Abstract
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.
Abstract
Background and study aims
The over-the-scope clip (OTSC) is a novel tool used to improve the maintenance of hemostasis for non-variceal upper gastrointestinal bleeding (NVUGIB); however, ...studies on the comparison with “conventional” techniques are lacking. In this study, we aimed to compare first-line endoscopic hemostasis achieved using conventional techniques with that achieved using OTSC placement for NVUGIB.
Patients and methods
From January 2007 to March 2018, 793 consecutive patients underwent upper endoscopy with the hemostasis procedure. Among them, 327 patients were eligible for inclusion (112 patients had OTSC placement and 215 underwent conventional hemostasis). After propensity score matching and adjustment for confounding factors, 84 patients were stratified into the “conventional” group and 84 into the OTSC group. Patient characteristics and outcomes (rebleeding rate, mortality rate within 30 days, and adverse events) were compared between the two groups.
Results
In the unmatched cohort, hemostasis with OTSC was more frequent in cases of duodenal ulcers with Forrest Ia to IIa and in patients with a higher Rockall score compared with the “conventional group”. In the matched cohort, 93 % of the patients in the “conventional group” underwent hemostasis with epinephrine + through-the-scope clip. Rebleeding events were significantly less frequent in the OTSC group (8 % vs 20 %, 95 %CI 3 – 16 vs 12 – 30;
P
= 0.02); however, the mortality rate in the two groups was not significantly different (6 % vs 2 %, 95 %CI 1 – 8 vs 2 – 13;
P
= 0.4).
Conclusions
OTSC is a safe and effective tool for achieving hemostasis, and we recommend its use as the first-line therapy for lesions with a high risk of rebleeding and in patients with a high risk Rockall score.
Background/Aims: Curing Helicobacter pylori infection remains challenging for clinicians, as no proposed first-line therapy achieves bacterial eradication in all treated patients so that several ...patients need two or more consecutive treatments. Bacterial culture with antibiotics susceptibility testing is largely unachievable in Italy, and empiric second-line and rescue therapies are generally used. This study aimed to identify what eradication regimens perform better in Italy, following first-line therapy failure. Methods: We performed a literature search on PubMed for studies on standard therapy regimens used as second-line or rescue treatments performed in adult patients. Studies including modified drug combinations were not considered. Both intention-to-treat and per- protocol analyses were computed for each therapy subgroup. Results: Data from 35 studies with a total of 4830 patients were eventually considered. As a second-line therapy, Pylera® (90.6%) and a sequential regimen (89.8%) achieved eradication rates significantly higher than other therapies. For third-line therapy, a levofloxacin-based regimen and Pylera® achieved comparable eradication rates (88.2% vs. 84.7%; p = 0.2). Among therapies used as fourth (or more) attempts, Pylera® and a rifabutin-based therapy achieved 77.4% and 66.4% cure rates, respectively (p = 0.013). A therapy sequence based on the type of first-line therapy used was proposed. Conclusions: Data obtained through our review indicate that standard therapies for H. pylori eradication can be used when following an appropriate sequence, allowing clinicians to improve the cure rate without resorting to bacterial culture.
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.
Background/Aims: Endoscopic submucosal dissection (ESD) has been proposed for removal of gastrointestinal subepithelial tumors (GI-SETs), but data are still scanty. This study aimed to report a case ...series from a western country. Patients and Methods: Data of patients with upper GI-SETs suitable for ESD removal observed in 4 centers were retrospectively reviewed. Before endoscopic procedure, the lesion was characterized by endosonographic evaluation, histology, and CT scan. The en bloc resection and the R0 resection rates were calculated, as well as incidence of complications, and the 1-year follow-up was reported. Results: Data of 84 patients with esophageal (N = 13), gastric (N = 61), and duodenal (N = 10) GI-SETs were collected. The mean diameter of lesions was 26 mm (range: 12–110 mm). There were 17 gastrointestinal stromal tumors, 12 neuroendocrine tumors, 35 leiomyomas, 18 lipomas, and 2 hamartomas. En bloc and R0 resection were achieved in 83 (98.8%) and in 80 (95.2%) patients, respectively. Overall, a complication occurred in 11 (13.1%) patients, including bleeding (N = 7) and perforation (N = 4). Endoscopic approach was successful in all bleedings, but 1 patient who required radiological embolization, and in 2 perforations, while surgery was performed in the other patients. Overall, a surgical approach was eventually needed in 5 (5.9%), including 3 in whom R0 resection failed and 2 with perforation. Conclusions: Our study found that ESD may be an effective and safe alternative to surgical intervention for both benign and localized malignant GI-SETs.
Endoscopic submucosal dissection (ESD) allows removing neoplastic lesions on gastric mucosa, including early gastric cancer (EGC) and dysplasia. Data on ESD from Western countries are still scanty. ...We report results of ESD procedures performed in Italy. Data of consecutive patients who underwent ESD for gastric neoplastic removal were analyzed. The
resection rate and the R0 resection rates for all neoplastic lesions were calculated, as well as the curative rate (i.e., no need for surgical treatment) for EGC. The incidence of complications, the one-month mortality, and the recurrence rate at one-year follow-up were computed. A total of 296 patients with 299 gastric lesions (80 EGC) were treated. The
resection was successful for 292 (97.6%) and the R0 was achieved in 266 (89%) out of all lesions. In the EGC group, the ESD was eventually curative in 72.5% (58/80) following procedure. A complication occurred in 30 (10.1%) patients. Endoscopic treatment was successful in all 3 perforations, whereas it failed in 2 out of 27 bleeding patients who were treated with radiological embolization (1 case) or surgery (1 case). No procedure-related deaths at one-month follow-up were observed. Lesion recurrence occurred in 16 (6.2%) patients (6 EGC and 10 dysplasia). In conclusion, the rate of both
and R0 gastric lesions removal was very high in Italy. However, the curative rate for EGC needs to be improved. Complications were acceptably low and amenable at endoscopy.
Helicobacter pylori (H. pylori) eradication in patients who failed one or more therapeutic attempts remains challenging. This study aimed to assess the efficacy of three-in-one capsules bismuth-based ...quadruple therapy (Pylera®) in these patients managed in clinical practice.
This was a prospective, open-label, multicenter study enrolling consecutive, adult patients with persistent H. pylori infection following at least one standard therapy. All patients received a rescue quadruple therapy with Pylera (3 capsules four times daily) and esomeprazole 20 mg (1 tablet twice daily) for 10 days. H. pylori eradication was assessed by using Urea Breath Test 4-6 weeks following therapy ending. H. pylori eradication rates, compliance, and side-effects were calculated.
A total of 208 patients in the 9 participating centres were enrolled. Overall, 180 patients were successfully cured from the infection, accounting for 86.5% (95% CI 81.9-91.2) and 92.3% (95% CI 88.6-96.1) eradication rates at intention-to-treat analysis and at per protocol analysis, respectively. Cure rates were similar across patients who failed one to three previous therapy attempts, but the success rate fell to 67% after 4 or more therapy failures. Compliance to therapy was good in 198 (95.2%) patients, whilst in 7 (5.3%) cases the therapy was interrupted within 5 days due to side effects. A total of 97 (46.6%) patients complained of at least one side effect; nausea, diarrhea and vomiting were the most frequently reported.
Our study found that this bismuth-based quadruple therapy is highly effective as second-line and rescue therapy for H. pylori eradication in clinical practice.
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