Quality of life following repair of large hiatal hernia is not influenced by the use of mesh-Longer-term follow-up from a randomized trial.

INTRODUCTION: The use of prosthetic mesh in laparoscopic repair of large hiatus hernias remains controversial. Clinical and quality of life outcomes from a randomized controlled trial of mesh versus suture repair previously showed few differences at early follow-up. This study evaluated longer-term quality of life outcomes from that trial. METHODS: A prospective, multicentre, double blind randomized controlled trial assessed three methods of repair for large hiatus hernias: sutures-only versus absorbable mesh versus non-absorbable mesh. Quality of life was assessed using the Short-Form 36 (SF-36) questionnaire which was completed preoperatively and then at 3, 6, 12 months following surgery and annually thereafter. SF-36 outcomes were compared across the three repair techniques at longer-term follow-up (3-6 years), and to earlier baseline and 12-month outcomes. RESULTS: 126 patients were randomized; 43-suture-only, 41-absorbable mesh and 42-non-absorbable mesh. Questionnaires were completed by 118 patients preoperatively, 115 at 12 months and 98 at longer-term follow-up (median 5 years). There were no significant differences between the repair techniques for the subscale and composite scores at longer-term follow-up. The mental component score improved significantly after surgery and was sustained across follow-up for all techniques. The physical component score also improved significantly but was lower at longer-term follow-up compared to the 12-month follow up in both mesh groups. CONCLUSION: Surgical repair of large hiatus hernias provides sustained long-term improvement in quality of life. The addition of mesh does not improve quality of life. TRIAL REGISTRATION: This trial is registered with the Australia and New Zealand Clinical Trials Registry ACTRN12605000725662.

Randomized Trial of Laparoscopic Nissen Versus Anterior 180 Degree Partial Fundoplication - Late Clinical Outcomes at 15 to 20 years.

OBJECTIVE: To determine very late clinical outcomes at up to 20 years follow-up from a randomized controlled trial of Nissen versus anterior 180-degree partial fundoplication. SUMMARY BACKGROUND DATA: Nissen fundoplication for gastroesophageal reflux can be followed by troublesome side effects. To address this, partial fundoplications have been proposed. Previously reports from a randomized controlled trial of Nissen versus anterior 180-degree partial fundoplication at up to 10 years follow-up showed good outcomes for both procedures. METHODS: One hundred seven participants were randomized to Nissen versus anterior 180-degree partial fundoplication. Fifteen to 20 year follow-up data was available for 79 (41 Nissen, 38 anterior). Outcome was assessed using a standardized questionnaire with 0 to 10 analog scores and yes/no questions to determine reflux symptoms, side-effects, and satisfaction with surgery. RESULTS: After anterior fundoplication heartburn (mean score 3.2 vs 1.4, P = .001) and proton pump inhibitor use (41.7% vs 17.1%, P = .023) were higher, offset by less dysphagia for solids (mean score 1.8 vs 3.3, P = .015), and better ability to belch (84.2% vs 65.9%, P = .030). Measures of overall outcome were similar for both groups (mean satisfaction score 8.4 vs 8.0, P = .444; 86.8% vs 90.2% satisfied with outcome). Six participants underwent revision after anterior fundoplication (Nissen conversion for reflux - 6), and 7 underwent revision after Nissen fundoplication (Nissen to partial fundoplication for dysphagia - 5; redo Nissen for reflux - 1; paraesophageal hernia -1). CONCLUSIONS: At 15 to 20 years follow-up Nissen and anterior 180-degree partial fundoplication achieved similar success, but with trade-offs between better reflux control versus more side-effects after Nissen fundoplication.

Responsiveness and convergent validity of QLU-C10D and EQ-5D-3L in assessing short-term quality of life following esophagectomy.

AIM: This study assessed the responsiveness and convergent validity of two preference-based measures; the newly developed cancer-specific EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D) relative to the generic three-level version of the EuroQol 5 dimensions (EQ-5D-3L) in evaluating short-term health related quality of life (HRQoL) outcomes after esophagectomy. METHODS: Participants were enrolled in a multicentre randomised controlled trial to determine the impact of preoperative and postoperative immunonutrition versus standard nutrition in patients with esophageal cancer. HRQoL was assessed seven days before and 42 days after esophagectomy. Standardized Response Mean and Effect Size were calculated to assess responsiveness. Ceiling effects for each dimension were calculated as the proportion of the best level responses for that dimension at follow-up/post-operatively. Convergent validity was assessed using Spearman's correlation and the level of agreement was explored using Bland-Altman plots. RESULTS: Data from 164 respondents (mean age: 63 years, 81% male) were analysed. HRQoL significantly reduced on both measures with large effect sizes (> 0.80), and a greater mean difference (0.29 compared to 0.16) on QLU-C10D. Both measures had ceiling effects (> 15%) on all dimensions at baseline. Following esophagectomy, ceiling effects were observed with self-care (86%), mobility (67%), anxiety/depression (55%) and pain/discomfort (19%) dimensions on EQ-5D-3L. For QLU-C10D ceiling effects were observed with emotional function (53%), physical function (16%), nausea (35%), sleep (31%), bowel problems (21%) and pain (20%). A strong correlation (r = 0.71) was observed between EQ-5D-3L anxiety and QLU-C10D emotional function dimensions. Good agreement (3.7% observations outside the limits of agreement) was observed between the utility scores. CONCLUSION: The QLU-C10D is comparable to the more widely applied generic EQ-5D-3L, however, QLU-C10D was more sensitive to short-term utility changes following esophagectomy. Cognisant of requirements by policy makers to apply generic utility measures in cost effectiveness studies, the disease-specific QLU-C10D should be used alongside the generic measures like EQ-5D-3L. TRIAL REGISTRATION: The trial was registered with the Australian New Zealand Clinical Trial Registry (ACTRN12611000178943) on the 15th of February 2011.

Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.

OBJECTIVE: To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair. SUMMARY OF BACKGROUND DATA: Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair. METHODS: Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years. RESULTS: 126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh. CONCLUSIONS: No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.

Randomized Trial of Division Versus Nondivision of Short Gastric Vessels During Nissen Fundoplication: 20-Year Outcomes.

OBJECTIVE: To evaluate late outcomes from a randomized trial of division versus no division of short gastric vessels during laparoscopic Nissen fundoplication at up to 20 years follow-up. BACKGROUND: Nissen fundoplication is an established procedure for the treatment of gastroesophageal reflux disease. Controversy about whether side effects such as dysphagia could be reduced by division of the short gastric vessels led to the establishment of a randomized trial in 1994. Early results showed equivalent reflux control and dysphagia, but more bloating after vessel division. METHODS: A total of 102 patients underwent a laparoscopic Nissen fundoplication between May 1994 and October 1995, and were randomized to short gastric vessel division (50) versus nondivision (52). Follow-up was obtained yearly to 20 years using a standardized questionnaire administered by a blinded investigator. Clinical outcomes at 20 years or most recent follow-up were determined. RESULTS: No significant differences for heartburn symptom and satisfaction scores or medication use were found between treatment groups. At 15 to 20 (mean 19.6) years follow-up, significant differences persisted for epigastric bloating: 26% versus 50% for nondivision versus division groups (P = 0.046). Heartburn symptom scores were low and not different for nondivision versus division groups (mean analog scores 1.4 vs 2.1/10, P = 0.152). Overall satisfaction after surgery was high in both groups (mean analog scores 8.1 vs 8.6/10, P = 0.989). CONCLUSIONS: Although laparoscopic Nissen fundoplication has durable efficacy for heartburn symptom control at up to 20 years follow-up, division of short-gastric vessels failed to confer any reduction in side effects, and was associated with persistent epigastric bloat symptoms at late follow-up in this trial.

Long-term Efficacy of Laparoscopic Antireflux Surgery on Regression of Barrett's Esophagus Using BRAVO Wireless pH Monitoring: A Prospective Clinical Cohort Study.

OBJECTIVE: To assess the long-term efficacy of antireflux surgery on Barrett's esophagus (BE) using BRAVO wireless pH monitoring. BACKGROUND: BE is associated with chronic gastroesophageal reflux and esophageal cancer. Till date, studies have failed to demonstrate that preventing gastroesophageal reflux with antireflux surgery halts the progression of BE, often because of difficulties in objectively proving an effective antireflux barrier. METHODS: Since 1991, all patients undergoing antireflux surgery across 2 hospital sites have been followed in a prospective database. Patients with BE and at least 5 years follow up after antireflux surgery were identified. All patients completed a clinical outcome questionnaire and underwent endoscopic assessment and histological evaluation of their BE. Fourty-eight hours pH monitoring was then performed with the wireless BRAVO system. RESULTS: A total of 50 patients (40 males:10 females) were included in the study, with an average follow up of 11.9 years. Approximately, 92% (46/50) reported their outcome of surgery as "excellent" or "good" and 86% (43/50) reported "none" or "mild" symptoms. Histological regression of BE was seen in 41% (20/49). Lower esophageal acid exposure (percentage time pH < 4) was significantly greater in those with no pathological regression (P = 0.008). Moreover, 64% (32/50) showed endoscopic reduction in the length of BE. Acid exposure was also significantly less in the group showing endoscopic reduction of BE (%time pH < 4, 0.2 vs 3.6, P = 0.007). CONCLUSIONS: Antireflux surgery is safe and effective in patients with Barrett's esophagus. An intact fundoplication, as assessed with BRAVO wireless pH monitoring, suggests that antireflux surgery may halt the progression of Barrett's esophagus, and this might reduce the risk of cancer development.

Quality and outcomes of synchronous two-team Ivor-Lewis oesophagectomy: Revisiting a variant technique.

BACKGROUND AND OBJECTIVES: In 1975, a modification of popular two-stage Ivor-Lewis oesophagectomy was published with synchronous resection in chest and abdomen. As data on this technique are rare and inconsistent, we aimed to investigate safety, feasibility, and outcome of this approach. METHODS: Outcome of 201 patients undergoing synchronous oesophagectomy from 2000 to 2013 was analysed retrospectively. Two groups (early: 2000-2006; late: 2007-2013) were analysed to allow comparison of outcome over time. RESULTS: Patients in the later period had fewer respiratory comorbidities (P = 0.010), median blood loss decreased significantly over time while lymph node yield increased (P < 0.001). Overall complications occurred in 58.9 (early) versus 51.7% (late) of patients (P = 0.320), anastomotic leaks in 14.3 versus 6.7% (P = 0.112), respiratory complications in 48.2 versus 34.8% (P = 0.063). Thirty-day/90-day mortality was 2.7% versus 3.4, respectively, 8.1% versus 6.8% (P ≤ 0.793). Long-term survival was better in the later cohort (P = 0.004). CONCLUSIONS: Our data of 201 patients over a period of 14 years suggests that this technique is a quick, feasible, safe, and reasonable alternative to standard two-stage Ivor-Lewis oesophagectomy. Quality of this approach and ultimate outcomes have improved over time, with similar complication rates/outcomes to literature accepted standards for two-stage approach, especially in the later time period. J. Surg. Oncol. 2016;114:719-724. © 2016 Wiley Periodicals, Inc.

Laparoscopic repair of very large hiatus hernia with sutures versus absorbable mesh versus nonabsorbable mesh: a randomized controlled trial.

OBJECTIVE: Determine whether absorbable or nonabsorbable mesh in repair of large hiatus hernias reduces the risk of recurrence, compared with suture repair. BACKGROUND: Repair of large hiatus hernia is associated with radiological recurrence rates of up to 30%, and to improve outcomes mesh repair has been recommended. Previous trials have shown less short-term recurrence with mesh, but adverse outcomes limit mesh use. METHODS: Multicentre prospective double blind randomized controlled trial of 3 methods of repair: sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome-hernia recurrence assessed by barium meal radiology and endoscopy at 6 months. Secondary outcomes-clinical symptom scores at 1, 3, 6, and 12 months. RESULTS: A total of 126 patients enrolled: 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Among them, 96.0% were followed up to 12 months, with objective follow-up data in 92.9%. A recurrent hernia (any size) was identified in 23.1% after suture repair, 30.8% after absorbable mesh, and 12.8% after nonabsorbable mesh (P = 0.161). Clinical outcomes were similar, except less heartburn at 3 and 6 months and less bloating at 12 months with nonabsorbable mesh; more heartburn at 3 months, odynophagia at 1 month, nausea at 3 and 12 months, wheezing at 6 months; and inability to belch at 12 months after absorbable mesh. The magnitudes of the clinical differences were small. CONCLUSIONS: No significant differences were seen for recurrent hiatus hernia, and the clinical differences were unlikely to be clinically significant. Overall outcomes after sutured repair were similar to mesh repair.

Quality of Life Following Repair of Large Hiatal Hernia is Improved but not Influenced by Use of Mesh: Results From a Randomized Controlled Trial.

INTRODUCTION: Laparoscopic surgery is the treatment of choice for repair of large hiatus hernia, but can be followed by recurrence. Repair with prosthetic mesh has been recommended to prevent recurrence, although complications following mesh repair have generated disagreement about whether or not mesh should be used. The early objective and clinical results of a randomized trial of repair with mesh versus sutures have been reported, and revealed few differences. In the current study, we evaluated quality of life outcomes within this trial at follow-up to 2 years. METHODS: In a multicenter prospective double-blind randomized trial three methods for repair of large hiatus hernia were compared: sutures versus repair with absorbable mesh (Surgisis) versus non-absorbable (Timesh). Quality of life assessment using the Short-Form 36 (SF-36) questionnaire was undertaken at 3, 6, 12 and 24 months after surgery. SF-36 outcomes (8 individual scales and 2 composite scales) were determined for each group, and compared between groups, and across different follow-up points. RESULTS: 126 patients were enrolled-43 sutures, 41 absorbable mesh and 42 non-absorbable mesh. 115 (91.3%) completed a preoperative questionnaire, and 113 (89.7%) completed the post-operative questionnaire at 3 months, 116 (92.1%) at 6 months, 114 (90.5%) at 12 months, and 91 (72.2%) at 24 months. The SF-36 Physical and Mental Component Scores (PCS and MCS) improved significantly following surgery, and this improvement was sustained across 24 months follow-up (p < 0.001 for PCS and MCS at each follow-up point). There were no significant differences between the groups for the component scores or the eight SF-36 subscale scores at each follow-up time. 29 individuals had a recurrence at 6 months follow-up, of which 9 were symptomatic. The PCS were higher in patients with recurrence versus without (p < 0.01), and in patients with a symptomatic recurrence versus asymptomatic recurrence versus no recurrence (p = 0.001). CONCLUSION: SF-36 measured quality of life improved significantly after repair of large hiatal hernia at up to 2 years follow-up, and there were no differences in outcome for the different repair techniques. The use of mesh versus no mesh in repair of large hiatal hernia did not influence quality of life.

Surveillance endoscopy at five or more years after cardiomyotomy for achalasia.

OBJECTIVE: To perform long-term histopathological and clinical assessment of patients who have previously undergone cardiomyotomy for achalasia. BACKGROUND: There are few studies on long-term outcome for patients treated by cardiomyotomy for achalasia. Recent publications suggest that these patients may be at high risk of both squamous cell carcinoma and adenocarcinoma of the esophagus. METHODS: All patients, in whom at least 5 years had elapsed since laparoscopic cardiomyotomy for achalasia, were identified from a prospective database. Patients were invited to attend for endoscopy and clinical outcome was assessed by questionnaire. RESULTS: Out of 171 patients identified, 2 had died from esophageal carcinoma. Of the remainder, 68 were recruited [mean age 52 years (range 26-72)]. Fifty-six percent reported minimal symptoms and 6% experienced frequent reflux symptoms. Almost all patients (93%) reported some dysphagia, but dysphagia scores remained significantly lower than preoperatively (P < 0.0001). Quality of life was comparable to normal subjects, and 97% of patients indicated they had made the correct decision to undergo surgery. At endoscopy 83% had evidence of chronic inflammation in the distal esophagus on histopathology, including 22% with moderate to severe esophagitis and 7% with Barrett's esophagus. Five patients showed esophageal candidiasis, and 2 had eosinophilic esophagitis. No dysplasia or malignancy was identified. CONCLUSIONS: The clinical outcome remains excellent in most patients at long-term follow-up after cardiomyotomy for achalasia. Surveillance endoscopy might identify high-risk patients but routine endoscopy in all patients is probably not necessary, particularly early after surgery.

Preoperative factors predicting clinical outcome following laparoscopic fundoplication.

BACKGROUND: Antireflux surgery is effective for the treatment of gastroesophageal reflux, but not all patients benefit equally from it. The challenge is to identify the patients who will ultimately benefit from antireflux surgery. The aim of this study was to identify preoperative factors that predict clinical outcome after antireflux surgery, with special interest in the influence of socioeconomic factors. METHODS: Preoperative clinical and socioeconomic data from 1,650 patients who were to undergo laparoscopic fundoplication were collected prospectively. Clinical outcome measures (persistent heartburn, dysphagia, satisfaction) were assessed at short-term (1 year) and longer-term (≥ 3 years) follow-up. RESULTS: At early follow-up, male gender (relative risk [RR] 1.091, p < 0.001) and the presence of a hiatus hernia (RR 1.065, p = 0.002) were independently associated with less heartburn. Male gender was also associated with higher overall satisfaction (RR 1.046, p = 0.034). An association was found between postoperative dysphagia and age (RR 0.988, p = 0.007) and the absence of a hiatus hernia (RR 0.767, p = 0.001). At longer-term follow-up, only male gender (RR 1.125, p < 0.001) was an independent prognostic factor for heartburn control. Male gender (RR 0.761, p = 0.001), the presence of a hiatus hernia (RR 0.823, p = 0.014), and cerebrovascular comorbidities (RR 1.306, p = 0.019) were independent prognosticators for dysphagia at longer-term follow-up. A hiatus hernia was the only factor associated with better overall satisfaction. Socioeconomic factors did not influence any clinical outcomes at short- and longer-term follow-up. CONCLUSION: Male gender and hiatus hernia are associated with a better clinical outcome following laparoscopic fundoplication, whereas socioeconomic status does not influence outcome.

Objective outcomes 14 years after laparoscopic anterior 180-degree partial versus nissen fundoplication: results from a randomized trial.

OBJECTIVE: To investigate late objective outcomes 14 years after laparoscopic anterior 180-degree partial versus Nissen fundoplication. BACKGROUND: Clinical outcomes from randomized clinical trials suggest good outcomes for anterior 180-degree partial fundoplication, with similar control of reflux symptoms and less side effects, compared with Nissen fundoplication. However, objective outcomes at late follow-up have not been reported. METHODS: A subset of participants from a randomized trial of anterior 180-degree versus Nissen fundoplication underwent stationary esophageal high-resolution manometry and ambulatory 24-hour impedance-pH monitoring at 14 years' follow-up. The subset and other patients in the trial also completed a standardized clinical questionnaire to ensure that they were representative of the overall trial. RESULTS: Eighteen patients (8 anterior, 10 Nissen) underwent objective testing and had a symptom profile similar to those who did not (n = 59) have testing. Total esophageal acid exposure time and the total number of acid and weakly acidic reflux episodes per 24 hours were higher after anterior fundoplication than after Nissen fundoplication. Proximal, midesophageal and distal reflux were proportionately increased after anterior 180-degree fundoplication. The number of liquid and mixed reflux episodes was also higher after anterior fundoplication, which was accompanied by higher clinical heartburn scores. There were no differences in gas reflux, gastric belches, and supragastric belches, which is in line with the observation that gas-related symptoms were similar for both groups. Mean LES resting and relaxation nadir pressure were lower after anterior fundoplication, which was reflected by lower dysphagia scores. Patient satisfaction was similar after both procedures. CONCLUSIONS: At 14 years after randomization, this study demonstrated that acid, weakly acidic, liquid and mixed reflux episodes are more common after anterior 180-degree fundoplication than after Nissen fundoplication. On the contrary, gas reflux and gastric belching and patient satisfaction are similar for both procedures. Mean LES resting and relaxation nadir pressure are lower after anterior fundoplication. Overall, these findings suggest less effective reflux control after anterior 180-degree partial fundoplication, offset by less dysphagia, leading to a clinical outcome that is equivalent to Nissen fundoplication at late follow-up.

Five-year outcome after laparoscopic anterior partial versus Nissen fundoplication: four randomized trials.

OBJECTIVE: To compare longer term (5-year) outcomes for reflux control and postsurgery side effects after laparoscopic anterior (90° and 180°) partial versus Nissen fundoplication for gastroesophageal reflux. BACKGROUND: Laparoscopic Nissen fundoplication is the most frequently performed surgical procedure for gastroesophageal reflux. It achieves excellent control of reflux, but in some patients it is followed by troublesome side effects. To reduce the risk of side effects laparoscopic anterior partial fundoplication variants have been advocated, although some studies suggest poorer reflux control. METHODS: From 1995 to 2003, 461 patients with gastroesophageal reflux were enrolled in 4 randomized controlled trials comparing anterior partial versus Nissen fundoplication. Two trials evaluated anterior 180° and 2 anterior 90° partial fundoplication. The original trial data were combined, and a reanalysis from original data was undertaken to determine outcomes at 5 years follow-up. Reflux symptom control and side effects were evaluated in a blinded fashion using standardized questionnaires, including 0 to 10 analog scores (0 = no symptoms, 10 = severe symptoms). RESULTS: At 5 years, patients who underwent an anterior 90° or 180° partial fundoplication had less side effects than those who underwent Nissen fundoplication and were equally satisfied with the overall outcome. Reflux control, measured by heartburn scores and antisecretory medication use, was similar for anterior 180° partial versus Nissen fundoplication, but inferior after anterior 90° partial versus Nissen fundoplication. CONCLUSIONS: Anterior 180° partial fundoplication achieves durable control of reflux symptoms and fewer side effects compared with Nissen fundoplication. Reflux control after anterior 90° partial fundoplication appears less effective than after Nissen fundoplication. This data supports the use of anterior 180° partial fundoplication for the surgical treatment of gastroesophageal reflux.

Accuracy of PET-CT in predicting survival in patients with esophageal cancer.

BACKGROUND: Positron emission tomography (PET) is an integral part of tumor staging for patients with esophageal cancer. Recent studies suggest a role for PET scan in predicting survival in these patients, but this relationship is unclear in the setting of neoadjuvant therapy. We examined pretreatment maximum standard uptake value (SUV(max)) of the primary tumor in patients treated with and without neoadjuvant therapy. METHODS: All patients undergoing esophagectomy with a preoperative PET scan over a nine-year period (2001-2010) were identified from a prospectively maintained database. Positron emission tomography data were obtained from computers housing the original PET scans. Overall survival was correlated with SUV(max) of the primary tumor. RESULTS: A total of 191 patients were identified, and 103 patients met inclusion criteria. Eighty-two had an adenocarcinoma (80%), and 21 (20%) had a squamous cell carcinoma. Fifty-seven (55%) patients received neoadjuvant therapy. In the surgery alone group, a SUV(max) of > 5.0 in the primary tumor was associated with poor prognosis [Hazard Ratio (HR) 0.32; p = 0.007], but this factor did not retain its significance on multivariate analysis (HR 0.65; p = 0.43). Pretreatment SUV(max) in patients who underwent neoadjuvant therapy was not significant in predicting overall survival (p = 0.10). CONCLUSIONS: This study does not support the use of SUV(max) on pretreatment PET scans as a prognostic tool for patients with esophageal cancer, especially in those who have received neoadjuvant therapy. Lymph node status is a more accurate predictor of outcome, and efforts to improve pretreatment staging should focus on this factor.

Factors associated with postoperative pulmonary morbidity after esophagectomy for cancer.

BACKGROUND: Most studies analyzing risk factors for pulmonary morbidity date from the early 1990s. Changes in technology and treatment such as minimally invasive esophagectomy (MIE) and neoadjuvant treatment mandate analysis of more contemporary cohorts. METHODS: Predictive factors for overall and specific pulmonary morbidity in 858 patients undergoing esophagectomy between 1998 and 2008 in five Australian university hospitals were analyzed by logistic regression models. RESULTS: A total of 394 patients underwent open esophagectomy, and 464 patients underwent MIE. A total of 259 patients received neoadjuvant chemoradiotherapy, 139 preoperative chemotherapy alone, and 2 preoperative radiotherapy alone. In-hospital mortality was 3.5%. Smoking and the number of comorbidities were risk factors for overall pulmonary morbidity (odds ratio [OR] 1.47, P = 0.016; OR 1.35, P = 0.001) and pneumonia (OR 2.29, P = 0.002; 1.56, P = 0.005). The risk of respiratory failure was higher in patients with more comorbidities (OR 1.4, P = 0.035). Respiratory comorbidities (OR 3.81, P = 0.017) were strongly predictive of postoperative acute respiratory distress syndrome (ARDS). ARDS (4.51, P = 0.032) or respiratory failure (OR 8.7, P < 0.001), but not anastomotic leak (OR 2.22, P = 0.074), were independent risk factors for death. MIE (OR 0.11, P < 0.001) and thoracic epidural analgesia (OR 0.12, P = 0.003) decreased the risk of respiratory failure. Neoadjuvant treatment was not associated with an increased risk of pulmonary complications. CONCLUSIONS: Preoperative comorbidity and smoking were risk factors for respiratory complications, whereas neoadjuvant treatment was not. MIE and the use of thoracic epidural analgesia decreased the risk of respiratory failure. Respiratory failure and ARDS were the only independent factors associated with an increased risk of in-hospital death, whereas anastomotic leakage was not.

Learning curve for laparoscopic repair of very large hiatal hernia.

BACKGROUND: Laparoscopic repair of a large hiatal hernia is technically challenging. A significant learning curve likely exists that has not been studied to date. METHODS: Since 1992, the authors have prospectively collected data for all patients undergoing laparoscopic repair of a very large hiatal hernia (50% or more of the stomach within the chest). Follow-up evaluation was performed after 3 months, then yearly. Visual analog scores were used to assess heartburn and dysphagia. Patients were grouped according to institutional and individual surgeons' experience to determine the impact of any learning curve. The outcome for procedures performed by consultant surgeons was compared with that for trainees. RESULTS: From 1992 to 2008, 415 patients with a 1-year minimum follow-up period were studied. Institutional and individual experience had a significant influence on operation time, conversion to open surgery, and length of hospital stay. However, except for heartburn scores during a 3-month follow-up evaluation of institutional experience (p=0.03), clinical outcomes were not influenced by either an institutional or individual learning curve. Furthermore, in general terms, whether the procedure was performed by a consultant or a supervised trainee had little effect on outcome. CONCLUSIONS: Institutional and individual learning curves had no significant influence on clinical outcomes, although improved experience was reflected in improved operation time, conversion rate, and hospital stay. These outcomes improved over the first 50 institutional cases, and the outcomes for individual surgeons improved for up to 40 cases.

Feasibility study of sentinel lymph node biopsy in esophageal cancer with conservative lymphadenectomy.

INTRODUCTION: Lymphoscintigraphy and sentinel node mapping is established in breast cancer and melanoma but not in esophageal cancer, even though many centers have shown that occult tumor deposits in lymph nodes influence prognosis. We report our initial experience with lymphoscintigraphy and sentinel lymph node biopsy in patients undergoing resection for esophageal cancer. METHODS: Sixteen of 17 consecutive patients underwent resection for invasive esophageal cancer along with sentinel lymph node retrieval (resection rate, 94%). Peritumoral injection of (99m)Tc antimony colloid was performed by upper endoscopy prior to the operation. A two-surgeon synchronous approach via right thoracotomy and laparotomy was performed with conservative lymphadenectomy. Sentinel lymph nodes were identified using a gamma probe both in vivo and ex vivo. Sentinel lymph nodes were sent off separately for serial sections and immunohistochemistry. RESULTS: Median patient age was 60.4 years (range, 45-75 years). Fifteen were male, and thirteen had adenocarcinoma. At least one sentinel lymph node (median, 2) was identified in 14 of 16 patients (success rate, 88%). Sentinel nodes were present in more than one nodal station in five patients (31%). In all 14 patients, the sentinel lymph node accurately predicted findings in non-sentinel nodes (accuracy, 100%). Three patients with positive sentinel lymph nodes had metastases identified in non-sentinel nodes (sensitivity, 100%). CONCLUSIONS: Sentinel lymph node biopsy is feasible in esophageal resection with conservative lymphadenectomy, and initial results suggest it is accurate in predicting overall nodal status. Further study is needed to assess impact on patient management and prognosis.

Prospective randomized trial of laparoscopic Nissen fundoplication with anterior versus posterior hiatal repair: late outcomes.

BACKGROUND: The technique used for hiatal closure in laparoscopic Nissen fundoplication might have an impact on the risk of postfundoplication dysphagia and hiatal herniation. In 1997, we commenced a randomized trial to evaluate the impact of anterior versus posterior hiatal repair techniques on these outcomes. In the present study, we evaluated the 10-year outcomes from this trial. METHODS: A total of 102 patients were randomized to undergo laparoscopic Nissen fundoplication with either anterior (47 patients) or posterior (55 patients) repair of the diaphragmatic hiatus. Outcomes were assessed using standardized clinical assessment scores that evaluated reflux symptoms, dysphagia, and satisfaction with the outcome following surgery. RESULTS: Clinical outcomes 10 years after surgery were available for 93% of patients, and outcome scores were obtained for 43 patients in each group. Patients undergoing anterior hiatal repair were less likely to report dysphagia for lumpy solid foods (14.0% vs. 39.5%, p = 0.01), although there were no significant differences in dysphagia outcomes for six other dysphagia assessment scores. There were no differences between the two groups for reflux symptoms, medication use, and overall satisfaction with the outcome of surgery. CONCLUSIONS: At the 10-year follow-up, the outcomes for the two groups were similar. Anterior hiatal repair is an acceptable technique for hiatal closure during laparoscopic Nissen fundoplication.

Isolated tumor cells in esophageal cancer: implications for the surgeon and the pathologist.

INTRODUCTION: Studies suggest that up to 56% of node-negative patients have tumor deposits in their lymph nodes that are missed by routine pathologic examination. However, few studies differentiate between isolated tumor cells and micrometastases using reproducible criteria, and their prognostic significance has not been established. METHODS: We identified 119 patients who had undergone surgical resection for esophageal cancer between 1997 and 2007, and who were classified as node-negative. Relevant paraffin blocks were identified, and 3 additional levels, each 250 mum apart, were cut of all lymph nodes. Isolated tumor cells and micrometastases were defined according to size criteria but additional data and characteristics were recorded. Two slides were made at each level (1 for hematoxylin and eosin, 1 for immunohistochemistry). Results were correlated with survival. RESULTS: One patient was found to have a metastasis (>2 mm), 8 patients (7%) had micrometastases, and 22 patients (18%) had isolated tumor cells. The 5-year survival rates were 60% for patients who remained node-negative, 33% for patients with isolated tumor cells, 40% for patients with micrometastases, and 0 for the patient with a metastasis (P = 0.02). A significant difference was found between node-negative patients versus patients whose lymph nodes contained isolated tumor cells (P = 0.014). Most tumor deposits (71%) were identified on the first additional section. CONCLUSIONS: Our results suggest that isolated tumor cells are as important as micrometastases in determining survival in patients with esophageal cancer. This has important implications in the retrieval and pathologic analysis of lymph nodes.

The effect of long-term control of reflux by fundoplication on aberrant deoxyribonucleic acid methylation in patients with Barrett esophagus.

OBJECTIVE: We investigated the relationship between reflux and aberrant deoxyribonucleic acid (DNA) methylation, comparing methylation in the columnar epithelium following successful fundoplication to that in subjects with a failed fundoplication. SUMMARY BACKGROUND DATA: Gastroesophageal reflux is the main risk factor for Barrett esophagus and adenocarcinoma. In these diseases, there is a high level of DNA methylation. METHODS: We enrolled 41 patients with Barrett esophagus and a fundoplication at least 5 years earlier for a 24-hour pH study, endoscopy, and collection of biopsies. Biopsies were obtained from 17 Barrett esophagus subjects who had not undergone esophageal surgery. RESULTS: At the time of the study, 31 subjects were pH normal, 10 abnormal. Columnar biopsies were collected from 21 of the pH normal and 9 pH abnormal subjects, and all no surgery subjects. Complete regression of columnar mucosa was seen in 7 subjects with pH normal and 1 with pH abnormal. The length of Barrett esophagus did not differ between groups preoperatively, but was significantly less at the time of the study in the pH normal compared with pH abnormal or no surgery groups. Significantly, fewer genes were methylated in the pH normal than the pH abnormal or no surgery groups, which did not differ from each other. The number of methylated genes correlated with increased reflux, intestinal metaplasia, and increased columnar-lined esophagus length, but not acid-suppression medication. CONCLUSIONS: Fundoplication that reduces reflux to normal levels can lead to regression of the columnar mucosa. Reflux is associated with aberrant DNA methylation, and control of reflux reduces deleterious genomic changes associated with cancer.