Federico Iacopini

A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy.

BACKGROUND & AIMS An inadequate level of bowel preparation can affect the efficacy and safety of colonoscopy. Although some factors have been associated with outcome, there is no strategy to identify patients at high risk for inadequate preparation. We searched for factors associated with an inadequate level of preparation and tested the validity of a predictive clinical rule based on these factors. METHODS We performed a prospective study of 2811 consecutive patients who underwent colonoscopy examinations at 18 medical centers; clinical and demographic data were collected before the colonoscopy. Bowel preparation was classified as adequate or inadequate; 925 patients (33%) were found to have inadequate preparation. Multivariate analysis was used to identify factors associated with inadequate preparation, which were expressed as odds ratio (OR) and used to build a predictive model. RESULTS Factors associated with inadequate bowel preparation included being overweight (OR, 1.5), male sex (OR, 1.2), a high body mass index (OR, 1.1), older age (OR, 1.01), previous colorectal surgery (OR, 1.6), cirrhosis (OR, 5), Parkinson disease (OR, 3.2), diabetes (OR, 1.8), and positive results in a fecal occult test (OR, 0.6). These factors predicted which patients would have inadequate cleansing with 60% sensitivity, 59% specificity, 41% positive predictive value, and 76% negative predictive value; they had an under the receiver operating characteristic curve value of 0.63. Assuming 100% efficacy of a hypothetical regimen to address patients predicted to be at risk of inadequate preparation, the rate would decrease from 33% to 13%. CONCLUSIONS We identified factors associated with inadequate bowel preparation for colonoscopy and used these to build an accurate predictive model.

2-Week Triple Therapy for Helicobacter pylori Infection is Better Than 1-Week in Clinical Practice: a Large Prospective Single-Center Randomized Study

Background:  Proton pump inhibitor (PPI)‐based triple therapies are considered the standard regimens for Helicobacter pylori eradication, but the optimal duration of these regimens is still controversial. The aim of this study was to compare the efficacy of 1‐week versus 2‐week triple therapies in H. pylori‐positive patients.

Video capsule endoscopy in patients with known or suspected small bowel stricture previously tested with the dissolving patency capsule

Goals To assess the safety of the Pillcam in patients with known or suspected radiologic stricture, previously tested for small bowel patency using the Given Patency capsule. Background Intestinal stricture contributes a major contraindication to video capsule endoscopy (VCE), because of the risk of capsule retention. Study Twenty-seven patients (16 female, mean age 44.2 y) with known or suspected intestinal stricture were enrolled prospectively. Twenty-four had Crohns disease, 2 had adhesive syndrome and 1 had a suspected ischemic stricture. Patients underwent the Patency capsule test. In patients in whom the Patency capsule was excreted intact within 72 hours postingestion without occurrence of any adverse event, VCE was performed to assess the presence of strictures or other gastrointestinal pathologies. The following parameters were evaluated: transit time of Patency capsules and/or tags from ingestion to excretion, condition of the Patency capsule at excretion, transit time of the Pillcam capsule, the ability of Pillcam capsule to detect intestinal strictures and small bowel pathologies, any adverse events. Results Twenty-five patients (92.6%) retrieved the Patency capsule in the stools. Six patients complained of abdominal pain, 4 of whom excreted a nonintact capsule. Hospitalization was required in 1 (4.3%) patient with Crohns disease due to occlusive syndrome. Fifteen patients (65.3%) excreted an intact Patency capsule after a mean transit time of 25.6 hours without any adverse events. These 15 patients underwent the VCE successfully. Conclusions Passage of an intact Patency capsule across a small bowel stricture provides direct evidence of functional patency of the gut lumen and allows a safe VCE. Intestinal strictures should not be considered an absolute contraindication for VCE.

Stepwise training in rectal and colonic endoscopic submucosal dissection with differentiated learning curves.

BACKGROUND Endoscopic submucosal dissection (ESD) has revolutionized the resection of GI superficial neoplasms, but adoption in Western countries is significantly delayed. OBJECTIVE To evaluate a stepwise colorectal endoscopic submucosal dissection (ESD) learning and operative training protocol. DESIGN Prospective study in the Western setting. SETTING This study took place in a nonacademic hospital with one endoscopist expert in therapeutic endoscopy but novice in ESD. PATIENTS Indications for ESD were superficial neoplasms 20 mm and larger without ulcerations or fibrosis. INTERVENTION Training consisted of 5 unsupervised ESDs on isolated stomach, an observation period at an ESD expert Japanese center, 1 supervised ESD on isolated stomach, and retraining on 1 rectal ESD under supervision. The operative training on patients was performed without supervision moving from the rectum to the colon according to the competence achieved. MAIN OUTCOME MEASUREMENTS Competence was defined as an 80% en bloc resection rate plus a statistically significant reduction in operating time per square centimeter. Learning curves were calculated based on consecutive blocks of 5 procedures. RESULTS From February 2009 to February 2012, 30 rectal and 30 colonic ESDs were performed. The rectal ESD learning curve showed that the en bloc resection rate was 80% after 5 procedures (P = not significant); the operating time per square centimeter significantly decreased after 20 procedures (P = .0079); perforation occurred in 1 patient. The colonic ESD learning curve showed that the en bloc resection rate was 80% after 20 procedures (P = not significant); the operating time per square centimeter significantly decreased after 20 procedures (P = .031); perforations occurred in 2 patients. LIMITATIONS Single-center design. CONCLUSIONS A minimal intensive training seems sufficient for endoscopists expert in therapeutic procedures to take up ESD in a not overly arduous incremental method with separate and sequential learning curves for the rectum and colon.

Endoscopic gallbladder drainage for acute cholecystitis: technical and clinical results

BACKGROUND AND STUDY AIMS Cholecystectomy is the standard treatment for acute cholecystitis while percutaneous drainage is reserved for high-risk patients. The aim of the present study was to assess the technical success rate and clinical efficacy of endoscopic gallbladder drainage in patients with acute cholecystitis. PATIENTS AND METHODS A total of 35 consecutive patients with acute cholecystitis and without residual common bile duct obstruction were retrospectively identified. Patients were stratified according to the pathogenesis and stages of acute cholecystitis, and the morphology of the cystic duct and/or its insertion in the common bile duct. Primary outcomes were technical success and early and late clinical success. RESULTS Endoscopic retrograde cholangiopancreatography (ERCP) was performed within the first 72 hours in 19 patients (54%). Technical success was achieved in 29 patients (83%); drainage was nasocholecystic in 21 of these (72%), plastic stenting in 6 (21%), and a combined method in 2 (7%). The pathogenesis and stage of acute cholecystitis, and the morphology both of the cystic duct and its insertion in the common bile duct, did not influence technical success. Clinical success was achieved in 24 cases (83%) after a median of 3 days (range 2-12). Four patients (14%) died within 3 days due to septic complications, and one accidentally removed the nasocholecystic drain after 24 hours. Late results, available in 21 patients after a median follow-up of 17 months, showed relapse of acute cholecystitis in 2 (10%) (both with stents) and of biliary pain in 2 patients (10%), both of whom had nasocholecystic drainage. CONCLUSIONS Endoscopic gallbladder drainage seems feasible and effective in resolving acute cholecystitis, but only as a temporary measure because of a 20% relapse rate in long-term follow-up. Prospective studies are necessary to identify which patients would benefit most from this endoscopic technique in the short and long term.

Oxidative Damage of the Gastric Mucosa in Helicobacter pylori Positive Chronic Atrophic and Nonatrophic Gastritis, Before and After Eradication

Background.  Helicobacter pylori is the main cause of gastritis and a primary carcinogen. The aim of this study was to assess oxidative damage in mucosal compartments of gastric mucosa in H. pylori positive and negative atrophic and nonatrophic gastritis.

Prognostic variables for the clinical success of flexible endoscopic septotomy of Zenker’s diverticulum

BACKGROUND AND AIMS Flexible endoscopy septotomy for Zenkers diverticulum (ZD) is an alternative to endostapling; however, long-term data are sparse and studies are heterogeneous. The aim of this study was to assess the clinical success of flexible endoscopy diverticuloscope-assisted septotomy according to all ZD-related symptoms and to identify potential prognostic variables. METHODS A prospective database of all patients with ZD undergoing septotomy and followed up for 24 months or longer was analyzed. Septotomy was conducted by using a diverticuloscope-assisted technique. Dysphagia, regurgitation, and respiratory symptoms (during the day and at night) were scored by their weekly frequency from 0 to 3 when on a solid food diet. Clinical success (asymptomatic state) was defined as a maximum of 2 symptoms with a score of 1 (once per week). Prognostic variables of clinical success included age, sex, pretreatment total symptom score, pre- and posttreatment ZD size, and septotomy length. The Kaplan-Meier method and Cox proportional hazards model were used to calculate the crude and adjusted hazard ratio (HR). RESULTS Septotomy was attempted and achieved in a single session in 89 patients. Clinical success at the intention-to-treat analysis was 69%, 64%, and 46% at 6, 24, and 48 months, respectively. Adverse events occurred in 3 patients: perforation in 2 (2%) and postprocedural bleeding in 1 (1%). Independent variables for failure at 6 months were a septotomy length ≤25 mm (HR 6.34) and pretreatment ZD size ≥50 mm (HR 11.08), whereas at 48 months, they were septotomy length ≤25 (HR 2.20) and posttreatment ZD size ≥10 mm (HR 2.03). Success rates for ZD ranging in size from 30 mm to 49 mm with a septotomy >25 mm were 100% and 71% at 6 months and 48 months, respectively. CONCLUSION Flexible endoscopic septotomy for ZD is feasible and safe. Treatment success correlates with the length of the septotomy and the size of ZD, which should ultimately determine the appropriate approach.

Heterotopic gastric mucosa in the anus and rectum: first case report of endoscopic submucosal dissection and systematic review

Background: Heterotopic gastric mucosa (HGM) is the most reported epithelial heterotopia, but it is very rare in the rectum and anus. Methods: The first case of an asymptomatic adult male with a large nonpolypoid HGM in the low rectum underwent complete resection by endoscopic submucosal dissection (ESD) is reported. The systematic review was based on a comprehensive search of MEDLINE, EMBASE and Google Scholar. Studies on humans were identified with the term ‘heterotopic gastric mucosa in the rectum and /or anus.’ Results: The search identified 79 citations, and 72 cases were evaluated comprising the present report. Congenital malformations were observed in 17 (24%) patients; rectal duplication accounted for most of the cases. The HGM was located in the anus and perineal rectum in 25 cases (41%) and low, middle and proximal pelvic rectum in 20 (33%), five (8%) and 11 cases (18%), respectively. Morphology was nonpolypoid in 37 cases (51%), polypoid in 26 cases (36%) and ulcerated in nine cases (13%). Specific anorectal symptoms were reported by 50 (69%) patients of the whole study population, and by 33 (97%) of 34 patients ≤ 18 years. Complications were observed in 23 cases (32%). The HGM was excised in 50 cases (83%). Endoscopic resection was performed in 17 cases (34%); resection was piecemeal in five of 12 lesions ≥15 mm, required argon plasma coagulation in two cases and was associated with residual tissue in two (17%). Intestinal metaplasia and an adenoma with low-grade dysplasia were described in three adults (4%). Discussion: This systematic review shows that the HGM in the rectum and anus may be associated with specific rectal symptoms and serious complications, mainly in the pediatric population, and a risk of malignancy in adults. Its complete excision should be recommended, and the ESD can overcome the technical limits of conventional endoscopic snare resection and avoid unnecessary surgery.

Development of an E-learning System for the Endoscopic Diagnosis of Early Gastric Cancer: An International Multicenter Randomized Controlled Trial

Background In many countries, gastric cancer is not diagnosed until an advanced stage. An Internet-based e-learning system to improve the ability of endoscopists to diagnose gastric cancer at an early stage was developed and was evaluated for its effectiveness. Methods The study was designed as a randomized controlled trial. After receiving a pre-test, participants were randomly allocated to either an e-learning or non-e-learning group. Only those in the e-learning group gained access to the e-learning system. Two months after the pre-test, both groups received a post-test. The primary endpoint was the difference between the two groups regarding the rate of improvement of their test results. Findings 515 endoscopists from 35 countries were assessed for eligibility, and 332 were enrolled in the study, with 166 allocated to each group. Of these, 151 participants in the e-learning group and 144 in the non-e-learning group were included in the analysis. The mean improvement rate (standard deviation) in the e-learning and non-e-learning groups was 1·24 (0·26) and 1·00 (0·16), respectively (P < 0·001). Interpretation This global study clearly demonstrated the efficacy of an e-learning system to expand knowledge and provide invaluable experience regarding the endoscopic detection of early gastric cancer (R000012039).

Colorectal endoscopic submucosal dissection: predictors and neoplasm-related gradients of difficulty

Background and study aim  The role of colorectal endoscopic submucosal dissection (ESD) is standardized in Japan and East Asia, but technical difficulties hinder its diffusion. The aim was to identify predictors of difficulty for each neoplasm type. Methods  A competent operator performed all procedures. ESD difficulty was defined as: en bloc with a slow speed (< 0.07 cm 2 /min; 30 × 30 mm neoplasm in > 90 min), conversion to endoscopic mucosal resection, or resection abandonment. Pre- and intraoperative difficulty variables were defined according to standard criteria, and evaluated separately for the rectum and colon. Difficulty predictors and gradients were evaluated by the multivariate logistic regression model. Results  A total of 140 ESDs were included: 110 in the colon and 30 in the rectum. Neoplasms were laterally spreading tumors – granular type (LST-G) in 85 cases (61 %); the median longer axis was 30 mm (range 15 – 180 mm); a scar was present in 15 cases (11 %). ESD en bloc resection and difficulty rates were 85 % (n = 94) and 35 % (n = 39) in the colon, and 73 % (n = 22) and 50 % (n = 15) in the rectum ( P  = 0.17 and 0.28, respectively). The scar was the only preoperative predictor of difficulty in the rectum (odds ratio [OR] 12.3, 95 % confidence interval [CI] 1.27 – 118.36), whereas predictors in the colon were: scar (OR 12.7, 95 %CI 1.15 – 139.24), LST – nongranular type (NG) (OR 10.5, 95 %CI 1.20 – 55.14), and sessile polyp morphology (OR 3.1, 95 %CI 1.18 – 10.39). Size > 7 – ≤ 12 cm 2 (OR 0.20, 95 %CI 0.06 – 0.74) and operator experience > 120 procedures (OR 0.19, 95 %CI 0.04 – 0.81) were predictors for a easy procedure. No intraoperative predictors of difficulty were identified in the rectum, whereas predictors in the colon were: severe submucosal fibrosis (OR 21.9, 95 %CI 2.11 – 225.64), ineffective submucosal exposure by gravity countertraction (OR 12.3, 95 %CI 2.43 – 62.08), and perpendicular submucosal dissection approach (OR 5.2, 95 %CI 1.07 – 25.03). When experience was /= 90, preoperative gradient of colonic ESD difficulty was the highest for LST-NGs (scar positive and negative up to 47 % and 20 %, respectively), intermediate for sessile polyps with scar (up to 23 %), and the lowest for LST-Gs (< 8 %). Different difficulty gradients between neoplasm types persisted with increasing experience: LST-NG rate up to 14 % after 120 procedures. Conclusions  Colonic and rectal ESD difficulty has qualitative differences. Preoperative predictors should be considered to identify the difficulty gradient of each neoplasm type and the appropriate setting for ESD.