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A relevant number of adenomas can be missed during colonoscopy.Assess the current status of colonoscopy procedures in Italian centers.A prospective observational study involving 17 hospitals (34 endoscopists) included consecutive patients undergoing standard colonoscopy. In the first phase, endoscopists performed consecutive colonoscopies. In the second phase, retraining via an online learning platform was planned, while in the third phase data were collected analogously to phase 1.A total of 3,504 patients were enrolled. Overall, a BBPS score ≥6 was obtained in 95.6% of cases (94.8% and 96.9% in the pre- and post-training phases, respectively). 88.4% of colonoscopies had a withdrawal time ≥6 min (88.2% and 88.7% in the pre- and post-training phases). Median adenoma detection rate (ADR) was 39.1%, with no significant differences between the pre- and post-training phases (40.1% vs 36.9%; P = 0.83). In total, 81% of endoscopists had a ADR performance above the 25% threshold.High colonoscopy quality standards are achieved by the Italian hospitals involved. Quality improvement initiatives and repeated module-based colonoscopy-training have been promoted in Italy during the last decade, which appear to have had a significant impact on quality colonoscopy metrics together with the activation of colorectal cancer screening programs.

Inflammation and oxidative stress play a crucial role in the development of colorectal cancer (CRC) and interference with these mechanisms represents a strategy in CRC chemoprevention. Allopurinol, a safe molecular scavenger largely used as antigout agent, has been shown to increase survival of patients with advanced CRC and to reduce CRC incidence in long-term gout users in epidemiologic studies. We conducted a randomized, double-blind, placebo-controlled preoperative trial in subjects with colorectal adenomatous polyps to assess the activity of allopurinol on biomarkers of colorectal carcinogenesis.After complete colonoscopy and biopsy of the index polyp, 73 subjects with colorectal adenomas were assigned to either placebo or one of two doses of allopurinol (100 mg or 300 mg) and treated for four weeks before polyp removal. Change of Ki-67 labeling index in adenomatous tissue was the primary endpoint. Secondary endpoints were the immunohistochemical (IHC) expression of NF-κB, β-catenin, topoisomerase-II-α, and terminal deoxynucleotidyl transferase–mediated dUTP nick end labeling (TUNEL) in adenomatous polyps and normal adjacent colonic tissue.Compared with placebo, Ki-67 levels were not significantly modulated by allopurinol, whereas β-catenin and NF-κB expression levels decreased significantly in adenomatous tissue, with a mean change from baseline of −10.6%, 95% confidence interval (CI), −20.5 to −0.7, and −8.1%, 95% CI, −22.7 to 6.5, respectively. NF-κB also decreased significantly in normal adjacent tissue (−16.4%; 95% CI, −29.0 to −3.8). No dose–response relationship was noted, except for NF-κB expression in normal tissue.Allopurinol can inhibit biomarkers of oxidative activation in colon adenomatous polyps and normal adjacent tissue. Further studies should define its potential chemopreventive activity. Cancer Prev Res; 6(2); 74–81. ©2012 AACR.

Commentary on This Article from A Randomized, Placebo-Controlled, Preoperative Trial of Allopurinol in Subjects with Colorectal Adenoma

Background Recent reports showed that the protective effect of flexible sigmoidoscopy (FS) screening was maintained up to17 years, although differences were reported by sex. Objective To assess long-term reduction of colorectal cancer (CRC) incidence and mortality after a single FS screening. Design Parallel randomized controlled trial. (ISRCTN registry number: 27814061). Setting 6 centers in Italy. Participants Persons aged 55 to 64 years expressing interest in having FS screening if invited, recruited from 1995 to 1999 and followed until 2012 (incidence) and 2014 to 2016 (mortality). Intervention Eligible persons were randomly assigned (1:1 ratio) to either the once-only FS screening group or control (usual care) group. Measurements Incidence and mortality rate ratios (RRs) and rate differences. Results A total of 34 272 persons (17 136 in each group) were included in the analysis; 9911 participants had screening in the intervention group. Median follow-up was 15.4 years for incidence and 18.8 years for mortality. Incidence of CRC was reduced by 19% (RR, 0.81 [95% CI, 0.71 to 0.93]) in the intention-to-treat (ITT) analysis, comparing the intervention with the control group, and by 33% (RR, 0.67 [CI, 0.56 to 0.81]) in the per protocol (PP) analysis, comparing participants screened in the intervention group with the control persons. Colorectal cancer mortality was reduced by 22% (RR, 0.78 [CI, 0.61 to 0.98]) in the ITT analysis and by 39% (RR, 0.61 [CI, 0.44 to 0.84]) in the PP analysis. Incidence of CRC was statistically significantly reduced among both men and women. Colorectal cancer mortality was statistically significantly reduced among men (ITT RR, 0.73 [CI, 0.54 to 0.97]) but not among women (ITT RR, 0.90 [CI, 0.59 to 1.37]). Limitation Self-selection of volunteers from the general population sample targeted for recruitment may limit generalizability. Conclusion The strong protective effect of a single FS screening for CRC incidence and mortality was maintained up to 15 and 19 years, respectively. Primary funding source Italian Association for Cancer Research, Italian National Research Council, Istituto Oncologico Romagnolo, Fondo "E. Tempia," University of Milan, and Local Health Unit ASL-Torino.

Colorectal cancer (CRC) screening programs help diagnose cancer precursors and early cancers and help reduce CRC mortality. However, currently recommended tests, the fecal immunochemical test (FIT) and colonoscopy, have low uptake. There is therefore a pressing need for screening strategies that are minimally invasive and consequently more acceptable to patients, most likely blood based, to increase early CRC identification. MicroRNAs (miRNAs) released from cancer cells are detectable in plasma in a remarkably stable form, making them ideal cancer biomarkers. Using plasma samples from FIT-positive (FIT+) subjects in an Italian CRC screening program, we aimed to identify plasma circulating miRNAs that detect early CRC. miRNAs were initially investigated by quantitative real-time PCR in plasma from 60 FIT+ subjects undergoing colonoscopy at Fondazione IRCCS Istituto Nazionale dei Tumori, then tested on an internal validation cohort (IVC, 201 cases) and finally in a large multicenter prospective series (external validation cohort [EVC], 1121 cases). For each endoscopic lesion (low-grade adenoma [LgA], high-grade adenoma [HgA], cancer lesion [CL]), specific signatures were identified in the IVC and confirmed on the EVC. A two-miRNA-based signature for CL and six-miRNA signatures for LgA and HgA were selected. In a multivariate analysis including sex and age at blood collection, the areas under the receiver operating characteristic curve (95% confidence interval) of the signatures were 0.644 (0.607-0.682), 0.670 (0.626-0.714) and 0.682 (0.580-0.785) for LgA, HgA and CL, respectively. A miRNA-based test could be introduced into the FIT+ workflow of CRC screening programs so as to schedule colonoscopies only for subjects likely to benefit most.

Cancer of the esophagus and of gastroesophageal junction can be cured, even if with lacking cure rate. Different approaches have been developed, mostly when carcinoma has loco-regional pattern. Multimodality therapy showed a survival rate superior than 10% if compared to a single approach. This is a systematic review, carried to assess the following matters: Which therapeutic opportunities are available? Who could benefit of them? Which adverse reactions could possibly verify? How can physicians definitely choose the proper strategy? Which is the role of surgery? We mean to give either General Practitioner or specialists clear and efficient updates about current treatment of this tumour, starting from physical examination. Four eminent guidelines were consulted for our study: Cancer Care Ontario's Program in Evidence-Based Care, NCCN, Belgian Health Care Knowledge Centre and Esmo.

To analyze treatment and survival in a series of resected patients with primary or recurrent retroperitoneal sarcoma (RPS) treated and prospectively followed at a single institution. Between July 1994 and December 2015, 89 patients (36 M, 53 F; mean age 60 years, range 25–79) were evaluated. For the purpose of analysis, complete resection was defined as removal of gross tumor with histologically confirmed clear resection margins. Eighty-three out of the 89 patients (93%), 46 of whom affected by primary RPS, and 37 by recurrent RPS, underwent surgical exploration. Sixty-two had a grossly and microscopically complete resection. Fifty-three out of 83 patients (64%) underwent removal of contiguous intra-abdominal organs. Preoperative mortality was nil and significant preoperative complications occurred in six cases only (7%). High-grade tumor pointed out to be a significant variable for a worse survival in all 83 patients amenable to undergo surgical resection (57% 5 years survival for low grade vs 14% for high grade; P = 0.0004). Among completely resected patients, only histologic grade clearly affected disease-free survival (72% 5 years survival for low grade vs 50% for high grade; P = 0.04), while the role of preoperative blood transfusions (67% 5 years survival for non-transfused patients vs 29% for transfused patients; P = 0.05) has to be evaluated in connection to patient complexity. Histological grade and recurrence are the most valuable prognostic predictors; in this clinical subset, an aggressive surgical approach in both primary and recurrent RPS is associated with a best long-term survival and disease-free survival.

Background Success of colonoscopy is linked to the adequacy of bowel cleansing. Polyethylene glycol 4 L (PEG 4 L) solutions are widely used for colonic cleansing but with limitations concerning tolerability and acceptability. Aim To demonstrate the equivalence of a new low-volume PEG containing citrates and simeticone (Clensia) versus a standard PEG 4 L. Methods In this, multicentre, randomised, observer-blind trial, patients received either Clensia 2 L or PEG 4 L solution. Primary endpoint was the proportion of patients with colon cleansing evaluated as excellent or good. Results 422 patients received Clensia (n = 213) or PEG 4 L (n = 209). Rate of excellent/good bowel cleansing was 73.6% and 72.3% in Clensia and PEG 4 L group respectively. Clensia was demonstrated to be equivalent to PEG 4 L. No SAEs were observed. Clensia showed better gastrointestinal tolerability (37.0% vs 25.4%). The acceptability was significantly better with Clensia in terms of proportion of subjects who felt no distress (Clensia 72.8% vs PEG 4 L 63%, P = 0.0314) and willingness-to-repeat (93.9% vs 82.2%, P = 0.0002). The rate of optimal compliance was similar with both formulations (91.1% for Clensia vs 90.9% for PEG 4 L, P = 0.9388). Conclusions The low-volume Clensia is equally effective and safe in bowel cleansing compared to the standard PEG 4 L, with better gastrointestinal tolerability and acceptability.

Background and Aims: Most of the evidence supporting endoscopic submucosal dissection (ESD) comes from Asia. European data are primarily reported by specialized referral centers and thus may not be representative of common European ESD practice. The aim of this study is to understand the current state of ESD practice across Italian endoscopy centers. Methods: All Italian endoscopists who were known to perform ESD were invited to complete a structured questionnaire including: operator features and competencies, ESD training details and clinical outcomes over a 2-year period. Results: Twenty-nine operators from 23 centers (69% response rate) completed the questionnaire: 18 (62%) were 150 in 8 (27.5%). Colorectal ESD was predominant for operators with an experience >80 cases. En-bloc resection rates ranged from 77.2 to 97.2% depending on the anatomic location with an R0 resection rate range of 75.3–93.6%. ESD perforation rates in the colon and rectum were significantly lower when experience was >150 compared to 80–150 cases (p < 0.0001 and p = 0.006 for colon and rectum, respectively). Conclusion: ESD in Italy is performed by a significant number of operators. Overall, Italian endoscopists performing ESD have achieved a good competence level. However, there is much variability in training protocols, initial supervision of procedures, practice settings, case mix and procedural volume/year that are likely responsible for some of the suboptimal resectional outcomes and increased perforation risk, mainly in the colon. Standardized training programs, practice parameters and auditing of outcomes are required.

Background Fluorouracil-based adjuvant chemotherapy in gastric cancer has been reported to be effective by several meta-analyses. Perioperative chemotherapy in locally advanced resectable gastric cancer (RGC) has been reported improving survival by two large randomized trials and recent meta-analyses but the role of neoadjuvant chemotherapy and optimal regimen remains to be determined. We compared a neoadjuvant with adjuvant docetaxel-based regimen in a prospective randomized phase III trial, of which we present the 10-year follow-up data. Patients and methods Patients with cT3–4 anyN M0 or anyT cN1–3 M0 gastric carcinoma, staged with endoscopic ultrasound, computed tomography, bone scan, and laparoscopy, were assigned to receive four 21-day/cycles of docetaxel 75 mg/m2 day 1, cisplatin 75 mg/m2 day 1, and fluorouracil 300 mg/m2/day over days 1–14, either before (arm A) or after (arm B) gastrectomy. Event-free survival was the primary end point, whereas secondary end points included overall survival, toxicity, down-staging, pathological response, quality of life, and feasibility of adjuvant chemotherapy. Results This trial was activated in November 1999 and closed in November 2005 due to insufficient accrual. Of the 70 enrolled patients, 69 were randomized, 34 to arm A and 35 to arm B. No difference in EFS (2.5 years in both arms) or OS (4.3 versus 3.7 years, in arms A and B, respectively) was found. A higher dose intensity of chemotherapy was observed in arm A and more frequent chemotherapy-related serious adverse events occurred in arm B. Surgery was safe after preoperative chemotherapy. A 12% pathological complete response was observed in arm A. Conclusion Docetaxel/cisplatin/fluorouracil chemotherapy is promising in preoperative setting of locally advanced RGC. The early stopping could mask the real effectiveness of neoadjuvant treatment. However, the complete pathological tumour responses, feasibility, and safe surgery warrant further investigation of a taxane-based regimen in the preoperative setting.

Background: Characteristics such as gender and lifestyle are not taken in account in colorectal cancer screening and surveillance recommendations. Aims: To identify factors associated with advanced neoplasia at initial and surveillance colonoscopy. Methods: In this observational study, 750 individuals with positive faecal occult blood test, aged 50-74 years, underwent a first screening colonoscopy in 2007-2009. We collected anthropometric data as well as data on physical activity, smoking and drinking habits, fruit and vegetable consumption and low-dose aspirin use through a questionnaire. Results: At initial colonoscopy advanced neoplasia (n = 399, 53.2%) was positively associated with age, male gender, smoking and alcohol drinking, and inversely associated with physical activity, fruit and vegetables consumption and long-term use of aspirin. These 7 factors were used to calculate a risk score, ranging from 0 (no unfavourable characteristics) to 7 (all unfavourable characteristics present), which was significantly associated with advanced neoplasia (odds ratio 1.55 for one point increase, P < 0.01). Among the 372 adenoma patients who returned for follow-up surveillance colonoscopy, the score remained associated with advanced neoplasia (odds ratio 1.28 for one point increase, P = 0.01). Conclusion: Besides age and gender, modifiable factors such as lifestyle and aspirin use were associated with the risk of advanced neoplasia at initial and surveillance colonoscopy.

In robotic right hemicolectomy for colorectal cancer (CRC), appropriate lymphadenectomy and anastomotic leak prevention are critical. Visualisation of lymph nodes and blood flow with near-infrared (NIR) fluorescence DaVinci® imaging system is a recent development. Herein, we present an improved robotic modified complete mesocolic excision (mCME) technique using indocyanine green (ICG) fluorescence. Before surgery, ICG is injected into the submucosa around the tumour with endoscopy for intraoperative detection of lymph nodes. Robotic mCME with central vascular ligation is performed, supplemented in most of the cases with selective extended lymphadenectomy. Intestinal blood flow before anastomosis is evaluated by administering ICG intravenously and NIR visualisation. Visualisation of the lymph nodes with ICG facilitates standard mCME lymphadenectomy and enables extended lymphadenectomy. Blood flow of the intestinal walls of the anastomotic site can be assessed and determines the extent of intestinal resection. Robotic double ICG technique for robotic right hemicolectomy enables improved lymphadenectomy and warrants the extent of intestinal resection; thus, becoming a strong candidate for gold standard in robotic resections of the right colon for CRC.

Benign anastomotic colonic stenosis sometimes occur after surgery and usually require surgical or endoscopic dilation. Endoscopic dilation of anastomotic colonic strictures by using balloon or bougie-type dilators has been demonstrated to be safe and effective in multiple uncontrolled series. However, few data are available on safety and efficacy of endoscopic electrocautery dilation. The aim of our study was to retrospectively investigate safety and efficacy of endoscopic electrocautery dilation of postsurgical benign anastomotic colonic strictures.Sixty patients (37 women; median age 63.6 years, range 22.6-81.7) with benign anastomotic colonic or rectal strictures treated with endoscopic electrocautery dilation between June 2001 and February 2013 were included in the study. Anastomotic stricture was defined as a narrowed anastomosis through which a standard colonoscope could not be passed. Only annular anastomotic strictures were considered suitable for electrocautery dilation which consisted of radial incisions performed with a precut sphincterotome. Treatment was considered successful if the colonic anastomosis could be passed by a standard colonoscope immediately after dilation. Recurrence was defined as anastomotic stricture reappearance during follow-up.The time interval between colorectal surgery and the first endoscopic evaluation or symptoms development was 7.3 months (1.3-60.7). Electrocautery dilation was successful in all the patients. There were no procedure-related complications. Median follow-up was 35.5 months (2.0-144.0). Anastomotic stricture recurrence was observed in three patients who were successfully treated with electrocautery dilation and Savary dilation.Endoscopic electrocautery dilation is a safe and effective treatment for annular benign anastomotic postsurgical colonic strictures.

We evaluated clinical activity of 90Yttrium-ibritumomab (90Y-ibritumomab) tiuxetan in extranodal marginal-zone lymphoma. From May 2004 to April 2011, 30 patients affected by relapsed/refractory marginal-zone lymphoma—arisen at any extranodal site—received 90Y-ibritumomab tiuxetan at the activity of 0.4 mCi/kg. Median age was 57 years. At time of treatment, 13 out of 30 patients had disseminated disease (stage III/IV). All patients had received a previous treatment with a maximum of 7. Overall response rate was 90%: 23 patients achieved a complete response (77%); partial response occurred in 4 patients (13%), stable disease in 2 patients (7%) and 1 progression (3%). With a median follow-up of 5.3 years, median time to relapse was not reached; 2 patients relapsed after complete response; 18 out of 23 complete responses are still responders after >3 years, 12 of them after >5 years. 90Y-ibritumomab tiuxetan seems to be active in patients with extranodal marginal-zone lymphoma relapsed/refractory to conventional treatment including radiotherapy. These results suggest that radioimmunotherapy could represent a possible option for the treatment in this subset of patients. Copyright © 2013 John Wiley & Sons, Ltd.

Background Diagnosis and management of Barrett's oesophagus are controversial. Technical improvements in real-time recognition of intestinal metaplasia and neoplastic foci provide the chance for more effective target biopsies. Confocal laser endomicroscopy allows to analyze living cells during endoscopy. Aims To assess the diagnostic accuracy, inter- and intra-observer variability of endomicroscopy for detecting in vivo neoplasia (dysplasia and/or early neoplasia) in Barrett's oesophagus. Methods Prospective pilot study. Patients referred for known Barrett's oesophagus were screened. Endomicroscopy was carried out in a circular fashion, every 1–2 cm, on the whole columnar-lined distal oesophagus. Visible lesions, when present, were analyzed first. Targeted biopsies were taken. Confocal images were classified according to confocal Barrett classification. Endomicroscopic and histological findings were compared. Results Forty-eight out of 50 screened patients underwent endomicroscopy. Visible lesions were observed in 3 patients. In a per-biopsy analysis, Barrett's-oesophagus-associated neoplasia could be predicted with an accuracy of 98.1%. The agreement between endomicroscopic and histological results was substantial ( κ = 0.76). Conclusions This study suggests that endomicroscopy can provide in vivo diagnosis of Barrett's oesophagus-associated neoplasia. Because it allows for the study of larger surface areas of the mucosa, endomicroscopy may lead to significant improvements in the in vivo screening and surveillance of Barrett's oesophagus.

Success of colonoscopy is linked to the adequacy of bowel cleansing. Polyethylene glycol 4L (PEG 4L) solutions are widely used for colonic cleansing but with limitations concerning tolerability and acceptability.To demonstrate the equivalence of a new low-volume PEG containing citrates and simeticone (Clensia) versus a standard PEG 4L.In this, multicentre, randomised, observer-blind trial, patients received either Clensia 2L or PEG 4L solution. Primary endpoint was the proportion of patients with colon cleansing evaluated as excellent or good.422 patients received Clensia (n=213) or PEG 4L (n=209). Rate of excellent/good bowel cleansing was 73.6% and 72.3% in Clensia and PEG 4L group respectively. Clensia was demonstrated to be equivalent to PEG 4L. No SAEs were observed. Clensia showed better gastrointestinal tolerability (37.0% vs 25.4%). The acceptability was significantly better with Clensia in terms of proportion of subjects who felt no distress (Clensia 72.8% vs PEG 4L 63%, P=0.0314) and willingness-to-repeat (93.9% vs 82.2%, P=0.0002). The rate of optimal compliance was similar with both formulations (91.1% for Clensia vs 90.9% for PEG 4L, P=0.9388).The low-volume Clensia is equally effective and safe in bowel cleansing compared to the standard PEG 4L, with better gastrointestinal tolerability and acceptability.

Aliment Pharmacol Ther 2012; 35: 222–237 Summary Background Previous reviews of bowel preparation for colonoscopy have given contradictory answers. Aim To provide a definitive insight, using PRISMA-compliant methodology. Methods A comprehensive literature review identified randomised controlled trials comparing bowel preparation regimens. Data for quality of bowel preparation were pooled in multiple meta-analyses exploring a range of inclusion criteria. Results A total of 104 qualifying studies were identified, the majority of which involved comparisons of sodium phosphate (NaP) or polyethylene glycol (PEG). There was no significant difference demonstrated between NaP and PEG overall (OR = 0.82; 95% CI = 0.56–1.21; P = 0.36). Cumulative meta-analysis demonstrated that this conclusion has been qualitatively similar since the mid 1990s, with little quantitative change for the past 10 years. Amongst studies with previous day dosing in both study arms there was a significant advantage in favour of PEG (OR = 1.78; 95% CI = 1.13–2.81; P = 0.006). Studies focussing on results in the proximal colon also favoured PEG (OR = 2.36; 95% CI = 1.16–4.77; P = 0.012). PEG was also significantly more effective than non-NaP bowel preparation regimens (OR = 2.02; 95% CI = 1.08–3.78; P = 0.03). Other comparisons showed no significant difference between regimens. Conclusions Although there is no compelling evidence favouring either of the two most commonly used bowel preparation regimens, this may reflect shortcomings in study design. Where studies have ensured comparable dosage, or the clinically relevant outcome of proximal bowel clearance is considered, PEG-based regimens offer the most effective option.

Colorectal cancer screening programs result in an early diagnosis of the disease. In 2007, 250 malignant polyps were identified in Lombardy, out of 1,329 screen-detected colorectal carcinomas. The Italian Group for Colorectal Cancer (GISCoR) promoted the multicentric study “Endoscopic Follow-up versus Surgical Radicalization of Malignant Polyps after Complete Endoscopic Polypectomy” (SEC-GISCoR). The protocol was a multicentric, prospective, observational, non-randomized study. It included patients diagnosed a colorectal malignant adenoma, after complete endoscopic removal. From November 2005 to September 2009, three participating centers enrolled 120 patients with malignant polyps after “complete” endoscopic polypectomy; malignant polyps were classified as “low risk” or “high risk”. The study had two arms: “Intensive follow-up” (42 patients: 32 with low-risk and 10 with high-risk polyps) and “Surgical radicalization” (78 patients: 5 with low-risk and 73 with high-risk polyps). Data were collected using an online CRF. Overall, 37/120 polyps (30.8%) were low risk and 83/120 (69.2%) were high risk. 42 out of 120 patients (35%) were enrolled in the “clinical follow-up” arm, while 78/120 (65%) entered the surgery arm. In 15 cases, patients were not enrolled in the correct arm, according to the criteria agreed upon before starting the study. There still is a high incidence (11.5%) of pathological mismatches. No clinical event was reported in 2.9 years of follow-up. In conclusion, some differences emerged in the management of patients with malignant polyps among participating centers (p

We assessed feasibility, short-term oncologic safety, and short-term outcomes in robotic total mesorectal excision (R-TME) for rectal cancer compared with laparoscopic TME. From March 2008 to June 2009, 50 patients with proven middle/lower rectal adenocarcinoma underwent minimally invasive TME; 25 received R-TME. The groups were balanced (R-TME versus L-TME) in terms of age (median 69 versus 62 years; p = 0.8), disease stage, and body mass index (median 23 versus 26.5 kg/m2; p = 0.06). There were 37 (74%) anterior resections and 13 (26%) abdominoperineal resections. Twenty-three (46%) patients received preoperative radiochemotherapy. The robot was a four-arm Da Vinci S (Intuitive Surgical, Sunnyvale, CA, USA). Median operating time (R-TME versus L-TME) was 240 versus 237 min (p = 0.2); first bowel movement was 2 versus 3 days (p = 0.5); median hospital stay was 6.5 versus 6 days (p = 0.4). Major complications with reoperation were two in R-TME (one anastomotic leakage, one small bowel perforation) and three in L-TME (one colonic ischemia, two anastomotic leakage). Postoperative complications were 16% versus 24% (p = 0.5). A median of 18 versus 17 (p = 0.7) lymph nodes were retrieved; distal resection margins were disease free in both groups; circumferential margin was involved (

Here, we present the results of a randomised clinical trial carried out between 1998 and 2004, evaluating the possible role of radiotherapy (RT) as consolidation treatment after induction chemotherapy (CT) in diffuse large B-cell (DLBC) gastric lymphoma. Fifty-four patients were enrolled and all received anthracycline containing regimens as induction CT. Patients were evaluated after four to six cycles and those in complete remission (CR) were randomised to receive gastric involved field (IF) RT or two addition cycles of the same CT. Forty-five patients (83%) were randomised after the induction CT. Clinical results of patients allocated to the RT arm showed a significant reduction in incidence of local relapse versus patients who received CT alone. However, overall survival was not different between the two arms. Our results confirm that CT could be considered as first line therapy for newly diagnosed gastric DLBC lymphoma; IF RT delivered in those patients achieving CR after induction CT is able to prevent local relapse.

Background & Aims: We conducted a study to estimate population coverage and detection rate (DR) achievable through different strategies of colorectal cancer (CRC) screening. Methods: A population-based multicenter randomized trial comparing 3 strategies was used: (1) biennial immunologic fecal occult blood test (FIT), (2) "once only" sigmoidoscopy (FS), and (3) "once only" colonoscopy (TC). A random sample of men and women, aged 55 to 64 years, was drawn from general practitioners' (GP) rosters. Eligible subjects, randomized within GP, were mailed a personal invitation. Nonresponders in groups 2 and 3 were invited again at 12 and 24 months. Screenees with "high-risk" distal polyps (villous component >20%, high-grade dysplasia, CRC, size ≥10 mm, >2 adenomas) at FS, or with positive FIT, were referred for TC. Results: The attendance rate was 32.3% (1965/6075) for FIT, 32.3% (1944/6018) for FS, 26.5% (1597/6021) for TC. FIT detected 2 patients with CRC (0.1%) and 21 with an advanced adenoma (1.1%). The corresponding figures were as follows: 12 (0.6%) and 86 (4.5%) patients, respectively, for FS; 13 (0.8%) and 100 (6.3%) patients, respectively, for TC. To detect 1 advanced neoplasm, it would be necessary to invite 264 people with FIT, 60 with FS, 53 with TC. FS would have detected 27.3% of the proximal advanced neoplasms detected at TC. Assuming the same participation rate at TC as at FS, 48 TCs would be necessary to detect 1 additional advanced neoplasm missed by FS. Conclusions: When participants are offered 1 screening test, participation is lower in a TC than in an FS program. However, DR of advanced neoplasia is higher with TC.

Colonoscopic polypectomy is effective in reducing the incidence of and mortality from colorectal cancer, but is not complication-free.To evaluate the incidence of early and delayed polypectomy complications and factors associated with their occurrence in a community setting.Web-database collection of patients' and polyp's features in consecutive colonic polypectomies during a 3-month period in 18 endoscopy centres.Data on 5178 polypectomies in 2692 patients (54.3% males, mean age 59 years) were collected. The majority of the polyps were10mm (83.5%). Antithrombotic agents were taken by 22.7% of patients, 57.3% of which withheld them before the procedure. Overall, 5 patients experienced perforations (0.2%) and 114 had bleeding (4.2%); the overall complication rate was 4.4%. Early complications were observed in 87 (3.2%); delayed complications (all major bleedings) occurred in 32 (1.2%). At multivariate analysis polyp size (size10mm: OR 4.35, 95% CI 5.53-7.48) and, inversely, right-sided location (OR 0.58, 95% CI 0.36-0.94) were correlated with bleeding events. The use of antithrombotics was associated with 5-fold increased risk of delayed bleeding.In the community setting, polypectomy was associated with a 1.4% risk of major complications. Polyp size and, inversely, right-sided location were associated with early bleeding; the use of antithrombotics increased the risk of delayed events.

Obstruction is a common complication of advanced colorectal cancer. Stent insertion can reduce the need for emergency surgery and allows chemotherapy to begin immediately.To evaluate the technical and clinical success and long-term outcome of stent placement in the management of acute malignant colorectal obstruction.From July 2002 to April 2005, 29 self-expanding metal stents were placed in 24 patients (13 men, mean age 67 years, range 36-83). Stents were inserted under endoscopic and fluoroscopic control. Patients were clinically and endoscopically followed up.Twenty-eight out of 29 stents were successfully placed (96.5%) in 23 out of 24 patients with 25 strictures. The clinical success rate was 95.8% (23/24). Two early stent migrations were observed in two patients (8.3%). Late complications developed in eight patients (33.3%) after a median of 3.8 months (range1-8.6): two migrations and six occlusions. The median survival was 9.8 months (range1-27). Eleven patients (45.8%) died from progressive disease without any clinical evidence of recurrent obstruction.Stent placement is safe and effective. Stent complications are frequent but not life-threatening, and are easy to manage. An improvement in stent design and well-scheduled follow-up are needed in order to prevent such complications.

This study reviewed the results of surgery for distal rectal cancer (where the tumour was within 6 cm of the anal verge) following the introduction of total mesorectal excision for rectal cancer in one institution. One hundred and fifty-three patients who had undergone elective curative surgical resection of rectal cancer within 6 cm of the anal verge were included. The demographic, operative and follow-up data were collected retrospectively. Comparisons were made between patients who had different surgical procedures. The overall operative mortality rate was nil, and the morbidity 41%. With a mean follow-up of 37 months (range 5–100 months), local recurrence occurred in 18 of the patients. The 5-year actuarial local recurrence rates for double-stapled anastomosis, low-strength anastomosis and abdominoperineal resection (APR) were 39, 17 and 11% respectively. The local recurrence rate was significantly higher for double-stapled low anterior resection than for the other types of operation (P=0.007). On multivariate analysis type of surgery (P=0.025) and tumour stage (P=0.043), were associated with local recurrence, but only stage was a significant prognosticator of overall survival (P=0.0006). With the practice of total mesorectal excision, APR was still necessary in 40% of patients with rectal cancer within 6 cm of the anal verge. The local recurrence rate was lower in patients treated with APR than in those with double-stapled low anterior resection; however, survival rates were similar in these two groups.

This study was designed to assess the predictive value for advanced proximal neoplasms (cancer, adenomaor = 10 mm, or villous component20 percent, or severe dysplasia) of the characteristics of distal polyps.The study was conducted among patients, aged 55 to 64 years, referred for colonoscopy in the Italian trial of sigmoidoscopy screening for colorectal cancer. Patients reporting a history of colorectal cancer, adenomas, inflammatory bowel disease, recent colorectal endoscopy, or two first-degree relatives with colorectal cancer were excluded. We compared the prevalence of advanced proximal neoplasia in patients with "low-risk" (1-2 tubular adenomas,10 mm, with low-grade dysplasia, or hyperplastic polyp) and in those with "high-risk" (size,or = 10 mm, oror = 3 adenomas, or villous component20 percent, or severe dysplasia) polyps in the distal colon.Of 426 patients with polyps5 mm, 29 (6.9 percent) were detected with an advanced proximal neoplasm (including 4 colorectal cancers). The prevalence of proximal advanced neoplasia was 9.4 percent among patients with high-risk distal polyps and 2.5 percent among those with low-risk lesions (adjusted odds ratio, 3.19; 95 percent confidence interval, 1.06-9.59). Approximately 40 people with low-risk distal polyps 6 to 9 mm should undergo colonoscopy to detect one proximal advanced neoplasm; the corresponding number for patients with high-risk distal polyps is 10.The 2.5 percent prevalence of proximal advanced neoplasms among people with low-risk 6-mm to 9-mm distal polyps is similar to the prevalence observed among people without distal polyps. Restricting colonoscopy referral to patients with high-risk distal polyps might represent a cost-effective strategy in a screening context.

Argon plasma coagulation is suitable for treating hemorrhagic GI tract lesions. This study evaluated the frequency and clinical outcomes of complications arising during use of argon plasma coagulation to treat chronic radiation-induced proctopathy.This uncontrolled prospective study included 27 consecutive patients. Fever and any rectal symptoms or signs were assessed by telephone with a structured questionnaire. Patients with symptoms underwent endoscopy; follow-up examination was performed when rectal complications developed.Fifty-nine therapeutic sessions were performed (mean 2 per patient; mean interval between sessions, 72.5 days); mean follow-up was 11.5 months. The treatment reduced the mean bleeding severity score from 2.8 to 0.5 (p0.001). Two patients (7%) experienced fever and anal pain, and 14 (52%) developed rectal ulcers but remained asymptomatic; ulcer detection never precluded further treatment. Ulcer healing was assessed in 7 patients after a mean of 141 days; no strictures were observed.The frequency of complications during argon plasma coagulation for radiation-induced proctopathy was high in the present series (59%), the most frequent untoward event being the development of rectal ulcers in asymptomatic patients. However, given the benign outcome, these lesions do not necessitate discontinuation of treatment or additional monitoring.

A single sigmoidoscopy examination at around age 60 years has been proposed as a cost-effective strategy to prevent colorectal cancer. A multicenter randomized controlled trial, the SCORE trial, is in progress in Italy to estimate the impact of this strategy on colorectal cancer incidence and mortality and the duration of the protective effect. We present the baseline screening outcomes.A questionnaire was mailed to a random sample of 236 568 people aged 55-64 years to assess their eligibility for and interest in screening. Those reporting a history of colorectal cancer, adenomas, inflammatory bowel disease, recent colorectal endoscopy, or two first-degree relatives with colorectal cancer were excluded. Eligible, interested respondents were assigned randomly to the control group (no further contact) or the intervention group (invitation to undergo sigmoidoscopy). Screenees with colorectal cancer, polyps larger than 5 mm, three or more adenomas, adenomas 5 mm or smaller with a villous component of more than 20%, or severe dysplasia were referred for colonoscopy.Of the 56 532 respondents (23.9% of those invited), 34 292 were enrolled and 17 148 were assigned to the screening group. Of those, 9999 attended and 9911 were actually examined by sigmoidoscopy. Distal adenomas were detected in 1070 subjects (10.8%). Proximal adenomas were detected in 116 of 747 (15.5%) subjects without cancer at sigmoidoscopy who then underwent colonoscopy. A total of 54 subjects was found to have colorectal cancer, a rate of 5.4 per 1000 (54% of which were Dukes' A). The procedures were relatively safe, with two perforations (one in 9911 sigmoidoscopy exams and one in 775 colonoscopies) and one hemorrhage requiring hospitalization after polypectomy during colonoscopy. The pain associated with sigmoidoscopy was described as mild or less than expected by 83.3% of the screenees.Sigmoidoscopy screening is generally acceptable to recipients and safe. The high yield of advanced adenomas is consistent with the projected impact of sigmoidoscopy screening on colorectal cancer incidence.

a b s t r a c t Background & aims: The recent enormous increase in colonoscopy demand prompted this multicentre observational study assessing overall acceptability and efficacy of commonly used bowel preparations in Italian clinical practice. Methods: Consecutive outpatients undergoing colonoscopy were recruited from 9 major gastroentero- logical centres in Italy. Each patient evaluated overall acceptability of the bowel cleansing preparation through a 0-100 mm Visual Analogue Scale. The Visual Analogue Scale score was dichotomized by a median split: 80-100 (high acceptability) vs. 0-79 (low acceptability). Bowel cleansing was assessed through a validated scale. The influence of potential individual determinants on patients' acceptability and cleansing efficacy of the bowel preparations was determined by multivariate analyses. Results: 599 evaluable patients were enrolled; 57.3% received 4L-PEG preparations, 29.5% 2L- PEG preparations and 13.2% 2-glasses-solutions (Na-phosphate/Mg-citrate/Na-picosulphate-containing preparations). Overall acceptability was significantly higher for 2L-PEG and 2-glasses solutions than 4L- PEG (adjusted odds ratio, 4.72; and adjusted odds ratio 2.07, respectively). Successful bowel cleansing achieved with 4L-PEG (85.9%) was similar to 2L-PEG (85.3%; adjusted odds ratio 0.82) and significantly higher than 2-glasses solutions (69.6%; adjusted odds ratio 0.34 vs. 4L-PEG). Split regimen, lower total preparation volume and colonoscopy reason (periodical control vs. 1st procedure) were significantly asso- ciated with high acceptability. Age ≥60 years, dissatisfaction with the preparation taken, and ≤4/week bowel movements were major determinants of a poor bowel cleansing. Conclusions: 2L-PEG and 4L-PEG preparations provide the most effective bowel cleansing for colonoscopy in clinical practice, with a significantly higher acceptability for 2L-PEG preparations.

Argon plasma coagulation (APC) is a new method of non-contact electrocoagulation, using high frequency current by means of ionized argon gas (argon plasma). Recently, this technique has become available for flexible endoscopic delivery through special probes. Aim of this study is to evaluate the efficacy, indications and the possible side effects of APC use in the palliative treatment of malignant airway obstructions and/or bleeding. Over a 24-month period, 47 patients underwent APC treatment for malignant neoplasms of the tracheobronchial system causing obstruction and/or recurrent bleeding. Immediate airway patency and haemostasis were obtained in 91.5% of cases (43/47). No complications or side effects caused by the treatment were observed. In two patients, the treatment allowed a radical surgical approach after induction chemotherapy. In all cases, APC proved to be highly effective and easy to perform. In our experience, APC has proven to be easy to perform, rapidly effective, safe and well tolerated by the patient, even after repeated application. This study highlights the value of endoscopic APC in the palliative management of tracheobronchial neoplasms.

The association between gastric carcinoma and lymphoma is rare. Confocal laser endomicroscopy is a new diagnostic tool that allows the identification of cellular and vascular architecture during endoscopy. This is the first report of an in vivo early gastric carcinoma diagnosis by confocal laser endomicroscopy in a patient successfully treated for a primary gastric diffuse large-B-cell lymphoma.

To evaluate the efficacy, tolerability, acceptability and feasibility of bisacodyl plus low volume polyethyleneglycol-citrate-simeticone (2-L PEG-CS) taken the same day as compared with conventional split-dose 4-L PEG for late morning colonoscopy.Randomised, observer-blind, parallel group, comparative trial carried out in 2 centres. Out patients of both sexes, aged between 18 and 85 years, undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up were eligible. The PEG-CS group received 3 bisacodyl tablets (4 tablets for patients with constipation) at bedtime and 2-L PEG-CS in the morning starting 5 h before colonoscopy. The control group received a conventional 4-L PEG formulation given as split regimen; the morning dose was taken with the same schedule of the low volume preparation. The Ottawa Bowel Preparation Scale (OBPS) score was used as the main outcome measure.A total of 164 subjects were enrolled and 154 completed the study; 78 in the PEG-CS group and 76 in the split 4-L PEG group. The two groups were comparable at baseline. The OBPS score in the PEG-CS group (3.09 ± 2.40) and in the PEG group (2.39 ± 2.55) were equivalent (difference +0.70; 95%CI: -0.09-1.48). This was confirmed by the rate of successful bowel cleansing in the PEG-CS group (89.7%) and in the PEG group (92.1%) (difference -2.4%; 95%CI: -11.40- 6.70). PEG-CS was superior in terms of mucosa visibility compared to PEG (85.7% vs 72.4%, P = 0.042). There were no significant differences in caecum intubation rate, time to reach the caecum and withdrawal time between the two groups. The adenoma detection rate was similar (PEG-CS 43.6% vs PEG 44.7%). No serious adverse events occurred. No difference was found in tolerability of the bowel preparations. Compliance was equal in both groups: more than 90% of subjects drunk the whole solution. Willingness to repeat the same bowel preparations was about 90% for both regimes.Same-day PEG-CS is feasible, effective as split-dose 4-L PEG for late morning colonoscopy and does not interfere with work and daily activities the day before colonoscopy.

Barrett's esophagus (BE) is a premalignant condition characterized by the replacement of normal squamous esophageal epithelium by metaplastic intestinal epithelium containing goblet cells. To be diagnosed and monitored, BE requires a thorough observation of epithelial macro- and microscopic changes. Confocal laser endomicroscopy (CLE) has recently revealed to be a useful technique for in vivo virtual histology for BE surveillance. We present a computer-based method for the automatic classification of gastric metaplasia (GM), intestinal metaplasia (IM) and neoplasia (NPL) on the basis of appearance features of confocal images. Comparing the automatic results with the histological gold standard, the proposed method classifies IM, GM, and NPL confocal images with accuracy comparable to human observer. Moreover, it increases the sensitivity and the specificity of CLE examinations, thus decreasing the number of biopsies needed for BE and neoplasia diagnosis.

We evaluated clinical activity of ⁹⁰Yttrium-ibritumomab (⁹⁰Y-ibritumomab) tiuxetan in extranodal marginal-zone lymphoma. From May 2004 to April 2011, 30 patients affected by relapsed/refractory marginal-zone lymphoma--arisen at any extranodal site--received ⁹⁰Y-ibritumomab tiuxetan at the activity of 0.4 mCi/kg. Median age was 57 years. At time of treatment, 13 out of 30 patients had disseminated disease (stage III/IV). All patients had received a previous treatment with a maximum of 7. Overall response rate was 90%: 23 patients achieved a complete response (77%); partial response occurred in 4 patients (13%), stable disease in 2 patients (7%) and 1 progression (3%). With a median follow-up of 5.3 years, median time to relapse was not reached; 2 patients relapsed after complete response; 18 out of 23 complete responses are still responders after3 years, 12 of them after5 years. ⁹⁰Y-ibritumomab tiuxetan seems to be active in patients with extranodal marginal-zone lymphoma relapsed/refractory to conventional treatment including radiotherapy. These results suggest that radioimmunotherapy could represent a possible option for the treatment in this subset of patients.

Adequate bowel preparation prior to colonic diagnostic procedures is essential to ensure adequate visualisation. This consensus aims to provide guidance as to the appropriate use of bowel preparation for a range of defined clinical circumstances. A consensus group from across Europe was convened and met to discuss appropriate bowel preparation. The use of polyethylene glycol (PEG), sodium picosulphate and sodium phosphate (NaP), together with other agents, prokinetics and simethicone, in colonoscopy and small bowel video capsule endoscopy were considered. A systematic review of the literature was carried out and additional unpublished data was obtained from the members of the consensus group where required. Recommendations were graded according to the level of evidence. PEG-based regimens are recommended first line for both procedures, since their use is supported by good efficacy and safety data. Sodium-picosulphate-based regimens are recommended second line as their cleansing efficacy appears less than PEG-based regimens. NaP is not recommended for bowel cleansing due to the potential for renal damage and other adverse events. However, the use of NaP is acceptable in patients in whom PEG or sodium picosulphate is ineffective or not tolerated. NaP should not be used in patients with chronic kidney disease, pre-existing electrolyte disturbances, congestive heart failure, cirrhosis or a history of hypertension. The timing of the dose, dietary restrictions, use in special patient groups and recording of the quality of bowel preparation are also considered for patients undergoing colonoscopy. During the development of the guidelines the European Society of Gastrointestinal Endoscopy (ESGE) issued guidance on bowel preparation for colonoscopy. The ESGE guidelines and these consensus guidelines share many recommendations; differences between the guidelines are reviewed. The use of bowel preparation should be tailored to the individual patient and their specific clinical circumstances