Newly designed OTS Clip for preventing fully-covered self-expandable metal stent migration in the gastrointestinal tract.

Background and study aims Fully-covered self-expandable metal stents (FCSEMS) are frequently used for endoscopic management of gastrointestinal lesions. However, stent migration occurs in up to one-third of patients. Different tools are used to anchor stents to prevent migration. A specifically designed over-the-scope device (Stentfix OTS Clip system) was recently introduced to prevent fully covered SEMS migration in the gastrointestinal tract. The study aimed to evaluate technical success and stent migration rates with the Stentfix device. Patients and methods Data were collected from consecutive patients at four participating centers who were at high risk of FCSEMS migration and in whom the anchoring system was used to prevent migration. Results A total of 31 patients were enrolled. Technically successful clip placement was achieved in all cases. At follow-up, the distal part of the device dislocated from the duodenum into the antrum at 3 days in one patient, accounting for a 3.2 % (95 % CI = 0-9.4) rate of stent migration. The underlying lesion being treated healed in all patients, but 10 patients died before stent removal due to neoplastic progression. Conclusions A dedicated over-the-scope stent fixation device appears to be safe and effective in preventing fully-covered SEMS migration through the gastrointestinal tract.

A Meta-Analysis of Endoscopic Stenting Versus Surgical Treatment for Malignant Gastric Outlet Obstruction.

BACKGROUND AND AIM: Surgical gastrojejunostomy (GJJ) and endoscopic stenting (ES) are the two most available treatments for palliation of malignant gastric obstruction (MGOO). The aim of this study is to compare these two techniques regarding efficacy, safety, time of hospitalization and survival. METHODS: We performed a literature search from January 2010 to September 2020 to identify available randomized controlled studies and observational studies that compared ES and GJJ for the treatment of MGOO. RESULTS: A total of 17 studies were found. ES and GJJ showed similar technical and clinical success rate. ES was superior to obtain early oral re-feeding, shorter length of hospitalization and a lower incidence of complications than GJJ. Surgical palliation had a lower recurrence rate of obstructive symptoms and longer overall survival than ES. CONCLUSIONS: Both procedures have advantages and disadvantages. Probably we should not find the best palliation but the best approach based on the patient characteristics and tumor type.

Familial pancreatic cancer.

Pancreatic cancer (PC) carries a poor prognosis with an overall 5-year survival of less than 10%. Early diagnosis, though cumbersome, is essential to allow complete surgical resection. Therefore, primary and secondary prevention are critical to reduce the incidence and to potentially prevent mortality. Given a relatively low lifetime risk of developing PC, identification of high-risk individuals is crucial to allow identification of pre-malignant lesions and small, localized tumors. Although 85-90% of PC cases are sporadic, we could consider risk stratification for the 5-10% of patients with a family history and the 3-5% of cases due to inherited genetic syndromes. These high-risk populations should be considered for screening and surveillance of PC. MRI/MRCP and EUS are the preferred modalities, due to their high sensitivity in lesion detection. Surveillance should be personalized, considering genetics and family history, and assessment of risk factors that may increase cancer risk. Screening programs should be limited to tertiary referral center, with high-volumes and adequate facilities to manage these patients.

Infliximab trough levels and persistent vs transient antibodies measured early after induction predict long-term clinical remission in patients with inflammatory bowel disease.

BACKGROUND: The use of therapeutic drug monitoring has been proposed as a useful tool in the management of patients with loss of response to biological therapy in patients with inflammatory bowel disease. AIMS: To evaluate whether early, post-induction anti-tumor necrosis factor trough levels and the presence of different types of anti-drug antibodies may impact long-term clinical remission in patients with inflammatory bowel disease. METHODS: We prospectively assessed anti-tumor necrosis factor trough levels and both persistent and transient anti-drug antibodies. The Harvey-Bradshaw Index and the partial Mayo score were evaluated at each visit or in case of relapse. RESULTS: At week 14, median infliximab trough levels were significantly lower in patients who experienced loss of response at week 48 as compared to patients in stable remission (1.3mcg/mL [range 0-10.2mcg/mL] vs. 10.1mcg/mL[range 0-42.8mcg/mL], P<0.0004). ROC curve identified an infliximab trough levels of 6.2mcg/mL as the cut-off value with the highest accuracy (c-index=0.864) for loss of response at week 48. At week 14 we observed a correlation between anti-drug antibodies concentration and infliximab trough levels (rs=-0.513, P=0.04). CONCLUSIONS: The results highlight the usefulness of assessing early biological TL in order to predict patients' long-term outcome.

Erratum: Positive PET in a Patient With Esophageal Leiomyoma.

This corrects the article DOI: 10.1038/ajg.2016.205.

Adalimumab trough serum levels and anti-adalimumab antibodies in the long-term clinical outcome of patients with Crohn's disease.

OBJECTIVE: Few data are available on the relevance of adalimumab (ADA) trough serum levels and anti-ADA antibodies (AAA) during long-term follow-up of patients with Crohn's Disease (CD), and their association with disease outcome. In this study, our aim was to assess ADA trough serum levels and the presence of AAA according to disease activity and clinical response during long-term follow-up in a series of patients with CD treated with ADA monotherapy. MATERIAL AND METHODS: We prospectively evaluated 23 consecutive, infliximab-naïve CD patients who achieved clinical remission/response after induction and were in maintenance treatment with ADA, and who were followed-up for at least 72 weeks. Blood samples were drawn at standardized time points to assess ADA through levels, AAA. RESULTS: At week 48, we found significantly (p = 0.027) different ADA trough serum levels in patients in remission (10.1 mcg/mL), mild (7.4 mcg/mL), and moderate/severe disease (4.5 mcg/mL). Median ADA trough levels were significantly lower in patients with AAA (3.7 mcg/mL versus 9.3 mcg/mL, p = 0.006). At the end of follow-up (median 102 weeks, range 73-112 weeks), ADA trough serum concentrations were significantly higher (11.9 mcg/mL) as compared to patients with mild and moderate/severe disease (5.5 mcg/mL, p = 0.0002). Furthermore, median ADA trough concentrations showed a trend towards lower levels in AAA positive patients (5.2 mcg/mL versus 7.2 mcg/mL, p = 0.371). CONCLUSIONS: Our results emphasize the relevance of therapeutic drug monitoring in CD patients on biologic treatment. ADA trough serum levels and the presence of AAA are important features in the management of patients on ADA treatment.

Comparison of Two Different Techniques to Assess Adalimumab Trough Levels in Patients with Crohn's Disease.

BACKGROUND AND AIMS: Loss of response to anti-tumor necrosis factor (TNF) drugs in patients with inflammatory bowel disease is likely due to low drug serum levels, and dosing anti-TNF drug concentrations may improve patients' outcome. However, there are limited data on the diagnostic accuracy and utility of currently available assays for measuring anti-TNF levels. In this study, our aim was to compare serum adalimumab concentrations with two different techniques. METHODS: We assessed serum adalimumab concentrations in 23 patients with Crohn's disease during a 96-week follow-up period. Adalimumab trough levels were assessed using a sandwich principle-based enzyme-linked immunosorbent assay (ELISA) and a homogeneous mobility shift assay (HMSA). RESULTS: At week 48, adalimumab trough levels were significantly lower in patients who experienced relapse compared to patients in remission, using both ELISA and HMSA methods: 4.8 mcg/mL (2.4-7.2 mcg/mL) vs. 7.5 mcg/mL (6.6-8.4 mcg/mL) (P=0.01) and 6.5 mcg/mL (3-10 mcg/mL) vs. 11.6 mcg/mL (7-16.2 mcg/ml) (P=0.004), respectively. Similar results were obtained at week 96: 5.9 mcg/mL (3.3-8.5 mcg/mL) vs. 12.8 mcg/mL (9.4-16.2 mcg/mL) (P=0.001) and 4.1 mcg/mL (1.6-6.6 mcg/mL) vs. 7.5 mcg/mL (5.7-9.3 mcg/mL) (P=0.009), respectively. There was a significant correlation between ELISA and HMSA adalimumab trough levels at both 48 (r = 0.691, P=0.0003) and 96 week (r = 0.822, P=0.0001). CONCLUSIONS: ELISA and HMSA assays are accurate methods to assess adalimumab trough levels in patients with Crohn's disease and those who experience loss of response. The preferential use of one of the two techniques should be based on local availability and physicians' experience.

Optimal management of constipation associated with irritable bowel syndrome.

Irritable bowel syndrome (IBS) is a common chronic functional disorder of the gastrointestinal tract, meanly characterized by recurrent abdominal pain or discomfort and altered bowel habit. It is a complex disorder involving biological, environmental, and psychosocial factors. The diagnosis is achieved according to the Rome III criteria provided that organic causes have been excluded. Although IBS does not constitute a life-threatening condition, it has a remarkable prevalence and profoundly reduces the quality of life with burdening socioeconomic costs. One of the principal concerns about IBS is the lack of effective therapeutic options. Up to 40% of patients are not satisfied with any available medications, especially those suffering from chronic constipation. A correct management of IBS with constipation should evolve through a global approach focused on the patient, starting with careful history taking in order to assess the presence of organic diseases that might trigger the disorder. Therefore, the second step is to examine lifestyle, dietary habits, and psychological status. On these bases, a step-up management of disease is recommended: from fiber and bulking agents, to osmotic laxative drugs, to new molecules like lubiprostone and linaclotide. Although new promising tools for relief of bowel-movement-related symptoms are being discovered, a dedicated doctor-patient relationship still seems to be the key for success.