The Impact of Magnetic Sphincter Augmentation (MSA) on Esophagogastric Junction (EGJ) and Esophageal Body Physiology and Manometric Characteristics.

OBJECTIVE: To evaluate the impact of MSA on lower esophageal sphincter (LES) and esophageal body using high resolution impedance manometry. BACKGROUND: MSA is an effective treatment in patients with gastroesophageal reflux disease, but there is limited data on its impact on esophageal functional physiology. METHODS: Patients who underwent MSA were approached 1-year after surgery for objective foregut testing consists of upper endoscopy, esophagram, high resolution impedance manometry, and esophageal pH-monitoring. Postoperative data were then compared to the preoperative measurements. RESULTS: A total of 100 patients were included in this study. At a mean follow up of 14.9(10.1) months, 72% had normalization of esophageal acid exposure. MSA resulted in an increase in mean LES resting pressure [29.3(12.9) vs 25(12.3), P < 0.001]. This was also true for LES overall length [2.9(0.6) vs 2.6(0.6), P = 0.02] and intra-abdominal length [1.2(0.7) vs 0.8(0.8), P < 0.001]. Outflow resistance at the EGJ increased after MSA as demonstrated by elevation in intrabolus pressure (19.6 vs 13.5 mmHg, P < 0.001) and integrated relaxation pressure (13.5 vs 7.2, P < 0.001). MSA was also associated with an increase in distal esophageal body contraction amplitude [103.8(45.4) vs 94.1(39.1), P = 0.015] and distal contractile integral [2647.1(2064.4) vs 2099.7(1656.1), P < 0.001]. The percent peristalsis and incomplete bolus clearance remained unchanged ( P = 0.47 and 0.08, respectively). CONCLUSIONS: MSA results in improvement in the LES manometric characteristics. Although the device results in an increased outflow resistance at the EGJ, the compensatory increase in the force of esophageal contraction will result in unaltered esophageal peristaltic progression and bolus clearance.

Removal of the magnetic sphincter augmentation device: an assessment of etiology, clinical presentation, and management.

BACKGROUND: Magnetic sphincter augmentation (MSA) erosion, disruption or displacement clearly requires device removal. However, up to 5.5% of patients without anatomical failure require removal for dysphagia or recurrent GERD symptoms. Studies characterizing these patients or their management are limited. We aimed to characterize these patients, compare their outcomes, and determine the necessity for further reflux surgery. METHODS: This is a retrospective review of 777 patients who underwent MSA at our institution between 2013 and 2021. Patients who underwent device removal for persistent dysphagia or recurrent GERD symptoms were included. Demographic, clinical, objective testing, and quality of life data obtained preoperatively, after implantation and following removal were compared between removal for dysphagia and GERD groups. Sub-analyses were performed comparing outcomes with and without an anti-reflux surgery (ARS) at the time of removal. RESULTS: A total of 40 (5.1%) patients underwent device removal, 31 (77.5%) for dysphagia and 9 (22.5%) for GERD. After implantation, dysphagia patients had less heartburn (12.9-vs-77.7%, p = 0.0005) less regurgitation (16.1-vs-55.5%, p = 0.0286), and more pH-normalization (91.7-vs-33.3%, p = 0.0158). Removal without ARS was performed in 5 (55.6%) GERD and 22 (71.0%) dysphagia patients. Removal for dysphagia patients had more complete symptom resolution (63.6-vs-0.0%, p = 0.0159), freedom from PPIs (81.8-vs-0.0%, p = 0.0016) and pH-normalization (77.8-vs-0.0%, p = 0.0455). Patients who underwent removal for dysphagia had comparable symptom resolution (p = 0.6770, freedom from PPI (p = 0.3841) and pH-normalization (p = 0.2534) with or without ARS. Those who refused ARS with removal for GERD had more heartburn (100.0%-vs-25.0%, p = 0.0476), regurgitation (80.0%-vs-0.0%, p = 0.0476) and PPI use (75.0%-vs-0.0%, p = 0.0476). CONCLUSIONS: MSA removal outcomes are dependent on the indication for removal. Removal for dysphagia yields excellent outcomes regardless of anti-reflux surgery. Patients with persistent GERD had worse outcomes on all measures without ARS. We propose a tailored approach to MSA removal-based indication for removal.

Measurement of outflow resistance imposed by magnetic sphincter augmentation: defining normal values and clinical implication.

INTRODUCTION: No manometric criteria have been defined to select patients for magnetic sphincter augmentation (MSA). The first step to establish such criteria is to measure the outflow resistance at esophagogastric junction (EGJ) imposed by MSA. This resistance needs to be overcome by the esophageal contraction in order for the esophagus to empty and to avoid postoperative dysphagia. This study was designed to measure the outflow resistance caused by MSA in patients free of postoperative dysphagia. METHODS: Records of the patients who underwent MSA in our institution were reviewed. A group of MSA patients with excellent functional outcome, who were free of clinically significant postoperative dysphagia, were selected. These patients then underwent high-resolution impedance manometry (HRIM) at a target date of 1 year after surgery. The outflow resistance was measured by the esophageal intrabolus pressure (iBP) recorded 2 cm proximal to the lower esophageal sphincter (LES). RESULTS: The study population consisted of 43 patients. HRIM was performed at mean of 20.4 (10.4) months after surgery. The mean (SD) amplitude of the iBP was 13.5 (4.3) before surgery and increased to 19.1 (5.6) after MSA (p < 0.0001). Patients with a smaller size LINX device (≤ 14 beads) had a similar iBP when compared to those with a larger device (> 15 beads) [19.7 (4.5) vs. 18.4 (5.9), p = 0.35]. There was a significant correlation between the iBP and % incomplete bolus clearance [Spearman R: 0.44 (95% CI 0.15-0.66), p = 0.0032]. The 95th percentile value for iBP after MSA was 30.4 mmHg. CONCLUSION: The EGJ outflow resistance measured by iBP is increased after MSA. The upper limit of normal for iBP is 30 mmHg in this cohort of patients who were free of dysphagia after MSA. This degree of resistance needs to be overcome by distal esophageal contraction and will likely be requisite to prevent persistent postoperative dysphagia.

Workload, Recurrence, Quality of Life and Long-term Efficacy of Endoscopic Therapy for High-grade Dysplasia and Intramucosal Esophageal Adenocarcinoma.

OBJECTIVE: To review the workload, type and frequency of recurrence, long-term quality of life (QOL), and late oncologic outcomes with endoscopic therapy. BACKGROUND: The short-term oncologic efficacy of endoscopic resection (ER) and ablation for patients with high-grade dysplasia (HGD) or intramucosal adenocarcinoma (IMC) is well-established in the literature. METHODS: A retrospective chart review was performed of the initial 40 patients who had endoscopic therapy from 2001 to 2010 at 1 center by 1 physician. RESULTS: Initial pathology was HGD in 22 and IMC in 18 patients, but 9 patients (41%) with HGD progressed to invasive cancer during endotherapy. The median follow-up was 82 months. Four patients had an esophagectomy, and in the remaining 36 patients, 70 ERs and 111 ablations were performed. The median number of endoscopic sessions was 4 in patients with short segment compared with 7 in patients with long-segment Barrett's. Complete resolution of intestinal metaplasia (CRIM) was achieved in 30 patients (83%) at a median of 21 months. In 18 patients (60%), CRIM was maintained, whereas 12 patients developed recurrence at a median of 14 months. Additional endotherapy (n = 11) led to CRIM again in 10 patients (83%). There were no cancer deaths when CRIM was achieved. Overall survival with endotherapy was 73% at 5 years and 67% at 10 years. Quality of life (QOL) was below population means in 4 of 8 areas, but alimentary satisfaction was good after endotherapy. CONCLUSIONS: Endotherapy is successful in most patients, but multiple sessions are usually required and disease progression can occur. Once CRIM is achieved, recurrence is common and mandates continued endoscopic follow-up. QOL is impaired with endotherapy, but alimentary satisfaction and oncologic outcomes support esophageal preservation with endotherapy for patients with HGD or IMC.

Ineffective Esophageal Motility in Patients with GERD is no Contraindication for Nissen Fundoplication.

BACKGROUND: Patients with preoperative ineffective esophageal motility (IEM) are thought to be at increased risk for postoperative dysphagia leading to the recommendations for tailoring or avoiding anti-reflux surgery in these patients. The aim of this study was to evaluate if IEM has an influence on postoperative outcome after laparoscopic Nissen fundoplication (LNF). METHODS: Seventy-two consecutive patients with IEM underwent LNF and were case-matched with 72 patients without IEM based on sex, age, BMI, HH size, total pH percentage time, total number of reflux episodes and the presence of BE. Standardized interview assessing postoperative gastrointestinal symptoms, proton pump inhibitor intake, GERD-health-related-quality-of-life (GERD-HRQL), alimentary satisfaction and patients' overall satisfaction was evaluated. RESULTS: Although a higher rate of preoperative dysphagia was observed in patients with IEM (29% IEM vs. 11% no IEM, p = 0.007), there was no significant difference in rates of dysphagia postoperatively (2 IEM vs. 1 no IEM, p = 0.559). Furthermore, no distinction was found in the postoperative outcome regarding symptom relief, quality of life, gas bloating syndrome, ability to belch and/or vomit or revision surgery between the two groups. CONCLUSION: Although preoperative IEM has an influence on GERD presentation, it has no effect on postoperative outcome after LNF. IEM should not be a cause for avoiding LNF, as is has been shown as the most effective and safe anti-reflux treatment.

Clinical outcome after laparoscopic Nissen fundoplication in patients with GERD and PPI refractory heartburn.

Typical reflux symptoms that respond well to proton pump inhibitor (PPI) therapy are key factors predictive of an excellent outcome with antireflux surgery for gastroesophageal reflux disease (GERD). Our aim was to evaluate whether poor preoperative heartburn (HB) relief with PPIs was associated with a worse outcome after Nissen fundoplication. Patients with a main symptom of HB and a positive pH-test who had a laparoscopic Nissen fundoplication between January 2008 and December 2014 were included. Prior to surgery, patients graded how effectively their HB symptoms were relieved by PPIs. Three groups were defined: good response (76-100% relief), partial response (26-75% relief) and poor response (0-25% relief). Outcomes and satisfaction were assessed at a minimum of 1 year after fundoplication. There were 129 patients who met inclusion criteria and 75 agreed to participate. The median follow-up was 48 months. Prior to Nissen fundoplication 13 patients had a good HB response to PPI-therapy, 36 had a partial response and 26 had a poor response. All patients were satisfied with their HB relief after fundoplication (mean satisfaction score: 9.5/10) and there was no difference in satisfaction score or heartburn relief between groups. Heartburn symptoms that respond poorly to PPI therapy are reliably relieved with a Nissen fundoplication in patients with objectively confirmed GERD. Patient satisfaction after Nissen fundoplication was excellent and was similar in patients with poor versus excellent HB relief with preoperative PPI therapy. Therefore, antireflux surgery is an option for patients with HB and confirmed GERD regardless of the degree of relief of HB symptoms provided by PPI medications.

Persistent dysphagia is a rare problem after laparoscopic Nissen fundoplication.

BACKGROUND: Although around 30% of patients with gastroesophageal reflux disease (GERD) are insufficiently treated with medical therapy, only 1% opt for surgical therapy. One of the reasons behind this multifactorial phenomenon is the described adverse effect of long-term dysphagia or gastric bloating syndrome after surgical treatment. Aim of this study was to evaluate the most common side effects associated with anti-reflux surgery, as well as long-term outcomes in a large cohort of highly surgically standardized patients after laparoscopic Nissen fundoplication (LNF). METHODS: Out of a prospective patients' database including all patients that underwent anti-reflux surgery between 01/2003 and 01/2017 at our institution, 350 consecutive patients after highly standardized LNF were included in this study. A standardized interview was performed by one physician assessing postoperative gastrointestinal symptoms, proton pump inhibitor intake (PPI), GERD-Health-Related-Quality-of-Life (GERD-HRQL), Alimentary Satisfaction (AS), and patients' overall satisfaction. RESULTS: After a median follow-up of 4 years, persistent dysphagia (PD) after LNF was observed in 8 (2%) patients, while postoperative gas-bloat syndrome in 45 (12.7%) cases. Endoscopic dilatation was needed in 7 (2%) patients due to dysphagia, and 19 (5%) patients underwent revision surgery due to recurrence of GERD. The postoperative GERD-HRQL total score was significantly reduced (2 (IQR 0-4.3) vs. 19 (IQR 17-32); p < 0.000) and the median AS was 9/10. Heartburn relief was achieved in 83% of patients. Eighty-three percent of patients were free of PPI intake after follow-up, whereas 13% and 4% of the patients reported daily and irregular PPI use, respectively. CONCLUSION: LNF is a safe and effective surgical procedure with low postoperative morbidity rates and efficient GERD-related symptom relief. PD does not represent a relevant clinical issue when LNF is performed in a surgical standardized way. These results should be the benchmark to which long-term outcomes of new surgical anti-reflux procedures are compared.

Hiatal hernia recurrence following magnetic sphincter augmentation and posterior cruroplasty: intermediate-term outcomes.

BACKGROUND: We have previously reported short-term outcomes after hiatal hernia repair (HHR) at the time of magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease (GERD). Here we report intermediate-term outcomes and hernia recurrence rate after concomitant MSA and HHR. METHODS: This is a retrospective cohort study of patients who underwent repair of a hiatal hernia 3 cm or larger at the time of MSA implantation between May 2009 and December 2015. The primary endpoint was hiatal hernia recurrence identified by routine postoperative videoesophagography or endoscopy. Recurrence was defined by a 2 cm or greater upward displacement of the stomach through the diaphragmatic esophageal hiatus. Secondary endpoints included cessation of proton-pump inhibitor (PPI), persistent dysphagia requiring intervention, and GERD health-related quality-of-life (HRQL) scores 1 year from surgery. RESULTS: During the study period, 47 of 53 (89%) patients underwent concomitant MSA with HHR and complied with surveillance. Hiatal hernias ranged from 3 to 7 cm (mean 4 ± 1). Mean clinical follow-up time was 19 months (range 1-39). GERD-HRQL score decreased from 20.3 to 3.1 (p < .001), 89% of patients remained off PPIs, and 97% of patients reported improvement or resolution of symptoms. Two recurrent hiatal hernias were identified on surveillance imaging for a recurrence rate of 4.3% at a mean 18 (± 10) months after initial operation. Persistent dysphagia occurred in 13% (6/47) over the first year, which resolved after a single balloon dilation in 67% (4/6). Two patients elected for device removal due to dilation-refractory dysphagia and persistent reflux symptoms. CONCLUSION: Concomitant magnetic sphincter augmentation and hiatal hernia repair in patients with gastroesophageal reflux disease and a moderate-sized hiatal hernia demonstrates durable subjective reflux control and an acceptable hiatal hernia recurrence rate at 1- to 2-year follow-up.

Results of Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease.

BACKGROUND: Magnetic sphincter augmentation (MSA) is a modern treatment option for gastroesophageal reflux disease (GERD); however, laparoscopic fundoplication remains the gold standard. The aim of the study was to evaluate outcomes of MSA patients at a reflux center. METHODS: A retrospective review was performed of all patients that underwent MSA between March 2012 and November 2017. Out of 110 patients, 68 with a follow-up >3 months were included. Postoperative gastrointestinal symptoms, proton pump inhibitor (PPI) intake, GERD-Health-related Quality of Life (GERD-HRQL) and alimentary satisfaction (AS) were assessed. Postoperative esophageal functioning tests were performed in 50% of patients. RESULTS: Sixty-eight patients underwent MSA; hiatal repair was performed in 31 cases. The median OR time was 27 min, and no intraoperative complications occurred. The median follow-up was 13 months (IQR 4.2-45). Endoscopic dilatation was performed in 2 patients (3%) and device removal in another 2 cases. The postoperative GERD-HRQL score was significantly reduced (3 vs. 24; p < 0.001) and the median AS was 8/10. Preoperative experienced heartburn, regurgitations and dysphagia were eliminated in 92, 96 and 100%. Postoperative new-onset difficulties swallowing with solids only were reported to occur occasionally by 16% and rarely by 21% of patients. Satisfaction with heartburn relief was 95%, and the overall outcome was rated excellent/good in 89%. PPI dependency was eliminated in 87%. The median total percentage pH < 4 and number of reflux episodes were significantly reduced. Postoperative pH results were negative or slightly above the norm in 79% and 12%, respectively. CONCLUSION: Sphincter augmentation results in significantly reduced reflux symptoms, increased GERD-specific Quality of Life and excellent alimentary satisfaction with low perioperative morbidity. This procedure should be considered an excellent alternative to fundoplication in the treatment of GERD.

Radiofrequency ablation in patients with large cervical heterotopic gastric mucosa and globus sensation: Closing the treatment gap.

BACKGROUND AND AIM: Symptomatic cervical heterotopic gastric mucosa, also known as cervical inlet patch (CIP), may present in various shapes and causes laryngopharyngeal reflux (LPR). Unfortunately, argon plasma coagulation, standard treatment of small symptomatic CIP, is limited in large CIP mainly because of concerns of stricture formation. Therefore, we aimed to investigate radiofrequency ablation (RFA), a novel minimally invasive ablation method, in the treatment of CIP focusing on large symptomatic patches. METHODS: Consecutive patients with macroscopic and histological evidence of large (≥20 mm diameter) heterotopic gastric mucosa were included in this prospective trial. Primary outcome was complete macroscopic and histological eradication rate of CIP. Secondary outcome measures were symptom improvement, quality of life, severity of LPR and adverse events. RESULTS: Ten patients (females, n = 5) underwent RFA of symptomatic CIP. Complete histological and macroscopic eradication of CIP was observed in 80% (females, n = 4) of individuals after two ablations. Globus sensations significantly improved from median visual analog scale score 8 (5-9) at baseline to 1.5 (1-7) after first ablation and 1 (1-2) after final evaluation (P < 0.001). Mental health scores significantly increased from 41.4 (± 8.5) to 54.4 (± 4.4) after RFA (P = 0.007). LPR improved significantly (P = 0.005) with absence of strictures after a mean follow up of 1.9 (± 0.5) years. CONCLUSIONS: This is the first study on RFA focusing on therapy of large symptomatic heterotopic gastric mucosa. Hereby, we demonstrate that this new technique can be successfully implemented in patients where treatment was limited so far (NCT03023280).

Electrical Stimulation of the Lower Esophageal Sphincter to Treat Gastroesophageal Reflux After POEM.

As per-oral endoscopic myotomy (POEM) is not followed by any anti-reflux procedure, a common concern is the risk of postoperative gastro-esophageal reflux disease (GERD). Electrical stimulation of the lower esophageal sphincter (LES-EST) could be an option for post-POEM GERD. A 68-year old male obese patient underwent successful POEM but developed GERD not responsive to proton pump inhibitors. Consecutively, the patient had implanted an electrical LES stimulation device, consisting of bipolar LES-electrodes connected to a subcutaneous pulse generator. POEM reduced the Eckardt score (9 vs. 0), the LES resting pressure (52.0 vs. 16.4 mmHg), and the Integrated Relaxation Pressure (62.0 vs. 10.0 mmHg). LES-EST substantially reduced post-POEM GERD symptoms. GERD-HRQL scores indicated the elimination of heartburn (26 vs. 7) and regurgitation (24 vs. 3) at three months. A reduced total number refluxes (82 vs. 14) was observed. The %-time of pH below 4 was only slightly reduced (8.6% to 6.2%).LES-EST appears to be a feasible option to symptomatically treat post-POEM GERD for patients not ideal for conventional anti-reflux surgery.

Outcome with Primary En-bloc Esophagectomy for Submucosal Esophageal Adenocarcinoma.

BACKGROUND: Intramucosal esophageal adenocarcinoma can be reliably treated endoscopically. Controversy exists about the use of endotherapy versus esophagectomy for submucosal tumors. Increasingly endotherapy is considered for submucosal tumors in part because of the presumed high mortality with esophagectomy and the perceived poor prognosis in patients with nodal disease. This study was designed to assess survival following primary en bloc esophagectomy (EBE) in patients with submucosal esophageal adenocarcinoma (EAC). METHODS: This is a retrospective review of all patients who underwent EBE for submucosal EAC between 1998 and 2015. No patient had neoadjuvant therapy. RESULTS: There were 32 patients (28M/4F; median age 64 years). The median tumor size was 1.5 cm (0.4-8.0), and the median number of resected nodes was 48 (23-85). There was one perioperative death. Lymph node metastases were present in 7 patients (22%). There was one involved node in four patients and 2, 3, and 31 nodes in one patient each. The one N3 patient received adjuvant therapy. The median follow-up was 87 months. Overall survival at 5 and 10 years was 84 and 70% respectively. Disease-specific survival at 10 years was 90%. Eight patients died, but only three deaths (9%) were related to EAC. Disease-specific survival at 10 years in node-positive patients was 71%. CONCLUSIONS: Survival after primary en bloc esophagectomy for submucosal adenocarcinoma was excellent even in node-positive patients. Mortality with esophagectomy was low and far less than the 22% risk of node metastases in patients with submucosal tumor invasion. Esophagectomy should remain the preferred treatment for T1b esophageal adenocarcinoma.

Gastric cancer in the young: An advanced disease with poor prognostic features.

BACKGROUND AND OBJECTIVES: Gastric cancer in young patients is rare. We analyzed the clinicopathological features and prognosis of early-onset gastric carcinoma. METHODS: We retrospectively reviewed patients with gastric adenocarcinoma aged ≤45 years and >45 years at our institution over a 17-year period. Clinicopathological features were compared and survival analysis was performed using Kaplan-Meier curves. RESULTS: A total of 121 patients with gastric carcinoma aged ≤45 years were identified. The young group (YG) had a higher incidence of stage III/IV disease (86.8% vs. 57.9%, P < 0.001), poorly-differentiated carcinoma (95.9% vs. 74.4%, P < 0.001), and signet-cell type tumor (88.4% vs. 32.2%, P < 0.001) relative to the older group (OG). The majority of tumors were in the middle third of the stomach in both groups (P = 0.108). Three-year survival in the YG was 87.1%, 32.2%, and 6.9% in stage I/II, III, and IV disease, respectively. Surgical intervention in young patients with advanced carcinoma was not associated with improved survival. Although median survival was shorter in the YG compared to the OG (11.7 vs. 41.0 months, P < 0.001), stage-specific survival was similar. CONCLUSION: Early-onset gastric cancer demonstrates advanced stage of disease, and a high incidence of poorly-differentiated and signet-cell type carcinoma. Overall survival is poor with no added benefit to surgical intervention in advanced disease.

Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias.

BACKGROUND: Magnetic sphincter augmentation (MSA) has demonstrated long-term safety and efficacy in the treatment of patients with gastroesophageal reflux (GERD), but its efficacy in patients with large hiatal hernias has yet to be proven. The aim of our study was to assess outcomes of MSA in patients with hiatal hernias ≥3 cm. METHODS: We retrospectively reviewed all patients who underwent MSA at our institutions over a 6-year period. Information obtained consisted of patient demographics, symptoms of GERD, preoperative GERD Health-Related Quality-of-Life (HRQL) scores, perioperative details, and implantation of the MSA device. Primary endpoints included postoperative GERD-HRQL scores, proton-pump inhibitor (PPI) use, symptom change, and procedure-related complications. A large hiatal hernia was defined as a hernia measuring ≥3 cm by intraoperative measurement. RESULTS: A total of 192 patients were reviewed. Median follow-up was 20 months (3-75 months). Mean GERD-HRQL scores in the overall population before and after MSA were 18.9 and 5.0, respectively (p < 0.001). In the majority of patients symptoms improved or resolved (N = 177, p < 0.001). Fifty-two patients (27.0 %) had a hiatal hernia ≥3 cm (range 3-7 cm). Their mean GERD-HRQL score decreased from 20.5 to 3.6 (p < 0.001) following MSA. When compared to patients with smaller hernias, patients with large hiatal hernias had decreased postoperative PPI requirement (9.6 vs. 26.6 %, p = 0.011) and lower mean postoperative GERD-HRQL scores (3.6 vs. 5.6, p = 0.027). The percent of patients requiring postoperative intervention for dysphagia was similar (13.5 vs. 17.9 %, p = 0.522), as was the incidence of symptom resolution or improvement (98.1 vs. 91.3 %, p = 0.118). CONCLUSION: MSA in patients with large hiatal hernias demonstrates decreased postoperative PPI requirement and mean GERD-HRQL scores compared to patients with smaller hernias. The incidence of symptom resolution or improvement and the percentage of patients requiring intervention for dysphagia are similar. Short-term outcomes of MSA are encouraging in patients with gastroesophageal reflux disease and large hiatal hernias.

Trabectedin in patients with metastatic soft tissue sarcoma: a retrospective single center analysis.

The aim of this study was to retrospectively evaluate the efficacy and safety of trabectedin treatment in patients with metastatic soft tissue sarcoma (STS) in the routine clinical setting. Further, the type and frequency of systemic treatments before commencing treatment with trabectedin and after its discontinuation, as well as the frequency of pulmonary metastasectomies, were analyzed. The current analysis includes retrospective data from consecutive STS patients treated with trabectedin at the Department of Medicine I, Division of Oncology, Medical University of Vienna, between January 2008 and December 2012. Patients were analyzed for median progression-free survival, overall survival (OS), and therapy-related toxicity. Data of 60 STS patients were included in the present analysis. In total, 198 cycles of trabectedin were administered, whereas the median number of cycles administered per patient was two (range 1-25). The median progression-free survival was 2.2 months and the median OS (mOS) was 11.8 months. mOS calculated from the first time point of detection of metastatic disease was 35.8 months. The 18 patients (30%) who underwent pulmonary metastasectomy had an mOS of 50.2 months. Further, trabectedin had a manageable toxicity profile comparable to data reported in previous phase II trials. Our findings support the use of trabectedin as an active and feasible therapeutic option among advanced, metastatic, and refractory STS patients. The good safety profile and lack of cumulative toxicity allow prolonged administration in highly pretreated patients. As visible from the present data, a considerable percentage of patients with advanced/metastatic STS benefit from sequential lines of drug therapy as well as pulmonary metastasectomy.

The prevalence of hemorrhoids in adults.

INTRODUCTION: Exact data on the prevalence of hemorrhoids are rare. Therefore, we designed a study to investigate the prevalence of hemorrhoids and associated risk factors in an adult general population. METHODS: Between 2008 and 2009, consecutive patients were included in a prospective study. They attended the Austrian national wide health care program for colorectal cancer screening at four medical institutions. A flexible colonoscopy and detailed examination were conducted in all patients. Hemorrhoids were defined according to a standardized grading system. Independent variables included baseline characteristics, sociodemographic data, and health status. Potential risk factors were calculated by univariate and multivariate analysis. RESULTS: Of 976 participants, 380 patients (38.93%) suffered from hemorrhoids. In 277 patients (72.89%), hemorrhoids were classified as grade I, in 70 patients (18.42%) as grade II, in 31 patients (8.16%) as grade III, and in 2 patients (0.53%) as grade IV. One hundred seventy patients (44.74%) complained about symptoms associated with hemorrhoids, whereas 210 patients (55.26%) reported no symptoms. In the univariate and multivariate analysis, body mass index (BMI) had a significant effect on the occurrence of hemorrhoids with p = 0.0391 and p = 0.0282, respectively. Even when correcting for other potential risk factors, an increase in the BMI of one increased the risk of hemorrhoids by 3.5%. CONCLUSION: Hemorrhoids occur frequently in the adult general population. Notably, a considerable number of people with hemorrhoids do not complain about symptoms. In addition, a high BMI can be regarded as an independent risk factor for hemorrhoids.

Determinants for postoperative complications after laparoscopic intestinal resection for Crohn's disease.

BACKGROUND: There is lack of studies that define parameters predictive of complications following laparoscopic resection for Crohn's disease. METHODS: Between 1998 and 2008, 182 patients underwent laparoscopic intestinal resection for Crohn's disease at a single institution. Conversion occurred in 12 patients (6.6%). We aimed to identify risk factors for short-term postoperative complications (<30 days) by using univariate and multiple regression tests. Complications were defined according to the Clavien-Dindo classification (grades I-V). Data were obtained from an institutional database and individual chart review retrospectively. RESULTS: There were 25 (13.7%) complications after surgery. According to the Clavien-Dindo classification, complications were classified as grade I in 9 patients, grade II in 9 patients, and grade IIIb in 7 patients. There were no deaths after laparoscopic surgery. A low level of hemoglobin after surgery (r (s )= -0.15, P = 0.0441) and an elevated CRP before surgery (r (s )= -0.16, P = 0.0346) seemed to increase the likelihood of postoperative complications. CONCLUSION: Laparoscopic surgery can be performed safely in Crohn's disease patients. An increased inflammation process before operation seems to be associated an eventful postoperative course.

Esophagitis dissecans superficialis (EDS) secondary to esophagogastric junction outflow obstruction (EGJOO): a case report and literature review.

Esophageal dissecans superficialis (EDS) is a rare disease with endoscopic findings of sloughing squamous tissue with underlying normal mucosa and had no known cause. The literature does support possible causality between the presence of an esophageal stricture and EDS however there has been no association to date between EDS and esophagogastric junction outflow obstruction (EGJOO). We present a case of newly diagnosed EGJOO in a patient with long standing gastroesophageal reflux disease who presented with dysphagia. Evaluation identified endoscopically normal mucosa and a diagnosis of esophagogastric junction outflow obstruction on high resolution impedance manometry. A month later, repeat endoscopy identified diffusely sloughing mucosa consistent with EDS. Endoscopic dilation followed by a robotic Heller myotomy with Dor fundoplication to relive the outflow obstruction resulted in resolution of EDS in this case.

Esophageal Squamous Cell Carcinoma After Radiofrequency Catheter Ablation Thermal Injury.

Radiofrequency ablation is a common treatment for atrial fibrillation, and esophageal complications are exceedingly rare. This report describes the case of a patient with no other known cancer risk factors who had esophageal squamous cell carcinoma that developed at the site of esophageal thermal injury, which occurred during a radiofrequency catheter ablation procedure.

Efficacy of Magnetic Sphincter Augmentation Across the Spectrum of GERD Disease Severity.

BACKGROUND: The performance and durability of various types of fundoplication are variable when stratified by disease severity. To date, magnetic sphincter augmentation (MSA) has not been evaluated in this context. We designed this study to determine the efficacy of MSA in the treatment of severe GERD. STUDY DESIGN: Guided by previous studies, a DeMeester score (DMS) ≥ 50 was used as a cutoff point to define severe reflux disease. Subjects were divided into 2 groups using this cutoff, and outcomes of severe cases were compared with those with less severe disease (DMS < 50). RESULTS: A total of 334 patients underwent MSA. Patients with severe disease had a higher mean preoperative DMS compared with those with mild to moderate GERD (79.2 [53.2] vs 22.8 [13.7], p < 0.0001). At a mean postoperative follow-up of 13.6 (10.4) months, there was no difference between the mean GERD Health-Related Quality of Life (HRQL) total scores in patients with severe disease compared with those with less severe GERD (8.8 [10] vs 9.2 [10.8], p = 0.9204). Postoperative mean DMS was not different between groups (17.3[23.0] vs 14.1[33.9], p = 0.71), and there was no difference in the prevalence of esophagitis (p = 0.52). Patients with severe disease were less likely to be free from use of proton pump inhibitors after surgery (85% vs 93.1%, p = 0.041). There were similar rates of postoperative dysphagia (10% vs 14%, p = 0.42) and need for device removal (3% vs 5%, p = 0.7463). CONCLUSIONS: MSA is an effective treatment in patients with severe GERD and leads to significant clinical improvement across the spectrum of disease severity, with few objective outcomes being superior in patients with mild-to-moderate reflux disease.