G. Sereni

A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions

BACKGROUND AND STUDY AIMS The study aimed to investigate whether the 25G needle is superior to the 22G needle when used in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of solid lesions. PATIENTS AND METHODS The study was a single-center randomized clinical trial. The setting was a tertiary referral hospital, where EUS-FNA of solid lesions was assisted by an on-site cytopathologist, who was blinded to the needle size. The main end point was the number of passes performed to obtain adequate samples. Crossover to the other type of needle was allowed after five passes, or when the gastroenterologist experienced difficulties in puncturing the lesions. RESULTS A total of 129 solid lesions were randomized and data regarding 127 lesions were analyzed. The mean number of passes was 3.7 (± 1.9) in the 22G needle group and 3.8 (± 2) in the 25G needle groups (difference of means: 0.1; 95% CI: -0.59 to 0.79). Fifty-eight of 63 (92.1%) and 60/64 samples (93.7%) in the 22G and 25G needle groups respectively were adequate (difference: -1.6%; 95%CI: -12.1% to 8.9%). Crossover to the other type of needle was performed in 11/63 (17.5%) and in 12/64 (18.7%) lesions in the two groups respectively (difference: -1.2%; 95%CI: -16.2% to 13.8%). A crossover to the 25G needle was successfully performed in four masses in the uncinate process; these lesions were difficult to puncture using the 22G needle. CONCLUSIONS Our study failed to demonstrate that the 25G is more effective than the 22G needle in EUS-FNA of solid lesions. However, targeting of lesions in the distal duodenum may be simplified by using the 25G needle.

Connections between genetics and clinical data: Role of MCP-1, CFTR, and SPINK-1 in the setting of acute, acute recurrent, and chronic pancreatitis.

OBJECTIVES:Acute, acute recurrent, and chronic pancreatitis are inflammatory diseases with multifactorial pathogenic mechanisms. Genetic mutations and polymorphisms have been correlated with pancreatitis. The aim of this study was to investigate the association of cystic fibrosis transmembrane conductance regulator (CFTR) and serine protease inhibitor Kazal type 1 (SPINK-1) gene mutations and monocyte chemoattractant protein 1 (MCP-1) –2518A/G polymorphism with acute pancreatitis (AP), acute recurrent pancreatitis (ARP), and chronic pancreatitis (CP), and to associate genetic backgrounds with clinical phenotype in these three conditions.METHODS:One hundred eighteen AP, 64 ARP, 142 CP patients, and 88 normal controls were enrolled consecutively. We analyzed MCP-1 serum levels using enzyme-linked immunosorbent assay. Polymorphism −2518 of MCP-1 and SPINK-1 N34S gene mutations were determined by PCR–restriction-fragment length polymorphism. Sequence analysis was performed when necessary. Thirty-three CFTR mutations were analyzed in CP and ARP patients using multiplex DNA testing.RESULTS:Serum MCP-1 levels were significantly higher in all patients affected by pancreatic inflammatory diseases. Moreover, we found a significant over-representation of the MCP-1G allele in ARP patients. We found a statistically significant association of CFTR gene mutations with ARP, but not with CP. We did not find a statistically significant association of ARP or CP with the N34S SPINK-1 gene mutation. Interestingly, 39 of 64 ARP patients (61%) carried at least one genetic mutation and/or polymorphism. Five of 64 ARP patients had pancreas divisum and four of these five also carried the G allele.CONCLUSIONS:Analysis of a comprehensive range of potential susceptibility variants is needed to support modeling of the effects of genes and environment in pancreatitis. As such, beyond gene mutations, the context within which those mutations exist must be considered. In pancreatitis the context includes the inflammatory response, clinical features, and exogenous factors.

Full-spectrum (FUSE) versus standard forward-viewing colonoscopy in an organised colorectal cancer screening programme

Objective Miss rate of polyps has been shown to be substantially lower with full-spectrum endoscopy (FUSE) compared with standard forward-viewing (SFV) colonoscopy in a tandem study at per polyp analysis. However, there is uncertainty on whether FUSE is also associated with a higher detection rate of colorectal neoplasia, especially advanced lesions, in per patient analysis. Methods Consecutive subjects undergoing colonoscopy following a positive faecal immunochemical test (FIT) by experienced endoscopists and performed in the context of a regional colorectal cancer population-screening programme were randomised between colonoscopy with either FUSE or SFV colonoscopy in seven Italian centres. Randomisation was stratified by gender, age group and screening history. Primary outcomes included detection rates of advanced adenomas (A-ADR), adenomas (ADR) and sessile-serrated polyps (SSPDR). Results Of 741 eligible subjects, 658 were randomised to either FUSE (n=328) or SFV (n=330) colonoscopy and included in the analysis. Overall, 293/658 and 143/658 subjects had at least one adenoma (ADR 44.5%) and advanced adenoma (A-ADR 21.7%), respectively, while SSP was the most advanced lesion in 18 cases (SSPDR 2.7%). ADR and A-ADR were 43.6% and 19.5% in the FUSE arm, and 45.5% and 23.9% in the SFV arm, with no difference for both ADR (OR for FUSE: 0.96, 95% CI 0.81 to 1.14) and A-ADR (OR for FUSE: 0.82, 95% CI 0.61 to 1.09). No difference in SSPDR or multiplicity was detected between the two arms. In the per polyp analysis, the mean number of adenomas and proximal adenomas per patient was 0.81±1.25 and 0.47±0.93 in the FUSE arm, and 0.85±1.33 and 0.48±0.96 in the SFV colonoscopy arm (p=NS for both comparisons). Conclusions No statistically significant difference in ADR and A-ADR between FUSE and SFV colonoscopy was detected in a per patient analysis in FIT-positive patients. Trial registration number ISRCTN10357435.

Impact of Screening Program on Incidence of Colorectal Cancer: A Cohort Study in Italy.

OBJECTIVES:Colorectal cancer (CRC) screening using the fecal occult blood test (FOBT) has been shown to be effective in reducing cause-specific mortality. However, although it detects pre-cancerous adenomas, it is uncertain whether FOBT reduces the incidence of invasive cancer. The objective is to evaluate the impact of screening with immunochemical FOBT (FIT) on CRC incidence and mortality.METHODS:An organized screening program was implemented in 2005 in the province of Reggio Emilia (Northern Italy). The program invites the resident population aged 50–69 for FIT every 2 years. Subjects who test positive are referred for colonoscopy. Incidence was studied through cancer registry. Person-times of people aged 50–74 from 1997 to 2012 were classified for exposure to screening according to age and period. Furthermore, two open cohorts—one never screened (aged 50–69 in 1997) and one invited for screening (aged 50–69 in 2005)—were followed up for 8 years.RESULTS:A total of 171,785 people have been invited, and approximately 70% have undergone FIT at least once (272,197 tests). The rate of colonoscopy participation has been about 90%, and 2896 cancers have been recorded (1237 in the screening period). The age-adjusted and sex-adjusted incidence rate ratios as compared with pre-screening were 1.60 (95% confidence interval (CI), 1.43–1.79), 0.86 (95% CI, 0.78–0.94), and 0.59 (95% CI, 0.50–0.69) for the first round, subsequent rounds, and post screening, respectively. Cumulative incidence and incidence-based mortality decreased by 10% (95% CI, 3–17%) and 27% (95% CI, 15–37%), respectively.CONCLUSIONS:FIT screening leads to a decrease in the incidence of CRC and in its mortality.

Inflammatory bowel diseases and human reproduction: A comprehensive evidence-based review

To evaluate the effects of inflammatory bowel diseases (IBDs) on human reproduction, we reviewed the current literature using a systematic search for published studies (articles and/or abstracts) without limits for English language. We searched on Medline (through PubMed), the Institute for Scientific Information, the Web of Science and the websites for the registration of controlled trials (http://controlled-trials.com/). Bibliographies of retrieved articles, books, expert opinion review articles and reviewed bibliographies from subject experts were manually searched. Titles and abstracts were screened initially, and potential relevant articles were identified and reviewed. Whenever possible, data were analyzed by comparing IBD patients vs healthy controls, and patients with active IBDs vs those with disease in remission. The effects of IBDs on female fertility, fertility in infertile couples, pregnancy and male infertility were examined separately. Patients with IBDs in remission have normal fertility. At the moment, there is no established guideline for the preservation of fertility in women with IBD undergoing surgery. Further data are needed regarding guidelines for the management of these patients. Data regarding IBDs and infertility are currently completely lacking. Considering the prevalence of intestinal pathology in young adults of childbearing age, this field is of great scientific and clinical interest, opening up important future perspectives. Another important and as yet unexplored point is the response to treatments for infertility in patients with IBDs. In particular, the question is whether the reproductive outcomes (clinical and biological) can be influenced by the IBD of one of the partners. The goals for successful reproductive outcomes in IBD population are correct counseling and disease remission. IBDs significantly affect several reproductive aspects of human (female, male, couple) reproduction. Further data are needed to develop guidelines for the clinical management of subjects of reproductive age with IBDs.

Endoscopic submucosal dissection of scar-embedded rectal polyps: a prospective study (Esd in scar-embedded rectal polyps).

BACKGROUND & AIMS Endoscopic submucosal dissection (ESD) was developed for en bloc resection of superficial neoplasm of the digestive tract. We evaluated feasibility and safety of ESD, as a salvage therapy of large refractory rectal polyps, in a tertiary care setting. METHODS We prospectively enrolled in the present study and treated by ESD 11 consecutive patients with rectal polyps (median diameter 3.5 cm; range 2-5 cm), who had previously undergone several attempts of endoscopic resection and not suitable for further standard endoscopic treatment. The ESD was carried out with a standard needle knife. Follow up examinations were scheduled at 3, 6, 12 and 24 months. RESULTS We achieved apparently complete resection of polyps in 10/11 patients. In one patient ESD was interrupted and the pathology of the resected fragment showed deep submucosal infiltration; this patient underwent surgery. Deep and lateral margins were shown to be free of neoplasm (radical resection) in six out of 11 patients. However all the 10 patients with apparently complete resection were free of recurrence after a mean follow up of 19.2 months (12-24). A T1 adenocarcinoma was radically resected by ESD, with no recurrence. We recorded 2 cases of subcutaneous emphysema, both treated conservatively. CONCLUSIONS Radical resection is difficult to be achieved by ESD in patients with rectal scar-embedded polyps. Nevertheless ESD may be proposed as a definitive treatment of selected patients with refractory polyps, avoiding surgery in the majority of them.

Endosonographically guided gallbladder drainage to treat neoplastic jaundice after Roux-en-Y gastric resection

A 81-year-old man, who had undergone subtotal gastric resection with Roux-en-Y anastomosis for gastric adenocarcinoma 2 years earlier, was admitted to our hospital for obstructive jaundice. Abdominal computed tomography showed a solid mass (30×30mm) at the pancreatic head, involving the common bile duct and the duodenum and suspicious for portal vein and mesenteric axis invasion (▶Fig. 1). An endoscopic ultrasonography (EUS)-guided fine needle aspiration was performed and a diagnosis of metastasis of gastric adenocarcinoma was made. Considering the post-surgical anatomy, and in order to obtain endoscopic biliary drainage, a transgastric intrahepatic EUS-guided approach was attempted. A linear echoendoscope (GF-UCT140; Olympus, Tokyo, Japan) was used but the intrahepatic bile ducts were not dilated enough to access them. However the hydropic gallbladder was clearly visible from the jejunal route. EUS-guided transluminal gallbladder drainage was therefore performed using a lumen-apposing metal stent (LAMS) (Hot Axios; Boston Scientific, Natick, Massachusetts, USA) with a lumen diameter of 10mm. The gallbladder was first punctured using a 19G access needle (EchoTip Ultra; Cook Medical, Limerick, Ireland) and a 0.035-inch guidewire (VisiGlide; Olympus) was left inside to stabilize the echoendoscope position. Subsequently the stent was introduced into the gallbladder lumen using its cautery tip. Finally the stent was deployed (▶Fig. 2), with subsequent rapid drainage of the gallbladder into the jejunal lumen (▶Fig. 3, and ▶Video1), and nasobiliary drainage was inserted through the stent into the lumen of the gallbladder (▶Fig. 4). The procedure was successful and the patient’s jaundice rapidly resolved; after 2 weeks total bilirubin had fallen from 11.3g/dL to 2.5 g/dL). E-Videos