Impact of treatments on fecal microbiota and fecal metabolome in symptomatic uncomplicated diverticular disease of the colon: a pilot study.

Symptomatic uncomplicated diverticular disease (SUDD) affects 50% of people having diverticulosis. We performed a pilot study assessing the effect of current treatments on fecal microbiota and metabolome in SUDD. Thirteen consecutive females with SUDD were treated with a 2-week therapeutic trial of 30 g/day fiber supplementation (3 patients), 1.6 g/day of mesalazine (3 patients), 900 billion/day of probiotic mixture VivoMixx® (3 patients), or 800 mg/day of rifaximin (4 patients). Stool samples were collected at entry (T0), at the end of the 2-week therapeutic course (T1), and 30 (T2) and 60 days (T3) after the end of the therapeutic course. Real-time PCR quantified targeted microorganisms. Fecal metabolome patterns were studied by high-resolution proton NMR spectroscopy. At cumulative analysis, symptoms significantly decreased at each time point during follow-up (p less than 0.0001), and only left-lower quadrant pain increased again at T3. The overall bacterial quantity was not altered by the treatments. The amount of Akkermansia muciniphila species was significantly reduced at T1 (p=0.017) and at T2 (p=0.026), while at T3 the reduction was not significant in comparison to enrollment (p=0.090). Fecal molecular profile showed significant changes at T1 and T2, while at T3 it became similar to that of T0. Differences were found for 18 of the quantified molecules (tryptophan, phenylalanine, tyrosine, 4-hydroxyphenylacetate, urocanate, X-6.363, X-5.779, uridylate, galactose, X-4.197, threonine, sarcosine, methionine, 2-oxoisocaproate, 5-aminolevulinate, alanine, leucine, valerate). Metabolome and microbiota changed in patients with SUDD under treatment, confirming a possible role of dysbiosis/dysmetabolome in the pathology.

Comparison of the effectiveness of infliximab and adalimumab in preventing postoperative recurrence in patients with Crohn's disease: an open-label, pilot study.

BACKGROUND: Endoscopic and clinical recurrence of Crohn's disease (CD) appears in up to 80 and 30 % of patients, respectively, 1 year after surgery. Both infliximab (IFX) and adalimumab (ADA) have been demonstrated to be effective in reducing the possibility of recurrence after surgery, but head-to-head studies have not been performed so far. The aim of this open-label prospective study was to compare endoscopic, histological and clinical recurrence after 1 year of treatment with IFX or ADA as postoperative prophylaxis in CD patients with a high risk of recurrence. METHODS: Consecutive CD patients who underwent curative ileocolonic resection were randomized to receive IFX or ADA for 1 year. Co-primary endpoints were endoscopic, histological and clinical recurrence after 12 months of therapy. RESULTS: Twenty consecutive CD patients (9 males and 11 females; median age 32.5 years, range 20-39 years) were enrolled after undergoing curative ileocolonic resection. Among the 10 patients treated with IFX, 2 (20 %) had endoscopic recurrence compared to 1 (10 %) in the group of 10 ADA patients (p = 1.0). Three out of 10 (30 %) IFX patients and 2 out of 10 (20 %) ADA patients had histological recurrence (p = 1.0). No significant clinical differences were found between the two groups. CONCLUSIONS: IFX and ADA were similar in preventing histological, endoscopic and clinical recurrence after curative ileocolonic resection in high risk CD patients.

Decreasing efficacy of the standard seven-day triple therapy containing amoxycillin and clarithromycin in curing Helicobacter pylori infection in clinical setting in Italy: a 10-year follow-up study.

AIM: The aim of the present study was to assess the efficacy of the standard triple therapy containing PPI plus amoxycillin and clarithromycin in curing Helicobacter pylori (H. pylori) infection during a long-term period. METHODS: A retrospective analysis was conducted on 1497 consecutive dyspeptic patients with proven H. pylori infection and enrolled from 1996 to 2006. Patients received a standard triple therapy with proton pump inhibitor (PPI) plus amoxicillin 1 g and clarithromycin 500 mg for 7 days (all twice daily) plus PPI every day for further 4 weeks in case of active peptic ulcer or severe gastritis detected at endoscopy. One month after conclusion of therapy, endoscopy was performed in those patients for whom the examinations were clinically relevant. The remaining patients were checked by ¹³C-urea breath test. RESULTS: The overall H. pylori eradication rate was 70.41% (on intention-to-treat analysis). However, it decreased significantly during the observation period, ranging from 90% (95% CI 87.14% to 93.91%) in 1996 to 51.11% (95% CI 48.14% to 55.91%) in 2006 (on i-t-t analysis) (P=0.001). No difference in eradicating the was found infection between Puglia and Lazio (1996: P=0.39; 2006: P=0.64). CONCLUSION: Standard triple therapy does not appear anymore a valid therapeutic strategy for the management of H. pylori infection in clinical practice.

Expression of basic fibroblastic growth factor, syndecan 1 and tumour necrosis factor α in resected acute colonic diverticulitis.

AIM: Inflammation and fibrosis are present in both colonic diverticulitis and Crohn's disease (CD). The molecular pattern of basic fibroblastic growth factor (bFGF) and syndecan 1 (SD1) expression is altered in stenosing CD, but their expression in resected complicated colonic diverticulitis (ACD) is unknown. METHOD: The expression of bFGF, SD1 and tumour necrosis factor α (TNF-α) in 20 patients after resection of ACD was compared with 15 patients having a resection for CD. Analysis was conducted using real-time reverse transcriptase polymerase chain reaction in biopsy samples. RESULTS: Lymphocytic and neutrophil inflammation scores were similar in both groups (P = 0.771 and P = 0.562). TNF-α and bFGF expression was significantly higher in ACD than in CD (P < 0.0001 and P = 0.009). SD1 expression was similar in both groups (P = 0.841). CONCLUSION: TNF-α and bFGF are significantly overexpressed in ACD with respect to CD, whilst SD1 levels do not differ. The findings confirm that inflammation and its association with altered molecular patterns of mucosal healing may play an important role in the phenotype of the diseases.

Intermittent versus every-day mesalazine therapy in preventing complications of diverticular disease: a long-term follow-up study.

BACKGROUND: Mesalazine seems to be effective in preventing recurrence of acute uncomplicated diverticulitis (AUD), but the optimal mesalazine scheme to achieve these results is still debated. AIM: To assess the effectiveness of two different mesalazine-based treatments in preventing recurrence of AUD and the occurrence of other complications of diverticular disease (DD) during a long-term follow-up. PATIENTS AND METHODS: We reviewed 311 patients suffer from recent episode of AUD and undergoing to mesalazine treatment: 207 (group A, 105 males, median age 63 years, range 47-74 years) were treated with mesalazine 1.6 g for 10 days each month, whilst 104 (group B, 55 males, median age 65 years, range 50-72 years) were treated with mesalazine 1.6 g every day. Patients were followed-up every 6 months (median 7.5 months, range 5-13 months). RESULTS: Patients were followed-up for a mean time of 3 years (range 12-72 months). Overall, occurrence of complication recurred more frequently in group A than in group B (p = 0.030, log-rank test). Acute diverticulitis recurred in 17 (8.2%) patients in group A and in 3 (2.9%) in group B; diverticular bleeding occurred in 4 (1.9%) patients in group A and in 1 (0.96%) patient in group B; surgery was required in 3 (1.4%) patients in group A and in no (0%) patient in group B. CONCLUSIONS: This is the first study showing that long-term mesalazine treatment is significantly better that intermittent mesalazine treatment in preventing occurrence of DD complications after an attack of acute diverticulitis.

Randomised clinical trial: mesalazine and/or probiotics in maintaining remission of symptomatic uncomplicated diverticular disease--a double-blind, randomised, placebo-controlled study.

BACKGROUND: Placebo-controlled studies in maintaining remission of symptomatic uncomplicated diverticular disease (SUDD) of the colon are lacking. AIM: To assess the effectiveness of mesalazine and/or probiotics in maintaining remission in SUDD. METHODS: A multicentre, double-blind, placebo-controlled study was conducted. Two hundred and ten patients were randomly enrolled in a double-blind fashion in four groups: Group M (active mesalazine 1.6 g/day plus Lactobacillus casei subsp. DG placebo), Group L (active Lactobacillus casei subsp. DG 24 billion/day plus mesalazine placebo), Group LM (active Lactobacillus casei subsp. DG 24 billion/day plus active mesalazine), Group P (Lactobacillus casei subsp. DG placebo plus mesalazine placebo). Patients received treatment for 10 days/month for 12 months. Recurrence of SUDD was defined as the reappearance of abdominal pain during follow-up, scored as ≥5 (0: best; 10: worst) for at least 24 consecutive hours. RESULTS: Recurrence of SUDD occurred in no (0%) patient in group LM, in 7 (13.7%) patients in group M, in 8 (14.5%) patients in group L and in 23 (46.0%) patients in group P (LM group vs. M group, P = 0.015; LM group vs. L group, P = 0.011; LM group vs. P group, P = 0.000; M group vs. P group, P = 0.000; L group vs. P group, P = 0.000). Acute diverticulitis occurred in six group P cases and in one group L case (P = 0.003). CONCLUSION: Both cyclic mesalazine and Lactobacillus casei subsp. DG treatments, particularly when given in combination, appear to be better than placebo for maintaining remission of symptomatic uncomplicated diverticular disease. (ClinicalTrials.gov: NCT01534754).

Effectiveness of different therapeutic strategies in preventing diverticulitis recurrence.

BACKGROUND: Colonic diverticulitis shows a high recurrence rate. AIMS: To assess the efficacy of three different therapeutic strategies in preventing diverticulitis recurrence. MATERIALS AND METHODS: One hundred thirty patients suffering from Acute Uncomplicated Diverticulitis (AUD) (81 males, 49 females, mean age 64.71 years, range 40-85) were prospectively assessed. After obtaining remission, considered present when both endoscopic and histological damage were absent, the patients were treated with mesalazine 1.6 g/day (59 patients, group A), or rifaximin 800 mg/day for 7 days every month (52 patients, group B). Clinical, endoscopic and histological follow-up was performed after 6, 12 and thereafter every 12 months after diagnosis of AUD. RESULTS: Seven patients were excluded from final evaluation because they were lost to follow-up. Fifty-five group A patients and 49 group B patients patients were available for the final assessment at the end of a 24-month follow-up. Sustained remission was significantly higher in group A with respect to group B. CONCLUSIONS: Patients taking mesalazine have lower risk of diverticulitis recurrence than patients taking rifaximin because of the lower prevalence of persisting endoscopic and histological inflammation.

Mucosal expression of basic fibroblastic growth factor, Syndecan 1 and tumor necrosis factor-alpha in diverticular disease of the colon: a case-control study.

BACKGROUND: Inflammation may be detected in diverticular disease (DD), and fibrosis may also develop. We assessed the mucosal expression of bFGF, SD1, and TNF-α in DD according to the severity of the disease. Moreover, we assessed the response to therapy of these cytokines in acute uncomplicated diverticulitis (AUD). METHODS: Fifteen patients affected by AUD and seven patients affected by symptomatic uncomplicated diverticular disease (SUDD) were enrolled. Patients with asymptomatic diverticulosis (AD), segmental colitis associated with diverticulosis (SCAD), ulcerative colitis (UC), and healthy subjects (HC) served as control groups. KEY RESULTS: The expression of bFGF, SD1, and TNF-α was significantly higher in diverticulitis than in healthy controls, in diverticulosis, and in uncomplicated diverticular disease. Cytokines were significantly higher in uncomplicated diverticular disease than in healthy controls. Cytokine expression in diverticulitis did not differ significantly from that of ulcerative colitis. After treatment, TNF-α expression dropped significantly. CONCLUSIONS & INFERENCES: Mucosal TNF-α is overexpressed only in symptomatic DD, while SD1 and bFGF are already overexpressed in AD. Finally, TNF-α but not SD1 or bFGF expression seems to be influenced by the treatment in AUD.

Musosal tumour necrosis factor α in diverticular disease of the colon is overexpressed with disease severity.

AIM: Inflammation occurs in diverticular disease (DD), but there is little information on inflammatory cytokines such as tumour necrosis factor α (TNF-α). The aim of this study was to assess TNF-α expression in DD and to see whether it is related to the severity of the disease. METHOD: Twenty-four patients with symptomatic DD were divided into those with acute uncomplicated diverticulitis (AUD) (12 patients) and those with symptomatic uncomplicated diverticular disease (SUDD) (12 patients). Twelve further patients with asymptomatic diverticulosis (AD), six with segmental colitis associated with diverticulosis (SCAD), with ulcerative colitis (UC) and six healthy individuals (HC) were enrolled as controls. TNF-α expression in the colonic mucosa was assessed by the amount of mRNA codifying for the synthesis of TNF-α. RESULTS: TNF-α expression was significantly higher in AUD than in HC (P=0.0007), in AD (P=0.0001) and in SUDD (P=0.0179). It was significantly higher also in SUDD than in HC (P=0.0007) and in AD (P=0.0001). TNF-α expression in AUD did not differ significantly from that in UC (P=0.0678) and SCAD (P=0.0610). It was significantly higher in UC, SCAD and AUD than in SUDD (P=0.0007, P=0.0001, P=0.0179). CONCLUSION: TNF-α expression in DD seems to be related to the severity of the disease. In particular, it appears to be overexpressed in DD with inflammation (AUD and SUDD) compared with DD without (AD).

Role of fecal calprotectin in the diagnosis and treatment of segmental colitis associated with diverticulosis.

AIM: Information about fecal calprotectin (FC) in segmental colitis associated with diverticulosis (SCAD) is lacking. We assessed FC in SCAD, comparing it healthy controls (HC), irritable bowel syndrome (IBS), diverticular disease (DD), ulcerative colitis (UC). Moreover, we compared FC levels in different degrees of SCAD and assessed FC SCAD before and after treatment. METHODS: Twenty-seven consecutive patients with a new endoscopic diagnosis of SCAD, and 16 patients for each control group, underwent to FC assessment. FC was assessed by semi-quantitative method. RESULTS: FC was not increased in HC and in IBS patients, whilst it was increased in DD, SCAD, and UC. FC concentration was higher in SCAD and UC than in DD (SCAD vs. DD, P=0.05). No difference was found in FC concentration between SCAD and UC (P=0.213), as well as between different degree of SCAD (P= 0.178). After treatment, FC values decreased to normal values in all patients obtaining remission (P<0.0005). Three patients experienced still symptoms (one SCAD type B and two SCAD type D patients), and in all of them FC was still detectable. CONCLUSION: FC may be useful in differentiating SCAD from functional syndromes. Moreover, it may be useful in assessing response to therapy.

Inflammatory manifestations at colonoscopy in patients with colonic diverticular disease.

BACKGROUND: Ulcerative colitis with diverticulosis (UCD), segmental colitis associated with diverticulosis (SCAD) and acute uncomplicated diverticulitis (AUD) may affect the same colonic regions, but the real incidence of these entities in clinical practice is unknown. AIM: To assess the incidence and the endoscopic findings of UCD, SCAD and AUD. METHODS: From January 2004 to June 2009, 8525 consecutive colonoscopies were performed. Diagnosis of the diseases was based on specific endoscopic and histological (UCD and SCAD), and on endoscopic and radiological (AUD) patterns. RESULTS: Ulcerative colitis with diverticulosis was diagnosed in 25 patients (0.3%), SCAD was diagnosed in 129 patients (2%) and AUD was diagnosed in 130 patients (2%). In UCD, the inflammation in colonic area harbouring diverticula always affects the overall colonic mucosa in all cases, involving also diverticular orifices. The endoscopic characteristic of SCAD is that inflammation is mainly detected within the inter-diverticular mucosa without involvement of the diverticular orifices. In AUD, the inflammation affects primarily diverticular orifice and peri-diverticular mucosa. CONCLUSIONS: In clinical practice, the incidence of mucosal inflammation in the presence of colonic diverticular disease is low and endoscopy is the mainstay of differential diagnosis.

Prevalence of celiac disease and symptoms in relatives of patients with celiac disease.

BACKGROUND AND OBJECTIVES: We determined the prevalence and clinical features of celiac disease (CD) in family-members (FMs) of a population-based cohort of index cases. MATERIALS AND METHODS: We recruited 108 CD index cases: mean age at diagnosis, 23.0 years (range, 1.5-45.2 years); 81 (75%) female. Three-hundred twelve (mean age, 41.6 years; 219 [70%] female) of FMs were analyzed. 153 (49%) were parents, 24 (7.7%) were children, 69 (22.2%) were siblings, 66 (21.1%) were second degree FMs. RESULTS: CD was diagnosed in 63 subjects (20.1%, 21 males and 42 females, mean age 34.24 years, range 2-81 years). Classic, subclinical, and silent forms of CD were recognized in 18 [28.6% (6 siblings, 6 parents, 3 child, 3 second-degree FMs)], in 27 [45.8% (9 siblings, 3 parent, 15 second-degree FMs)], and in 18 [28.6% (6 siblings, 6 parents, 6 second-degree FMs)] cases, respectively. Most of patients suffering from "classical" (18/63 patients, 28.7%) and "subclinical" (27/63 patients, 42.9%) form of CD were older than patients suffering from "silent " CD (18/63 patients, 28.7%) (p=0.01). Most of patients suffering from subclinical disease showed autoimmune diseases (Hashimoto's thyroiditis, and psoriasis), and other atypical symptoms, as gastroesophageal reflux disease (GERD), were also recorded. CONCLUSIONS: We found an high-prevalence of CD between CD FMs, and most of them were olygo- or asymptomatic.

Safety and effectiveness of infliximab for inflammatory bowel diseases in clinical practice.

BACKGROUND AND OBJECTIVES: Our aim was to assess the efficacy and safety of infliximab (IFX) in clinical practice in three Primary Care, Hospital Centers. MATERIAL AND METHODS: From September 2004 to December 2008 62 patients (28 males, 34 females, mean age 30.25 years, range 15-55 years), affected by ulcerative colitis (UC) (23 pts) or by Crohn's disease (CD) (39 patients) were treated. Clinical efficacy, safety, mucosal healing and quality of life were assessed both in UC and CD. RESULTS: A total of 746 infusions were performed. IFX was administered for a mean of 26 months (range 8-44 months). 33/39 (84.61%) pts with CD were in remission under treatment with IFX for a mean time of 19 months (range 12-44 months). Mean Crohn Disease Activity Index (CDAI) score decreased from 295 (range 258-346) to 136 (range 98-136) (p < 0.005). Inflammatory Bowel Disease Quality of Life (IBDQL) improved from 48 (at entry) to 198 (at the end of the study) (p < 0.005). 20/23 (86.95%) patients with UC were in remission under treatment with IFX for a mean of 18 months (range 8-34 months). Mean Disease Activity Index (DAI) decreased from 11 (range 9-12) to < 3 (range 2-3) (p < 0.05). Mean Mayo Subscore for Endoscopy decreased from 3 to < 1 (range 0-1). IBDQL improved from 56 (at entry) to 194 (at the end of the study) (p < 0.005). Only 5 patients (8.06%) experienced side-effects. CONCLUSIONS: Long-term outpatients treatment with IFX seems to be safe and effective in managing patients affected by IBD in clinical practice.

The endoscopic spectrum of segmental colitis associated with diverticulosis.

OBJECTIVE: An endoscopic classification of 'Segmental colitis associated with diverticulosis' (SCAD) is lacking. Our aim was therefore to assess the endoscopic spectrum of SCAD, comparing it with the histological and clinical features. METHOD: A prospective study was performed from January 2004 to October 2007. Diagnosis of SCAD was made on the basis of specific endoscopic and histological patterns. RESULTS: A total of 6230 consecutive colonoscopies were performed during the study period. SCAD was diagnosed in 92 (1.48%) patients, with four endoscopic patterns: pattern A, 'crescentic fold disease' (52.20%); pattern B, 'Mild-to moderate ulcerative colitis-like' pattern (30.40%); pattern C, 'Crohn's disease colitis-like' pattern (10.90%); pattern D, 'Severe ulcerative colitis-like' pattern (6.50%). Most patients with patterns A (58.33%, P < 0.018) and B (89.29%, P < 0.00001) showed histological alterations resembling moderate ulcerative colitis (UC). In pattern C, larger histological variability was found (P < 0.01). All patients showing pattern D showed the typical histological alteration changes of severe UC (P < 0.0001). In pattern A (60.42%, P = n.s.) and pattern B (46.43%, P = n.s.), diarrhoea was the most common symptom whilst abdominal pain was the most frequent in pattern C (50%, P = n.s.) and pattern D (83.33%, P = n.s.) patients. CONCLUSIONS: Endoscopic patterns of SCAD may range from mild to severe inflammation. The histopathological findings but not clinical features showed a statistically significant association with the degree of endoscopic severity.

Effect of mesalazine on epithelial cell proliferation in colonic diverticular disease.

BACKGROUND AND AIMS: Increased epithelial cell proliferation may be detected in diverticular disease, but antibiotics have failed in reducing it. We assess therefore the effect of mesalazine on epithelial cell proliferation in diverticular disease. METHODS: A prospective study was conducted on 20 consecutive patients with a new endoscopic diagnosis of symptomatic uncomplicated diverticular disease. The patients were treated with mesalazine 1.6 mg/day for 1 year. The Ki-67 antigen index of the whole crypt and in the upper third was separately evaluated before and after starting the treatment. RESULTS: Cell proliferation index was higher in diverticular disease patients than healthy controls both in the whole crypt (median 6.7%, range 2-9% vs. median 1.6%, range 1-3%, p=0.001) and in the upper third of the crypt (median 6.8%, range 2-8% vs. median 1.8%, range 1-3%, p=0.001). Cell proliferation decreased throughout the follow-up. In the whole crypt it was 6.7% at entry and 3.8% at the end of treatment (p<0.005), whereas it was 6.8% at entry and 2.9% at the end of treatment in the upper third of the crypt (p<0.005). CONCLUSIONS: We found mesalazine effective in reducing the colonic cell proliferation in long-term treatment for colonic diverticular disease.

Crohn's disease and celiac disease: association or epiphenomenon?

Recent literature data show a certain relation between Crohn's disease and celiac disease. We describe herein what are the pro and the cons about a possible association between Crohn's disease and celiac disease.

Endoscopic and histological findings in the duodenum of adults with celiac disease before and after changing to a gluten-free diet: a 2-year prospective study.

BACKGROUND AND STUDY AIMS: Published follow-up data on small-intestinal recovery in patients with celiac disease are scarce and contradictory. This is especially the case for adult patients, who often show incomplete histological recovery after starting a gluten-free diet (GFD). We conducted a 2-year prospective study to evaluate the effectiveness of a GFD in improving the endoscopic and histological duodenal findings in adults with celiac disease. PATIENTS AND METHODS: We studied 42 consecutive adults with newly diagnosed celiac disease (13 men, 29 women; mean age 32.7 years, range 15 - 72 years). All the patients underwent esophagogastroduodenoscopy and small-bowel biopsy. We devised our own grading system for the endoscopic appearance of the duodenum, which ranged from "normal" appearance to "mild", "moderate", or "severe" alterations. Small-bowel biopsies were obtained from the second part of the duodenum (and from the duodenal bulb when it had a micronodular appearance). The histopathological appearances were described according to modified Marsh criteria. RESULTS: A normal endoscopic appearance in the duodenum was found in 5/42 patients (11.9 %) at entry and in 32/42 patients (76.2 %) after 2 years on a GFD. Subdividing the patients according to age, patients aged from 15 years to 60 years showed significant improvement within 12 months ( P < 0.0001 for patients aged from 15 years to 45 years; P < 0.003 for patients in the 46 years to 60 years group), whereas the improvement in endoscopic findings in patients older than 60 years was not statistically significant, even 24 months after starting the GFD. "Normal" histology was reported in none of the patients at entry, but in 25 patients (59.5 %) after 24 months on a GFD, but this parameter did not show a significant improvement until the patients had been on the GFD for 12 months ( P < 0.0001). Only the younger patients (5 - 30 years) showed significant improvement of histology within 12 months ( P < 0.034); older patients (>30 years) showed histological improvement but this was not statistically significant, even after 24 months on a GFD. CONCLUSIONS: This study shows for the first time that endoscopic recovery is faster than histological recovery in adults with celiac disease who go on a GFD. Moreover, older patients showed incomplete endoscopic and histological recovery even 24 months after starting a GFD. We therefore advise, as a minimum recommendation, that follow-up biopsies should be taken 1 - 2 years after starting a GFD in adults with celiac disease.

Symptomatic gastric leiomyoma mimicking giant gastric polyp: endoscopic diagnosis and removal.

Gastric leiomyoma is an uncommonly found benign submucosal neoplasm which may cause hemorrhage in rare cases. A 67-years-old patient was admitted to our attention due to two episodes of hematemesis and melena occurred in the previous two days. Esophagogastroduodenoscopy showed a giant semi-pedunculated gastric polyp (diameter of 4 centimeters) located at the distal body. A large ulcer with a clot was seen on the polyp. We treated endoscopically the giant polyp using the new two-steps-technique recently described by us for the treatment of the large pedunculated gastric and colorectal polyps, and the polypectomy was successfully performed without immediate or delayed complications. Histological evaluation of the transected polyp revealed morphology according to a gastric submucosal leiomyoma. Endoscopic control, performed one and four weeks and 12 months later, showed complete reepithelization of the gastric mucosa, without any sign of endoscopic, endosonographic and histological recurrence of the disease. This case report shows that our endoscopic approach may be successfully used also for giant semi-pedunculated gastric polyps.