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1.
Gastrointest Endosc ; 2023 Dec 01.
Article in English | MEDLINE | ID: mdl-38042207

ABSTRACT

BACKGROUND AND AIMS: Endoscopic resection is standard treatment for adenomatous colorectal lesions. Depending on lesion morphology and resection technique, recurrence can occur. Scarred adenomas are challenging to resect and may require surgical management. This study evaluated the safety and effectiveness of an endoscopic powered resection (EPR) system for scarred adenomatous colorectal lesions. METHODS: This single-arm, prospective, multicenter study was conducted from January 2018 to January 2021 at 12 sites. Patients with persistent flat or sessile colorectal lesions were enrolled. Primary end points were technical success (the ability of the device to resect the lesion[s] without use of other resection devices without device-related serious adverse events [AEs]) and safety (the occurrence of AEs through 90 days). Secondary end points included endoscopic confirmation of resection completeness, occurrence of colon stenosis, disease persistence, and diagnostic value of resected specimens. RESULTS: Sixty-five patients were in the intention-to-treat/safety analysis population. Primary analysis was performed on 45 per-protocol (PP) patients with 48 lesions. All PP patients were solely treated by using the EPR device. Technical success was achieved in 44 (98%) patients. Three (5%) serious AEs occurred: 2 delayed self-limited bleeds and 1 perforation. Nonserious AEs included 4 (6%) cases of mild intraprocedural bleeding. Completeness of resection and histopathologic diagnosis of tissue specimens were achieved in all patients. Twenty-one (46.7%) patients had disease persistence after the first treatment, and there was no colon stenosis. CONCLUSIONS: EPR is safe and effective for benign, persistent, large (>20 mm), scarred colorectal adenomas and should be considered as an alternative treatment in lieu of surgery. A persistence rate of 46.7% indicates that >1 treatment is necessary for effective endoscopic treatment. (Clinical trial registration number: NCT04203667.).

2.
Endoscopy ; 55(2): 150-157, 2023 02.
Article in English | MEDLINE | ID: mdl-35672016

ABSTRACT

BACKGROUND: Digital single-operator pancreatoscopy (DSOP)-guided lithotripsy is a novel treatment modality for pancreatic endotherapy, with demonstrated technical success in retrospective series of between 88 % and 100 %. The aim of this prospective multicenter trial was to systematically evaluate DSOP in patients with chronic pancreatitis and symptomatic pancreatic duct stones. METHODS: Patients with symptomatic chronic pancreatitis and three or fewer stones ≥ 5mm in the main pancreatic duct (MPD) of the pancreatic head or body were included. The primary end point was complete stone clearance (CSC) in three or fewer treatment sessions with DSOP. Current guidelines recommend extracorporeal shock wave lithotripsy (ESWL) for MPD stones > 5 mm. A performance goal was developed to show that the CSC rate of MPD stones using DSOP was above what has been previously reported for ESWL. Secondary end points were pain relief measured with the Izbicki pain score (IPS), number of interventions, and serious adverse events (SAEs). RESULTS: 40 chronic pancreatitis patients were included. CSC was achieved in 90 % of patients (36/40) on intention-to-treat analysis, after a mean (SD) of 1.36 (0.64) interventions (53 procedures in total). The mean (SD) baseline IPS decreased from 55.3 (46.2) to 10.9 (18.3). Overall pain relief was achieved in 82.4 % (28/34) after 6 months of follow-up, with complete pain relief in 61.8 % (21/34) and partial pain relief in 20.6 % (7/34). SAEs occurred in 12.5 % of patients (5/40), with all treated conservatively. CONCLUSION: DSOP-guided endotherapy is effective and safe for the treatment of symptomatic MPD stones in highly selected patients with chronic pancreatitis. It significantly reduces pain and could be considered as an alternative to standard ERCP techniques for MPD stone treatment in these patients.


Subject(s)
Calculi , Lithotripsy , Pancreatic Diseases , Pancreatitis, Chronic , Humans , Retrospective Studies , Prospective Studies , Treatment Outcome , Pancreatic Diseases/therapy , Pancreatic Diseases/complications , Pancreatitis, Chronic/etiology , Calculi/complications , Lithotripsy/adverse effects , Lithotripsy/methods , Pancreatic Ducts/diagnostic imaging , Pain/etiology , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Cholangiopancreatography, Endoscopic Retrograde/methods
5.
Endosc Int Open ; 10(11): E1454-E1461, 2022 Nov.
Article in English | MEDLINE | ID: mdl-36397863

ABSTRACT

Background and study aims Two different techniques for percutaneous endoscopic gastrostomy (PEG) have been developed: classical pull-through and direct puncture techniques. This study compared the complication rate for both techniques in a large retrospective patient cohort. Patients and methods Clinical data from patients who received a PEG in four high-volume centers for endoscopy were included retrospectively between January 2016 and December 2018. Patient characteristics and complication rates were correlated in univariate and multivariate analyses. Results Data from 1014 patients undergoing a PEG insertion by the pull-through technique were compared to 183 patients for whom the direct puncture technique was used. The direct puncture technique was associated with a 50 % reduction in minor and 85.7 % reduction in major complications when compared to the pull-through technique. Multivariate analysis of these data revealed an odds ratio of 0.067 (0.02-0.226; P  < 0.001) for major complications in the direct puncture group. Conclusions Compared to the pull-through technique, the direct puncture technique resulted in a significant reduction in complications. Despite the retrospective design of this study, these results suggest that the direct puncture technique may be preferable to improve patient safety.

6.
PLoS One ; 17(10): e0275029, 2022.
Article in English | MEDLINE | ID: mdl-36302047

ABSTRACT

BACKGROUND: Endoscopic ultrasound-guided biliary drainage (EUS-BD) was associated with better clinical success and a lower rate of adverse events (AEs) than fluoroscopy-guided percutaneous transhepatic biliary drainage (PTBD) in recent single center studies with mainly retrospective design and small case numbers (< 50). The aim of this prospective European multicenter study is to compare both drainage procedures using ultrasound-guidance and primary metal stent implantation in patients with malignant distal bile duct obstruction (PUMa Trial). METHODS: The study is designed as a non-randomized, controlled, parallel group, non-inferiority trial. Each of the 16 study centers performs the procedure with the best local expertise (PTBD or EUS-BD). In PTBD, bile duct access is performed by ultrasound guidance. EUS-BD is performed as an endoscopic ultrasound (EUS)-guided hepaticogastrostomy (EUS-HGS), EUS-guided choledochoduodenostomy (EUS-CDS) or EUS-guided antegrade stenting (EUS-AGS). Insertion of a metal stent is intended in both procedures in the first session. Primary end point is technical success. Secondary end points are clinical success, duration pf procedure, AEs graded by severity, length of hospital stay, re-intervention rate and survival within 6 months. The target case number is 212 patients (12 calculated dropouts included). DISCUSSION: This study might help to clarify whether PTBD is non-inferior to EUS-BD concerning technical success, and whether one of both interventions is superior in terms of efficacy and safety in one or more secondary endpoints. Randomization is not provided as both procedures are rarely used after failed endoscopic biliary drainage and study centers usually prefer one of both procedures that they can perform best. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03546049 (22.05.2018).


Subject(s)
Cholestasis , Humans , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Cholestasis/diagnostic imaging , Cholestasis/surgery , Drainage/adverse effects , Drainage/methods , Endosonography/methods , Multicenter Studies as Topic , Prospective Studies , Retrospective Studies , Stents/adverse effects , Ultrasonography, Interventional
7.
Cancers (Basel) ; 14(15)2022 Jul 23.
Article in English | MEDLINE | ID: mdl-35892851

ABSTRACT

OBJECTIVES: Current prospective studies investigating the frequency of hereditary criteria in a Caucasian population for adenocarcinoma of the esophagogastric junction (AEG) and stomach (GC) are missing. Genetic testing criteria (screening criteria) for hereditary diffuse gastric cancer (HDGC) were updated in 2020, but do not address patients with intestinal histology (familial intestinal gastric cancer FIGC). Thus, we prospectively screened patients residing in Berlin newly diagnosed with AEG or GC for hereditary criteria to gain insights into the frequency of HDGC. METHODS: Prospective documentation of familial/clinical parameters in patients residing in Berlin with AEG or GC over three years was conducted. Besides HDGC criteria from 2015 and revised 2020, we also documented patients fulfilling these criteria but with intestinal type gastric cancer (FIGC). Statistical analysis was performed using X2-test. RESULTS: One hundred fifty-three patients were finally included (92 GC; male: 50 (n.s.); 61 AEG; male: 47; p = 0.007). Hereditary criteria for HDGC were detected in 9/92 (9.8%) (2015 criteria) and in 14/92 (15.2%) (2020 criteria) of GC patients (AEG: 2015 criteria 3/61 (4.9%) versus 4/61 according to 2020 criteria (6.5%)). Patients fulfilling hereditary criteria but with intestinal histology (FIGC) increased from 8.7% (2015) to 14.1%, respectively (2020) (AEG: 3.2% (2015) versus 6.6% (2020)). Hereditary criteria including intestinal histology were found in 29.3% (GC) and 13.1% (AEG) (p = 0.03) according to the 2020 criteria. CONCLUSIONS: HDGC criteria were found in 15.2% of GC patients according to the 2020 criteria. Percentage increased to 29.3% including patients with intestinal histology among the GC group, and was 13.1% in cases with AEG. These data indicate that family history seems to be of utmost importance in GC to further detect potential hereditary genetic risks. This equally applies for patients with intestinal subtype GC.

8.
Article in English | MEDLINE | ID: mdl-33812217

ABSTRACT

OBJECTIVE: Cyclooxygenase (COX)-derived prostaglandin E2 (PGE2) is an important lipid mediator in colorectal carcinoma (CRC) pathogenesis. Other lipid mediators derived from lipoxygenases (LOX) have also been implicated in neoplastic processes in the colon. In this study we aimed to characterize lipid mediators, so called oxylipins, in human colon adenomatous polyps. DESIGN: We quantified oxylipins in healthy colon tissue and colorectal adenoma tissue procured during routine colonoscopy examinations. Lipid metabolite profiles were analyzed by liquid chromatography-tandem mass spectrometry. RESULTS: Adenoma tissue showed a distinct prostaglandin profile as compared to normal colon mucosa. Interestingly, PGE2 was not higher in adenoma tissue as compared to normal mucosa. In contrast, we found significantly lower levels of prostaglandin D2, prostaglandin J2, and prostaglandin D1 in adenoma tissue. Furthermore, levels of 5-LOX and 12-LOX pathway products were clearly increased in adenoma biopsy samples. We also investigated the effect of aspirin treatment on prostaglandin profiles in adenoma tissue in a subset of patients and found a trend towards decreased prostaglandin levels in response to aspirin. CONCLUSION: The human data presented here show specific changes of oxylipin profiles in colon adenoma tissue with decreased prostaglandin D2 levels as well as increased 5- and 12-LOX metabolites.


Subject(s)
Adenoma/pathology , Colon/pathology , Colonic Neoplasms/pathology , Oxylipins/metabolism , Adenoma/metabolism , Aged , Arachidonate 5-Lipoxygenase/metabolism , Case-Control Studies , Colon/metabolism , Colonic Neoplasms/metabolism , Cyclooxygenase 2/metabolism , Female , Humans , Male , Pilot Projects , Prostaglandin D2/analogs & derivatives , Prostaglandin D2/metabolism , Prostaglandins D/metabolism
9.
Gastroenterology ; 157(1): 74-86.e15, 2019 07.
Article in English | MEDLINE | ID: mdl-30922997

ABSTRACT

BACKGROUND & AIMS: Swallowed topical-acting corticosteroids are recommended as first-line therapy for eosinophilic esophagitis (EoE). Asthma medications not optimized for esophageal delivery are sometimes effective, although given off-label. We performed a randomized, placebo-controlled trial to assess the effectiveness and tolerability of a budesonide orodispersible tablet (BOT), which allows the drug to be delivered to the esophagus in adults with active EoE. METHODS: We performed a double-blind, parallel study of 88 adults with active EoE in Europe. Patients were randomly assigned to groups that received BOT (1 mg twice daily; n = 59) or placebo (n = 29) for 6 weeks. The primary end point was complete remission, based on clinical and histologic factors, including dysphagia and odynophagia severity ≤2 on a scale of 0-10 on each of the 7 days before the end of the double-blind phase and a peak eosinophil count <5 eosinophils/high power field. Patients who did not achieve complete remission at the end of the 6-week double-blind phase were offered 6 weeks of open-label treatment with BOT (1 mg twice daily). RESULTS: At 6 weeks, 58% of patients given BOT were in complete remission compared with no patients given placebo (P < .0001). The secondary end point of histologic remission was achieved by 93% of patients given BOT vs no patients given placebo (P < .0001). After 12 weeks, 85% of patients had achieved remission. Six-week and 12-week BOT administration were safe and well tolerated; 5% of patients who received BOT developed symptomatic, mild candida, which was easily treated with an oral antifungal agent. CONCLUSIONS: In a randomized trial of adults with active EoE, we found that budesonide oral tablets were significantly more effective than placebo in inducing clinical and histologic remission. Eudra-CT number 2014-001485-99; ClinicalTrials.gov ID NCT02434029.


Subject(s)
Budesonide/administration & dosage , Eosinophilic Esophagitis/drug therapy , Glucocorticoids/administration & dosage , Administration, Oral , Adult , Antifungal Agents/therapeutic use , Candidiasis, Oral/chemically induced , Candidiasis, Oral/drug therapy , Double-Blind Method , Eosinophilic Esophagitis/pathology , Esophagoscopy , Female , Humans , Male , Middle Aged , Tablets , Treatment Outcome
10.
Dtsch Med Wochenschr ; 143(16): 1182-1185, 2018 Aug.
Article in German | MEDLINE | ID: mdl-30086564

ABSTRACT

HISTORY: The 43-year-old patient was admitted because of vomiting and abdominal pain. He had a history of depression and multiple discus prolapses. He reported the consumption of three beers per day. FINDINGS: The patient presented diffuse abdominal pain. The serume-kreatine was elevated (205 µmol/l), there was a leucocytosis (18,4^3/µl) and a mild elvation of y-GT (2,3µkat/l). Stool culture was negative. An abdominal ultrasound and a gastroscopy did not show groundbreaking findings. THERAPY AND COURSE: The acute kidney injury was treated by administration of intravenous fluid. The vomiting persisted despite of administration of Metoclopramid and Dimenhydrinat. Just Lorazepam and hot showers brought relief of symptoms. A decided drug history revealed a marijuana abusus. After ceasing marijuana consumption and administration of Haloperidol the vomiting stopped. CONCLUSIONS: The cannabinoid hyperemesis syndrome is characterized by vomiting, diffuse abdominal pain and taking hot showers. With typical combination of symptoms a drug history should be taken. The knowledge of this syndrome can help to avoid overdiagnostic.


Subject(s)
Abdominal Pain/etiology , Abdominal Pain/therapy , Marijuana Abuse/etiology , Marijuana Abuse/therapy , Steam , Vomiting/etiology , Vomiting/therapy , Acute Kidney Injury/etiology , Acute Kidney Injury/therapy , Adult , Combined Modality Therapy , Fluid Therapy , Humans , Lorazepam/therapeutic use , Male , Syndrome
11.
World J Gastroenterol ; 24(31): 3556-3566, 2018 Aug 21.
Article in English | MEDLINE | ID: mdl-30131662

ABSTRACT

AIM: To evaluate the ability of PillCamColon2 to visualize colonic segments missed by incomplete optical colonoscopy (OC) and to assess the diagnostic yield. METHODS: This prospective multicentre study included 81 patients from nine centres who underwent second-generation colon capsule endoscopy (CCE) following incomplete OC performed by an experienced gastroenterologist (> 1000 colonoscopies). Patients with stenosis were excluded. According to patient preferences, CCE was performed the following day (protocol A) after staying on clear liquids and 0.75 L Moviprep in the morning or within 30 d after new split-dose Moviprep (protocol B). Boosts consisted of 0.75 L and 0.25 L Moviprep, and phospho-soda was given as a rescue if the capsule was not excreted after seven hours. RESULTS: Seventy-four patients were analysed (51% of them in group A; 49% in group B). Bowel cleansing was adequate in 67% of cases, and CCE could visualize colonic segments missed by incomplete colonoscopy in 90% of patients under protocol A and 97% of patients under protocol B (P = 0.35, n.s.). Significant polyps including adenocarcinoma were detected in 24% of cases. Detection rates for all polyps and significant polyps per patient were similar in both protocols. Polyps were found predominantly in the right colon (86%) in segments that were not reached by OC. Extracolonic findings - such as reflux esophagitis, suspected Barrett esophagus, upper GI-bleeding, gastric polyps, gastric erosions and angiectasia - were detected in eight patients. PillCamColon2 capsule was retained in the ileum of one patient (1.4%) without symptoms and removed during an uneventful resection for unknown Crohn's disease that was diagnosed as the cause of anemia, which was the indication for colonoscopy. CCE was well tolerated. One patient suffered from self-limiting vomiting after consuming the phospho-soda. CONCLUSION: Second-generation CCE using a low-volume preparation is useful after incomplete OC, and it allows for the detection of additional relevant findings, but cleansing efficiency could be improved.


Subject(s)
Adenocarcinoma/diagnostic imaging , Capsule Endoscopy/methods , Colonic Polyps/diagnostic imaging , Colonoscopy/methods , Adenocarcinoma/pathology , Aged , Capsule Endoscopes , Capsule Endoscopy/adverse effects , Capsule Endoscopy/instrumentation , Cathartics/administration & dosage , Colon/diagnostic imaging , Colon/pathology , Colonic Polyps/pathology , Colonoscopy/adverse effects , Colonoscopy/instrumentation , Female , Humans , Male , Middle Aged , Patient Preference , Polyethylene Glycols/administration & dosage , Prospective Studies , Vomiting/epidemiology , Vomiting/etiology
12.
Dtsch Med Wochenschr ; 143(10): 735-740, 2018 May.
Article in German | MEDLINE | ID: mdl-29727889

ABSTRACT

The clinical spectrum of gastrointestinal bleeding ranges from the possibly clinically,but often only amenable to laboratory anemia to fulminant bleeding with shock and acute danger to life. Endoscopic haemostasis is in many cases the method of choice. There are several methods available that are dependent be used by cause and localization of the bleeding.


Subject(s)
Endoscopy, Gastrointestinal , Gastrointestinal Hemorrhage/therapy , Hemostasis, Endoscopic , Humans
13.
Surg Endosc ; 32(9): 3981-3988, 2018 09.
Article in English | MEDLINE | ID: mdl-29532224

ABSTRACT

BACKGROUND AND AIMS: The aim of the study was to evaluate the usefulness and diagnostic and therapeutic outcome of the single-operator cholangiopancreatoscopy (SOC) with SpyGlassDS™. METHODS: In a retrospective multicenter study between November 2015 and January 2017, SpyGlassDS™ procedures were analyzed in participating centers. Indications, accuracy of SOC-guided biopsies, management of large bile duct stones, and complications were analyzed. Follow-up was 4 months. RESULTS: Two hundred and six patients out of 250 examinations were evaluated. Indications were biliary stones (n = 132), bile duct stenosis (n = 93), stones and stenosis combined (n = 24), and bile duct leakage (n = 1). Of the 117 cases which were suspicious of malignancy, in 99 cases the lesion could be stratified into benign (n = 55) or malignant (n = 44) indicating a sensitivity of 95.5% and a specificity of 94.5% for the indication tumor. SOC-guided biopsies revealed a sensitivity of 57.7% with a specificity of 100%. In 107 examinations, biliary stones were visualized and could be completely removed in 91.1% with a need of three procedures (range 1-6) to achieve final stone clearance. In 75 cases, lithotripsy was performed and was successful in 71 cases (95%). Four out of 45 patients (8.9%) underwent cholecystectomy with surgical bile duct revision as a final therapy. Adverse Event (AE) occurred in 33/250 patients (13.2%) and Serious Adverse Event (SAE) occurred in 1/250 patients (0.4%). Cholangitis was 1% (n = 102) after peri-interventional administration of antibiotics and 12.8% (n = 148) without antibiotic prophylaxis (p < 0.001). CONCLUSIONS: SOC with SpyGlassDS™ became a new standard for the diagnosis of indefinite biliary lesions and therapy of large bile duct stones. The diagnostic yield of SOC-guided biopsies facilitated a definite diagnosis in most cases and should be improved by standardized biopsy protocols. SOC-guided interventions allowed removal of large biliary stones by SOC-guided lithotripsy. The complication rate of 13.2% can be considerably reduced by use of a single-shot antibiotic treatment.


Subject(s)
Bile Duct Neoplasms/diagnosis , Cholestasis , Endoscopy, Digestive System/methods , Gallstones , Adult , Aged , Aged, 80 and over , Cholecystectomy , Cholestasis/diagnosis , Cholestasis/therapy , Cohort Studies , Female , Gallstones/diagnosis , Gallstones/therapy , Humans , Lithotripsy , Male , Middle Aged , Retrospective Studies , Sensitivity and Specificity
14.
J Lipid Res ; 59(5): 864-871, 2018 05.
Article in English | MEDLINE | ID: mdl-29444936

ABSTRACT

Eicosanoids, including prostaglandins (PGs) and thromboxanes, are broadly bioactive lipid mediators and increase colon tumorigenesis possibly through chronic inflammatory mechanisms. Epidemiological and experimental data suggest that acetylsalicylic acid (ASA) helps prevent colorectal cancer (CRC), possibly through cyclooxygenase (COX)-mediated suppression of eicosanoid, particularly PGE2, formation. Recent studies suggest that statins prevent CRC and improve survival after diagnosis. We identified patients on ASA and/or statin treatment undergoing routine colonoscopy and measured eicosanoid levels in colonic mucosa with targeted metabolomics technology (LC-MS/MS). ASA-treated individuals (n = 27) had significantly lower tissue eicosanoid levels of most COX-derived metabolites than untreated individuals (n = 31). In contrast, COX-derived lipid metabolites tended to be higher in patients with statin treatment (n = 7) as compared with those not receiving statins (n = 24). This effect was not discernible in subjects treated with ASA and statins (n = 11): Individuals treated with both drugs showed a pronounced suppression of COX-derived eicosanoids in colon tissue, even compared with subjects treated with ASA alone. Our data from a routine clinical setting support the hypothesis that ASA and statins could inhibit CRC development via lipid mediator modification. Further studies should directly investigate the effect of dual ASA and statin treatment on colon tumorigenesis in humans.


Subject(s)
Aspirin/pharmacology , Colon/drug effects , Colon/metabolism , Eicosanoids/biosynthesis , Hydroxymethylglutaryl-CoA Reductase Inhibitors/pharmacology , Aged , Aspirin/administration & dosage , Cohort Studies , Colonoscopy , Eicosanoids/analysis , Female , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Male
16.
J Gastrointestin Liver Dis ; 25(3): 295-302, 2016 Sep.
Article in English | MEDLINE | ID: mdl-27689192

ABSTRACT

BACKGROUND AND AIMS: Split-dose regimens are generally recommended for bowel cleansers. However, other regimens still remain in the summary of product characteristics of some bowel cleansers in Europe. The aim of this study is to compare the efficacy and safety of a split-dose regimen of sodium picosulfate/magnesium citrate (SPMC) with a prior-day schedule (AM/PM). METHODS: Multicenter, randomized (EudraCT no. 2013-001620-20), endoscopist-blinded, parallel study, carried out in subjects 18 years or older undergoing elective colonoscopy. The primary endpoint was the bowel cleansing assessment using a binary transformation (adequate/inadequate) of the Global Preparation Assessment (GPA) scale. Additional parameters analyzed were the segmental assessment of bowel cleansing (RSS), the adenoma detection rate and safety evaluations. RESULTS: 315 subjects comprised the ITT set. A significantly higher proportion of patients in the split-dose regimen had an adequate bowel preparation (AM/PM: 30.8% vs split-dose: 79.9%; p<0.0001). The mean global RSS was significantly lower in the split-dose group (AM/PM: 5.0 [SD: 2.91] vs split-dose: 2.6 [SD: 2.14]; p<0.0001). Flat polyps were detected in a higher proportion of subjects in the split-dose group compared with the AM/PM group (AM/PM: 16.0% vs split-dose: 22.0%). Both regimens were equally safe and well tolerated, with no serious treatment-emergent adverse events or discontinuations due to adverse events. CONCLUSION: A split-dose regimen of SPMC is superior to the AM/PM regimen administered the day before colonoscopy. Split regimen of SPMC should be considered the standard of use.


Subject(s)
Adenomatous Polyps/diagnosis , Cathartics/administration & dosage , Citrates/administration & dosage , Citric Acid/administration & dosage , Colonic Neoplasms/diagnosis , Colonic Polyps/diagnosis , Colonoscopy , Defecation/drug effects , Organometallic Compounds/administration & dosage , Picolines/administration & dosage , Adenomatous Polyps/pathology , Adult , Aged , Aged, 80 and over , Cathartics/adverse effects , Citrates/adverse effects , Citric Acid/adverse effects , Colonic Neoplasms/pathology , Colonic Polyps/pathology , Drug Administration Schedule , Drug Combinations , Female , Germany , Humans , Male , Middle Aged , Organometallic Compounds/adverse effects , Picolines/adverse effects , Predictive Value of Tests , Single-Blind Method , Time Factors , Treatment Outcome , Young Adult
17.
J Clin Gastroenterol ; 50(10): e95-e100, 2016.
Article in English | MEDLINE | ID: mdl-27552329

ABSTRACT

BACKGROUND AND STUDY AIMS: Hemostatic powders have been introduced to improve the management of gastrointestinal (GI) bleeding and to extend the variety of tools available for emergency endoscopy. The aim of the present pilot study was to evaluate the indication profiles and the short-term outcome of EndoClot. PATIENTS, MATERIALS AND METHODS: In a prospective observational pilot study patients with acute nonvariceal GI bleeding were included. Primary or secondary application of EndoClot was assessed. Hemoglobin, prothrombine time and platelets were documented before and after hemostasis. The efficacy of EndoClot was assessed 72 hours and 1 week after application. RESULTS: Seventy patients with acute GI bleeding were recruited into the study. Eighty-three percent (58/70) of the patients had upper and 17% (12/70) had lower GI bleeding. In the upper GI tract treatment success was achieved in 64% (30/47, 95% confidence interval, 50%-76%) after primary use and in all patients, when used after established techniques had failed (95% confidence interval, 70%-100%). In lower GI bleeding hemostasis was achieved in 83% of cases (10/12, 95% confidence interval 54%-97%). Rebleeding occurred in 11% (8/70), in 10% EndoClot served as a bridge to surgery (7/70). CONCLUSIONS: EndoClot expanded the therapeutic options in the management of GI bleeding. It was applicable as a monotherapy or in combination with other techniques from oozing bleeding type or lower. It was most effective in diffuse or extensive bleeding activity or when access to the bleeding vessel was difficult. EndoClot can be applied as a bridge to surgery when classical methods of hemostasis have failed.


Subject(s)
Gastrointestinal Hemorrhage/therapy , Polysaccharides/administration & dosage , Aged , Female , Germany , Hemostasis, Endoscopic , Humans , Male , Pilot Projects , Postoperative Complications , Prospective Studies , Treatment Outcome
18.
Endoscopy ; 48(10): 909-15, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27448051

ABSTRACT

BACKGROUND AND STUDY AIM: The aim of the study was to compare the latest narrow-band imaging (NBI) device with high-definition white light (HDWL) endoscopy for accuracy of real-time optical diagnosis of small colorectal polyps. PATIENTS AND METHODS: We conducted a randomized, prospective, multicenter trial at three study sites in Germany. In the NBI arm, endoscopists used NBI for the prediction of polyp pathology on the basis of the NBI International Colorectal Endoscopic classification. In the HDWL arm, NBI was not used for optical classification of polyp histology. The primary outcome was accuracy of optical diagnoses (neoplastic vs. non-neoplastic) in small polyps measuring < 10 mm. Secondary end points included sensitivity and negative predictive value (NPV). RESULTS: A total of 380 patients were randomized 1:1 to either the NBI or HDWL arm. A total of 421 polyps measuring < 10 mm were detected (55.8 % neoplastic, 44.2 % non-neoplastic). Accuracy, sensitivity, and NPV were 73.7 %, 82.4 %, and 75.5 %, respectively, in the NBI arm and 79.2 %, 79.8 %, and 73.4 %, respectively, in the HDWL arm (P = 0.225, P = 0.667, P = 0.765). More polyps were assessed with high confidence in the HDWL arm (82.6 %) than in the NBI arm (73.7 %; P = 0.038). The NPV of the prediction of neoplastic histology in diminutive polyps (≤ 5 mm) rated with high confidence was 90.3 % in the NBI arm. We detected significant differences between the participating study sites in the performance data of predictions. CONCLUSION: The levels of accuracy for real-time prediction of polyp histology (< 10 mm) did not differ between NBI and HDWL for optical diagnosis. Variation in the performance of optical diagnosis was apparent between study centers. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02009774).


Subject(s)
Colonic Polyps , Colonoscopy , Diagnostic Errors/prevention & control , Narrow Band Imaging , Transillumination , Adult , Aged , Biopsy/methods , Biopsy/standards , Colonic Polyps/diagnosis , Colonic Polyps/diagnostic imaging , Colonic Polyps/pathology , Colonoscopy/methods , Colonoscopy/standards , Comparative Effectiveness Research , Dimensional Measurement Accuracy , Female , Germany , Humans , Male , Middle Aged , Narrow Band Imaging/methods , Narrow Band Imaging/standards , Predictive Value of Tests , Transillumination/methods , Transillumination/standards , Tumor Burden
19.
Endoscopy ; 48(5): 489-96, 2016 May.
Article in English | MEDLINE | ID: mdl-26862844

ABSTRACT

This Guideline is an official statement of the European Society of Gastrointestinal Endoscopy (ESGE). It addresses the removal of foreign bodies in the upper gastrointestinal tract in adults. Recommendations Nonendoscopic measures 1 ESGE recommends diagnostic evaluation based on the patient's history and symptoms. ESGE recommends a physical examination focused on the patient's general condition and to assess signs of any complications (strong recommendation, low quality evidence). 2 ESGE does not recommend radiological evaluation for patients with nonbony food bolus impaction without complications. We recommend plain radiography to assess the presence, location, size, configuration, and number of ingested foreign bodies if ingestion of radiopaque objects is suspected or type of object is unknown (strong recommendation, low quality evidence). 3 ESGE recommends computed tomography (CT) scan in all patients with suspected perforation or other complication that may require surgery (strong recommendation, low quality evidence). 4 ESGE does not recommend barium swallow, because of the risk of aspiration and worsening of the endoscopic visualization (strong recommendation, low quality evidence). 5 ESGE recommends clinical observation without the need for endoscopic removal for management of asymptomatic patients with ingestion of blunt and small objects (except batteries and magnets). If feasible, outpatient management is appropriate (strong recommendation, low quality evidence). 6 ESGE recommends close observation in asymptomatic individuals who have concealed packets of drugs by swallowing ("body packing"). We recommend against endoscopic retrieval. We recommend surgical referral in cases of suspected packet rupture, failure of packets to progress, or intestinal obstruction (strong recommendation, low quality evidence). Endoscopic measures 7 ESGE recommends emergent (preferably within 2 hours, but at the latest within 6 hours) therapeutic esophagogastroduodenoscopy for foreign bodies inducing complete esophageal obstruction, and for sharp-pointed objects or batteries in the esophagus. We recommend urgent (within 24 hours) therapeutic esophagogastroduodenoscopy for other esophageal foreign bodies without complete obstruction (strong recommendation, low quality evidence). 8 ESGE suggests treatment of food bolus impaction in the esophagus by gently pushing the bolus into the stomach. If this procedure is not successful, retrieval should be considered (weak recommendation, low quality evidence). The effectiveness of medical treatment of esophageal food bolus impaction is debated. It is therefore recommended, that medical treatment should not delay endoscopy (strong recommendation, low quality evidence). 9 In cases of food bolus impaction, ESGE recommends a diagnostic work-up for potential underlying disease, including histological evaluation, in addition to therapeutic endoscopy (strong recommendation, low quality evidence). 10 ESGE recommends urgent (within 24 hours) therapeutic esophagogastroduodenoscopy for foreign bodies in the stomach such as sharp-pointed objects, magnets, batteries and large/long objects. We suggest nonurgent (within 72 hours) therapeutic esophagogastroduodenoscopy for medium-sized blunt foreign bodies in the stomach (strong recommendation, low quality evidence). 11 ESGE recommends the use of a protective device in order to avoid esophagogastric/pharyngeal damage and aspiration during endoscopic extraction of sharp-pointed foreign bodies. Endotracheal intubation should be considered in the case of high risk of aspiration (strong recommendation, low quality evidence). 12 ESGE suggests the use of suitable extraction devices according to the type and location of the ingested foreign body (weak recommendation, low quality evidence). 13 After successful and uncomplicated endoscopic removal of ingested foreign bodies, ESGE suggests that the patient may be discharged. If foreign bodies are not or cannot be removed, a case-by-case approach depending on the size and type of the foreign body is suggested (weak recommendation, low quality evidence).


Subject(s)
Endoscopy, Gastrointestinal/methods , Foreign Bodies , Adult , Europe , Foreign Bodies/diagnosis , Foreign Bodies/surgery , Gastroenterology/methods , Gastroenterology/standards , Humans , Societies, Medical , Upper Gastrointestinal Tract/diagnostic imaging , Upper Gastrointestinal Tract/pathology , Upper Gastrointestinal Tract/surgery
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