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OBJECTIVE: Clinical predictors of pathological complete response have not reliably identified patients for whom an organ-sparing approach following neoadjuvant chemoradiation be undertaken for esophageal cancer patients. We sought to identify high-risk predictors of residual carcinoma that may preclude patients from a selective surgical approach. BACKGROUND: Patients treated with neoadjuvant chemoradiation followed by esophagectomy for esophageal adenocarcinoma were identified. PATIENTS AND METHODS: Correlation between clinical and pathologic complete responses were examined. Regression models and recursive partitioning were utilized to identify features associated with residual carcinoma. External validation of these high-risk factors was performed on a data set from an independent institution. RESULTS: A total of 326 patients were identified, in whom clinical complete response was noted in 104/326 (32%). Pathologic complete response was noted in only 33/104 (32%) of these clinical complete responders. Multivariable analysis identified that the presence of stricture ( P =0.011), positive biopsy ( P =0.010), and signet ring cell histology ( P =0.019) were associated with residual cancer. Recursive partitioning corroborated a 94% probability of residual disease, or greater, for each of these features. The positive predictive value was >90% for these characteristics. A SUV max >5.4 at the esophageal primary in the absence of esophagitis was also a high-risk factor for residual carcinoma. External validation confirmed these high-risk factors to be implicated in the finding of residual carcinoma. CONCLUSIONS: Clinical parameters of response are poor predictors of complete pathologic response leading to challenges in selecting candidates for active surveillance. However, we characterize several high-risk features for residual carcinoma which indicate that esophagectomy should not be delayed.
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Adenocarcinoma , Neoplasias Esofágicas , Humanos , Terapia Neoadyuvante , Neoplasias Esofágicas/terapia , Neoplasias Esofágicas/patología , Adenocarcinoma/terapia , Adenocarcinoma/patología , Esofagectomía , Estudios Retrospectivos , Estadificación de NeoplasiasRESUMEN
BACKGROUND & AIMS: The straight leg raise (SLR) maneuver during high-resolution manometry (HRM) can assess esophagogastric junction (EGJ) barrier function by measuring changes in intraesophageal pressure (IEP) when intra-abdominal pressure is increased. We aimed to determine whether increased esophageal pressure during SLR predicts pathologic esophageal acid exposure time (AET). METHODS: Adult patients with persistent gastroesophageal reflux disease (GERD) symptoms undergoing HRM and pH-impedance or wireless pH study off proton pump inhibitor were prospectively studied between July 2021 and March 2022. After the HRM Chicago 4.0 protocol, patients were requested to elevate 1 leg at 45º for 5 seconds while supine. The SLR maneuver was considered effective when intra-abdominal pressure increased by 50%. IEPs were recorded 5 cm above the lower esophageal sphincter at baseline and during SLR. GERD was defined as AET greater than 6%. RESULTS: The SLR was effective in 295 patients (81%), 115 (39%) of whom had an AET greater than 6%. Hiatal hernia (EGJ type 2 or 3) was seen in 135 (46%) patients. Compared with patients with an AET less than 6%, peak IEP during SLR was significantly higher in the GERD group (29.7 vs 13.9 mm Hg; P < .001). Using receiver operating characteristic analysis, an increase of 11 mm Hg of peak IEP from baseline during SLR was the optimal cut-off value to predict an AET greater than 6% (area under the receiver operating characteristic curve, 0.84; sensitivity, 79%; and specificity, 85%), regardless of the presence of hiatal hernia. On multivariable analysis, an IEP pressure increase during the SLR maneuver, EGJ contractile integral, EGJ subtype 2, and EGJ subtype 3, were found to be significant predictors of AET greater than 6% CONCLUSIONS: The SLR maneuver can predict abnormal an AET, thereby increasing the diagnostic value of HRM when GERD is suspected. CLINICALTRIALS: gov ID: NCT04813029.
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Reflujo Gastroesofágico , Hernia Hiatal , Adulto , Humanos , Pierna/patología , Reflujo Gastroesofágico/patología , Unión Esofagogástrica/patología , Esfínter Esofágico Inferior , Manometría/métodosRESUMEN
BACKGROUND: Diaphragmatic reconstruction is a vital, but challenging component of hiatal hernia and antireflux surgery. Results are optimized by minimizing axial tension along the esophagus, assessed with intra-abdominal length, and radial tension across the hiatus, which has not been standardized. We categorized hiatal openings into 4 shapes, as a surrogate for radial tension, to correlate their association with operative interventions and recurrence. METHODS: We retrospectively reviewed all primary hiatal hernias (≥3 cm) repaired at a single center between 2010 and 2020. Patients with intraoperative hiatal photos with at least 1 year of follow-up were included. The hiatal openings were classified into 4 shapes: slit, inverted teardrop, "D," and oval, and ordered in this manner of hypothesized increased complexity and tension. RESULTS: A total of 239 patients were studied, with 113 (47%) having a recurrence. Age (P < .001), proportion of paraesophageal hernias (P < .001), hernia axial length (P < .001), and hiatal width (P < .001) all increased as shape progressed from slit to inverted teardrop to "D" to oval. Mesh (P = .003) and relaxing incisions (P < .001) were more commonly employed in more advanced shapes, "D" and ovals. However, recurrence (P = .88) did not correlate with hiatal shape. CONCLUSION: Four different hiatal shapes are commonly seen during hernia repair. These shapes represent a spectrum of hernia chronicity and complexity necessitating increased use of operative measures but not correlating with recurrence. Despite failing to be a direct marker for recurrence risk, hiatal shape may serve as an intraoperative tool to inform surgeons of the potential need for additional hiatal interventions.
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BACKGROUND: Antireflux surgery (ARS) and hiatal hernia repair (HHR) are common surgical procedures with modest morbidity. Increasing age is a risk factor for complications; however, details regarding acute morbidity are lacking. This study aimed to describe the incidence rates and types of morbidities across the spectrum of ages. METHODS: A total of 2342 consecutive cases were retrospectively reviewed from 2003 to 2020 for 30-day complications. All complications were assessed using the Clavien-Dindo (CD) grading system. Patients were divided into 5 age groups: ≤59, 60 to 69, 70 to 79, 80 to 89, and ≥90 years. RESULTS: The numbers per age group were 1100 patients aged ≤59 years, 684 patients aged 60 to 69 years, 458 patients aged 70 to 79 years, 458 patients aged 80 to 89 years, and 6 patients aged ≥90 years. A total of 427 complications (18.2%) occurred, including 2 mortalities, each in the 60- to 69-year age group and the 70- to 79-year age group, for a mortality rate of 0.2%. The complication rate increased from 13.5% (149) in patients aged ≤59 years to 35.0% (35) in patients aged ≥80 years (P = .006), with CD grades I and II accounting for >70% of complications, except in patients aged ≥80 years (57.1%). CD grades IIIa and IIIb were higher in patients aged ≥80 years (26.5% [P = .001] and 11.8% [P = .021], respectively). CD grade IVa and IVb complications were rare overall. CONCLUSION: There is a modest rate of morbidity that increases as patients age, regardless of hernia type, elective or primary surgery, with most being minor complications (CD grade≤II). Our data should help patients, referring physicians, and surgeons counsel patients regarding the effect of increasing age in ARS and HHR.
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Reflujo Gastroesofágico , Hernia Hiatal , Herniorrafia , Complicaciones Posoperatorias , Humanos , Hernia Hiatal/cirugía , Hernia Hiatal/complicaciones , Persona de Mediana Edad , Anciano , Estudios Retrospectivos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/mortalidad , Anciano de 80 o más Años , Femenino , Masculino , Factores de Edad , Herniorrafia/efectos adversos , Reflujo Gastroesofágico/cirugía , Incidencia , Fundoplicación/efectos adversos , Fundoplicación/métodos , Adulto , Factores de RiesgoRESUMEN
BACKGROUND: The historic morbidity and mortality rates of anti-reflux and hiatal hernia surgery are reported as 3-21% and 0.2-0.5%, respectively. These data come from either large national/population level or small institutional studies, with the former focusing on broad 30-day outcomes while lacking granular data on complications and their severity. Institutional studies tend to focus on long-term and quality of life outcomes. Our objective is to describe and evaluate the incidence of 30 and 90-day morbidity and mortality in a large, single institution dataset. STUDY DESIGN: We retrospectively reviewed 2342 cases of anti-reflux and hiatal hernia surgery from 2003-2020 for intra-operative complications causing post-operative sequelae, as well as morbidity and mortality within 90 days. All complications were graded using the Clavien-Dindo (CD) Grading System. The highest-grade of complication was used per patient during 30-day and 31-90-day intervals. RESULTS: Out of 2342 patients, the overall 30-day morbidity and mortality rates were 18.2% (427/2342) and 0.2% (4/2342), respectively. Most of the complications were CD<3a at 13.1% (306/2342). In the 31-90-day post-operative period, morbidity and mortality rates decreased to 3.1% (78/2338) and 0.09% (2/2338). CD<3a complications accounted for 1.9% (42/2338). CONCLUSIONS: Anti-reflux and hiatal hernia surgery are safe operations with rare mortality and modest rates of morbidity. However, the majority of complications patients experience are minor (CD<3a) and are easily managed. A minority of patients will experience major complications (CD≥3a) that require additional procedures and management to secure a safe outcome. These data are helpful to inform patients of the risks of surgery, and guide physicians for optimal consent.
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OBJECTIVE: A definitive diagnosis of gastroesophageal reflux disease (GERD) depends on endoscopic and/or pH-study criteria. However, high resolution manometry (HRM) can identify factors predicting GERD, such as ineffective esophageal motility (IEM), esophago-gastric junction contractile integral (EGJ-CI), evaluating esophagogastric junction (EGJ) type and straight leg raise (SLR) maneuver response. We aimed to build and externally validate a manometric score (Milan Score) to stratify the risk and severity of the disease in patients undergoing HRM for suspected GERD. METHODS: A population of 295 consecutive patients undergoing HRM and pH-study for persistent typical or atypical GERD symptoms was prospectively enrolled to build a model and a nomogram that provides a risk score for AET > 6%. Collected HRM data included IEM, EGJ-CI, EGJ type and SLR. A supplemental cohort of patients undergoing HRM and pH-study was also prospectively enrolled in 13 high-volume esophageal function laboratories across the world in order to validate the model. Discrimination and calibration were used to assess model's accuracy. Gastroesophageal reflux disease was defined as acid exposure time >6%. RESULTS: Out of the analyzed variables, SLR response and EGJ subtype 3 had the highest impact on the score (odd ratio 18.20 and 3.87, respectively). The external validation cohort consisted of 233 patients. In the validation model, the corrected Harrel c-index was 0.90. The model-fitting optimism adjusted calibration slope was 0.93 and the integrated calibration index was 0.07, indicating good calibration. CONCLUSIONS: A novel HRM score for GERD diagnosis has been created and validated. The MS might be a useful screening tool to stratify the risk and the severity of GERD, allowing a more comprehensive pathophysiologic assessment of the anti-reflux barrier. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT05851482).