Surgery News - October 2008 - (Page 13)

OCTOBER 2008 • SURGERY NEWS NEWS B Y D A V I D M . O TA , M . D . , FA C S , A N D H E I D I N E L S O N , M . D . , FA C S FROM Describe the adverse events associated with cryoablation. Prospectively gather pain assessment data on cryoablation and surgical resection. Explore technical variables that may affect success of cryoablation. The target accrual is 99 patients. Magnetic resonance imaging (MRI) for the breast has increased surgeons’ ability to better identify localized early disease, which is suitable for in situ ablation. Post-ablation MRI will also be used to see if residual disease remains. In this trial design (see chart), all patients will undergo resection of the ablation site so that microscopic evaluation for residual disease can be done. There is also an optional correlative science component to investigate the immune response to cryoablation, which includes three blood samples. Patient eligibility criteria include the following: Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. Patients with multifocal THE COLLEGE Surgeons or radiologists wishing to participate must initially meet at least one of the following criteria: 1. Surgeon is certified in ultrasound by the American Society of Breast Surgeons and has completed at least five ultrasound-guided cryoablations for breast fibroadenoma/cancer. 2. Surgeon is partnering with a radiologist certified by the American College of Radiology in breast ultrasound and has completed at least five ultrasoundguided cryoablations for breast fibroadenoma/cancer. 3. Surgeon can provide case list documentation of the last 20 breast interventional ultrasounds within the past 6 months and has completed at least five ultrasound-guided cryoablations for breast fibroadenoma/cancer. The trial will be conducted in up to 20 clinical sites. Contact Dr. Simmons at rms2002@med.cornell.edu. ■ DR. OTA, of Durham, N.C., and DR. NELSON, of Rochester, Minn., are ACOSOG co-chairs. Breast Cancer Trial Explores Cryoablation he American College of Surgeons Oncology Group (ACOSOG) is conducting a cryoablation trial of T1 breast cancers to determine if early cancers can be completely ablated. The primary objective of the study—Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma (ACOSOG Z1072)—is to determine the rate of complete tumor ablation (defined as no remaining invasive or in situ carcinoma present upon pathological examination of the targeted lesion) in patients treated with cryoablation. Led by Rache Simmons, M.D., FACS, the study has the following secondary objectives: Evaluate the negative predictive value of MRI in the post-ablation setting to determine residual in situ or invasive breast carcinoma. T and/or multicentric ipsilateral breast cancer, multifocal calcifications, or ductal carcinoma in situ with microinvasion are not eligible. Patients with contralateral disease will remain eligible. No history of rotational vacuumassisted core biopsies, en bloc open surgical biopsy, and/or lumpectomy for diagnosis/treatment of the index breast cancer. Tumor size is <2.0 cm in greatest diameter. Specifically, the tumor must measure <2.0 cm in the axis parallel to the treatment probe and <1.5 cm in the axis antiparallel to the treatment probe. Largest size measured by mammogram, ultrasound, or MRI will be used to determine eligibility. Tumor enhancement is present in prestudy MRI. Tumor biopsy has <25% intraductal components in the aggregate. There is no prior or planned neoadjuvant chemotherapy for breast cancer. Patient is not pregnant or lactating. Adequate breast size for safe cryoablation. Patients with core biopsy– proven invasive ductal breast carcinoma 2.0 cm in diameter. Local pathology review for ER/PR and HER2 Mammogram Breast ultrasound Breast MRI REGISTER Pain assessment Blood draw (optional) CRYOABLATION Pain assessment Breast MRI Blood draw (optional) Surgery Pain assessment Blood draw (optional) new Sentinel Event Alert issued by The Joint Commission warns that rude language and hostile behavior among health care professionals go beyond being unpleasant and pose a serious threat to patient safety and the overall quality of care. Intimidating and disruptive behaviors are so concerning that, in addition to the Sentinel Event Alert, The Joint Commission is introducing new standards requiring more than 15,000 accredited health care organizations to create a code of conduct that defines acceptable and unacceptable behaviors and to establish a formal process for managing unacceptable behavior. The new standards take effect January 1, 2009, for hospitals, nursing homes, home health agencies, laboratories, ambulatory care facilities, and behavioral health care facilities across the U.S. Verbal outbursts, condescending attitudes, refusal to take part in assigned duties, and physical threats all create breakdowns in the teamwork, communication, and collaboration necessary to deliver patient care. The Institute for Safe Medication Practices found that Joint Commission Sets Conduct Standards A 40% of clinicians have kept quiet or remained passive during disruptive events occurring during patient care rather than question a known intimidator. “Most health care workers do their jobs with care, compassion, and professionalism,” said Mark R. Chassin, M.D., MPP, MPH, and president of The Joint Commission. “But sometimes professionalism breaks down, and caregivers engage in behaviors that threaten patient safety. It is important for organizations to take a stand by clearly identifying such behaviors and refusing to tolerate them.” To help stop intimidating and disruptive behaviors among physicians, nurses, pharmacists, therapists, support staff, and administrators, the Sentinel Event Alert recommends that health care organizations take 11 specific steps, including the following: Educate all health care team members about professional behavior, including training in basics such as courteousness during telephone interactions, business etiquette, and general people skills. Hold all team members accountable for modeling desirable behaviors, and enforce the code of conduct consistently and equitably. Establish a comprehensive approach to addressing intimidating and disruptive behaviors that includes a zero-tolerance policy, obtaining strong involvement and support from physician leadership, reducing fears of retribution against those who report intimidating and disruptive behaviors, and empathizing with and apologizing to patients and families who are involved in or witness intimidating or disruptive behaviors. Determine how and when disciplinary actions should begin. Develop a system to detect and receive reports of unprofessional behavior, and use nonconfrontational interaction strategies to address intimidating and disruptive behaviors within the context of an organizational commitment to the health and well-being of all staff and patients. Visit The Joint Commission’s Web site at www.jointcommission.org/ SentinelEvents/SentinelEventAlert/ for more information. ■ Apply Now for ACS Traveling Fellowship T he ACS International Relations Committee announces the availability of the Australia and New Zealand (ANZ) Chapter of the ACS Traveling Fellowship: a $12,000 scholarship for a U.S. or Canadian Fellow of the ACS. This fellowship is intended to encourage international exchange of information concerning surgical science, practice, and education, and to establish professional and academic collaborations and friendships. The ANZ Traveling Fellow will attend the annual Scientific Congress of the Royal Australasian College of Surgeons, in Perth, Australia, May 4-8, 2010. The Fellow will also visit surgical centers in Australia and New Zealand. The closing date for receipt of completed applications is Nov. 17, 2008. For more information, contact kearly@facs.org. or visit www.facs.org/memberservices/ traveling.html. ■ http://www.jointcommission.org/SentinelEvents/SentinelEventAlert http://www.jointcommission.org/SentinelEvents/SentinelEventAlert http://www.facs.org/memberservices/traveling.html http://www.facs.org/memberservices/traveling.html

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Surgery News - October 2008 Contents Call to Action Issued to Support DVT, PE Prevention Protocol Changes May Increase Donor Organs CMS Targets 2011 for Switch to ICD-10 Opinion: Election 2008 The 20/20 Vision: Children's Health News From the College: Survival Strategy General Surgery: Innovations

Surgery News - October 2008

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