Reduction of esophageal stent migration rate with a novel over-the-scope fixation device (with video).

BACKGROUND AND AIMS: Self-expandable metal stent (SEMS) placement is routinely performed in a variety of benign and malignant GI diseases. One of the most frequent adverse events after esophageal SEMS placement is stent migration. We evaluated a novel over-the-scope clip device (stentfix OTSC; Ovesco Endoscopy, Tuebingen, Germany) designed and approved for SEMS fixation. METHODS: This single-center retrospective observational cohort study was performed to analyze stent migration rates before and after availability of the stentfix OTSC device. A cohort of patients who consecutively underwent SEMS fixation with the stentfix OTSC system (SF cohort) was compared with an historical cohort of patients who did not receive stentfix OTSC fixation or any other stent fixation method (NF cohort) before the stentfix OTSC system became available. Outcome variables including technical success, adverse events and clinical success were analyzed. RESULTS: Seventy-seven patients (SF cohort, 26; NF cohort, 51) underwent esophageal SEMS implantation for malignant (69%) and benign (31%) conditions. The technical success rate of stent fixation was 100%, and no procedure-related adverse events were observed. The stent migration rate was significantly lower in the SF cohort compared with the NF cohort (8.3% vs 35.4%, P < .001), indicating a relative risk reduction of 76.5% associated with stentfix OTSC application. Stent implantation across the gastroesophageal junction was identified as a predictor of stent migration. CONCLUSIONS: In patients with benign or malignant gastroesophageal diseases, there was a significantly lower stent migration rate in patients managed with the stentfix OTSC system compared with those without stent fixation. The application was technically successful in all cases, and no adverse events related to clip application or removal were observed.

Esophageal lichen planus: towards diagnosis of an underdiagnosed disease.

Background: Although lichen planus (LP) is a common skin disorder, the prevalence of esophageal involvement (ELP) and its clinical manifestations are poorly defined. We aimed to establish diagnostic criteria and characterize disease outcomes of ELP.Methods: Clinical, endoscopic, histological, and immunofluorescence data from consecutive patients with known LP between 2013 and 2018 were analyzed. We established endoscopic (denudation and tearing of the mucosa, hyperkeratosis and trachealization) and histological criteria (mucosal detachment, T-lymphocytic infiltrate, intraepithelial apoptosis, dyskeratosis, and fibrinogen deposits along the basement membrane) to grade disease severity. Endoscopic findings were correlated with clinical symptoms. Response to medical therapy was monitored.Results: Fifty-two consecutive patients (median age 59.5 years) were analyzed. According to our grading system, 16 patients were considered as severe and 18 as mild ELP. Dysphagia was the only symptom which differentiated patients with severe (14/16) or mild ELP (8/18) from patients without ELP (1/18). Concomitant oral and genital involvement of LP was associated with the presence of ELP, while oral involvement alone was not. Follow-up of 14/16 patients with severe EPL for at least one year revealed that most of these patients responded to topical corticosteroids (budesonide: n = 9/10 or fluticasone n = 2/2). Three budesonide patients experienced a resolution of symptomatic esophageal stenosis.Conclusions: Esophageal involvement of LP is frequent, but may be asymptomatic. ELP can be diagnosed using the diagnostic criteria proposed here. Dysphagia and combined oral and genital manifestation are associated with ELP. Therapy with topical corticosteroids appears to be a prudent therapeutic approach for ELP.

Comparative efficacy and safety of the duodenal-jejunal bypass liner in obese patients with type 2 diabetes mellitus: A case control study.

AIMS: The duodenal-jejunal bypass liner (DJBL) is an endoscopic device mimicking surgical duodenal-jejunal bypass, and is indicated for the treatment of obesity-associated type 2 diabetes mellitus. This analysis was conducted to evaluate the efficacy and safety of the DJBL in comparison to lifestyle changes and antidiabetic drugs. MATERIALS AND METHODS: To determine the efficacy and long-term safety of the DJBL, data concerning 235 obese patients with type 2 diabetes mellitus from the German DJBL registry were analysed. For comparison with standard treatment, propensity-score-matching with patients from the German DPV registry, including the matching parameters sex, age, diabetes duration, baseline BMI and baseline HbA1c, was applied. The final matched cohort consisted of 111 patients in the DJBL group and 222 matched control DPV patients. RESULTS: Mean treatment time with the DJBL was 47.5 ± 12.2 weeks, mean BMI reduction was 5.0 kg/m2 (P < .001) and mean HbA1c reduction was 1.3% (11.9 mmol/mol) (P < .001). Reduction of antidiabetic medications and improvements in other metabolic and cardiovascular risk parameters was observed. In comparison to the matched control group, mean reductions in HbA1c (-1.37% vs -0.51% [12.6 vs 3.2 mmol/mol]; P < .0001) and BMI (-3.02 kg/m2 vs -0.39 kg/m2 ; P < .0001) were significantly higher. Total cholesterol, LDL cholesterol and blood pressure were also significantly better. CONCLUSION: This study provides the largest, so far, hypothesis-generating evidence for a putative positive risk/benefit ratio for treatment of obese patients with type 2 diabetes mellitus with the DJBL as an alternative treatment option for this patient population.

Impact of duodenal-jejunal bypass liner (DJBL) on NAFLD in patients with obesity and type 2 diabetes mellitus.

OBJECTIVES: Non-alcoholic fatty liver disease (NAFLD) represents an excessively rising entity of chronic liver disease and is a leading cause of mortality among patients with metabolic syndrome. The duodenal-jejunal bypass liner (DJBL) is a minimally invasive endoscopic treatment option for patients with obesity and type 2 diabetes (T2DM). Although beneficial effects of DJBL therapy on body weight reduction and glycemic control have been described, the effects of DJBL implantation on NAFLD is unknown. The aim of this study was to to evaluate the effects of DJBL implantation for 6 to 9 months on biochemical and clinical biomarkers of NAFLD in a large cohort of patients. METHODS: The effect of DJBL treatment on biochemical and clinical parameters of NAFLD were assessed in a study cohort of 71 patients with obesity and T2DM. DJBL was implanted for 9 to 12 months and patients were regularly monitored during the implantation period and for a follow-up period of 6 months after explantation. RESULTS: DJBL therapy was associated with a significant decrease in fatty liver index during time of implantation (explantation versus implantation: 93.38 versus 98.22, P < 0.001). Moreover, DJBL implantation was associated with decreases of alanine aminotransferase (29.03 versus 42.29 U/L, P < 0.0001) and cytokeratin-18 fragments (CK18 MF30; 190.6 versus 276 U/L, P < 0.0001), that further remained stable during 6 months after explantation. NAFLD fibrosis and aspartate aminotransferase-to-platelet ratio index (APRI) scores decreased significantly during implantation (-0.83 versus 0.19, P < 0.001, 0.26 versus 0.36, P < 0.0001, respectively). CONCLUSIONS: To our knowledge, this is the first study to demonstrate significant effects of DJBL treatment on biochemical and clinical markers of NAFLD activity. Significant effects of DJBL treatment on NAFLD fibrosis and APRI score further suggests protective effects of DJBL on liver-related morbidity and mortality in patients with obesity and T2DM.

Duodenal-Jejunal Bypass Liner (DJBL) Improves Cardiovascular Risk Biomarkers and Predicted 4-Year Risk of Major CV Events in Patients with Type 2 Diabetes and Metabolic Syndrome.

BACKGROUND: The duodenal-jejunal bypass liner (DJBL) represents a novel endoscopic minimally invasive treatment option for obesity-associated type 2 diabetes (T2D), affecting body weight and metabolic control. Until now, the effects of DJBL on cardiovascular risk have never been investigated. METHODS: Between 2012 and 2017, 71 patients with T2D and metabolic syndrome (MS) were recruited for implantation of DJBL for 9-12 months. Within DJBL treatment and a follow-up period of 6 months, patients were analysed for dynamics of cardiovascular biomarkers. Overall cardiovascular risk was estimated by the ADVANCE Risk Engine at time of implantation, explantation and 6 months after explantation of DJBL. RESULTS: DJBL-induced weight loss and improvements in blood sugar control were accompanied by significant decreases of the cardiovascular biomarkers high-sensitive CRP, lipoprotein-associated phospholipase A2 and small dense lipoprotein fraction LDL-4 (p = 0.001, p < 0.001 and p = 0.04, respectively). Estimated overall cardiovascular risk decreased significantly after DJBL implantation and remained stable within 6 months after explantation. CONCLUSIONS: In addition to beneficial effects of DJBL on weight loss, glycaemic control and lipid parameters in patients with MS, this is the first study that could further reveal significant impact on serological cardiovascular biomarkers and estimated CV risk, suggesting putative protective effects of DJBL on CV outcome.

Ischemic Duodenal Ulceration after Transarterial Chemoembolization for Hepatocellular Carcinoma: A Case Report.

Drug-eluting bead transarterial chemoembolization (DEB-TACE) is a well-established, minimally invasive interventional treatment for nonresectable hepatocellular carcinoma (HCC). Generally, TACE is regarded as safe and effective with a low complication rate. However, remote gastrointestinal ischemia due to the carryover of embolic material into visceral arteries is a rare but serious complication of TACE. In this report, we present a case of duodenal ulceration with contained perforation and severe necrotizing pancreatitis after TACE in a patient with nonresectable HCC and underlying hepatitis C virus associated with Child-Pugh stage B liver cirrhosis. This patient showed, for the first time, complete endoscopic and clinical recovery within 2 months of conservative treatment. Considering the high mortality rate from surgical intervention in all previously reported patients, the significant recovery potential demonstrated by our case suggests conservative treatment with antibiotics and parenteral nutrition combined with close clinical, radiological, and endoscopic monitoring should be considered in all clinically stable patients without signs of peritonism or septic sequelae.

Esophageal involvement is frequent in lichen planus: study in 32 patients with suggestion of clinicopathologic diagnostic criteria and therapeutic implications.

OBJECTIVE: Lichen planus (LP) is a classic skin disease that can involve the skin, hair, and nails, as well as the oral and genital mucosa. Histopathology is characterized by a T-lymphocytic, lichenoid, and interface dermatitis. Multiple case reports and small case series have shown that LP can involve the esophagus. However, the diagnostic criteria, incidence, and best treatment options remain uncertain. This study aimed to refine the diagnostic criteria, estimate prevalence, and present an outlook on treatment options to prevent long-term sequelae. PATIENTS AND METHODS: Thirty-two consecutive patients with LP of the skin, hair, nails, oral mucosa, and/or genital mucosa underwent a comprehensive clinicopathologic assessment. Esophagogastroduodenoscopy was performed, and biopsies were evaluated histologically, immunohistochemically, and by direct immunofluorescence. Patients diagnosed with esophageal lichen planus (ELP) were followed up prospectively where possible. RESULTS: In total, 20 of 32 patients had ELP. Ten of these 20 patients were classified as having proven ELP, with clear-cut endoscopically visible lesions; the other 10 were classified as having probable ELP. Eight of 10 patients with proven ELP were started on new or additional therapy because of esophageal findings. Treatment with a topical budesonide formulation or systemic corticosteroids was successful in most patients with proven ELP and reversed functional esophageal stenosis. CONCLUSION: ELP can be found in more than 50% of patients with proven mucocutaneous LP when clinical and pathologic findings are correlated carefully. Topical or systemic corticosteroids are the first-line therapy for ELP. Timely medical therapy seems to prevent scarring stenosis of the esophagus.

Klatskin tumor treated by inter-disciplinary therapies including stereotactic radiotherapy: a case report.

In view of the poor prognosis of patients with cholangiocarcinoma (CCC), there is a need for new therapeutic strategies. Inter-disciplinary therapy seems to be most promising. Radiotherapy is an effective alternative to surgery for hilar CCC (Klatskin tumors) if an adequate radiation dose can be delivered to the liver hilus. Here, we describe a patient for whom we used a stereotactic radiotherapy technique in the context of an inter-disciplinary treatment concept. We report a 45-year-old patient with a locally advanced Klatskin tumor. Explorative laparotomy showed that the tumor was not resectable. A metallic stent was implanted and the patient was treated by stereotactic radiotherapy using a body frame. A total dose of 48 Gy (3X4 Gy/wk) was administered. Therapy was well tolerated. After 32 mo, local tumor recurrence and a chest wall metastasis developed and were controlled by radio-chemotherapy. After more than 56 mo with a good quality of life, the patient died of advanced neoplastic disease. Stereotactic radiotherapy led to a long-term survival of this patient with a locally advanced Klatskin tumor. In the context of inter-disciplinary treatment concepts, this radiotherapy technique is a promising choice of treatment for patients with hilar CCC.

Small intestinal bacterial overgrowth in human cirrhosis is associated with systemic endotoxemia.

OBJECTIVES: Systemic endotoxemia has been implicated in various pathophysiological sequelae of chronic liver disease. One of its potential causes is increased intestinal absorption of endotoxin. We therefore examined the association of small intestinal bacterial overgrowth with systemic endotoxemia in patients with cirrhosis. METHODS: Fifty-three consecutive patients with cirrhosis (Child-Pugh group A, 23; group B, 18; group C, 12) were included. Jejunal secretions were cultivated quantitatively and systemic endotoxemia determined by the chromogenic Limulus amoebocyte assay. Patients were followed up for 1 yr. RESULTS: Small intestinal bacterial overgrowth, defined as > or = 10(5) total colony forming units per milliliter of jejunal secretions, was present in 59% of patients and strongly associated with acid suppressive therapy. The mean plasma endotoxin level was 0.86 +/- 0.48 endotoxin units/ml (range = 0.03-1.44) and was significantly associated with small intestinal bacterial overgrowth (0.99 vs 0.60 endotoxin units/ml, p = 0.03). During the 1-yr follow-up, seven patients were lost to follow up or underwent liver transplantation and 12 patients died. Multivariate Cox regression showed Child-Pugh group to be the only predictor for survival. CONCLUSIONS: Small intestinal bacterial overgrowth in cirrhotic patients is common and associated with systemic endotoxemia. The clinical relevance of this association remains to be defined.