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A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.

Publication ,  Journal Article
Ferris, RL; Flamand, Y; Holsinger, FC; Weinstein, GS; Quon, H; Mehra, R; Garcia, JJ; Hinni, ML; Gross, ND; Sturgis, EM; Duvvuri, U; Méndez, E ...
Published in: Oral Oncol
November 2020

PURPOSE: Understanding the role of transoral surgery in oropharyngeal cancer (OPC) requires prospective, randomized multi-institutional data. Meticulous evaluation of surgeon expertise and surgical quality assurance (QA) will be critical to the validity of such trials. We describe a novel surgeon credentialing and QA process developed to support the ECOG-ACRIN Cancer Research Group E3311 (E3311) and report outcomes related to QA. PATIENTS AND METHODS: E3311 was a phase II randomized clinical trial of transoral surgery followed by low- or standard-dose, risk-adjusted post-operative therapy with stage III-IVa (AJCC 7th edition) HPV-associated OPC. In order to be credentialed to accrue to this trial, surgeons were required to demonstrate active hospital credentials and technique-specific surgical expertise with ≥20 cases of transoral resection for OPC. In addition, 10 paired operative and surgical pathology reports from the preceding 24 months were reviewed by an expert panel. Ongoing QA required <10% rate of positive margins, low oropharyngeal bleeding rates, and accrual of at least one patient per 12 months. Otherwise surgeons were placed on hold and not permitted to accrue until re-credentialed using a new series of transoral resections. RESULTS: 120 surgeons trained in transoral minimally invasive surgery applied for credentialing for E3311 and after peer-review, 87 (73%) were approved from 59 centers. During QA on E3311, positive final pathologic margins were reported in 19 (3.8%) patients. Grade III/IV and grade V oropharyngeal bleeding was reported in 29 (5.9%) and 1 (0.2%) of patients. CONCLUSIONS: We provide proof of concept that a comprehensive credentialing process can support multicenter transoral head and neck surgical oncology trials, with low incidence of positive margins and *grade III/V oropharyngeal bleeding.

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Published In

Oral Oncol

DOI

EISSN

1879-0593

Publication Date

November 2020

Volume

110

Start / End Page

104797

Location

England

Related Subject Headings

  • Surgeons
  • Robotic Surgical Procedures
  • Quality Assurance, Health Care
  • Prospective Studies
  • Oropharyngeal Neoplasms
  • Oncology & Carcinogenesis
  • Middle Aged
  • Humans
  • Female
  • Dentistry
 

Citation

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Chicago
ICMJE
MLA
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Ferris, R. L., Flamand, Y., Holsinger, F. C., Weinstein, G. S., Quon, H., Mehra, R., … Burtness, B. (2020). A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311. Oral Oncol, 110, 104797. https://doi.org/10.1016/j.oraloncology.2020.104797
Ferris, Robert L., Yael Flamand, F Christopher Holsinger, Gregory S. Weinstein, Harry Quon, Ranee Mehra, Joaquin J. Garcia, et al. “A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.Oral Oncol 110 (November 2020): 104797. https://doi.org/10.1016/j.oraloncology.2020.104797.
Ferris RL, Flamand Y, Holsinger FC, Weinstein GS, Quon H, Mehra R, et al. A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311. Oral Oncol. 2020 Nov;110:104797.
Ferris, Robert L., et al. “A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311.Oral Oncol, vol. 110, Nov. 2020, p. 104797. Pubmed, doi:10.1016/j.oraloncology.2020.104797.
Ferris RL, Flamand Y, Holsinger FC, Weinstein GS, Quon H, Mehra R, Garcia JJ, Hinni ML, Gross ND, Sturgis EM, Duvvuri U, Méndez E, Ridge JA, Magnuson JS, Higgins KA, Patel MR, Smith RB, Karakla DW, Kupferman ME, Malone JP, Judson BL, Richmon J, Boyle JO, Bayon R, O’Malley BW, Ozer E, Thomas GR, Koch WM, Bell RB, Saba NF, Li S, Sigurdson ER, Burtness B. A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311. Oral Oncol. 2020 Nov;110:104797.
Journal cover image

Published In

Oral Oncol

DOI

EISSN

1879-0593

Publication Date

November 2020

Volume

110

Start / End Page

104797

Location

England

Related Subject Headings

  • Surgeons
  • Robotic Surgical Procedures
  • Quality Assurance, Health Care
  • Prospective Studies
  • Oropharyngeal Neoplasms
  • Oncology & Carcinogenesis
  • Middle Aged
  • Humans
  • Female
  • Dentistry