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Jobe B.A.,Western Pennsylvania Hospital | Richter J.E.,University of South Florida | Hoppo T.,Western Pennsylvania Hospital | Peters J.H.,University of Rochester | And 14 more authors.
Journal of the American College of Surgeons | Year: 2013

Background Gastroesophageal reflux disease (GERD) is a very prevalent disorder. Medical therapy improves symptoms in some but not all patients. Antireflux surgery is an excellent option for patients with persistent symptoms such as regurgitation, as well as for those with complete symptomatic resolution on acid-suppressive therapy. However, proper patient selection is critical to achieve excellent outcomes. Study Design A panel of experts was assembled to review data and personal experience with regard to appropriate preoperative evaluation for antireflux surgery and to construct an evidence and experience-based consensus that has practical application. Results The presence of reflux symptoms alone is not sufficient to support a diagnosis of GERD before antireflux surgery. Esophageal objective testing is required to physiologically and anatomically evaluate the presence and severity of GERD in all patients being considered for surgical intervention. It is critical to document the presence of abnormal distal esophageal acid exposure, especially when antireflux surgery is considered, and reflux-related symptoms should be severe enough to outweigh the potential side effects of fundoplication. Each testing modality has a specific role in the diagnosis and workup of GERD, and no single test alone can provide the entire clinical picture. Results of testing are combined to document the presence and extent of the disease and assist in planning the operative approach. Conclusions Currently, upper endoscopy, barium esophagram, pH testing, and manometry are required for preoperative workup for antireflux surgery. Additional studies with long-term follow-up are required to evaluate the diagnostic and therapeutic benefit of new technologies, such as oropharyngeal pH testing, multichannel intraluminal impedance, and hypopharyngeal multichannel intraluminal impedance, in the context of patient selection for antireflux surgery. © 2013 by the American College of Surgeons Published by Elsevier Inc.

Bell R.C.W.,SurgOne | Mavrelis P.G.,Internal Medicine Associates | Barnes W.E.,Livingston Hospital and Healthcare Services Inc. | Dargis D.,Allegan Surgical Associates | And 6 more authors.
Journal of the American College of Surgeons | Year: 2012

Background: This study was undertaken to validate previously reported safety and symptomatic outcomes of transoral incisionless fundoplication (TIF), evaluate the relative benefit of TIF within different gastroesophageal reflux disease (GERD) subgroups, and to determine predictors of success in community settings. Study Design: Between January 2010 and February 2011, 100 consecutive patients who underwent TIF procedures at 10 centers were enrolled in this prospective, open-label, multicenter, single-arm study. Symptom improvement and objective outcomes of TIF were analyzed at 6-month follow-up. Results: One hundred TIF procedures were performed. No complications were reported. Median GERD symptom duration was 9 years (range 1 to 35 years) and median duration of proton pump inhibitor (PPI) use was 7 years (1 to 20 years). Maximal medical therapy resulted in incomplete symptom control for 92% of patients; GERD Health-Related Quality of Life (GERD-HRQL) total score was normalized in 73%. Median heartburn and regurgitation scores improved significantly, from 18 (range 0 to 30) and 15 (range 0 to 30) on PPIs before TIF to 3 (range 0 to 25) and 0 (range 0 to 25), respectively; p < 0.001. Median Reflux Symptom Index scores were reduced after TIF from 24 (range 14 to 41) to 7 (range 0 to 44); p < 0.001. Eighty percent of patients were completely off PPIs after TIF vs 92% of patients on PPIs before TIF. Preoperative factors associated with clinical outcomes were less severe heartburn (total GERD-HRQL ≤ 30, p = 0.02) and the presence of esophagitis (p < 0.02). Conclusions: Transoral incisionless fundoplication is safe and effective in multiple community-based settings in the treatment of medically refractory GERD, as demonstrated by an absence of complications, excellent symptom relief, and complete cessation of PPIs at 6-month follow-up. © 2012 American College of Surgeons.

Lei R.Y.,Rocky Mountain Cancer Centers | Lei R.Y.,Rocky Mountain Cancer Center | Leonard C.E.,Rocky Mountain Cancer Centers | Howell K.T.,Rocky Mountain Cancer Centers | And 9 more authors.
Breast Cancer Research and Treatment | Year: 2013

This prospective Phase II single-arm study gathered data on the use of intensity-modulated radiotherapy (IMRT) to deliver accelerated partial breast irradiation (APBI). Four-year efficacy, cosmesis, and toxicity results are presented. Between February 2004 and September 2007, 136 consecutive patients with Stage 0/I breast cancer and negative margins ≥0.2 cm were treated on protocol. Patients received 38.5 Gy in 10 equal fractions delivered twice daily. Breast pain and cosmesis were rated by patient, and cosmesis was additionally evaluated by physician per Radiation Therapy Oncology Group (RTOG) criteria. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0) was used to grade toxicities. 136 patients (140 breasts) with median follow-up of 53.1 months (range, 8.9-83.2) were evaluated. Population characteristics included median age of 61.9 years and Tis (13.6 %), T1a (18.6 %), T1b (36.4 %), and T1c (31.4 %). Kaplan-Meier estimates at 4 years: ipsilateral breast tumor recurrence 0.7 %; contralateral breast failure 0 %; distant failure 0.9 %; overall survival 96.8 %; and cancer-specific survival 100 %. At last follow-up, patients and physicians rated cosmesis as excellent/good in 88.2 and 90.5 %, respectively; patients rated breast pain as none/mild in 97.0 %. Other observations included edema (1.4 %), telangiectasia (3.6 %), five cases of grade 1 radiation recall (3.6 %), and two cases of rib fractures (1.4 %). This analysis represents the largest cohort and longest follow-up of APBI utilizing IMRT reported to date. Four-year results continue to demonstrate excellent local control, survival, cosmetic results, and toxicity profile. © 2013 The Author(s).

Lei R.Y.,Rocky Mountain Cancer Centers | Leonard C.E.,Rocky Mountain Cancer Centers | Howel K.T.,Rocky Mountain Cancer Centers | Henkenberns P.L.,Rocky Mountain Cancer Centers | And 7 more authors.
Frontiers in Oncology | Year: 2014

Purpose: To report outcomes in breast cancer patients with prior breast augmentation treated with external beam accelerated partial breast irradiation (EB-APBI) utilizing intensity-modulated radiotherapy or 3-dimensional conformal radiotherapy, both with IGRT. Materials and Methods: Sixteen stage 0/1 breast cancer patients with previous elective bilateral augmentation were treated post-lumpectomy on institutional EB-APBI trials (01185132 and 01185145 on clinicaltrials.gov). Patients received 38.5 Gy in 10 fractions over five consecutive days. Breast/chest wall pain and cosmesis were rated by patient; cosmesis was additionally evaluated by physician per RTOG criteria. Results: The median follow-up from accelerated partial breast irradiation (APBI) completion was 23.9 months (range, 1.2-58.6). Little to no change in cosmesis or pain from baseline was reported. Cosmetic outcomes at last follow-up were judged by patients as excellent/good in 81.2% (13/16), and by physicians as excellent/good in 93.8% (15/16). Ten patients (62.5%) reported no breast/chest wall pain, five (31.2%) reported mild pain, and one (6.2%) reported moderate pain. All patients remain disease free at last follow-up. The median ipsilateral breast, planning target volume (PTV), and implant volumes were 614, 57, and 333 cm3. The median ratios of PTV/ipsilateral breast volume (implant excluded) and PTV/total volume (implant included) were 9 and 6%. Conclusion: These 16 breast cancer cases with prior bilateral augmentation treated with EB-APBI demonstrate favorable clinical outcomes. Further exploration of EB-APBI as a treatment option for this patient population is warranted. © 2014 Lei, Leonard, Howell, Henkenberns, Johnson, Hobart, Kercher, Widner, Kaske, Barke and Carter.

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