SIED-GISCOR recommendations for colonoscopy in screening programs: Part I - Diagnostic.

The implementation of FIT programs reduces incidence and mortality from CRC in the screened subjects. The ultimate efficacy for CRC morbidity and mortality prevention in a FIT program depends on the colonoscopy in FIT+ subjects that has the task of detecting and removing these advanced lesions. Recently, there has been growing evidence on factors that influence the quality of colonoscopy specifically withing organized FIT programs, prompting to dedicated interventions in order to maximize the benefit/harm ratio of post-FIT colonoscopy. This document focuses on the diagnostic phase of colonoscopy, providing indications on how to standardise colonoscopy in FIT+ subjects, regarding timing of examination, management of antithrombotic therapy, bowel preparation, competence and sedation.

EUS-guided gastroenterostomy using a novel electrocautery lumen apposing metal stent for treatment of gastric outlet obstruction (with video).

BACKGROUND AND AIM: Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) for the treatment of gastric outlet obstruction (GOO) has been actually performed only with one type of electrocautery lumen-apposing metal stents (EC-LAMS). We aimed to evaluate the safety, technical and clinical effectiveness of EUS-GE using a newly available EC-LAMS in patients with malignant and benign GOO. MATERIALS AND METHODS: Consecutive patients who underwent EUS-GE for GOO using the new EC-LAMS at five endoscopic referral centers were retrospectively evaluated. Clinical efficacy was determined utilizing the Gastric Outlet Obstruction Scoring System (GOOSS). RESULTS: Twenty-five patients (64% male, mean age 68.7 ± 9.3 years) met the inclusion criteria; 21 (84%) had malignant etiology. Technically, EUS-GE was successful in all patients, with a mean procedural time of 35 ± 5 min. Clinical success was 68% at 7 days and 100% at 30 days. The mean time to resume oral diet was 11.4 ± 5.8 h, with an improvement of at least one point of GOOSS score observed in all patients. The median hospital stay was 4 days. No procedure-related adverse events occurred. After a mean follow-up of 7.6 months (95% CI 4.6-9.2), no stent dysfunctions were observed. CONCLUSION: This study suggests EUS-GE can be performed safely and successfully using the new EC-LAMS. Future large multicenter prospective studies are needed to confirm our preliminary data.

Endoscopic Papillectomy for Ampullary Adenomas: Different Outcomes in Sporadic Tumors and Those Associated with Familial Adenomatous Polyposis.

BACKGROUND: Ampullary adenomas are rare and potentially malignant. Surgery was the standard treatment but endoscopic papillectomy (EP) is a possible alternative. AIM: We retrospectively evaluated the principal clinical outcomes of EP in all patients referred to our unit also dividing sporadic ampullary adenoma (SAA) from familial adenomatous polyposis (FAP)-associated adenomas. METHODS: All consecutive patients who underwent endoscopic papillectomy because of ampullary adenoma were considered. The primary outcome was the technical success of EP. Secondary outcomes included the number of procedures, the adverse event rate, the recurrence rate, the concordance of histology pre- and post-EP, and the evaluation of factors related to technical success. RESULTS: Between January 2001 and December 2015, sixty-two patients were included (21 FAP and 41 SAA). Technical success was achieved in 75.8% and was different in the two groups (FAP 95.2%, SAA 65.8%, p 0.025). Intraductal invasion was negatively associated with technical success (41.7% vs. 84.0%; p 0.005). The intestinal subtype was predictive of success (79.7% vs. 0%; p 0.012) as well as en bloc resection (90.3% vs. 61.3%; p 0.016). Adverse events were reported in 14 patients (22.6%). CONCLUSIONS: EP is an effective and safe procedure and is a viable alternative to surgery. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03494543.

Endoscopic ultrasound-guided biliary drainage for malignant biliary obstruction after failed ERCP in low performance status patients.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) with the placement of a biliary stent is the treatment of choice for palliation of malignant obstructive jaundice. In 5-10% of cases ERCP fails. In these cases an effective alternative is endoscopic ultrasonography-guided biliary drainage (EUS-BD). AIM: Evaluation of the principal clinical outcomes of direct transluminal EUS-BD. PATIENTS AND METHODS: This study is a retrospective analysis. All consecutive patients with malignant obstructive jaundice, in whom ERCP had failed, were enrolled. The primary outcome was the technical success of EUS-BD defined as the correct placement of the metal or plastic stent across the stomach or duodenum to the biliary tree. The most important secondary outcomes were early and late clinical success, both linked to the decrease of bilirubin haematic level. RESULTS: Between January 2011 and November 2017 thirty-six patients were included. Technical success was obtained in 91.6%. A clinical success, early or late was obtained in 75.8%. The ECOG performance status of less than 3 was correlated with clinical success. Adverse events occurred in 30.3% of patients. CONCLUSIONS: EUS-BD is an effective and safe procedure.

Ki-67 cytological index can distinguish well-differentiated from poorly differentiated pancreatic neuroendocrine tumors: a comparative cytohistological study of 53 cases.

The Ki-67 labeling index has been found to bear prognostic significance in gastrointestinal neuroendocrine tumors (NETs), and it was recently incorporated in NET histological grading. Nevertheless, a reliable preoperative determination of NET grading could be useful in clinical practice. The aim of this study is to compare the results of Ki-67 labeling index, as measured on cytological samples and on surgical specimens of patients with pancreatic NETs (P-NETs). We also investigated whether concordance might be improved, using a 5 % (instead of 2 %) cutoff value for defining G2 tumors. We retrospectively identified 48 consecutive patients with 53 P-NETs, from our five institutions, and we measured Ki-67 labeling index on their cytological samples and surgical specimens. The traditional 2 % and the alternative 5 % cutoff values were used to classify G2 tumors. The concordance rate between cytological and histological grading was 46/53 (86.8 %; weighted κ statistic 0.77; 95 % confidence interval (95 % CI) 0.60-0.94). No cases of cytological G1-G2 NETs were upgraded to G3 neuroendocrine carcinoma (NEC) at histological grading. Cytology was found to be highly specific in the diagnosis of both G2 (94.1 %; 95 % CI 80.3-99.3) and G3 tumors (100.0 %; 95 % CI 92.8-100), but the sensitivity was poor for G2 NETs (66.7 %; 95 % CI 38.4-88.2) and high for the prediction of G3 NECs (100 %; 95 % CI 39.8-100.0). When the 5 % cutoff value was adopted, concordance rate was 49/53 (92.4 %; weighted κ 0.82; 95 % CI 0.64-1.00). In conclusion, Ki-67 cytological expression can distinguish well-differentiated (both G1 and G2) from poorly differentiated P-NETs, and it may be useful for their preoperative classification.

Efficacy of a therapeutic strategy for eradication of Helicobacter pylori infection.

AIM: To determine the efficacy of our therapeutic strategy for Helicobacter pylori (H. pylori) eradication and to identify predictive factors for successful eradication. METHODS: From April 2006 to June 2010, we retrospectively assessed 2428 consecutive patients (1025 men, 1403 women; mean age 55 years, age range 18-92 years) with gastric histology positive for H. pylori infection referred to our unit for 13-C urea breath test (UBT), after first-line therapy with proton pump inhibitor (PPI) b.i.d. + amoxicillin 1 g b.i.d. + clarithromycin 500 mg b.i.d. for 7 d. Patients who were still positive to UBT were recommended a second-line therapy (PPI b.i.d. + amoxicillin 1 g b.i.d. + tinidazole 500 mg b.i.d. for 14 d). Third choice treatment was empirical with PPI b.i.d. + amoxicillin 1 g b.i.d. + levofloxacin 250 mg b.i.d. for 14 d. RESULTS: Out of 614 patients, still H. pylori-positive after first-line therapy, only 326 and 19 patients respectively rechecked their H. pylori status by UBT after the suggested second and third-line regimens. "Per protocol" eradication rates for first, second and third-line therapy were 74.7% (95% CI: 72.7%-76.4%), 85.3% (95% CI: 81.1%-89.1%) and 89.5% (95% CI: 74.9%-103%) respectively. The overall percentage of patients with H. pylori eradicated after two treatments was 97.8% (95% CI: 97.1%-98.4%), vs 99.9% (95% CI: 99.8%-100%) after three treatments. The study found that eradication therapy was most effective in patients with ulcer disease (P < 0.05, P = 0.028), especially in those with duodenal ulcer. Smoking habits did not significantly affect the eradication rate. CONCLUSION: First-line therapy with amoxicillin and clarithromycin produces an H. pylori eradication rate comparable or superior to other studies and second-line treatment can still be triple therapy with amoxicillin and tinidazole.

[Test and programme sensitivities of screening for colorectal cancer in Reggio Emilia]. / Sensibilità del test immunochimico e del programma nello screening del cancro del colon retto nella provincia di Reggio Emilia.

OBJECTIVE: to estimate the sensitivity of the immunochemical test for faecal occult blood (FOBT) and the sensitivity of the colorectal tumour screening programme in the province of Reggio Emilia. DESIGN AND SETTINGS: retrospective cohort study, including a sample of 80,357 people of both genders, aged 50-69, who underwent FOBT, during the first round of the screening programme in the province of Reggio Emilia, from April 2005 to December 2007. MAIN OUTCOME MEASURES: incidence of interval cancer. The proportional incidence method was used to estimate the sensitivity of FOBT and of the screening programme. Data were stratified according to gender, age and year of interval. RESULTS AND CONCLUSIONS: the overall sensitivity of FOBT was 73.2% (95%IC 63.8-80.7). The sensitivity of FOBT was lower in females (70.5% vs 75.1%), higher in the 50-59 age group (78.6% vs 70.2%) and higher in the colon than rectum (75.1% vs 68.9%). The test had a significantly higher sensitivity in the 1st year of interval than in the 2nd (84.4% vs 60.5%; RR=0.39, 95%IC 0.22-0.70), a difference which was confirmed, also when data were stratified according to gender. The overall sensitivity of the programme is 70.9% (95%IC 61.5-78.5). No statistically significant differences were shown, if data were stratified according to gender, age or site. Again the sensitivity in the 1st year was significantly higher than in the 2nd year of interval (83.2% vs 57.0%; RR=0.41, 95%IC 0.24-0.69). Overall our data confirmed the findings of similar Italian studies, despite subgroup analysis showed some differences in sensitivity in our study.

Multicentric GISCoR Study "intensive clinical follow-up versus surgical radicalization after complete endoscopic polypectomy of a malignant adenoma" (SEC-GISCoR).

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 < 0.001), mismatches can be explained by high surgical risk or patient's choice. Only in 5 cases (4.2%), did data analysis not allow to exactly determine the reason for a choice different from protocol criteria. The availability of new risk factors and the evidence of pathological mismatches confirmed the need for future studies on this issue.

Ga-68 DOTATOC PET, endoscopic ultrasonography, and multidetector CT in the diagnosis of duodenopancreatic neuroendocrine tumors: a single-centre retrospective study.

PURPOSE: In this report, we compared endoscopic ultrasonography (EUS), multidetector CT (MDCT), and Ga-68 DOTATOC PET/CT in patients with neuroendocrine tumors (NETs). We report our experience with use of these methods in patients suspected to have duodenopancreatic primitive NET. METHODS: Nineteen consecutive patients (mean age, 56; 21-80), who underwent both Ga-68 DOTATOC PET/CT and EUS between March 2007 and November 2008 were retrospectively included in the study (16 underwent MDCT). Suspicion of NET was confirmed by EUS-FNA and/or surgery. Operative characteristics of PET, EUS, and MDCT were compared. RESULTS: Twenty-three neuroendocrine lesions were diagnosed in 13/19 patients. EUS, PET, and MDCT correctly identified as affected 13/13 (100%), 12/13 (92%), and 10/11 (91%) patients, respectively. On a lesion basis, EUS, PET, and MDCT identified correctly as NETs 22/23 (96%), 20/23 (87%), and 13/18 (72%) lesions (P = 0.08 EUS vs. CT). Both on a patient and on a lesion basis, specificity was 67%, 83%, and 80% for EUS, PET, and MDCT, respectively. CONCLUSIONS: EUS, Ga-68 DOTATOC PET, and MDCT seem to have comparable accuracy in diagnosis of duodenopancreatic NET and their combination may allow an optimal preoperative diagnosis.

The natural history of upper gastrointestinal subepithelial tumors: a multicenter endoscopic ultrasound survey.

GOALS: To evaluate the natural course of <3-cm upper gastrointestinal subepithelial tumors by endoscopic ultrasound (EUS) and to determine the appropriate timing for EUS follow-up. BACKGROUND: Subepithelial tumors (SETs) can range from benign lesions to tumors with malignant behavior or potential to become malignant such as gastrointestinal stromal tumors (GISTs). EUS is considered a valuable tool for their evaluation as it estimates the exact size and layer of origin, and also additional morphologic features that can suggest the diagnosis. For high surgical risk patients and when no worrisome EUS features are seen, EUS surveillance of subepithelial tumors is often used. METHODS: Fifty-one patients (mean age, 61.2+/-11.8 y; median, 63 y) with asymptomatic <3-cm SETs of second and fourth echolayer were followed for a mean period of 29.7 months (range, 3 to 84; median, 23 mo) in 3 tertiary care institutions. Evaluation included location, echolayer, tumor diameter, internal echo pattern, and outer margin of lesions by EUS. EUS was performed by using miniprobes, radial and linear echoendoscopes. RESULTS: Follow-up revealed increase in size and/or change in echogenic features in 7/51 (13.7%) patients. Surgical follow-up was available for 3 of 7 of these patients. Two of the fourth layer SETs, which had both increase in size and change in echogenicity were found to be GISTs (+c-kit). CONCLUSIONS: The majority of <3-cm SETs does not change during a median of 23 months. The change in echogenicity and increase in size may indicate a GIST.

Clearance of irretrievable bile duct and pancreatic duct stones by extracorporeal shockwave lithotripsy, using a transportable device: effectiveness and medium-term results.

BACKGROUND AND GOALS: Extracorporeal shockwave lithotripsy (ESWL) is an established treatment of irretrievable biliary and pancreatic stones, but the cost of the shockwave generators limits its widespread use. We revised data about the effectiveness of our treatment for refractory stones using a transportable shockwave generator. STUDY: We retrospectively evaluated the short and medium-term outcomes of patients who underwent ESWL using a transportable electromagnetic shockwave generator between 1998 and 2003 at our unit, for the treatment of irretrievable bile duct or pancreatic duct stones. All patients received intravenous conscious sedation and antibiotic prophylaxis. RESULTS: Complete stone clearance was achieved in 70/82 patients (85.4%), in 66 of the patients (94.2%) with 1 session of ESWL. Despite the insertion of a stent in the bile duct, 2 patients had moderate cholangitis, while they waited for the next ESWL session. We did not record any moderate-severe complication of ESWL, but 2 patients underwent surgery owing to perforation/bleeding during endoscopic removal of residual fragments. A symptomatic recurrence of stones was recorded in 10/69 (14.5%) patients, who had been previously cleared and whose follow-up data (median follow-up 29 mo; range 7 to 66) were available. CONCLUSIONS: We obtained satisfactory stone clearance by using a transportable shockwave generator. Most patients required 1 session. Our experience confirmed the safety of the treatment, even though patients may experience cholangitis while awaiting definitive treatment. The use of a transportable ESWL generator may be a valuable option in centers, while ensuring a sufficient proficiency in biliary endoscopy.

Proposal of a new clinical index predictive of endoscopic severity in ulcerative colitis.

Assessment of disease activity by clinical parameters in ulcerative colitis is still controversial. Different clinical indexes have been proposed. Colonoscopy provides detailed information on mucosal damage. The aim of this study was to identify, among 21 clinical and laboratory parameters, which were predictive of endoscopic activity. We included 137 consecutive patients with ulcerative colitis who underwent colonoscopy, clinical examination, and blood tests within 4 weeks. Endoscopic severity was recorded using a simple score (range, 0-30). The multiple stepwise regression coefficient of each significant variable predictive of mucosal damage was used to develop a new activity index predictive of endoscopic appearance (Endoscopic-Clinical Correlation Index; ECCI). We tested the ability of our score to discriminate patients with severe endoscopic disease, calculating the area under the receiver operator characteristic curve, and we compared it to activity indexes proposed by other authors. Endoscopic severity was significantly influenced by four parameters: bloody stool, nocturnal bowel movements, body temperature >37.5 degrees C, and serum albumin. The new scoring system was calculated as ECCI = {[serum albumin x (-26)] + (bloody stool x 17) + (nocturnal bowel movements x 16) + [fever (0 or 1) x 39]} + 107. The ECCI accurately identified patients with severe endoscopic disease in our sample (sensitivity = 81%, specificity = 95%). In conclusion, the ECCI should be useful in clinical practice because it is simple and strongly related to endoscopic activity.