Real-life efficacy and safety of Ustekinumab as second- or third-line therapy in Crohn's disease: results from a large Italian cohort study.

OBJECTIVE: Ustekinumab (UST) is an anti-IL12/23 antibody for the treatment of Crohn's Disease (CD). The aim of this study was to compare the efficacy and safety of UST in a large population-based cohort of CD patients who failed previous treatment with other biologics. PATIENTS AND METHODS: 194 CD patients (108 males and 86 females, mean age 48 years (range 38-58 years) were retrospectively reviewed. 147 patients were already treated with anti-TNFα (75.8%), and 47 (24.2%) patients were already treated with anti-TNFα and vedolizumab. Concomitant treatment with steroids was present in 177 (91.2%) patients. RESULTS: At week 12, clinical remission was achieved in 146 (75.2%) patients. After a mean follow-up of 6 months, clinical remission was maintained in 135 (69.6%) patients; at that time, mucosal healing was assessed in 62 (31.9%) patients, and it was achieved in 33 (53.2) patients. Three (1.5%) patients were submitted to surgery. Steroid-free remission was achieved in 115 (59.3%) patients. Both serum C-Reactive Protein and Fecal Calprotectin (FC) levels were significantly reduced with respect to baseline levels during follow-up. A logistic regression, UST therapy as third-line therapy (after both anti-TNFα and vedolizumab), FC >200 µg/g, and HBI ≥8 were significantly associated with lack of remission. Adverse events occurred in 5 (2.6%) patients, and four of them required suspension of treatment. CONCLUSIONS: UST seemed to be really effective and safe in CD patients unresponsive to other biologic treatments, especially when used as second-line treatment.

Protein-losing enteropathy in inflammatory bowel diseases.

Protein-loosing enteropathy in patients with inflammatory bowel diseases (IBDs) is an uncommon complication, but should be considered in any patient with hypoproteinemia in whom other causes have been excluded such as concomitant hepatic disease, severe malnutrition or proteinuria. The diagnosis is based on determination of fecal alpha-1 antitripsin clearance and stool analysis. Prognosis depends upon the patient and the disease location, severity and complication. Treatment is directed at control of the underlying IBDs but also includes albumin infusion in the most severe cases of hypoalbuminemia and fluid retention, dietary modifications for recovery and maintenance of nutritional status and supportive care to prevent further complication like deep venous thrombosis. Surgery is not curative in Crohn's disease patients, but in severe protein-loosing enteropathy with severe disease, not responding to conventional therapy, it may be the best choice.

Alpha-galactosidase versus active charcoal for improving sonographic visualization of abdominal organs in patients with excessive intestinal gas.

UNLABELLED: Intestinal gas is a frequent cause of poor visualization during gastrointestinal ultrasound (US). The enzyme alpha-galactosidase may reduce intestinal gas production, thereby improving abdominal US visualization. We compared the efficacies of alpha-galactosidase and active charcoal in improving US visualization in patients with previous unsatisfactory abdominal US scans caused by excessive intestinal gas. MATERIALS AND METHODS: 45 patients with poor visualization of at least one target organ: pancreas, hepatic lobes (score 0-2) or common bile duct (CBD) (score 0-1) were enrolled in a prospective randomized, crossover, observer-blinded study. The patients received alpha-galactosidase (Sinaire Forte, Promefarm, Milan, Italy) 600 GalU t.i.d. for 2 days before abdominal US plus 900 GalU the morning of exam or active charcoal 448 mg t.i.d., for 2 days before the exam plus 672 mg the morning of the exam. Visualization was graded as follows: 0 = none (complete gas interference); 1 = severe interference, 2 = moderate interference, 3 = mild interference; 4 = complete (no gas interference). RESULTS: 42 patients completed the study. Both alpha-galactosidase and active charcoal improved the visualization of target organs. Visualization of the right hepatic lobe, CBD and pancreatic tail was significantly improved (vs. baseline) only by alpha-galactosidase (p < 0.01). Scores ≥3 for all parts of the pancreas and both hepatic lobes were achieved in only 12.5% of the patients after both treatments. Both products were well tolerated. CONCLUSION: Alpha-galactosidase and active charcoal can improve US visualization of abdominal organs in patients whose scans are frequently unsatisfactory due to excessive intestinal gas. Visualization of the pancreatic tail and right hepatic lobe was significantly improved only by alpha-galactosidase. However, both treatments allowed adequate visualization of all target organs during the same examination only in a few patients.

Reproducibility of bowel ultrasonography in the evaluation of Crohn's disease.

BACKGROUND: Bowel ultrasonography is increasingly used in the detection and follow-up of patients with Crohn's disease, but a limitation to its further diffusion is the lack of standardisation of ultrasonography parameters. AIMS: This study aimed to standardise the most common bowel ultrasonography parameters in order to develop an unequivocal imaging interpretation and to assess bowel ultrasonography reproducibility. PATIENTS: Twenty patients with Crohn's disease were examined. METHODS: Six ultrasonographers (mean bowel ultrasonography experience=16 years) performed the study. They chose and discussed a common assessment methodology concerning eight ultrasonography parameters: bowel wall thickness, bowel wall pattern, bowel wall blood flow, enlarged mesenteric lymph nodes, mesenteric hypertrophy, abdominal free fluid, and stenosis or fistulae at four preliminary meetings. The day of the study operators were randomised to two rooms where they independently and in turn performed ultrasonography scans. Interobserver agreement was scored by kappa statistics. RESULTS: Excellent k values were observed for bowel wall thickness (0.72-1). k Values were poor for bowel wall pattern (-0.22-0.85) and good for bowel wall blood flow (0.53-0.89). The presence of lymph nodes was reproducible (0.56-0.90) except in one case (0.25). Concordance on free fluid was excellent (0.85-1), whereas that on mesenteric hypertrophy was generally poor (0.14-0.69). Agreement was excellent for stenosis (0.81-1) whereas that for fistula was fair in room abscesses (0.31-0.48) and very good in room B (0.87-1). CONCLUSION: Bowel ultrasonography signs used in Crohn's disease can be standardised as most of them showed a fair to good reproducibility. In particular, bowel wall thickness, the most relevant parameter for Crohn's disease detection, showed an excellent reproducibility.

Autologous haematopoietic stem cell transplantation without CD34+ cell selection in refractory Crohn's disease.

OBJECTIVES: Autologous haematopoietic stem cell transplantation (HSCT) with CD34(+) cell selection has recently been used in the treatment of refractory Crohn's disease, showing good safety and promising efficacy. We investigated the safety and efficacy of HSCT with unselected peripheral blood stem cells (PBSCs) in moderate-severe refractory Crohn's disease. PATIENTS: Four patients (three male, one female; age range 26-45 years) with active moderate-severe Crohn's disease (median Crohn's Disease Activity Index (CDAI) 319, range 272-345), refractory or intolerant to multiple drugs including infliximab, were enrolled. INTERVENTIONS: Unselected PBSCs were collected after mobilisation with cyclophosphamide (CTX) 1.5 g/m2 and granulocyte-colony stimulating factor (G-CSF) 10 microg/kg. The conditioning regimen included CTX 50 mg/kg on days -5 to -2 and rabbit anti-thymocyte globulin (ATG) 2.5 mg/kg on days -4 to -2. MAIN OUTCOME MEASURES: Primary endpoints were toxicity and clinical remission (CDAI<150) at 3 months. Secondary endpoints were clinical and endoscopic response at 3 months and toxicity, clinical and endoscopic remission at 12 months. RESULTS: No improvement or slight deterioration was observed following mobilisation (median CDAI 339, range 258-404). At the third month, the primary endpoint of clinical remission was achieved in all patients, with a median CDAI of 91 (range 56-102), and complete endoscopic remission was achieved in 2/3 patients. After a median follow-up of 16.5 months, 3/4 patients maintained both clinical and endoscopic remission, despite withdrawal of all drugs, and complete fistula closure was observed in all affected patients. No deaths or life-threatening infection occurred. Unexpected adverse events included a perianal abscess after mobilisation in one patient, pleural and pericardial effusions in another and BK virus-related macrohaematuria in another, all rapidly resolved with conservative treatment. CONCLUSION: Autologous HSCT with unselected PBSC appears to be safe and can induce and maintain remission in previously refractory Crohn's disease patients.

Imaging of perianal Crohn's disease.

Perianal fistulas and abscesses are common complications of Crohn's disease, affecting up to 50% of patients during their disease course. Accurate diagnosis and classification of perianal disease is crucial before and during treatment to plan an adequate approach for each patient and to avoid irreversible functional consequences. Although examination under anaesthesia has been considered the gold standard for diagnosis and classification of Crohn's disease perianal fistulas, taken alone it does not have perfect accuracy, stressing the need for concomitant or alternative, non-invasive, methods of evaluation. In this context, imaging modalities assessed for diagnosis, classification and monitoring of Crohn's disease perianal fistulas include pelvic magnetic resonance imaging, anorectal endoscopic ultrasonography, transcutaneous perianal ultrasound, fistulography and computed tomography. In particular, magnetic resonance imaging and endoscopic ultrasonography findings have shown the best accuracy, and the ability to influence therapeutic management of these patients. For transcutaneous perianal ultrasound too, good preliminary data have been reported. This paper reviews the available data on imaging methods for the management of perianal Crohn's disease.

"Cervia II Working Group Report 2006": guidelines on diagnosis and treatment of Helicobacter pylori infection in Italy.

Proper management of Helicobacter pylori infection in clinical practice--when supported by evidence-based data--is expected to produce substantial cost-efficacy advantages. This consideration has prompted the Cervia Working Group to organise a meeting of experts to update the National Guidelines on the diagnosis and treatment of H. pylori infection in Italy. Recommendations in the new European Guidelines were considered in the National setting, here in the light of factors such as the incidence of gastric cancer and gastric lymphoma, the accessibility to different diagnostic tools, the prevalence of bacterial resistance against antibiotics, and the availability of different drugs. The main revisions in respect to the previous guidelines include H. pylori eradication in non-ulcer dyspepsia patients and in non-steroidal, anti-inflammatory drug users, as well as in patients with idiopathic thrombocytopenic purpura and iron deficiency anaemia. The stool antigen test is now accepted as a valid test for confirmation of H. pylori eradication following therapy. New therapeutic approaches have been recommended for both first- (sequential therapy) and second-line (levofloxacin-based) treatment in our country.

Transient small-bowel intussusceptions in adults: significance of ultrasonographic detection.

AIM: To investigate the frequency, clinical significance, and outcome of small-bowel intussusceptions in adults detected using ultrasound in an outpatient setting. PATIENTS AND METHODS: In two different retrospective (January 2001 to April 2003) and prospective (May 2003 to June 2005) periods, 33 small-bowel intussusceptions were found in 32 patients (13 females; mean age: 38.1 years) with known or suspected intestinal disease. Patients underwent diagnostic work-up to assess any organic disease. Patients with self-limiting intussusception were submitted to clinical and ultrasonographic follow-up. RESULTS: Of the 32 patients with small-bowel intussusception, 25 were identified in the prospective series of 4487 examinations (0.53%) and seven in the retrospective series of 5342 examinations (0.15%; p=0.002). Four patients had persistent and 28 self-limiting intussusceptions. Self-limiting intussusceptions were idiopathic in 11 patients (39%) or associated with organic diseases in 17 (Crohn's disease in 11 patients, celiac disease in three, ulcerative colitis in one patient, and previous surgery for cancer in two). Self-limiting intussusceptions were asymptomatic in 25% of patients. CONCLUSION: Small-bowel intussusceptions in adults are not rare and are frequently self-limiting, idiopathic, or related to organic diseases, mainly Crohn's disease and coeliac disease.

Autoantibody profile during short-term infliximab treatment for Crohn's disease: a prospective cohort study.

BACKGROUND: The potential clinical implications of autoimmunity during treatment with infliximab are unclear. AIM: To determine the frequency and correlation of autoantibody formation in patients with Crohn's disease treated with infliximab in a routine clinical setting. METHODS: Sixty-three patients with refractory/inflammatory (31) and/or fistulising Crohn's disease (32), received an infliximab infusion at a dose 5 mg/kg in weeks 0, 2 and 6, and were evaluated for the development of antinuclear, anti-double-stranded DNA, anti-Sm, anti-RNP, anti-SSA, anti-SSB and antihistone antibodies. The correlates with pharmacological treatments, the response to infliximab and adverse events were evaluated. RESULTS: Antinuclear antibodies were found in five of the 63 patients (8%) at baseline and in 26 (42%) after 10 weeks (P < 0.001). Of the 26 antinuclear antibody-positive patients who were further subtyped, nine of 63 (17%) had anti-double-stranded DNA (P = 0.003), and 1.5% were extractable nuclear antigen (ENA) and antihistone-positive. Five patients were initially positive for anticardiolipin antibodies and two more patients became positive during infliximab treatment. New autoantibody formation was more frequent in the patients with inflammatory/refractory disease than in those with fistulising disease (17 vs. 7; P = 0.02). One patient developed drug-induced lupus without major organ damage. CONCLUSIONS: Autoantibody formation occurs in 42% of patients (8% of these patients were positive before infliximab treatment) with Crohn's disease receiving induction treatment with infliximab, but the clinical significance of this remains to be determined.

Prevalence, detection rate and outcome of cytomegalovirus infection in ulcerative colitis patients requiring colonic resection.

OBJECTIVE: To determine the prevalence of cytomegalovirus infection in patients with steroid-refractory ulcerative colitis who required colonic resection, and to assess its possible association with the use of immunosuppressive and steroid treatment and outcome after colectomy. PATIENTS AND METHODS: The study included surgical specimens and related pre-operative endoscopic biopsy specimens of 77 consecutive ulcerative colitis patients (34 females) who underwent colectomy because of intractable steroid-refractory ulcerative colitis (55 patients), toxic megacolon (6 patients), dysplasia or cancer (7 patients) or loss of function of the colon (9 patients). Clinical features and current and past treatments were analysed. Haematoxylin and eosin and specific immunohistochemical staining for cytomegalovirus were used to detect inclusion bodies in all specimens. RESULTS: Cytomegalovirus infection was found in 15 of 55 steroid-refractory ulcerative colitis patients (27.3%) and in 2 of 22 non-refractory patients (9.1%) (p=0.123). Only six patients had positive staining for cytomegalovirus in pre-operative endoscopic biopsy specimens. Detection of cytomegalovirus inclusion in biopsy specimens was not related to the number of biopsies or to time that had elapsed since colonoscopy and index surgery. Cytomegalovirus-positive patients were more likely to be on systemic corticosteroids (p=0.03). In contrast, current use and duration of immunosuppressive treatment, number of steroid cycles since diagnosis and in the last year, as well as chronic use of steroid in the last year were not significantly related to cytomegalovirus infection. Cytomegalovirus-positive patients did not receive antiviral therapy following proctocolectomy but did not show endoscopic or histological cytomegalovirus reactivation in the ileo-anal pouch and in the remaining bowel. CONCLUSIONS: Cytomegalovirus infection is frequently found in surgical specimens of patients with steroid-refractory ulcerative colitis and is more likely in patients on corticosteroid treatment. Cytomegalovirus infection is frequently unrecognised in pre-operative biopsy specimens, thus raising concerns about the accuracy of the available diagnostic tools. Unrecognised and untreated cytomegalovirus infection does not affect the outcome of ulcerative colitis patients following proctocolectomy.

Role of early ultrasound in detecting inflammatory intestinal disorders and identifying their anatomical location within the bowel.

BACKGROUND: Although bowel ultrasound is a widely accepted diagnostic tool in bowel diseases, its value as the primary imaging procedure in patients with symptoms/signs suggestive of inflammatory bowel disorders is still unclear. AIM: To investigate the accuracy of bowel ultrasound compared with barium X-ray studies, computed tomography, endoscopy and bowel surgery in the initial assessment of inflammatory bowel disorders. METHODS: Four hundred and eighty-seven patients hospitalized consecutively for symptoms or signs suggestive of a bowel disorder between December 1999 and March 2002 were initially enrolled in the study. All patients underwent bowel ultrasound as the first imaging procedure within 36 h of admission; radiographic evaluations, endoscopy and/or surgery were then performed as appropriate and the results of these investigations were used as the gold standard. RESULTS: Three hundred and thirty-six patients had pathological findings of the bowel detectable at ultrasound as the final diagnosis. The main organic disorders found were Crohn's disease (56%), ulcerative/indeterminate colitis (30%), bowel tumours (5%), appendicitis/diverticulitis (2%) and other inflammatory conditions (8%). The overall sensitivity and specificity of bowel ultrasound were 85% and 95%, respectively, whereas the positive and negative predictive values were 98% and 75%, respectively. Comparisons of ultrasound with X-ray or endoscopic results by disease localization showed that the diagnostic performance of ultrasound was higher for inflammatory conditions of the ileum and sigmoid/descending colon (sensitivity of 92% and 87%, respectively), whereas abnormalities localized in the rectum, duodenum and proximal jejunum were often missed by ultrasound. CONCLUSIONS: In expert hands, bowel ultrasound is highly predictive of inflammatory disease localized in the ileum or colon, and may well be used as the primary imaging method when Crohn's disease or ulcerative colitis is suspected on a clinical basis.

Small bowel stenosis in Crohn's disease: clinical, biochemical and ultrasonographic evaluation of histological features.

AIM: To establish whether intestinal ultrasound, clinical or biochemical indices of activity can assess histological features of ileal stenosis in Crohn's disease. METHODS: In 43 patients undergoing surgery for a single ileal stenosis, clinical and biochemical parameters, as well as intestinal ultrasound, were assessed prior to surgery. The echo pattern of thickened bowel segments at the site of stenosis was classified as hypoechoic, stratified or mixed (segments with/without stratification). During surgery, stenoses were identified, resected and then histologically examined using standardized criteria. RESULTS: Clinical and biochemical indices of activity showed an overall weak positive correlation with histological inflammatory parameters and a negative correlation with fibrosis. The intestinal ultrasound echo pattern at the stenosis site was stratified in 25 patients, hypoechoic in 14 and mixed in four. Stenoses characterized by a stratified echo pattern showed a significantly higher degree of fibrosis, those characterized by hypoechoic echo pattern showed a higher degree of inflammation, while stenoses with a mixed echo pattern showed high degrees of both fibrosis and inflammation. CONCLUSION: Ultrasound and, to a lesser degree, clinical and laboratory indices discriminate between inflammatory and fibrotic ileal stenoses complicating Crohn's disease, thus allowing appropriate medical and/or surgical treatment to be defined.

[Efficacy of medical therapy in preventing the post-surgical recurrence in Crohn's disease]. / Efficacia della terapia medica nella prevenzione della recidiva post-chirurgica della malattia di Crohn.

Crohns Disease (CD) is a chronic intestinal inflammatory disease of unknown origins that cannot be definitely resolved with surgical intervention. Therefore, pharmacologic therapies are of great importance both in preventing relapses and by determining remissions. In this paper the authors analyse the different drugs available for the treatment of Crohns disease, and focus on their efficacy and tollerability.

[Surgical options in the treatment of perianal Crohn's disease]. / Opzioni chirurgiche nel trattamento della malattia di Crohn a localizzazione perianale.

INTRODUCTION: About 40% of patients with Crohns disease (CD) have a perianal involvement. Despite the recent introduction of anti-TNF antibody, this therapy has uncertain long-term results and surgery still remains a major treatment option. AIMS & METHODS: This study relates our experience in surgical management of perianal CD without anti-TNF treatment. From July 92 to February 02, 37 patients with perianal Crohns disease were treated, 43 underwent local operations or faecal diversion for fistulas and/or abscesses. Patients not requiring surgery or in therapy with anti-TNF. were excluded from the study. We analysed the outcome of surgical treatment for perianal CD. RESULTS: Male to female ratio was 1:0.6, median age was 36,9 years (range 17-62). Perianal disease included 32 fistulas (16 trans-sphincteric, 2 superficial, 2 ano-vaginal, 10 multiple and complex, 2 horseshoe) and 7 abscesses (5 perianal, 2 ischio-rectal). Local surgery included 1 abscess drainage, 5 abscess drainage and fistula incision with seton insertion, 2 fistulotomy, 9 partial fistulectomy and seton insertion. At surgery, 40% of patients were ongoing a medical treatment with 5-ASA and/or antibiotics, 40% with steroids and/or immunosoppressors, 15% only with 5-ASA and 5% no ongoing treatment. The horseshoe fistulas were managed with a fistulotomy and seton insertion. One patient with ano-vaginal fistula required proctectomy and the other one total proctocolectomy. Patients treated by diverting colonostomy (3) had fistula recurrence after its closure in 100%. 20% of patients required total proctocolectomy and ileostomy for extensive intestinal disease. Of the 27 patients undergoing seton insertion or fistulotomy none had faecal incontinence due to the operation and 38% had a 1 year recurrence. CONCLUSIONS: Perianal CD is a heterogeneous entity, therefore its management is still controversial. Moreover, a high percentage of patients (18% in our series) requires a major surgery due to the extension and seriousness of rectal involvement. In our survey only 12 patients (39%), with trans-sphincteric fistula, could have been theoretically treated with anti-TNF. We wonder if the cost-and-benefit of this medical treatment justifies its application on patients that could undergo a surgical treatment with good long-term results.

[Strictureplasty in the surgical treatment of complicated Crohn's disease]. / Le stricturoplastiche nel trattamento chirurgico della malattia di Crohn complicata.

INTRODUCTION: Crohns disease is a panintestinal chronic inflammatory condition. Its remitting-relapsing behaviour may require in the single patient repeated surgeries, with the aim of resolving the complications of the disease. The awereness that surgery cannot resolve the disease has led, in the last years, to the development of new "conservative surgical techniques", which preserve as much of the intestinal tissue as possible. These techniques are minimal resection and strictureplasty (SP). Aim of the study was to perform a prospective analysis of the long-term outcome of SP in a consecutive series of patients undergoing surgery for complicated Crohns Disease at the Division of general surgery, L. Sacco University Hospital, Milano, Italia. METHODS AND RESULTS: During the period of October 1992 to June 2002, 286 patients underwent surgical procedures for jejunoileal Crohns disease. 116 of them underwent SP resulting in a total of 217 procedures, of which: 111 Heineke-Mikulicz SP (51.2%), 36 ileoileal side-to-side SP (16.6%), 40 ileoceacal SP (18.4%) and the remaining 30 ileocolic SP (13.8%), as previously described by A.M. Taschieri. Fiftyone of the patients (23.5%) had concomitantly a minimal bowel resection. Postoperative mortality was nil, while in 3 cases (2.59%) repeated surgery was necessary due to postsurgical complications. Time-to-event estimates were performed using the Kaplan-Meier function. CONCLUSIONS: mortality, morbidity, and long-term results in this population of patients who underwent SP are encouraging and in line with reports in the international literature. It is suggested that SP together with minimal bowel resections, may be considered as first line surgical therapy in patients with Crohns Disease.

[Bowel ultrasound in Crohn's disease. Surgical importance]. / L'ecografia intestinale nel morbo di Crohn. Rilevanza chirurgica.

The use of ultrasound in Crohns disease has a recent history. This method is useful in various situations like: the diagnosis of the disease, the diagnosis of intra-abdominal complications and the follow-up of the operated patient. Moreover, thanks to its practicality of use, ripetibility and accuracy, ultrasounds can represent a first line diagnostic instrument for Crohns disease both in elective and emergency conditions. The authors, in this paper, consider its usefulness and various aspects in these conditions.

Gastric cancer in young patients with no alarm symptoms: focus on delay in diagnosis, stage of neoplasm and survival.

BACKGROUND: The test and treat strategy for Helicobacter pylori infection has raised some concern since young gastric cancer patients may have no alarm symptoms. In this study the frequency of alarm symptoms was assessed in a series of young gastric cancer patients, as well as the impact of absence of alarm symptoms on delay in diagnosis and stage of gastric cancer at diagnosis and survival. METHODS: A retrospective study was carried out on 92 gastric cancer patients < or = 45 years of age identified from databases in four hospitals between January 1985 and December 2001. Characteristics analysed included duration and features of dyspeptic symptoms, presence of alarm symptoms, time interval from the onset of symptoms to diagnosis, pTNM stage and survival. RESULTS: Of the 92 patients, 54 (58.7%) presented uncomplicated dyspepsia and 38 (41.3%) alarm symptoms. In those with uncomplicated dyspepsia, epigastric pain was the most common complaint (64.1%) followed by vomiting (30.4%), heartburn and nausea. Weight loss was the most common alarm symptom (30.4%), followed by anorexia (10.9%), dysphagia or anaemia (7.6%). The mean delay from first symptoms to final diagnosis was 16.8 +/- 13.9 weeks in patients with alarm symptoms and 29.3 +/- 39.9 weeks in patients without alarm symptoms (P:ns). Patients without alarm symptoms showed significantly less aggressive gastric cancer compared to patients with alarm symptoms in relation to TNM stage and survival (cumulative 5-year survival rate: 76% versus 49% P: 0.01). The survival rate, at 5 years, of patients without alarm symptoms, and with a history of dyspepsia of more than 24 weeks, was higher than that in patients with early diagnosis (93.4% versus 66.5%: P: 0.05). CONCLUSIONS: A large proportion of young gastric cancer patients present without alarm symptoms. Despite the delay in diagnosis, these patients have a better outcome than those with alarm symptoms. Thus the delay in diagnosis of patients without alarm symptoms does not affect survival.