Dynamic Profiling of the Immune Tumor Microenvironment in Locally Advanced Gastric Cancer Treated with Perioperative Chemotherapy.

INTRODUCTION: In locally advanced gastric cancer (GC), FLOT represents the standard perioperative regimen and combination with immunotherapy is under investigation. However, the role of immune tumor microenvironment (TME) is poorly recognized in this setting. We aimed to study TME characteristics and dynamics during FLOT. METHODS: Paired biopsy (PRE) and surgical (POST) samples of 25 patients treated with FLOT were prospectively analyzed. After collection of clinic-pathological data, NanoString analyses were performed. The primary objective of the study was to assess the changes induced by chemotherapy in POST compared to PRE samples. RESULTS: The unsupervised hierarchical method analysis clearly distinguished PRE and POST samples, even though some cases showed high immune gene expression at baseline. When POST samples were compared with PRE, a differential expression in hyper-expressed gene sets related to cytotoxicity, T-cell functions, complement system, tumor necrosis factor superfamily, cell cycle, and regulation was recognized. Downstaging of the primary tumor (T-regression, measured by pathologic compared to clinical T stage) was the covariate most frequently associated with these changes. Using the immune cell profiling, cases with T-regression reported a significant increase of T, CD8+ T and B cells and a decrease in mast cells, while nonresponders demonstrated an increase of T, B, cytotoxic, and mast cells. CONCLUSION: Our analysis shows that FLOT significantly influences immune TME of GC. While relevant modifications preferentially occur in tumors showing primary tumor regression, response to treatment seems to be associated with a specific immune profile.

Impact of COVID-19 outbreak on esophageal cancer surgery in Northern Italy: lessons learned from a multicentric snapshot.

Coronavirus Disease-19 (COVID-19) outbreak has significantly burdened healthcare systems worldwide, leading to reorganization of healthcare services and reallocation of resources. The Italian Society for Study of Esophageal Diseases (SISME) conducted a national survey to evaluate changes in esophageal cancer management in a region severely struck by COVID-19 pandemic. A web-based questionnaire (26 items) was sent to 12 SISME units. Short-term outcomes of esophageal resections performed during the lockdown were compared with those achieved in the same period of 2019. Six (50%) centers had significant restrictions in their activity. However, overall number of resections did not decrease compared to 2019, while a higher rate of open esophageal resections was observed (40 vs. 21.7%; P = 0.034). Surgery was delayed in 24 (36.9%) patients in 6 (50%) centers, mostly due to shortage of anesthesiologists, and occupation of intensive care unit beds from intubated COVID-19 patients. Indications for neoadjuvant chemo (radio) therapy were extended in 14% of patients. Separate COVID-19 hospital pathways were active in 11 (91.7%) units. COVID-19 screening protocols included nasopharyngeal swab in 91.7%, chest computed tomography scan in 8.3% and selective use of lung ultrasound in 75% of units. Postoperative interstitial pneumonia occurred in 1 (1.5%) patient. Recovery from COVID-19 pandemic was characterized by screening of patients in all units, and follow-up outpatient visits in only 33% of units. This survey shows that clinical strategies differed considerably among the 12 SISME centers. Evidence-based guidelines are needed to support the surgical esophageal community and to standardize clinical practice in case of further pandemics.

Immune Checkpoint Inhibitors in Esophageal Cancers: are we Finally Finding the Right Path in the Mist?

Esophageal cancer remains a challenging disease due to limited treatment options and poor prognosis. In recent years, immune checkpoint inhibitors (ICI) have been proven to be safe and effective in the treatment of highly lethal malignancies, such as non-small cell lung cancer and melanoma. Recent clinical trials also showed promising activity in immune checkpoint inhibitors in pretreated advanced esophageal carcinoma and a potentially significant impact on the outcome of selected patients, independently of histology. Combination studies evaluating immunotherapy and chemotherapy and, in localized disease, radiotherapy are in progress and will hopefully confirm their promises in the near future. However, reliable predictive biomarkers are still lacking. Indeed, at present, the role of programmed cell death ligand 1 expression and other factors (such as microsatellite instability and tumor mutational burden) as predictive biomarkers of benefit to immune checkpoint inhibitors is still controversial. Our aim was to explore the rationale of ICIs in esophageal cancer, review the results already available in multiple settings, and investigate future perspectives with single-agent and combination strategies.

Giant fibrovascular polyp of the esophagus-imaging techniques for proper treatment planning: report of two cases.

Giant fibrovascular polyps of the esophagus are rare, benign mesenchymal intraluminal lesions that arise from the cervical esophagus and can reach a very large size. Surgical excision is the treatment of choice, since endoscopic removal alone is not always feasible due to the presence of a very much vascularized stalk in most cases. We present two archetypal cases emphasizing the fact that these lesions can grow to huge masses with various and bizarre clinical presentation and they can arise (although rarely) at the level of the hypopharynx. We also aim to point out the role of imaging in defining the exact origin and characteristics of the stalk (width, vascularization) and the polyp structure (tissue components), thus providing useful information for planning the most appropriate surgical approach.

Robotic Heller-Dor for Idiopathic Achalasia: the Pisa experience.

Achalasia is a rare motility disorder of the esophagus. According to the Chicago Classification criteria, there are three clinical types of Achalasia and the treatment is patient-tailored. Laparoscopic Heller-Dor is the gold-standard treatment for the most frequent types of Achalasia. However, robotic surgery is able to combine the clinical advantages of minimally invasive surgery with a powerful dexterity on complex anatomic structures. The aim of this study is to report the institutional experience developed in a referral center of esophageal surgery in the treatment of Achalasia by Robotic Heller-Dor. We retrospectively analyzed data of patients that consecutively underwent Robotic Heller-Dor at our institution between January 2012 and January 2020 using the Da Vinci® Surgical System. Sixty-nine patients underwent Robotic Heller-Dor. Among the patients, 35 (51%) were classified as type I, 29 (42%) as type II, and 5 (7%) as type III. The Da Vinci® SI HD Surgical System and the Da Vinci® XI HD Surgical System were used in 56 (81%) and 13 (19%) patients, respectively. No mucosal perforation was observed and post-operative mortality was absent. The mean follow-up was 23.3 months (6-84). Ten patients (14.5%) reported post-operative complaints. In our opinion, Robotic Heller-Dor is an effective tool in the treatment of Achalasia. Robotic Heller-Dor may be a suitable procedure for learning and teaching robotic surgery in the perspective of pursing more complex esophago-gastric surgical procedures.

Upper GI training of young surgeons: a reality full of hurdles. An international survey.

OBJECTIVE: Anecdotal evidence suggests that the training of young surgeons in Upper GI is not homogeneous across the world. This survey aimed to investigate the different training programs and the level of satisfaction of young surgeons with their surgical and scientific education pathway. DESIGN: A multiple-choice and single best answer format questionnaire was sent to 36 Upper GI chairs from international referral centres and then forwarded to young surgeons (attending physician less than 40 years old). The same questionnaire containing 5 main topics (demographics, residency, fellowship, academic research and activities, manual skill improvement) was posted online on a Surveymonkey website. SETTING: San Luigi University Hospital, Orbassano (Turin), Italy; Tertiary University Hospital. RESULTS: Fourteen replies were received from colleagues in 36 referral centres (39% response rate) and 65 voluntary answers from the survey monkey platform. During residency training, only 43% of residents had a specific training in upper GI tract surgery, which was characterized by a small number of interventions performed both with trainer scrubbed and unscrubbed. Fellowship programmes were undertaken by 49% of participants and 64% spent this training period abroad. Operative experience was reported by nearly all respondents with only 27% performing > 10 gastrectomies and only 11% performing > 10 oesophagectomies with the trainer scrubbed. The majority attended less than 10 meetings (58%), and 70% of them published less than 5 papers. CONCLUSIONS: The present survey reveals that the young surgeons of the twenty-first century face many hurdles during their surgical training. Overall, the surgical education settings are limited for both practical and scientific training for upper GI trainees. As a result, it is not possible to train in upper GI surgery to a level of competent independent practice.

Preoperative or Perioperative Docetaxel, Oxaliplatin, and Capecitabine (GASTRODOC Regimen) in Patients with Locally-Advanced Resectable Gastric Cancer: A Randomized Phase-II Trial.

Docetaxel associated with oxaliplatin and 5-fluorouracil (FLOT) has been reported as the best perioperative treatment for gastric cancer. However, there is still some debate about the most appropriate number and timing of chemotherapy cycles. In this randomized multicenter phase II study, patients with resectable gastric cancer were staged through laparoscopy and peritoneal lavage cytology, and randomly assigned (1:1) to either four cycles of neoadjuvant chemotherapy (arm A) or two preoperative + two postoperative cycles of docetaxel, oxaliplatin, and capecitabine (DOC) chemotherapy (arm B). The primary endpoint was to assess the percentage of patients receiving all the planned preoperative or perioperative chemotherapeutic cycles. Ninety-one patients were enrolled between September 2010 and August 2016. The treatment was well tolerated in both arms. Thirty-three (71.7%) and 24 (53.3%) patients completed the planned cycles in arms A and B, respectively (p = 0.066), reporting an odds ratio for early interruption of treatment of 0.45 (95% confidence interval (CI): 0.18-1.07). Resection was curative in 39 (88.6%) arm A patients and 35 (83.3%) arm B patients. Five-year progression-free survival (PFS) was 51.2% (95% CI: 34.2-65.8) in arm A and 40.3% (95% CI: 28.9-55.2) in arm B (p = 0.300). Five-year survival was 58.5% (95% CI: 41.3-72.2) and 53.9% (95% CI: 35.5-69.3) (p = 0.883) in arms A and B, respectively. The planned treatment was more frequently completed and was more active, albeit not significantly, in the neoadjuvant arm than in the perioperative group.

Incidence and treatment of mediastinal leakage after esophagectomy: Insights from the multicenter study on mediastinal leaks.

BACKGROUND: Mediastinal leakage (ML) is one of the most feared complications of esophagectomy. A standard strategy for its diagnosis and treatment has been difficult to establish because of the great variability in their incidence and mortality rates reported in the existing series. AIM: To assess the incidence, predictive factors, treatment, and associated mortality rate of mediastinal leakage using the standardized definition of mediastinal leaks recently proposed by the Esophagectomy Complications Consensus Group (ECCG). METHODS: Seven Italian surgical centers (five high-volume, two low-volume) affiliated with the Italian Society for the Study of Esophageal Diseases designed and implemented a retrospective study including all esophagectomies (n = 501) with intrathoracic esophagogastric anastomosis performed from 2014 to 2017. Anastomotic MLs were defined according to the classification recently proposed by the ECCG. RESULTS: Fifty-nine cases of ML were recorded, yielding an overall incidence of 11.8% (95%CI: 9.1%-14.9%). The surgical approach significantly influenced the occurrence of ML: the proportion of leakage was 10.5% and 9% after open and hybrid esophagectomy (HE), respectively, and doubled (20%) after totally minimally invasive esophagectomy (TMIE) (P = 0.016). No other predictive factors were found. The 30- and 90-d overall mortality rates were 1.4% and 3.2%, respectively; the 30- and 90-d leak-related mortality rates were 5.1% and 10.2%, respectively; the 90-d mortality rates for TMIE and HE were 5.9% and 1.8%, respectively. Endoscopy was the first-line treatment in 49% of ML cases, with the need for retreatment in 17.2% of cases. Surgery was needed in 44.1% of ML cases. Endoscopic treatment had the lowest mortality rate (6.9%). Removal of the gastric tube with stoma formation was necessary in 8 (13.6%) cases. CONCLUSION: The incidence of ML after esophagectomy was high mainly in the TMIE group. However, the general and specific (leak-related) mortality rates were low. Early treatment (surgical or endoscopic) of severe leaks is mandatory to limit related mortality.

EGFR and AKT1 overexpression are mutually exclusive and associated with a poor survival in resected gastric adenocarcinomas.

PURPOSE: The evaluation of molecular targets in gastric cancer has demonstrated the predictive role of HER2 amplification for trastuzumab treatment in metastatic gastric cancer. Besides HER2, other molecular targets are under evaluation in metastatic gastric tumors. However, very little is known about their role in resected tumors. We evaluated the expression of HER2, EGFR, MET, AKT1 and phospho-mTOR in resected stage II-III adenocarcinomas. METHODS: Ninety-two patients with resected stomach (63%) or gastro-esophageal adenocarcinomas (27%) were evaluated. Antibodies anti-HER2, EGFR, MET, AKT1 and phospho-mTOR were used for immunostaining of formalin-fixed paraffin-embedded slides. Using FISH, HER2 amplification was evaluated in cases with an intermediate (+2) staining. RESULTS: EGFR overexpression (11%) was a poor prognostic factor for overall survival (3-year OS: 47% vs 77%; Log-Rank p= 0.033). MET overexpression (36%) was associated with a trend for a worse survival (3-year OS: 65% vs 77%; Log-Rank p= 0.084). HER2 amplification/overexpression and mTOR hyper-phosphorylation were observed in 13% and 48% of tumors, respectively. AKT1 overexpression (8%) was not a prognostic factor by itself (p= 0.234). AKT1 and EGFR overexpression was mutually exclusive and patients with EGFR or AKT1 overexpression experienced a poor prognosis (3-year OS: 52% vs. 79%, Log-Rank p= 0.005). CONCLUSIONS: EGFR is confirmed a poor prognostic factor in resected gastric cancers. We firstly describe a mutually exclusive overexpression of EGFR and AKT1 with potential prognostic implications, suggesting the relevance of this pathway for the growth of gastric cancers.

Prognostic Significance of 2-Deoxy-2-[18F]-Fluoro-D-Glucose PET/CT in Patients With Locally Advanced Esophageal Cancer Undergoing Neoadjuvant Chemoradiotherapy Before Surgery: A Nonparametric Approach.

To investigate the prognostic value of tumor metabolism measurements on serial 2-deoxy-2-[18F]fluoro-D-glucose positron emission tomography and computed tomography scans in patients with locally advanced esophageal cancer undergoing neoadjuvant chemoradiotherapy. Forty-five patients (63 ±â€Š7 years, 6 female) treated with concomitant chemoradiotherapy before surgery were followed up for 24 ±â€Š18 months (range 4-71). Positron emission tomography and computed tomography scans were obtained within 1 week before the start (PET1) and 1 month after the completion of the treatment (PET2). Total body tumor metabolic activity was measured as the sum of the parameters: SUVmax, SUV corrected for lean body mass, and total lesion glycolysis (TLG40/50/70%). Then, delta values for the parameters between PET1 and PET2 were calculated and expressed as percentage of PET1 results. At the time of the analysis, 27 patients were dead and 18 were alive. There was no difference between the 2 groups in terms of age, sex, site of the disease, histology, and the presence/absence of linfonodal metastases (P = NS). Survival random forest analysis (20,000 trees) resulted in an estimate of error rate of 36%. The nonparametric approach identified ΔTLG40 as the most predictive factor of survival (relative importance 100%). Moreover, T (17%), N (5%), and M (5%) stage of the disease, cancer histology (11%), TLG70 (5%) at the end of chemioradioterapy, and ΔTLG(50-70) (17%-5%) were positively associated with patient outcome. The nonparametric analysis confirmed the prognostic importance of some clinical parameters, such as TNM stage and cancer histology. Moreover, ΔTLG resulted to be the most important factor in predicting outcome and should be considered in risk stratification of patients treated with neoadjuvant chemoradiotherapy.

Surgery or Peroral Esophageal Myotomy for Achalasia: A Systematic Review and Meta-Analysis.

To date very few studies with small sample size have compared peroral esophageal myotomy (POEM) with the current surgical standard of care, laparoscopic Heller myotomy (LHM), in terms of efficacy and safety, and no recommendations have been proposed.To investigate the efficacy and safety of POEM compared with LHM, for the treatment of achalasia.The databases of Pubmed, Medline, Cochrane, and Ovid were systematically searched between January 1, 2005 and January 31, 2015, with the medical subject headings (MeSH) and keywords "achalasia," "POEM," "per oral endoscopic myotomy," and "peroral endoscopic myotomy," "laparoscopic Heller myotomy" (LHM), "Heller myotomy."All types of study designs including adult patients with diagnosis of achalasia were selected. Studies that did not report the comparison between endoscopic and surgical treatment, experimental studies in animal models, single case reports, technical reports, reviews, abstracts, and editorials were excluded.The total number of included patients was 486 (196 in POEM group and 290 in LHM group).There were no differences between POEM and LHM in reduction in Eckardt score (MD = -0.659, 95% CI: -1.70 to 0.38, P = 0.217), operative time (MD = -0.354, 95% CI: -1.12 to 0.41, P = 0.36), postoperative pain scores (MD = -1.86, 95% CI: -5.17 to 1.44, P = 0.268), analgesic requirements (MD = -0.74, 95% CI: -2.65 to 1.16, P = 0.445), and complications (OR = 1.11, 95% CI: 0.5-2.44, P = 0.796). Length of hospital stay was significantly lower for POEM (MD = -0.629, 95% CI: -1.256 to -0.002, P = 0.049). There was a trend toward significant reduction in symptomatic gastroesophageal reflux rate in favors of LHM compared to POEM group (OR = 1.81, 95% CI: 1.11-2.95, P = 0.017).All included studied were not randomized. Furthermore all selected studies did not report the results of follow-up longer than 1 year and most of them included patients who were both treatment naive and underwent previous endoscopic or surgical interventions for achalasia.POEM represents a safe and efficacy procedure comparable to the safety profile of LHM for achalasia at a short-term follow-up. Long-term clinical trials are urgently needed.

Difficult polypectomy-giant hypopharyngeal polyp: case report and literature review.

Giant esophageal and hypopharyngeal polyps are benign tumors rarely encountered in clinical practice. In most cases, they are completely asymptomatic; however, despite the rarity of these tumors, interest in giant esophageal polyps derives from their degree of growth (characterized by slow growth into the esophageal lumen) and their mobility. In fact, if regurgitation occurs, they can ascend into the oral cavity and be aspirated into the airways, with potentially lethal consequences. The removal of these giant polyps is recommended. An adequate preoperative evaluation to identify the correct origin of the stalk is mandatory for a successful endoscopic or surgical treatment. A 60-year-old man was admitted to our hospital for anemia. The patient underwent gastroscopy, contrast computed tomography and endoscopic ultrasound. At the conclusion of the procedure, during the extraction of the echoendoscope, the patient began retching and regurgitated the polyp, without experiencing respiratory distress. The patient underwent a left cervicotomy and polyp dissection via a pharyngotomy.

Laparoscopic Heller myotomy plus Dor fundoplication in 137 achalasic patients: results on symptoms relief and successful outcome predictors.

Aim of this study was to review our experience with laparoscopic Heller-Dor (LHD) intervention and identify possible success predictors. LHD is an effective and safe treatment for achalasia. However, open debates are still held on which antireflux procedure should be added and on how long the myotomy on to the stomach should be. A lot of successful outcome predictors have been investigated with sometimes conflicting results. 137 achalasic patients underwent LHD at our institution. Pre-operatively all underwent a complete morphologic and functional work-up. Follow-up visits were scheduled at 1, 3, 6 months and then every year. Median follow-up was 65 months. Pre-operatively dysphagia was present in 100% cases, regurgitation in 84.6% and mean lower esophageal sphincter (LES) resting pressure was 29.1 mmHg. We observed 3 mucosal perforations. Mortality was null. The median of oral food intake resumption was second post-operative day and mean post-operative hospital stay was 3.4 days. Dysphagia was treated with success in 94.78% cases and regurgitation in 82.84%. Post-operative mean LES resting pressure was 13.64 mmHg. New-onset heartburn was observed in 10.9% of patients. 9.7% of cases required pneumatic dilations and 1.5% a laparoscopic re-do myotomy. An high pre-operative dysphagia score resulted to be the only statistically significant prognostic factor. Sex, age, dysphagia duration and LES resting pressure did not reach statistical significance. LHD is a safe procedure with good results in about 90% of patients even at a long-term follow-up. Predictors of successful outcome are still poorly plain and sometimes conflicting in literature.

Giant hiatal hernias: direct hiatus closure has an acceptable recurrence rate.

The purpose of this retrospective study was to analyze our results after laparoscopic repair of giant hiatal hernias with direct closure of the hiatus, since the reports document a radiological recurrence rate as high as 42%. Various studies have shown that laparoscopic hernia repair is safe and effective, and carries a lower morbidity than the open approach, but the high recurrence rates still being reported (ranging from 10 to 42%) have prompted many authors to recommend using a prosthesis. This is a report on the follow-up of 38 patients with type III and IV hiatal hernia who underwent laparoscopic repair with direct hiatal closure without the aid of meshes. From January 2000 to March 2010, 38 patients with III and IV hiatal hernia were treated at the Surgery Division of Cisanello Hospital in Pisa. Data were collected retrospectively and included demographics, preoperative symptoms, radiographic and endoscopic findings, intraoperative and postoperative complications, postoperative symptoms, barium X-ray and follow-up by medical examination and symptoms questionnaire. The sample included 12 males and 26 females, between 36 and 83 years (median age 62) with 26 type III (68.4%) and 12 type IV (31.6%) hernias. There were no conversions to laparotomy and no intraoperative or postoperative mortality. A 360° Nissen fundoplication was performed in 22 patients (57.9%) and a 270° Toupet fundoplication in 16 patients (42.1%). One patient had intraoperative complications (2.6%), and postoperative complications occurred in another three (7.9%). The follow-up was complete in all patients and ranged from 12 to 88 months (median 49 months). Barium swallow was performed in all patients and recurrence was found in five patients (13.1%); three of these patients (7.9%) were asymptomatic, while two (5.2%) were reoperated. All 38 patients' symptoms improved. Judging from our data, the recurrence rate after laparoscopic giant hiatal hernia repair with direct hiatal closure can be lowered by complying with several crucial surgical principles, e.g., complete sac excision and appropriate crural closure, adequate esophageal lengthening, and the addition of an antireflux procedure and a gastropexy. We recorded a radiological recurrence rate of 13.1% (5/38) and patient satisfaction in our series was quite high (92%). Based on these findings, the laparoscopic treatment of giant hernias with direct hiatal closure seems to be a safe and effective procedure.

A single-institutional brachytherapy experience in the management of esophageal cancer.

PURPOSE: The aim of this work was to analyze the efficacy of high-dose-rate brachytherapy in the management of patients with esophageal cancer. METHODS AND MATERIALS: Between 2001 and 2008, 104 patients (88 males and 16 females) received a brachytherapy treatment as a part of a personalized multimodal approach. The median age was 72 years, and the median Karnofsky performance status was 60. Brachytherapy was used in different situations: to complete a primary treatment with radical intent in patients not suitable for surgery; to control local recurrences; or to obtain a rapid and durable palliation of dysphagia in patients with metastases or in poor general condition. In selected cases, endoscopic ultrasound images were integrated in treatment planning procedure to obtain a more accurate volume definition. Efficacy in controlling dysphagia was assessed 1 month after brachytherapy. RESULTS: Fifty-one patients received a radical treatment, and 53 patients were treated to relieve the symptoms. The median overall survival was 20.8 months. Lymph node involvement was found to be a significant prognostic factor for overall survival and dysphagia. Dysphagia was controlled in 88 patients (84.6%), and the median dysphagia-free interval was 17.5 months. Early and late adverse events were generally mild to moderate. The most severe effects were esophagotracheal fistulas, observed in 3 patients. CONCLUSIONS: Brachytherapy has an important role in the management of esophageal cancer with a low rate of complications. endoscopic ultrasound-assisted treatment planning can be useful for a better individualization of curative treatments.

The short esophagus: intraoperative assessment of esophageal length.

OBJECTIVE: To define the frequency and predictors of short esophagus in a case series of patients undergoing antireflux surgery. METHOD: An observational prospective study from September 10, 2004, to October 31, 2006, was performed at 8 centers. The distance between the esophagogastric junction as identified by intraoperative esophagoscopy and the apex of the diaphragmatic hiatus was measured intraoperatively before and after esophageal mediastinal dissection; a distance of 1.5 cm was arbitrarily determined to categorize cases as long (>1.5 cm) or short (

Helicobacter pylori eradication: a randomized prospective study of triple therapy versus triple therapy plus lactoferrin and probiotics.

OBJECTIVES: Helicobacter pylori is causally associated with gastritis and peptic ulcer diseases. Recent data (meta-analysis) have demonstrated that triple therapy with amoxicillin, clarithromycin, and a proton pump inhibitor has an eradication rate of only 74-76% and new therapeutic protocols may be necessary. The aim of this study was to examine whether adding bovine lactoferrin (bLf) and probiotics (Pbs) to the standard triple therapy for H. pylori infection could improve the eradication rate and reduce side effects. METHODS: H. pylori infection was diagnosed in 206 patients: in 107 based on an upper endoscopy exam and a rapid urease test, and in 99 by means of the H. pylori stool antigen-test and the C(13) urea breath test (C(13) UBT). The patients were randomized into two groups: 101 patients (group A) underwent standard triple eradication therapy (esomeprazole, clarithromycin, amoxicillin), while 105 patients (group B) underwent a modified eradication therapy (standard triple eradication therapy plus bLf and Pb). Successful eradication therapy was defined as a negative C(13) UBT 8 wk after completion of the treatment. Results were evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. Data were evaluated and considered positive when P<0.05. RESULTS: At the end of the study 175/206 patients showed negative C(13) UBT results. According to intention-to-treat analysis, the infection was eradicated in 73/101 patients from Group A and in 93/105 from Group B. PP analysis showed 73/96 patients from Group A and 93/101 from Group B to have been successfully treated. More patients from group A than from group B reported side effects from their treatment (P<0.05). CONCLUSIONS: The results of our study suggest that the addition of bLf and Pbs could improve the standard eradication therapy for H. pylori infection--bLf serving to increase the eradication rate and Pbs to reduce the side effects of antibiotic therapy.

Efficacy of Nissen fundoplication versus medical therapy in the regression of low-grade dysplasia in patients with Barrett esophagus: a prospective study.

OBJECTIVE: The aim of this study is to compare the effect of medical and surgical treatment on the history of patients with Barrett esophagus (BE) and histologic evidence of low-grade dysplasia (LGD). SUMMARY BACKGROUND DATA: BE is a complication of severe gastroesophageal reflux. It is considered a major risk factor for esophageal adenocarcinoma, which may develop through stages from nondysplastic metaplasia to dysplasia (LGD and high-grade dysplasia). Presently, there are no recommended therapeutic guidelines for patients with LGD. METHODS: Between 1998 through 2003, 6592 patients underwent upper endoscopy; 327 of 6592 (5%) patients had BE, and 35 of 327 (10.7%) had LGD. Nineteen patients with LGD were treated with high-dose proton pump inhibitors, and 16 patients underwent laparoscopic Nissen fundoplication. Endoscopic and histologic follow-up was available in all patients after 18 months. We used multiple logistic regression to examine the effect of the 2 treatments on regression of LGD. RESULTS: LGD was predominant in men (male-to-female ratio: 1.7:1). Mean age was 58 +/- 13.5 years. Sixty percent of patients had no endoscopic evidence of esophagitis. A regression from LGD to BE was observed in 12 of 19 (63.2%) patients in the medical group and in 15 of 16 (93.8%) patients in the surgical group (statistically significant difference). Differences between the 2 groups were statistically significant (P = 0.03). CONCLUSION: The results of our study suggest that surgical treatment may be more effective than medical therapy to modify the natural history of LGD in patients with BE, perhaps because it not only controls acid but also biliopancreatic reflux into the esophagus.

Cervical and mediastinal hematoma: presentation of an asymptomatic cervical parathyroid adenoma: case report and literature review.

The spontaneous rupture with extracapsular hemorrhage of a cervical parathyroid adenoma is a rare cause of cervical and mediastinal hematoma. We describe this case to emphasize that a failure to consider this diagnosis may result in delayed operative intervention with potentially fatal complications.