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1.
Nat Med ; 2024 Jul 30.
Article in English | MEDLINE | ID: mdl-39079993

ABSTRACT

Gastric cancer is a leading cause of cancer-related deaths in China. Affecting more than 40% of the world's population, Helicobacter pylori is a major risk factor for gastric cancer. While previous clinical trials indicated that eradication of H. pylori could reduce gastric cancer risk, this remains to be shown using a population-based approach. We conducted a community-based, cluster-randomized, controlled, superiority intervention trial in Linqu County, China, with individuals who tested positive for H. pylori using a 13C-urea breath test randomly assigned to receiving either (1) a 10-day, quadruple anti-H. pylori treatment (comprising 20 mg of omeprazole, 750 mg of tetracycline, 400 mg of metronidazole and 300 mg of bismuth citrate) or (2) symptom alleviation treatment with a single daily dosage of omeprazole and bismuth citrate. H. pylori-negative individuals did not receive any treatment. We examined the incidence of gastric cancer as the primary outcome. A total of 180,284 eligible participants from 980 villages were enrolled over 11.8 years of follow-up, and a total of 1,035 cases of incident gastric cancer were documented. Individuals receiving anti-H. pylori therapy showed a modest reduction in gastric cancer incidence in intention-to-treat analyses (hazard ratio 0.86, 95% confidence interval 0.74-0.99), with a stronger effect observed for those having successful H. pylori eradication (hazard ratio 0.81, 95% confidence interval 0.69-0.96) than for those who failed treatment. Moderate adverse effects were reported in 1,345 participants during the 10-day treatment. We observed no severe intolerable adverse events during either treatment or follow-up. The findings suggest the potential for H. pylori mass screening and eradication as a public health policy for gastric cancer prevention. Chinese Clinical Trial Registry identifier: ChiCTR-TRC-10000979 .

2.
Am J Cancer Res ; 11(2): 561-575, 2021.
Article in English | MEDLINE | ID: mdl-33575087

ABSTRACT

In addition to Helicobacter pylori (H.pylori), gastric microbiota may be involved in carcinogenesis process. However, the longitudinal study to assess changes in the gastric microbiota associated with the development of gastric carcinogenesis is still limited. The aim of this study is to explore dynamic microbial alterations in gastric cancer (GC) development based on a 4-year endoscopic follow-up cohort in Linqu County, China. Microbial alterations were investigated by deep sequencing of the microbial 16S ribosomal RNA gene in 179 subjects with various gastric lesions, and validated in paired gastric biopsies prospectively collected before and after lesion progression and in non-progression controls. Significant differences were found in microbial diversity and community structure across various gastric lesions, with 62 candidate differential taxa between at least two lesion groups. Further validations identified Helicobacter, Bacillus, Capnocytophaga and Prevotella to be associated with lesion progression-to-dysplasia (DYS)/GC (all P < 0.05), especially for subjects progressing from intestinal metaplasia (IM) to DYS/GC. The combination of the four genera in a microbial dysbiosis index showed a significant difference after lesion progression-to-DYS/GC compared to controls (P = 0.027). The panel including the four genera identified subjects after progression-to-DYS/GC with an area under the receiver-operating curve (AUC) of 0.941. Predictive significance was found before lesion progression-to-DYS/GC with an AUC = 0.776 and an even better AUC (0.927) for subjects progressing from IM to DYS/GC. Microbiota may play different roles at different stages in gastric carcinogenesis. A panel of bacterial genera associated with gastric lesions may help to assess gastric microbial dysbiosis and show potential predictive values for lesion progression. Our findings provide new clues for the microbial mechanism of H.pylori-associated carcinogenesis.

3.
Z Gastroenterol ; 59(2): 135-142, 2021 Feb.
Article in English | MEDLINE | ID: mdl-33147637

ABSTRACT

BACKGROUND AND AIMS: Colon diverticula (CD) and adenomatous polyps are frequently found during colonoscopy. Data from the literature contains inconsistent information about whether patients with CD have a higher risk for colon adenomas. A positive correlation might influence the current guidelines for screening colonoscopies. The aim of this study was to examine whether presence of CD is associated with endoscopic adenoma detection. MATERIALS AND METHODS: This was a prospective study at 2 centers in Germany. Patients with an indication for colonoscopy were included. The number and localization of diverticula were recorded. Detected polyps were resected, and histopathological results were captured. Logistic regression models were fitted to the data to evaluate the association between CD and adenoma detection. RESULTS: A total of 938 colonoscopies was included. CD occurred in 49.1 % of the colonoscopies. The polyp and adenoma detection rates (PDR, ADR) were 50.3 % and 32.3 %. In 37.5 % of the patients with diverticula, at least 1 adenoma was detected, whereas this was the case in 27.3 % in the absence of diverticula. The presence of diverticula was positively correlated with the detection of adenomas in univariate analysis (p = 0.001), but no significant association could be found in multivariable analysis (p = 0.775). Increasing age (p < 0.001), male sex (p = 0.005), and longer withdrawal time (p < 0.001) were significant predictors for adenoma detection in the multivariable analysis. Similar results were also observed for both the distal and the proximal colon. DISCUSSION: Diverticula and adenomas are frequently found during colonoscopies. However, diverticula disease was not significantly associated with adenoma detection after adjustment for relevant prognostic factors. Older age, male sex, and duration of withdrawal time are predictors for the detection of adenomatous polyps.


Subject(s)
Adenomatous Polyps/diagnosis , Colonic Neoplasms/diagnosis , Colonoscopy/methods , Diverticulum, Colon/diagnostic imaging , Adenomatous Polyps/epidemiology , Aged , Colonic Neoplasms/epidemiology , Germany/epidemiology , Humans , Male , Prospective Studies , Retrospective Studies , Risk Factors
4.
Endosc Int Open ; 8(10): E1522-E1529, 2020 Oct.
Article in English | MEDLINE | ID: mdl-33043124

ABSTRACT

Background and study aims Colonoscopic polypectomy is an essential endoscopic skill. The simulators available for training are limited and based on raw porcine colons. Animal intestines are inconvenient and offer limited advantages for polypectomy training. These limitations are avoided by two novel mechanical simulators - the magnetic system based simulator (MSPS) and the simulator for polypectomy with high frequency current (HFPS) - described here. They are equipped to demonstrate self-repair of polyps after making a cut and hybrid polyps. The aim of this study was to describe and establish face, content, and construct validity of the two simulators and to assess their perceived utility as training and assessment tools. Methods Ten novice, seven intermediate, and 10 advanced endoscopists participated in this study. Each one performed two polypectomies in MSPS and then one polypectomy and polyp retrieval in HFPS. The median times were compared among the three groups to preliminarily assess construct validity as a primary outcome. To establish face validity, the novices and intermediates completed a questionnaire about the credibility of each simulator after finishing the tasks. For content validity, the experts completed a questionnaire grading different aspects of the simulators' realism and their usefulness for training. Results All 27 participants completed the modules. Median times needed to complete the tasks in both simulators differed significantly between the participants with different levels of experience ( P  < 0.05). Both MSPS and HFPS received favorable scores regarding face and content validity. No technical problems were encountered. Conclusion This study provides preliminary validation for MSPS and HFPS as useful training tools in a preclinical setting as well as during colonoscopy training. Moreover, we demonstrated the construct validity of both simulators, which confirms their use as a skill assessment tool during a colonoscopy training program.

5.
Z Gastroenterol ; 58(3): 234-240, 2020 Mar.
Article in English | MEDLINE | ID: mdl-32018316

ABSTRACT

OBJECTIVES: Angiodysplasia (AD) is a common source of gastrointestinal bleeding. Yet, little is known about factors forwarding bleeding in these vascular malformations. The presented study aims to determine risk factors for bleeding that occurs only in patients with symptomatic, but not with asymptomatic, AD. METHODS: Case-control study in patients with AD and either a positive or a negative history of gastrointestinal bleeding in Munich, Germany. Groups were compared by clinical, laboratory, and endoscopic features. RESULTS: 80 patients with (58, f 31, med. age 72) or without bleeding AD (22, f 12, med. age 61) were included. Bleeding from AD was significantly associated with the total number of AD (OR 1.4 (95 % CI 1.1-1.7) p = 0.01) and closure time in PFA/collagen-epinephrine test (OR 1.0 (95 % CI 1.0-1.0) p < 0.01). The total number of AD correlated significantly with age (r = 0.36; p = 0.01). AD were mainly detected in the upper small intestine (> 30 %). Although patients with aortic stenosis suffered not significantly more frequently from bleeding from AD, they demonstrated a loss of high molecular multimers of VWF. CONCLUSIONS: The amount of AD is clearly correlated to the age of the patient. A higher number of ADs and inhibition of primary hemostasis increase the risk of bleeding.


Subject(s)
Angiodysplasia/etiology , Gastrointestinal Hemorrhage/etiology , Aged , Angiodysplasia/epidemiology , Case-Control Studies , Female , Germany/epidemiology , Humans , Male , Middle Aged , Risk Factors
6.
Gut ; 69(9): 1598-1607, 2020 09.
Article in English | MEDLINE | ID: mdl-31857433

ABSTRACT

OBJECTIVE: Gastrointestinal microbiota may be involved in Helicobacter pylori-associated gastric cancer development. The aim of this study was to explore the possible microbial mechanisms in gastric carcinogenesis and potential dysbiosis arising from H. pylori infection. DESIGN: Deep sequencing of the microbial 16S ribosomal RNA gene was used to investigate alterations in paired gastric biopsies and stool samples in 58 subjects with successful and 57 subjects with failed anti-H. pylori treatment, relative to 49 H. pylori negative subjects. RESULTS: In H. pylori positive subjects, richness and Shannon indexes increased significantly (both p<0.001) after successful eradication and showed no difference to those of negative subjects (p=0.493 for richness and p=0.420 for Shannon index). Differential taxa analysis identified 18 significantly altered gastric genera after eradication. The combination of these genera into a Microbial Dysbiosis Index revealed that the dysbiotic microbiota in H. pylori positive mucosa was associated with advanced gastric lesions (chronic atrophic gastritis and intestinal metaplasia/dysplasia) and could be reversed by eradication. Strong coexcluding interactions between Helicobacter and Fusobacterium, Neisseria, Prevotella, Veillonella, Rothia were found only in advanced gastric lesion patients, and were absent in normal/superficial gastritis group. Changes in faecal microbiota included increased Bifidobacterium after successful H. pylori eradication and more upregulated drug-resistant functional orthologs after failed treatment. CONCLUSION: H. pylori infection contributes significantly to gastric microbial dysbiosis that may be involved in carcinogenesis. Successful H. pylori eradication potentially restores gastric microbiota to a similar status as found in uninfected individuals, and shows beneficial effects on gut microbiota.


Subject(s)
Dysbiosis , Gastritis, Atrophic , Gastrointestinal Microbiome/genetics , Helicobacter Infections , Helicobacter pylori , Stomach Neoplasms , Anti-Bacterial Agents/therapeutic use , Biopsy/methods , Dysbiosis/diagnosis , Dysbiosis/microbiology , Feces/microbiology , Female , Gastric Mucosa/microbiology , Gastric Mucosa/pathology , Gastritis, Atrophic/microbiology , Gastritis, Atrophic/pathology , Helicobacter Infections/drug therapy , Helicobacter Infections/pathology , Helicobacter pylori/isolation & purification , Helicobacter pylori/pathogenicity , Humans , Male , Metaplasia/microbiology , Metaplasia/pathology , Microbial Interactions , Middle Aged , RNA, Ribosomal, 16S/isolation & purification , Stomach Neoplasms/microbiology , Stomach Neoplasms/pathology
7.
J Clin Gastroenterol ; 54(1): 43-49, 2020 01.
Article in English | MEDLINE | ID: mdl-30614939

ABSTRACT

BACKGROUND: For eosinophilic esophagitis (EoE) recently an association with immunoglobulin (Ig)G4 rather than IgE has been reported. Gastroesophageal reflux disease (GERD) is the most important differential diagnosis of EoE. We compared esophageal IgG4 plasma cell infiltration and serum IgG4 levels of EoE patients (before and after budesonide therapy) with GERD patients. METHODS: Prospectively collected serum samples of 17 EoE patients before and after 8 weeks of therapy with budesonide (1 mg BID) were analyzed for total and antigen-specific IgG4 and IgE levels. Also, immunohistochemical analysis of total and IgG4-positive plasma cells was performed on esophageal biopsies of these patients. In total, 14 GERD patients without histologic proof of eosinophilic infiltration were taken as a control group. RESULTS: Total IgG4 serum levels in EoE patients were significantly higher than in GERD patients (121.0 vs. 71.2 mg/dL; P=0.038) and decreased under budesonide therapy (121.0 vs. 104.2 mg/dL; P=0.019). IgE levels did not differ significantly between all groups. In EoE patients also a high number of esophageal IgG4-positive plasma cells was detected and significantly reduced under therapy (29.1 vs. 0.1 IgG4-positive cells; P<0.001). In GERD patients no relevant esophageal plasma cell infiltration could be seen. CONCLUSIONS: In EoE patients elevated systemic IgG4 serum levels compared with GERD patients can be seen and decrease under topical steroid therapy. Also, local IgG4 plasma cells expression is high in EoE, but not in GERD patients and normalize under therapy. These findings are further proof for a possible association of EoE with IgG4.


Subject(s)
Eosinophilic Esophagitis/blood , Eosinophilic Esophagitis/diagnosis , Gastroesophageal Reflux/blood , Gastroesophageal Reflux/diagnosis , Immunoglobulin G/blood , Adult , Aged , Biopsy , Budesonide/therapeutic use , Clinical Trials as Topic , Diagnosis, Differential , Eosinophilic Esophagitis/drug therapy , Esophagus/pathology , Female , Humans , Male , Middle Aged , Prospective Studies , Young Adult
9.
Digestion ; 100(2): 127-138, 2019.
Article in English | MEDLINE | ID: mdl-30423561

ABSTRACT

BACKGROUND/AIMS: The gut microbiota is altered in irritable bowel syndrome (IBS), and microbiota manipulations by diet or antibiotics can reduce its symptoms. As fecal microbiota transfer (FMT) in IBS is still controversial, we investigated the clinical and side effects of FMT in a cohort of IBS patients with recurrent, treatment refractory symptoms, and studied gut microbiota signatures. METHODS: Using an observational, prospective study design, we applied FMTs from one unrelated, healthy donor to 13 IBS patients. Fecal samples of patients and the donor were analyzed by 16S ribosomal RNA amplicon sequencing. RESULTS: On a symptom level, primarily abdominal pain symptoms were reduced after FMT, and no adverse effects were observed. Studying the microbiome, we found an increase in alpha diversity and changes in the composition of the gut microbiota after FMT. Beta diversity changes after FMT were prominent in a subset of 7 patients with microbiota profiles coming very close to the donor. These patients also showed most pronounced visceral pain reduction. The relative abundance of Akkermansia muciniphila was inversely correlated with pain reduction in our cohort. CONCLUSION: Although exploratory in nature and with a pilot character, this study highlights the potential role of microbiota manipulations in IBS and describes a novel association of intestinal Akkermansia and pain modulation.


Subject(s)
Abdominal Pain/therapy , Fecal Microbiota Transplantation/methods , Feces/microbiology , Irritable Bowel Syndrome/therapy , Verrucomicrobia/isolation & purification , Abdominal Pain/diagnosis , Abdominal Pain/etiology , Adult , Akkermansia , DNA, Bacterial/isolation & purification , Female , Gastrointestinal Microbiome/genetics , Humans , Intestinal Mucosa/microbiology , Irritable Bowel Syndrome/complications , Irritable Bowel Syndrome/microbiology , Male , Pain Measurement , Pilot Projects , Prospective Studies , RNA, Ribosomal, 16S/genetics , Treatment Outcome , Verrucomicrobia/genetics , Young Adult
10.
Article in English | MEDLINE | ID: mdl-29971220

ABSTRACT

Eradication of Helicobacter pylori has been found to be effective for gastric cancer prevention, but uncertainties remain about the possible adverse consequences such as the potential microbial dysbiosis. In our study, we investigated the association between gut microbiota and H. pylori-related gastric lesions in 47 subjects by deep sequencing of microbial 16S ribosomal RNA (rRNA) gene in fecal samples. The dominant phyla in fecal samples were Bacteroidetes, Firmicutes, and Proteobacteria with average relative abundances of 54.77, 31.37 and 12.91%, respectively. Microbial diversity analysis showed that observed species and Shannon index were increased in subjects with past or current H. pylori infection compared with negative subjects. As for the differential bacteria, the average relative abundance of Bacteroidetes was found to significantly decrease from H. pylori negative (66.16%) to past infection group (33.01%, p = 0.007), as well as from normal (76.49%) to gastritis (56.04%) and metaplasia subjects (46.83%, p = 0.027). For Firmicutes and Proteobacteria, the average relative abundances showed elevated trends in the past H. pylori infection group (47.11, 20.53%) compared to negative group (23.44, 9.05%, p = 0.068 and 0.246, respectively), and similar increased trends were also found from normal (18.23, 5.05%) to gastritis (35.31, 7.23%, p = 0.016 and 0.294, respectively) or metaplasia subjects (32.33, 20.07%, both p < 0.05). These findings suggest that the alterations of fecal microbiota, especially the dominant phyla of Bacteroidetes, Firmicutes and Proteobacteria, may be involved in the process of H. pylori-related gastric lesion progression and provide hints for future evaluation of microbial changes after H. pylori eradication.


Subject(s)
DNA, Bacterial/genetics , Gastrointestinal Microbiome/genetics , Helicobacter Infections/microbiology , Helicobacter pylori/genetics , Stomach Neoplasms/microbiology , Adult , Aged , Dysbiosis/microbiology , Dysbiosis/pathology , Feces/microbiology , Female , Gastric Mucosa/microbiology , Gastric Mucosa/pathology , Gastritis/microbiology , Gastritis/pathology , Helicobacter Infections/diagnosis , Humans , Male , Metaplasia/microbiology , Metaplasia/pathology , Middle Aged , Stomach Neoplasms/pathology
11.
Hepatobiliary Pancreat Dis Int ; 17(1): 49-54, 2018 Feb.
Article in English | MEDLINE | ID: mdl-29428104

ABSTRACT

BACKGROUND: Occlusion of self-expanding metal stents (SEMS) in malignant biliary obstruction occurs in up to 40% of patients. This study aimed to compare the different techniques to resolve stent occlusion in our collective of patients. METHODS: Patients with malignant biliary obstruction and occlusion of biliary metal stent at a tertiary referral endoscopic center were retrospectively identified between April 1, 1994 and May 31, 2014. The clinical records were further analyzed regarding the characteristics of patients, malignant strictures, SEMS, management strategies, stent patency, subsequent interventions, survival time and case charges. RESULTS: A total of 108 patients with biliary metal stent occlusion were identified. Seventy-nine of these patients were eligible for further analysis. Favored management was plastic stent insertion in 73.4% patients. Second SEMS were inserted in 12.7% patients. Percutaneous transhepatic biliary drainage and mechanical cleansing were conducted in a minority of patients. Further analysis showed no statistically significant difference in median overall secondary stent patency (88 vs. 143 days, P = 0.069), median survival time (95 vs. 192 days, P = 0.116), median subsequent intervention rate (53.4% vs. 40.0%, P = 0.501) and median case charge (€5145 vs. €3473, P = 0.803) for the treatment with a second metal stent insertion compared to plastic stent insertion. In patients with survival time of more than three months, significantly more patients treated with plastic stents needed re-interventions than patients treated with second SEMS (93.3% vs. 57.1%, P = 0.037). CONCLUSIONS: In malignant biliary strictures, both plastic and metal stent insertions are feasible strategies for the treatment of occluded SEMS. Our data suggest that in palliative biliary stenting, patients especially those with longer expected survival might benefit from second SEMS insertion. Careful patient selection is important to ensure a proper decision for either management strategy.


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde/instrumentation , Cholestasis/therapy , Digestive System Neoplasms/complications , Drainage/instrumentation , Self Expandable Metallic Stents , Aged , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Cholangiopancreatography, Endoscopic Retrograde/economics , Cholestasis/diagnostic imaging , Cholestasis/economics , Cholestasis/etiology , Clinical Decision-Making , Cost-Benefit Analysis , Digestive System Neoplasms/diagnosis , Drainage/adverse effects , Drainage/economics , Feasibility Studies , Female , Hospital Costs , Humans , Male , Middle Aged , Palliative Care , Patient Selection , Plastics , Prosthesis Design , Prosthesis Failure , Retrospective Studies , Risk Factors , Self Expandable Metallic Stents/economics , Tertiary Care Centers , Time Factors , Treatment Outcome
12.
Endosc Int Open ; 5(12): E1289-E1298, 2017 Dec.
Article in English | MEDLINE | ID: mdl-29218322

ABSTRACT

BACKGROUND AND STUDY AIMS: Longer observation times are associated with increased adenoma detection rates (ADR) in the entire colon. However, adenomas in the proximal colon are at risk of being missed during colonoscopy. The aim of this study was to investigate the impact of observation time on detection of adenomatous polyps in the proximal colon. PATIENTS AND METHODS: This was a prospective study at a university hospital in Germany. Colonoscopies were conducted using magnetic endoscope imaging (MEI) in order to determine the exact position of the scope. Exact observation times spent for the detection of polyps in the proximal and distal colon segments were assessed. The primary outcome was adenoma detection in the proximal colon. ROC curves were generated in order to test the correlation between observation time and adenoma detection. Logistic regression analysis was used to check for interfering factors. RESULTS: A total 480 procedures with 538 polyps were available for analysis. The overall adenoma detection rate was 38.5 %. ADR in the proximal colon was 28.0 %. There was a significant association between observation time in the proximal colon and the detection of proximal adenomas ( P  < 0.001). The impact of the time factor on ADR was stronger in the proximal compared to the distal colon ( P  = 0.030). A net period of 4 min 7 sec was found to be the minimum time span for sufficient adenoma detection in the proximal colon. CONCLUSION: Observation time is significant in terms of adenoma detection in the proximal colon. The impact of observation time on ADR is stronger in the proximal compared to the distal colon. In the proximal colon a minimum time span of 4 minutes should be spent in order to ensure adequate adenoma detection.

13.
Sci Rep ; 7(1): 2072, 2017 05 18.
Article in English | MEDLINE | ID: mdl-28522798

ABSTRACT

The performance of diagnostic tests in intervention trials of Helicobacter pylori (H.pylori) eradication is crucial, since even minor inaccuracies can have major impact. To determine the cut-off point for 13C-urea breath test (13C-UBT) and to assess if it can be further optimized by serologic testing, mathematic modeling, histopathology and serologic validation were applied. A finite mixture model (FMM) was developed in 21,857 subjects, and an independent validation by modified Giemsa staining was conducted in 300 selected subjects. H.pylori status was determined using recomLine H.pylori assay in 2,113 subjects with a borderline 13C-UBT results. The delta over baseline-value (DOB) of 3.8 was an optimal cut-off point by a FMM in modelling dataset, which was further validated as the most appropriate cut-off point by Giemsa staining (sensitivity = 94.53%, specificity = 92.93%). In the borderline population, 1,468 subjects were determined as H.pylori positive by recomLine (69.5%). A significant correlation between the number of positive H.pylori serum responses and DOB value was found (rs = 0.217, P < 0.001). A mathematical approach such as FMM might be an alternative measure in optimizing the cut-off point for 13C-UBT in community-based studies, and a second method to determine H.pylori status for subjects with borderline value of 13C-UBT was necessary and recommended.


Subject(s)
Algorithms , Breath Tests/methods , Helicobacter Infections/diagnosis , Molecular Diagnostic Techniques/standards , Stomach Neoplasms/diagnosis , Adult , Carbon Isotopes , Clinical Trials as Topic , Female , Humans , Limit of Detection , Male , Middle Aged , Models, Theoretical , Stomach Neoplasms/microbiology , Urea
14.
Surg Technol Int ; 30: 131-140, 2017 Jul 25.
Article in English | MEDLINE | ID: mdl-28537351

ABSTRACT

To bridge the gap between the long-term intake of proton pump inhibitors (PPIs) and the potential risks of laparoscopic fundoplication, a number of endoscopic procedures for the treatment of gastro-esophageal reflux disease (GERD) have been developed over the past 30 years. Because of the minimally invasive approach, short operative time, and efficacy in selected patients, endoluminal sphincter augmentation appears to be highly attractive. However, most early devices have proven to be unsafe or failed to provide long-term symptom relief. Accordingly, products for endoluminal sphincter augmentation have undergone several modifications to achieve an increased lower esophageal sphincter (LES) baseline pressure to re-establish the LES as an efficacious anti-reflux barrier. This paper reviews and discusses the two latest products for endoluminal sphincter augmentation, the MUSE™ device (Medigus, Ltd., Omer, Israel) and the GERDX™ system (G-SURG GmbH, Seeon-Seebruck, Germany). While the currently available literature has proven their effectiveness in principle, long-term results are lacking. Further studies and developments are necessary to determine whether these two new devices will truly impact GERD therapy.


Subject(s)
Endoscopy, Digestive System , Esophagogastric Junction/surgery , Gastroesophageal Reflux/surgery , Endoscopy, Digestive System/adverse effects , Endoscopy, Digestive System/instrumentation , Endoscopy, Digestive System/methods , Endoscopy, Digestive System/statistics & numerical data , Humans
15.
Am J Gastroenterol ; 112(5): 725-733, 2017 05.
Article in English | MEDLINE | ID: mdl-28291239

ABSTRACT

OBJECTIVE: Examination of major duodenal papilla (MDP) by standard forward-viewing esophagogastroduodenoscopy (S-EGD) is limited. Cap assisted esophagogastroduodenoscopy (CA-EGD) utilizes a cap fitted to the tip of the endoscope that can depress the mucosal folds and thus might improve visualization of MDP. The aim of this study was to compare CA-EGD to S-EGD for complete examination of the MDP. METHODS: Prospective, randomized, blinded, controlled crossover study. Subjects scheduled for elective EGD were randomized to undergo S-EGD (group A) or CA-EGD (group B) before undergoing a second examination by the alternate method. Images of the MDP were evaluated by three blinded multicenter-experts. Our primary outcome measure was complete examination of the papilla. Secondary outcome measures were duration and overall diagnostic yield. RESULTS: A total of 101 patients were randomized and completed the study. Complete examination of MDP was achieved in 98 patients using CA-EGD compared to 24 patients using S-EGD (97 vs. 24%, P<0.001). Median duration from intubation of the esophagus until localization of the MDP was shorter with CA-EGD (46. vs. 96 s., P<0.001). In group A, 11 extra lesions and 12 additional incidental findings were detected by secondary CA-EGD, whereas neither were detected by secondary S-EGD in group B (22 vs. 0% and 24 vs. 0%, P<0.001 and P<0.001). CONCLUSION: CA-EGD enabled complete examination of MDP in almost all cases compared to a low success rate of S-EGD. CA-EGD detected a significant amount of lesions and incidental findings when added to S-EGD. CA-EGD is a safe and effective method for examination of MDP.


Subject(s)
Ampulla of Vater/diagnostic imaging , Endoscopy, Gastrointestinal/instrumentation , Gastrointestinal Diseases/diagnostic imaging , Incidental Findings , Operative Time , Adult , Clinical Competence , Cross-Over Studies , Female , Humans , Male , Middle Aged , Prospective Studies , Single-Blind Method
17.
Arab J Gastroenterol ; 17(3): 113-116, 2016 Sep.
Article in English | MEDLINE | ID: mdl-27671863

ABSTRACT

BACKGROUND AND STUDY AIM: Optimal therapy concepts in patients with laryngo-pharyngeal reflux (LPR) are still under discussion. Aim of this study was to evaluate long term symptom relief according to results in combined pH/multichannel impedance (MII) monitoring to predict therapy response and symptom relief during long term follow-up. PATIENTS AND METHODS: In patients with predominant LPR symptoms, pH/MII monitoring and subsequent proton pump inhibitor (PPI) therapy were evaluated retrospectively after a minimum follow-up period of 36months. Patients were asked to complete symptom based questionnaires. RESULTS: 45 patients were evaluated and classified according to results of pH/MII. Twenty one patients showed a pathological finding in pH/MII. These patients reported significantly higher LPR-symptom intensity scores and a significantly higher LPR symptom-induced impairment of everyday life scores compared to patients with normal pH/MII monitoring at baseline and at follow-up. PPI associated symptom relief was significantly higher in patients with pathologic pH/MII monitoring (p=0.003). CONCLUSION: In conclusion, combined pH/MII monitoring can reliably predict therapy response to PPIs in LPR patients. With negative results, PPI therapy should be avoided. This approach should be assessed in future prospective clinical trials.


Subject(s)
2-Pyridinylmethylsulfinylbenzimidazoles/therapeutic use , Laryngopharyngeal Reflux/drug therapy , Laryngopharyngeal Reflux/physiopathology , Proton Pump Inhibitors/therapeutic use , Adult , Aged , Esophageal pH Monitoring , Female , Humans , Male , Middle Aged , Pantoprazole , Retrospective Studies , Severity of Illness Index , Surveys and Questionnaires
18.
United European Gastroenterol J ; 4(4): 541-5, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27536364

ABSTRACT

AIM: Diagnosis of laryngopharyngeal reflux (LPR) has dramatically increased over the last years. For diagnosis of gastroesophageal reflux, a newly designed pharyngeal probe (Dx-pH) was recently introduced. It is also recommended to guide therapy decision in antireflux surgery. However, diagnostic results are questionable. Therefore, we establish a reliable reference group with asymptomatic patients after total gastrectomy and, thus, complete extinction of gastric acid production. METHODS: Pharyngeal pH monitoring was performed in 10 consecutive patients with history of total gastrectomy. All patients were off proton pump inhibitor (PPI) therapy and followed a non-acid diet during the complete measurement period. RESULTS: All procedures were performed without any complication. Six of the 10 asymptomatic gastrectomy patients (60%) had pathological results derived from the validated reference values (Ryan score) in pharyngeal pH monitoring. CONCLUSION: Pathological pH values assessed by the Dx-pH device, usually interpreted as pathological aerosolized acidic gastroesophageal and/or laryngopharyngeal reflux, are obviously dissociated from gastric acid production. Further studies are required to determine diagnostic value of the new system. Therefore, the pharyngeal pH monitoring system seems currently not to be useful to guide any diagnostic or therapeutic decisions, in particular if surgical therapy is considered.

19.
Endoscopy ; 48(10): 916-22, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27441684

ABSTRACT

BACKGROUND AND STUDY AIM: The use of magnetic endoscope imaging (MEI) has been previously shown to facilitate colonoscopy procedures. We aimed to evaluate the benefits of MEI in terms of reduction in propofol dosage in patients undergoing routine colonoscopy. METHODS: We conducted a randomized prospective trial in a university hospital in Germany. Endoscopists were randomly assigned 1:1 to use MEI during colonoscopy (MEI arm) or to conduct colonoscopy without the use of MEI (standard arm). The desired level of sedation was conscious sedation as assessed using the Observer's Assessment of Alertness and Sedation scores. After complete recovery, patient satisfaction was assessed using a numeric rating scale (NRS) ranging from 1 to 10 points. The primary outcome was total propofol dosage. Secondary outcome measures were patient satisfaction, patients' cooperation, and complication rates, as well as cecal intubation time and adenoma detection. RESULTS: Among 334 randomized patients, no severe adverse events were observed. Median propofol dosage was significantly lower in the MEI arm compared with the standard arm (150 mg vs. 180 mg; P = 0.04). Deep sedation was observed in 7.8 % of patients in the MEI group and 3.6 % in the standard arm (P = 0.10). Patient satisfaction scores were higher in the MEI arm compared with standard procedures (9.0 vs. 8.5; P = 0.04). No significant differences in patients' cooperation, cecal intubation time, and adenoma detection were observed between the study arms. CONCLUSION: The use of MEI may be useful in reducing propofol dosage for colonoscopy and improving patient satisfaction.ClinicalTrials.gov identifier: NCT02121704.


Subject(s)
Cecal Neoplasms , Colonoscopy , Magnetic Resonance Imaging/methods , Propofol , Adult , Aged , Cecal Neoplasms/diagnostic imaging , Cecal Neoplasms/pathology , Colonoscopy/methods , Colonoscopy/psychology , Deep Sedation/methods , Dose-Response Relationship, Drug , Female , Humans , Hypnotics and Sedatives/administration & dosage , Hypnotics and Sedatives/adverse effects , Image Enhancement/methods , Male , Middle Aged , Outcome Assessment, Health Care , Patient Satisfaction , Propofol/administration & dosage , Propofol/adverse effects , Randomized Controlled Trials as Topic
20.
Gut ; 65(3): 390-9, 2016 Mar.
Article in English | MEDLINE | ID: mdl-25792708

ABSTRACT

OBJECTIVE: To investigate the efficacy and safety of two different budesonide formulations (effervescent tablet for orodispersible use (BET) and viscous suspension (BVS)) with different daily dosages for short-term treatment of eosinophilic oesophagitis (EoE). DESIGN: Adults with active EoE (n=76) randomly received 14 days' treatment with either BET 2×1 mg/day (BET1, n=19) or BET 2×2 mg/day (BET2, n=19), or BVS 2×5 mL (0.4 mg/mL)/day (BVS, n=19) or placebo (n=19) in a double-blind, double-dummy fashion, with a 2-week follow-up. Primary end point was histological remission (mean of <16 eosinophils/mm(2 )hpf). Secondary end points included endoscopy score, dysphagia score, drug safety and patient's preference for drug formulation. RESULTS: Histological remission occurred in 100%, 94.7% and 94.7% of budesonide (BET1, BET2, BVS, respectively) and in 0% of placebo recipients (p<0.0001). The improvement in total endoscopic intensity score was significantly higher in the three budesonide groups compared with placebo. Dysphagia improved in all groups at the end of treatment; however, improvement of dysphagia persisted only in those treated with BET1 (p=0.0196 vs placebo). There were no serious adverse events. Local fungal infection (stained fungi) occurred in two patients of each budesonide group (10.5%). The effervescent tablet was preferred by 80% of patients. CONCLUSIONS: BET or BVS was highly effective and safe for short-term treatment of EoE. The 1 mg (twice daily) dosage was equally effective as the 2 mg twice daily dosage. The majority of patients preferred the effervescent tablet formulation. CLINICALTRIALSGOV NUMBER: NCT02280616; EudraCT number, 2009-016692-29.


Subject(s)
Anti-Inflammatory Agents/administration & dosage , Budesonide/administration & dosage , Eosinophilic Esophagitis/drug therapy , Administration, Oral , Adolescent , Adult , Aged , Anti-Inflammatory Agents/therapeutic use , Budesonide/therapeutic use , Double-Blind Method , Drug Administration Schedule , Female , Follow-Up Studies , Humans , Male , Middle Aged , Remission Induction , Suspensions , Tablets , Treatment Outcome , Young Adult
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