is a consultant for Boston Scientific. Dr. Diehl Md Consultant for Boston Scientific, Olympus, Pentax, Cook Medical, Merit, ConMed, US Endoscopy, Medtronic, Lumendi. Dr. Chang consultant for Apollo, Boston Scientific, Cook, Covidien, Erbe, Endogastric Solutions, Mauna Kea Mederi, Medtronic, Olympus, Ovesco, Pentax, Torax. Dr. Samarasena has educational grant from Cook and consultant for Mauna Kea, Medtronic, Olympus, Pentax, US Endoscopy. Dr. Al-Haddad received research and teaching support from Boston Scientific. Dr. Pohl received grants from Boston Scientific, US Endoscopy, and Aries/Cosmo Pharamceuticals. Dr. Templeton is a consultant for Boston Scientific and Medtronic. Dr. Ginsberg is a consultant for Olympus Inc. and Boston Scientific. Dr. Fukami is consultant for Boston Scientific and Olympus. Dr. Sharaiha is consultant for Boston Scientific, Olympus, Apollo, and Medtronic. Dr. Ichkhanian, Dr. Vosoughi, Dr. James, Dr. Hajifathalian, Dr. Tokar, Dr. Lee, Dr. Mizrahi, Dr. Barawi, Dr. Friedland, Dr. Korc, Dr. Kowalski, Dr. Novikov, Dr. Oza, Dr. Panuu, Dr. Lajin, Dr. Kumta, Dr. Tang, Dr. Naga, and Dr. Brewer have no conflicts of interest or financial ties to disclose

Ethical approval

IRB approval for this study across the multiple centers performed in accordance with the principles of the Declaration of Helsinki. The formal informed consent was waived.

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The formal informed consent was waived.

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Ichkhanian, Y., Vosoughi, K., Diehl, D.L. et al. A large multicenter cohort on the use of full-thickness resection device for difficult colonic lesions. Surg Endosc 35, 1296–1306 (2021). https://doi.org/10.1007/s00464-020-07504-9

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