новая папка / Operative Standards for Cancer Surgery Volume I 1st Edition

Foreword

It is a great pleasure to recognize the first edition of Operative Standards for Cancer Surgery, produced through cooperation between the American College of Surgeons and the Alliance for Clinical Trials in Oncology. This represents a unique benefit of the decade-long relationship between the ACS and National Cancer Institute cooperative groups and is in line with the hundred-year history of our commitment to quality.

As with any component of the care of patients, there is evidence of what is effective and there is accompanying variability in the actual practice. Much of clinical surgery is based on principles of ablation, correction of anatomic deficits, and reconstruction. The effectiveness of cancer operations has generally followed the principle of surgical removal. The technical elements that are critical to the proper conduct of a cancer operation ensure the best practice in optimal long-term outcomes. When evidence and experience demonstrate a technique that is essential for optimal outcomes, it is essential to teach that technique with precision and put it forth as an evidence-based standard.

This manual, using both text and illustrations, focuses on describing technical elements critical to proper conduct of cancer operations where best practice can be demonstrated. The authors have attempted to use the best evidence available, and this evidence represents the opinions of diverse and representative groups who care for cancer patients.

Defining those critical elements of each operation that are essential for surgical success is the purpose of Operative Standards for Cancer Surgery, and the areas covered have achieved this noble goal. Drs. Heidi Nelson and Kelly Hunt, along with the other surgeons that led disease site groups, are to be congratulated for the work they have done in producing this landmark approach to surgical care. This effort will become the standard by which cancer care is judged going forward and should be a standard for how all of surgical care is taught.

David B. Hoyt, MD, FACS Executive Director American College of Surgeons

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“It is part of your job to get out of your rut and see how others are doing things, what steps are being taken at the frontiers of your science or art, and bring those ideas home.”

--Francis D. Moore, MD

“People never improve unless they look to some standard or example higher or better than themselves.”

--Tyron Edwards American Theologian 1809-1894

Surgery is an art, not a science. All surgeons know that the specifics of surgery for an individual patient, with all of their special anatomical and biologic features, cannot be reduced to a formula. As a result, surgery cannot be learned from a textbook; it must be learned in the operating room, in the clinic, on the wards, and during morbidity and mortality conferences. Surgery is learned by watching other surgeons and by adapting their examples to one’s own style. Dr. John Mannick, the Chair of Surgery during my own training, famously stated, “Every surgery training program should have at least one really bad surgeon so that residents learn what not to do.” We all knew that he was joking because bad surgery was not tolerated, but we also knew that learning from mistakes was a powerful source of education. Another favorite expression, attributed to Dr. Francis D. Moore,

was, “Good surgical judgment comes from experience, and experience comes from having poor judgment.”

Although it is an art, surgery at its best is informed by science—by objective data that guide optimal practice. During my own training, the “no touch” procedure for cancer surgery was advocated by some practitioners. These surgeons believed that meticulously ligating each vessel surrounding a tumor before manipulating it in any way could prevent metastatic spread by limiting the number of cells that broke free into the circulation. Although it is true that tumor cells are introduced into circulation at increased numbers during the conduct of surgery, we now have data showing that no clinical benefit is derived from extraordinary methods to prevent this. Other new surgical techniques have been added based on data from clinical studies. For example, total mesorectal excision is now a proven method of reducing mortality for rectal cancer, and the management of regional lymph nodes for breast cancer and melanoma has changed dramatically following results from clinical trials. Changes in surgical approaches continue to occur as a result of new instrumentation facilitating minimally invasive surgery and in response to improvements in chemotherapy and radiation therapy.

P.xxi This publication represents an outstanding collaboration among many leaders in surgical oncology. It provides a detailed roadmap for optimal surgery as we know it today, and it therefore meets an important unmet need as an educational tool. Broad application of these standards to clinical practice will improve outcomes for many cancer patients. In addition, because data to guide optimal care can only be identified through standardization of techniques, this work provides an essential platform for developing further improvements. Fortunately, it is the nature of good surgeons to constantly refine their technique. We can therefore be confident that innovative surgeons will build upon this foundation in ways that will greatly benefit our patients.

Monica M. Bertagnolli, MD, FACS Group Chair Alliance for Clinical Trials in Oncology

Preface

It is with great pleasure that we introduce the first edition of Operative Standards for Cancer Surgery. This manual, presented by the American College of Surgeons (ACS) and the Alliance for Clinical Trials in Oncology, represents one of the unique benefits of the decade-long relationship between the ACS and the National Cancer Institute (NCI) Cooperative Groups. Since its inception 100 years ago, the ACS has demonstrated unwavering dedication to the creation and implementation of surgical standards. Standards were considered a founding principle of the ACS, and standards formed the basis for many of the programs that evolved within the ACS, including the Commission on Cancer, Committee on Trauma, the National Accreditation Program for Breast Centers, and the American Joint Committee on Cancer. For their part, the NCI Cooperative Groups, including the three legacy groups of the Alliance (the ACS Oncology Group, Cancer and Leukemia Group B, and North Central Cancer Treatment Group), have also provided much impetus over the years for surgeons to create standards for specific surgeries. Furthermore, clinical trials in cancer patients have often required that surgeons define the technical elements considered vital to cancer outcomes. In fact, trials whose study hypothesis focuses on a surgical question have required that surgery be performed according to a well-defined technical protocol complete with measures for quality assurance and control, as well as procedures for correlating surgical techniques with outcomes. The focus of the ACS and NCI Cooperative Groups on surgical standards and the emphasis clinical trials have placed on defining surgical techniques and correlating them with outcomes have brought us to a point at which we can provide, in this manual, the first comprehensive, evidence-based examination of cancer surgery techniques as standards.

In this manual, text and illustrations are used to describe the technical elements that are considered critical to the proper conduct of a cancer operation to ensure best practices and optimal oncologic outcomes. This manual is not a technical atlas, and its text and illustrations do not describe all aspects of a cancer operation; furthermore, it does not cover all perioperative standards, such as antibiotic use or prophylaxis for thromboembolic events, or even all intraoperative standards, such as the surgical pause or checklist, used in the surgical treatment of cancer patients. Instead, this manual focuses on the surgical activities that occur between skin incision and skin closure that directly affect cancer outcomes. It simply provides the best evidence available in the literature, as determined using state-of-the art methodologies, in support of specific surgical oncology techniques. This manual does not represent the expressed opinion of a single surgeon; rather, its authors were drawn from diverse and representational groups, including the ACS, the Alliance and NCI Cooperative Groups, and the Commission on Cancer, as well as national societies and organizations with an interest in the four cancer types covered herein.

P.xxiv We have tremendous respect for and are grateful to all the surgeons, leaders, and support staff who helped to create and shape this manual. First, we wish to thank the dozens of surgeons who spent nights, weekends, and holidays conducting searches, reviewing literature, debating key points, writing chapters, and selecting artwork and illustrations to assemble this manual. Without their volunteerism, this manual would never have been realized. Second, we wish to acknowledge the superb leadership skills of the surgeons who led the disease site groups (Drs. Blair, Chang, Katz, and Veeramachaneni). We would also like to acknowledge the art directors who gathered the illustrations and materials that bring visual clarity to the concepts described in this manual (Drs. Dickson-Witmer, Halverson, Martin, and Vollmer). Finally, we thank the dedicated and brilliant methodologists who walked us through the process of gathering and analyzing the evidence to produce the highest quality standards (Drs. Baxter, Chang, Pawlik, and Puri). We are also indebted to our publisher and colleagues (Keith Donnellan, acquisitions editor, Professional & Education, and Brendan Huffman, product manager-Editorial) for believing in this project and helping it take shape and form.

Of course, this project emerged because past ACS leadership saw the wisdom in engaging more surgeons in the NCI Cooperative Groups and because subsequent ACS and Alliance leadership preserved such engagement through the formation and support of the ACS Clinical Research Program. We therefore thank the ACS Board of Regents and Drs. Samuel Wells, Thomas Russell, David Hoyt, and Monica Bertagnolli. Finally, nothing of substance would have been accomplished without the steadfast dedication and logistical support of the ACS staff. Thank you, Carla Amato-Martz, for seeing this project through from start to finish.

We hope this first edition of Operative Standards for Cancer Surgery brings value to your practice as well as to your education and training programs. We also hope this manual inspires some readers to take an active role in creating an expanded second edition that includes additional cancer sites and/or challenge current standards and create new standards. If this manual helps surgeons, students, and/or trainees sharpen their focus on that which matters most during cancer surgery or improve the way in which they report and communicate their work, we will have fulfilled our ambitions.

Respectfully submitted,

Heidi Nelson, MD, FACS Chair, Department of Surgery Fred C. Andersen Professor of Surgery Mayo Clinic Rochester, New York

Kelly K. Hunt, MD, FACS

Hamill Foundation Distinguished Professor of Surgery in

Honor of Dr. Richard G. Martin Sr

Chief, Breast Surgical Oncology

Department of Surgical Oncology

The University of Texas

MD Anderson Cancer Center

Houston, Texas

Editorial

Operative Standards for Cancer Surgery describes the essential intraoperative steps surgeons should follow to assure optimal oncologic outcomes. The first edition of this manual, a product of a collaborative effort between the Alliance and the Clinical Research Program of the American College of Surgeons, focuses on four common cancers, including breast, lung, pancreas, and colon.

Although adjuvant systemic therapy and radiation therapy play an important role in the management of these cancers, surgical resection remains the mainstay for any expectation for long-term cure. Accordingly, it is incumbent on the surgeon to perform the procedure in an organized, meticulous manner based on the best available evidence, putting aside any preconceived ideas that may have developed during training or prior experiences. Variations, no doubt, continue to exist. The mentality of “This is how I was trained to do it” or “This is the only correct way, my way, to do it” must shift to a willingness to adhere to the latest evidence-based technical information on the essential oncologic steps from incision to closure. This manual will be most effective when reviewed by both the managing surgeon and trainee preparing for a cancer resection in order to synchronize and understand the rationale for the essential steps. Imagine the undesirable situation where the trainee has studied the manual and the attending surgeon may not be quite up to date.

The manual will assist with standardization of surgical resection in patients who are enrolled in a clinical trial. Often, the criteria for an oncologic resection vary based on the principle investigator or the cooperative group. Future clinical trials should adopt the essential components of oncologic operations as described in this manual.

Operative Standards for Cancer Surgery is not just another surgical manual. It is unique for several reasons: (1) essential operative steps are evidence-based, (2) the strength or weakness of the evidence is cited, (3) it chronicles how an extensive literature search supports the recommended steps, (4) it poses controversial questions for each cancer site that could be answered best through a clinical trial, and (5) it makes the important distinction between the right and wrong thing to do during a cancer operation.

This beautifully illustrated and richly referenced manual is the culmination of expert input from a wide variety of surgeons with a special interest in cancer resections for these four sites. It is a seminal piece of work, a mustread for general surgeons, surgical oncologists, colorectal surgeons, thoracic surgeons, and surgical trainees caring for patients with cancers of the breast, lung, pancreas, and colon. Hopefully, future editions will expand the number of sites and be continuously updated.

David P. Winchester, MD, FACS Medical Director, Cancer Programs American College of Surgeons

Daniel P. McKellar, MD, FACS

Chair, Commission on Cancer

American College of Surgeons

Methodology Research Protocol

INTRODUCTION

When the four disease sites were selected for the first edition of the manual, teams were developed to populate the disease site working groups. Representatives were sought from each of the NCI cooperative groups, the major professional societies for each of the disease sites, and the Commission on Cancer. The disease site working groups determined the operative procedures that would be included in the first edition and then assigned team members to each procedure, with a team leader responsible for organizing the team activities. Surgeons with expertise in health services research were assigned to each working group to serve as methodologists. The methodologists were responsible for developing a uniform process for the working groups to develop critical elements and key questions for each procedure.

METHODOLOGY FOR CRITICAL ELEMENTS

Critical elements for each procedure were developed by the working groups to include steps of the operative procedure that impact oncologic outcomes that occur from the time of skin incision to the time of skin closure. Once the list of critical elements was developed, surveys were used to rank order the elements by oncologic importance. The disease site working groups met by teleconference to choose the top four to five critical elements for each procedure for inclusion in the manual. Each step required consensus by all of the members of the disease site working groups. Literature reviews were performed for each critical element, and recommendations were made for each critical element to include the type of data available and the strength of the recommendation based on consensus of the experts populating the disease site working group.

METHODOLOGY FOR KEY QUESTIONS

Key questions were identified during the process of constructing critical elements for each procedure. Key questions were areas of controversy where consensus could not be assured in order to qualify as a critical element. The methodologists determined a process for systematic review of the literature and for summarizing the findings of the working groups. It was suggested that a professional librarian be involved in the literature search whenever possible. At least two individuals were assigned to perform the literature searches and to provide a critical appraisal of the literature.

The general framework was to include literature from the English language only using the PUBMED database to include literature published between 1990 and 2014. Randomized trials were preferred; however, when this type of data was not available,

P.xxviii a literature review could include retrospective institutional studies with a minimum of 100 patients published after 1990 and cohort studies published after 1990.

Team members were asked to include all details of the literature review, including the date of search, a list of all search terms, a list of all abstracts reviewed (including total number reviewed), all inclusion and exclusion criteria, and all literature chosen for review in detail. Consort diagrams for workflow were developed for each key question to include the number of abstracts reviewed and number of manuscripts reviewed in detail. In some cases the GRADE system (see table below) was used to grade the level of evidence included in the detailed literature review. Summary tables were developed for each key question followed by recommendations based on the type of data and strength of available data. What follows is the process and workflow utilized by the disease site working group.

1.Identify key issues to address with literature review based on preliminary research and expert consensus regarding the key operative steps.

a.Based on this preliminary review, identify key statements/questions for which detailed evidence review will be obtained.

i.Question should include detail about the population, the intervention, and the outcome. For example, “In patients with T4 colorectal cancer, does performing an en bloc resection reduce the risk of local recurrence?”

2.Search strategy

a.MeSH terms or keyword search of search engines: PUBMED, EMBASE, Cochrane

i.Document search terms, total number of hits, number of abstracts reviewed, number of full papers reviewed.

b.Previously published guidelines and consensus statements (e.g. National Guideline Clearinghouse: www.guideline.gov; relevant professional societies and organizations)

c.Prior protocols from cooperative groups

i.Obtain surgical specifications (if available) from prior cooperative group trials.

d.Hand search of references, consultation with experts

e.e. Limits

i.e.g., Publication year 1990+

ii.English language

iii.Type of publication

f.Documentation

i.Search terms

ii.Total number of hits

iii.Number of abstracts reviewed

iv.Number of full papers reviewed

v.Number of papers included in the review

3.Data extraction

a.Classify by study design (e.g. RCT, observational [cohort, case-control, case series], systematic reviews)

i.Was there a stated objective or hypothesis?

ii.Population

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iii.Retrospective/prospective

iv.Intervention

v.Comparison

vi.Outcome

b. Summarize key findings.

5. Recommendations

a.Assign overall strength of recommendation and quality of supportive evidence for each corresponding question.

b.Review GRADE based on evidence for group consensus.

i.Group should review the document with the statements as presented by the primary reviewer(s) and ensure general agreement.

c.Compare recommendations to those of others.

From Guyatt G, Gutterman D, Baumann MH, et al. Grading strength of recommendations and quality of evidence in clinical guidelines: report from an american college of chest physicians task force. Chest 2006;129(1):174-81

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6. Overall themes

a.Pragmatic approach recognizing that resources and time are limited

i.Targeted, not exhaustive search of the literature but ensure balance

b.Group members are an expert source for evaluating the validity of the recommendations.

c.Expected in the reviews

i.List of key statements/questions

ii.Search strategy for each question

iii.Documentation of search results for each question

iv.List of excluded studies for each question

v.Evidence summary tables for each question

vi.Recommendation for each question