Stefano Santi

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 C13 urea breath test (C13 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 C13 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 C13 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.

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

AbstractTo 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.

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.

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.

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.

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.

AbstractTo 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 ± 7 years, 6 female) treated with concomitant chemoradiotherapy before surgery were followed up for 24 ± 18 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 &Dgr;TLG40 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 &Dgr;TLG50–70 (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, &Dgr;TLG resulted to be the most important factor in predicting outcome and should be considered in risk stratification of patients treated with neoadjuvant chemoradiotherapy.

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.

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.