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

Robert L. Ferris; Yael Flamand; F. Christopher Holsinger; Gregory S. Weinstein; Harry Quon; Ranee Mehra; Joaquin J. Garcia; Michael L. Hinni; Neil D. Gross; Erich M. Sturgis; Umamaheswar Duvvuri; Eduardo Méndez; John A. Ridge; J. Scott Magnuson; Kerry A. Higgins; Mihir R. Patel; Russel B. Smith; Daniel W. Karakla; Michael E. Kupferman; James P. Malone; Benjamin L. Judson; Jeremy Richmon; Jay O. Boyle; Rodrigo Bayon; Bert W. O'Malley; Enver Ozer; Giovana R. Thomas; Wayne M. Koch; R. Bryan Bell; Nabil F. Saba; Shuli Li; Elin R. Sigurdson; Barbara Burtness

doi:10.1016/j.oraloncology.2020.104797

Back

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

Journal article

Open access

Peer reviewed

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

Robert L. Ferris, Yael Flamand, F. Christopher Holsinger, Gregory S. Weinstein, Harry Quon, Ranee Mehra, Joaquin J. Garcia, Michael L. Hinni, Neil D. Gross, Erich M. Sturgis, …

Oral oncology, Vol.110, pp.104797-104797

11/2020

DOI: 10.1016/j.oraloncology.2020.104797

PMCID: PMC7771718

PMID: 32679405

Files and links (1)

url

https://www.ncbi.nlm.nih.gov/pmc/articles/7771718View

Open Access

Abstract

•Transoral surgery is FDA approved for removal of oropharynx cancer.•Credentialing and quality assurance can standardize surgical clinical trials.•Our results may apply to other surgical disciplines and clinical trials. 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. 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. 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. 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.

Head and neck cancer

HPV

Quality assurance

Transoral surgery

Details

Title: Subtitle: A novel surgeon credentialing and quality assurance process using transoral surgery for oropharyngeal cancer in ECOG-ACRIN Cancer Research Group Trial E3311
Creators: Robert L. Ferris - UPMC Hillman Cancer Center, Pittsburgh, PA, United States
Yael Flamand - Dana-Farber Cancer Institute
F. Christopher Holsinger - Stanford University
Gregory S. Weinstein - Annenberg Public Policy Center
Harry Quon - Johns Hopkins University
Ranee Mehra - University of Maryland, Baltimore
Joaquin J. Garcia - Mayo Clinic Rochester MN United States
Michael L. Hinni - Mayo Clinic in Arizona, Phoenix, AZ, United States
Neil D. Gross - The University of Texas MD Anderson Cancer Center
Erich M. Sturgis - The University of Texas MD Anderson Cancer Center
Umamaheswar Duvvuri - UPMC Hillman Cancer Center, Pittsburgh, PA, United States
Eduardo Méndez - University of Washington
John A. Ridge - Fox Chase Cancer Center
J. Scott Magnuson - AdventHealth Celebration
Kerry A. Higgins - ECOG-ACRIN Cancer Research Group
Mihir R. Patel - Winship Cancer Institute at Emory University, Atlanta, GA, United States
Russel B. Smith - University of Nebraska at Omaha
Daniel W. Karakla - Sentara Norfolk General Hospital
Michael E. Kupferman - The University of Texas MD Anderson Cancer Center
James P. Malone - UPMC Central Pa
Benjamin L. Judson - Yale Cancer Center
Jeremy Richmon - Massachusetts Eye and Ear Infirmary
Jay O. Boyle - Memorial Sloan Kettering Cancer Center
Rodrigo Bayon - University of Iowa
Bert W. O'Malley - Annenberg Public Policy Center
Enver Ozer - The Ohio State University
Giovana R. Thomas - University of Miami
Wayne M. Koch - Johns Hopkins University
R. Bryan Bell - Providence Portland Medical Center
Nabil F. Saba - Emory University
Shuli Li - Dana-Farber Cancer Institute
Elin R. Sigurdson - Fox Chase Cancer Center
Barbara Burtness - Yale Cancer Center
Resource Type: Journal article
Publication Details: Oral oncology, Vol.110, pp.104797-104797
DOI: 10.1016/j.oraloncology.2020.104797
PMID: 32679405
PMCID: PMC7771718
NLM abbreviation: Oral Oncol
ISSN: 1368-8375
eISSN: 1879-0593
Publisher: Elsevier Ltd
Language: English
Date published: 11/2020
Academic Unit: Otolaryngology
Record Identifier: 9984312244102771

Metrics

21 Record Views

39 Times Cited - Web of Science