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1.
Dis Esophagus ; 32(9)2019 Nov 13.
Article in English | MEDLINE | ID: mdl-30596900

ABSTRACT

The overall metastatic potential of surgically treated early esophageal adenocarcinoma has not been studied in detail. This paper therefore assessed lymph node metastases at surgery, loco regional and distant metastases, in order to assess the metastatic potential of early esophageal adenocarcinoma. Two hundred and seventeen patients (53 T1a, 164 T1b; median follow-ups 87 and 75 months, 187 males) diagnosed with early esophageal adenocarcinoma and treated with esophagectomy in our tertiary center's database between July 2000 and December 2015 were included. All metastatic events were retrospectively analyzed, their topographic distribution was assessed, and the overall metastatic rate was calculated. Lymph node metastases occurred in 39 patients (18%) and 29 (13.4%) developed recurrences. Lymph node metastases were absent in m1 and m2 tumors and rare in m3 (1/18), m4 (5/21), and sm1 (4/42), but more frequent in sm2 (11/44) and sm3 tumors (18/78). Locoregional recurrences were exceedingly rare in m3 (2/18), m4 (1/21), sm1 (1/42), and sm2 (2/44), but frequent in sm3 (12/78). In contrast, distant metastases were more frequent with 2/18 in m3, 1/21 in m4, 4/42 in sm1, 4/44 in sm2, and 13/78 in sm3. Overall metastatic rates of 11.9% in sm1 (submucosal layer divided into equal thirds), 27.3% in sm2, and 32.1% in sm3 tumors were calculated. This first report of the metastatic potential of early esophageal adenocarcinoma provides a meticulous assessment of the overall metastatic risk. Metastatic events pose a relevant risk in surgically treated patients with esophageal adenocarcinoma with distant metastases being more frequent than locoregional recurrences.


Subject(s)
Adenocarcinoma/pathology , Esophageal Neoplasms/pathology , Esophagectomy , Lymphatic Metastasis , Neoplasm Recurrence, Local/epidemiology , Adenocarcinoma/diagnosis , Adenocarcinoma/surgery , Adult , Aged , Aged, 80 and over , Esophageal Neoplasms/diagnosis , Esophageal Neoplasms/surgery , Female , Follow-Up Studies , Humans , Lymphatic Metastasis/diagnosis , Male , Middle Aged , Neoplasm Recurrence, Local/diagnosis , Neoplasm Staging , Prognosis , Retrospective Studies
3.
Aliment Pharmacol Ther ; 45(10): 1339-1349, 2017 May.
Article in English | MEDLINE | ID: mdl-28326569

ABSTRACT

BACKGROUND: Proton pump inhibitors and laparoscopic anti-reflux surgery (LARS) offer long-term symptom control to patients with gastro-oesophageal reflux disease (GERD). AIM: To evaluate the process of 'normalisation' of the squamous epithelium morphology of the distal oesophagus on these therapies. METHODS: In the LOTUS trial, 554 patients with chronic GERD were randomised to receive either esomeprazole (20-40 mg daily) or LARS. After 5 years, 372 patients remained in the study (esomeprazole, 192; LARS, 180). Biopsies were taken at the Z-line and 2 cm above, at baseline, 1, 3 and 5 years. A severity score was calculated based on: papillae elongation, basal cell hyperplasia, intercellular space dilatations and eosinophilic infiltration. The epithelial proliferative activity was assessed by Ki-67 immunohistochemistry. RESULTS: A gradual improvement in all variables over 5 years was noted in both groups, at both the Z-line and 2 cm above. The severity score decreased from baseline at each subsequent time point in both groups (P < 0.001, all comparisons), attaining a normal level by 5 years. Corresponding decreases in Ki-67 expression were observed (P < 0.001, all comparisons). No significant differences were found between esomeprazole treatment and LARS. Neither baseline severity score nor Ki-67 expression predicted the risk of treatment failure. CONCLUSIONS: Five years of treatment is generally required before squamous epithelial cell morphology and proliferation are 'normalised' in patients with chronic GERD, despite endoscopic and symptomatic disease control. Control of the acid component of the refluxate seems to play the predominant role in restoring tissue morphology.


Subject(s)
Gastroesophageal Reflux/drug therapy , Gastroesophageal Reflux/surgery , Mucous Membrane/physiopathology , Wound Healing , Adult , Biopsy , Esomeprazole/therapeutic use , Female , Gastroesophageal Reflux/physiopathology , Humans , Laparoscopy/adverse effects , Male , Middle Aged , Mucous Membrane/drug effects , Mucous Membrane/pathology , Mucous Membrane/surgery , Proton Pump Inhibitors/therapeutic use , Time Factors , Treatment Outcome , Wound Healing/drug effects
4.
Dis Esophagus ; 30(3): 1-11, 2017 Feb 01.
Article in English | MEDLINE | ID: mdl-26952572

ABSTRACT

The rate of lymph-node (LN) metastasis in early adenocarcinoma (EAC) of the esophagus with mid to deep submucosal invasion (pT1b sm2/3) has not yet been precisely defined. The aim of the this study was to evaluate the rate of LN metastasis in pT1b sm2/3 EAC depending on macroscopic and histological risk patterns to find out whether there may also be options for endoscopic therapy as in cancers limited to the mucosa and the upper third of the submucosa. A total of 1.718 pt with suspicion of EAC were referred for endoscopic treatment (ET) to the Dept. of Internal Medicine II at HSK Wiesbaden 1996-2010. In 230/1.718 pt, the suspicion (endoscopic ultrasound, EUS) or definitive diagnosis of pT1b EAC (ER/surgery) was made. Of these, 38 pt had sm2 lesions, and 69 sm3. Rate of LN metastasis was analyzed depending on risk patterns: histologically low-risk (hisLR): G1-2, L0, V0; histologically high-risk (hisHR): ≥1 criterion not fulfilled; macroscopically low-risk (macLR): gross tumor type I-II, tumor size ≤2 cm; macroscopically high-risk (macHR): ≥1 criterion not fulfilled; combined low-risk (combLR): hisLR+macLR; combined high-risk (combHR): at least 1 risk factor. LN rate was only evaluated in pt who had proven maximum invasion depth of sm2/sm3, and who in case of ET had a follow-up (FU) by EUS of at least 24 months. 23/38 pt with pT1b sm2 lesions and 39/69 pt with sm3 lesions fulfilled our inclusion criteria. In the pT1b sm2 group, rate of LN metastasis in the hisLR, hisHR, combLR, and combHR groups were 8.3% (1/12), 36.3% (4/11), 0% (0/5), and 27.8% (5/18). In the pT1b sm3 group, rate of LN metastasis in the hisLR, hisHR, combLR and combHR groups were 28.6% (2/7), 37.5% (12/32), 25% (1/4), and 37.1% (13/35). 30-day mortality of surgery was 1.7% (1/58 pt). In EAC with pT1b sm2/3 invasion, the frequency of LN metastasis depends on macroscopic and histological risk patterns. Surgery remains the standard treatment, because the rate of LN metastasis appears to be higher than the mortality risk of surgery. Whether a highly selected group of pT1b sm2 patients with a favourable risk pattern may be candidates for endoscopic therapy cannot be decided until the results of larger case volumes are available.


Subject(s)
Adenocarcinoma/diagnostic imaging , Adenocarcinoma/pathology , Endosonography/methods , Esophageal Mucosa/pathology , Esophageal Neoplasms/diagnostic imaging , Esophageal Neoplasms/pathology , Lymph Nodes/pathology , Adenocarcinoma/surgery , Adult , Aged , Aged, 80 and over , Early Detection of Cancer/methods , Esophageal Mucosa/diagnostic imaging , Esophageal Mucosa/surgery , Esophageal Neoplasms/surgery , Esophagectomy , Esophagoscopy/methods , Esophagus/pathology , Female , Humans , Lymph Node Excision , Lymph Nodes/diagnostic imaging , Lymph Nodes/surgery , Lymphatic Metastasis , Male , Middle Aged , Neoplasm Invasiveness/diagnostic imaging , Neoplasm Staging , Retrospective Studies , Risk Factors , Tumor Burden
5.
Z Gastroenterol ; 54(8): 733-9, 2016 Aug.
Article in German | MEDLINE | ID: mdl-27529524

ABSTRACT

INTRODUCTION: Administering sedation is an established standard in gastrointestinal endoscopy, particularly in situations in which sedation is used to make the examination more comfortable for the patient (e. g., during preventive check-up examinations). It is important to have precise information about the risk of sedation-associated complications. AIMS AND METHODS: The aim of this study was to record the incidence and type of sedation-associated complications in a low-risk group of patients (ASA 1 or 2) undergoing elective diagnostic esophagogastroduodenoscopy or colonoscopy. Risk factors for the development of a sedation complication were also to be identified. Using a prospective multicenter study design, sedation-associated complications were documented in the ProSed2 study using an electronic endoscopy documentation system. RESULTS: Thirty-nine research centers took part in the study from December 2011 to June 2014. A total of 368 206 endoscopies were recorded. 177 944 of the procedures met the defined criteria for subgroup analysis (endoscopy with sedation, patient in ASA class 1 or 2, esophagogastroduodenoscopy or colonoscopy, no emergency endoscopies, no therapeutic procedures). The patients received propofol alone in 64.4 % of the sedations, or a combination of propofol and midazolam in 22.4 %. Sedation was administered by the endoscopist or endoscopy assistant in 56.5 % of cases, or by a third person in 43.5 % (anesthesist < 0.1 %, intensive-care specialist 5.7 %, nurse-administered propofol sedation 37.8 %). A total of 332 minor complications were documented (0.2 %). No major complications or deaths occurred. The following risk factors were identified for the development of sedation-associated complications: Patients in ASA class 2 and sedation with midazolam in combination with an opiate. CONCLUSIONS: These findings on sedation-associated complications show that severe complications and deaths do not occur, and that minor complications occur very rarely. Sedation can therefore be regarded as extremely safe in this group of patients. Even though this analysis did not include therapeutic colonoscopies (e. g. polypectomy), these data should lower the threshold for patients undergoing preventive check-up examinations and it should therefore be offered as a standard.


Subject(s)
Colonoscopy/statistics & numerical data , Conscious Sedation/statistics & numerical data , Drug-Related Side Effects and Adverse Reactions/epidemiology , Gastroscopy/statistics & numerical data , Hypnotics and Sedatives/administration & dosage , Registries , Adolescent , Adult , Aged , Aged, 80 and over , Female , Germany/epidemiology , Humans , Incidence , Male , Middle Aged , Patient Safety , Retrospective Studies , Risk Factors , Survival Rate , Young Adult
6.
Z Gastroenterol ; 53(6): 568-72, 2015 Jun.
Article in German | MEDLINE | ID: mdl-26075367

ABSTRACT

BACKGROUND: Detecting early neoplasias in Barrett's oesophagus (BE) is challenging. Recent publications have been focusing on improving the detection of such lesions during Barrett's surveillance. However in a recently published Danish register study calculating the risk for cancer-development in BE two-thirds of the diagnosed tumors were identified during the first examination or in the first year. This means that index endoscopy might be more effective than surveillance in detecting early neoplasia in BE. METHODS: In the period from January 2010 to April 2011, all patients who consecutively presented with a diagnosis of early neoplastic changes in BE were recorded prospectively. ANALYSIS: The analysis included data for 121 patients. In patients with short-segment BE (SSBE), neoplasia was only diagnosed in 6 % of cases in the surveillance examination, compared with 44 % of cases in long-segment BE (LSBE). The neoplastic lesion was identified visually in 43 patients (36 %) during the external EGD. Type II tumours were detected in 40 % (39/98) and were correctly assessed as neoplastic in 25 % of cases (24/98). CONCLUSIONS: 1. in patients with SSBE almost all early tumours are diagnosed by index endoscopy and not by Barrett's surveillance; 2. around 40 % of all early neoplasias are endoscopically invisible and are only diagnosed using four-quadrant biopsies; 3. the macroscopic tumour type has a substantial influence on the detection rate for neoplasia. If efforts to increase the detection rate for early neoplasia in BE are focused solely on the Barrett's surveillance method, then only a minority of patients - 20 % in the present group - will benefit from the measure. German clinical trials register, DRKS00 004 168.


Subject(s)
Barrett Esophagus/pathology , Early Detection of Cancer/methods , Esophageal Neoplasms/pathology , Esophagoscopy/methods , Esophagus/pathology , Precancerous Conditions/pathology , Adult , Aged , Aged, 80 and over , Biopsy/methods , Female , Humans , Male , Middle Aged , Random Allocation , Reproducibility of Results , Sensitivity and Specificity
7.
Aliment Pharmacol Ther ; 41(11): 1162-74, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25858519

ABSTRACT

BACKGROUND: Control of chronic gastro-oesophageal reflux disease may be achieved either by anti-reflux surgery (ARS) or by long-term medical therapy with proton pump inhibitors (PPIs). The primary efficacy results of the SOPRAN study, comparing long-term omeprazole use with open ARS, and the LOTUS study, comparing long-term esomeprazole use with laparoscopic ARS, have been reported. A secondary objective of these studies was to address the long-term safety of these respective therapeutic strategies and thereby provide a valid scientific platform for assessing long-term PPI safety. AIM: To assess the safety of long-term PPI therapy with omeprazole and esomeprazole through analyses of data from the randomised SOPRAN and LOTUS studies. METHODS: Safety data were collected from patients during the 12-year period of the SOPRAN study (n = 298) and the 5-year period of the LOTUS study (n = 514). Reported serious adverse events (SAEs) and changes in laboratory variables were analysed. RESULTS: Across both studies, SAEs were reported at a similar frequency in the PPI and ARS treatment groups. Taking the time frames into consideration, the number of fatal SAEs in the two studies was low in both treatment groups. Laboratory results, including routine haematology and tests for liver enzymes, electrolytes, vitamin D, vitamin B12 , folate and homocysteine, showed no clinically relevant changes over time. As expected, gastrin and chromogranin A were elevated in the PPI groups, with the greatest increases observed in the first year. CONCLUSION: No major safety concerns arose during 5-12 years of continuous PPI therapy. (ClinicalTrials.gov: NCT00251927 and NCT00256737).


Subject(s)
Esomeprazole/adverse effects , Gastroesophageal Reflux/drug therapy , Omeprazole/adverse effects , Proton Pump Inhibitors/adverse effects , Aged , Chromogranin A/metabolism , Esomeprazole/therapeutic use , Female , Gastrins/metabolism , Gastroesophageal Reflux/surgery , Humans , Laparoscopy/adverse effects , Laparoscopy/methods , Male , Middle Aged , Omeprazole/therapeutic use , Proton Pump Inhibitors/therapeutic use , Randomized Controlled Trials as Topic , Young Adult
8.
Curr Med Res Opin ; 30(12): 2493-503, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25180609

ABSTRACT

BACKGROUND: Colonoscopy requires effective bowel preparation for adequate mucosal visualization. Safety and acceptability of bowel preparation are key components in colorectal cancer screening (CRC) populations. OBJECTIVE: To compare the efficacy, safety and acceptability of bowel preparation with polyethylene glycol (PEG), ascorbic acid, sodium ascorbate (ascorbate components), sodium sulfate and electrolytes (PEG+Asc) or sodium phosphate (NaP). METHODS: Consenting adults undergoing elective out-patient colonoscopy for CRC were randomized to take 2 L PEG+Asc or 90 mL NaP (control) following manufacturer's instructions. PEG+Asc was taken the evening before and morning of the colonoscopy; NaP was taken the morning and evening before colonoscopy. Participants followed a restricted diet specific to each preparation. Primary endpoint was bowel cleansing success (100% colon mucosa visible) rated by an independent expert panel (all experienced endoscopists) unaware of treatment allocations. Subject reported outcomes about the preparations were elicited. Adverse events were recorded. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov: NCT00427089. RESULTS: Successful bowel cleansing rate was significantly higher in the PEG+Asc (N = 242) than the NaP (N = 114) group (PEG+Asc 93.4% [95% CI 89.5-96.2] versus NaP 22.8% [15.5-31.6%], p < 0.0001). Subject reported outcomes on acceptability of the two different preparations were not significantly different (p = 0.238). However, taste ratings for PEG+Asc were significantly better versus NaP (mean VAS: 31.2 and 38.1 respectively, p = 0.0111). The proportion of patients prepared to receive the same preparation again was significantly higher in the PEG+Asc group (88.4% vs. 78.1%, p < 0.0001). CONCLUSIONS: PEG+Asc provided superior bowel cleansing to NaP and was well tolerated. Findings for PEG+Asc are aligned with previous similar studies; however, differences observed in NaP cleansing results, especially for the proximal colon segments, may be due to factors including: differences in demographics and population types and the use of the validated Harefield Cleansing Scale as an assessment tool combined with expert reviews, which may have resulted in conservative cleansing assessments.


Subject(s)
Cathartics/administration & dosage , Colonoscopy , Colorectal Neoplasms/diagnosis , Polyethylene Glycols/administration & dosage , Adolescent , Adult , Aged , Aged, 80 and over , Ambulatory Care , Female , Humans , Male , Middle Aged , Patient Satisfaction , Phosphates/administration & dosage , Preoperative Care , Young Adult
9.
Z Gastroenterol ; 52(8): 802-6, 2014 Aug.
Article in English | MEDLINE | ID: mdl-25111719

ABSTRACT

BACKGROUND AND STUDY AIMS: Serrated polyposis syndrome is a rare condition in which multiple serrated lesions develop all over the colon, which is thought to be associated with an increased risk for the development of cancer. The aim of this study was to investigate the feasibility of endoscopic treatment and standardised surveillance in patients with this increasingly recognised syndrome. METHODS: From September 2010 to November 2013, consecutive patients were included in a prospective study. All patients underwent chromoendoscopy at first presentation and during surveillance. Follow-up examinations were carried out at 3 month intervals until complete clearance was achieved. Afterwards, patients entered a standardised surveillance protocol with a chromoendoscopic colonoscopy annually. RESULTS: Altogether 100 colonoscopies were carried out in 28 patients, with endoscopic resection of 436 lesions. Total clearance was accomplished in 27 patients (96.0 %) after 2.5 colonoscopies (range 1 - 8). Histology revealed 359 hyperplastic polyps (82.3 %), 37 sessile serrated adenomas (8.5 %), 36 low-grade adenomas (8.3 %), and one patient with advanced colorectal cancer. Twelve patients (42.8 %) had serrated polyps > 10 mm in size. During the surveillance period, 86 additional lesions were detected and resected. The mean follow-up period was 21.5 months (range 2 - 39 months). No interval carcinoma was detected during the surveillance. CONCLUSIONS: The present study indicates that endoscopic management in patients who meet the diagnostic criteria for serrated polyposis syndrome is feasible and safe. In particular, the incidence of colorectal cancer in this cohort was lower in comparison with previous studies.


Subject(s)
Adenomatous Polyposis Coli/surgery , Colonic Neoplasms/surgery , Colonoscopy , Precancerous Conditions/surgery , Rectal Neoplasms/surgery , Uterine Cervical Dysplasia/surgery , Adenomatous Polyposis Coli/diagnosis , Adenomatous Polyposis Coli/epidemiology , Adenomatous Polyposis Coli/pathology , Administration, Topical , Adult , Aged , Cohort Studies , Colonic Neoplasms/diagnosis , Colonic Neoplasms/epidemiology , Colonic Neoplasms/pathology , Disease Progression , Feasibility Studies , Female , Follow-Up Studies , Humans , Incidence , Indigo Carmine , Male , Middle Aged , Precancerous Conditions/diagnosis , Precancerous Conditions/epidemiology , Precancerous Conditions/pathology , Prospective Studies , Rectal Neoplasms/diagnosis , Rectal Neoplasms/epidemiology , Rectal Neoplasms/pathology , Tertiary Care Centers , Treatment Outcome , Uterine Cervical Dysplasia/diagnosis , Uterine Cervical Dysplasia/epidemiology , Uterine Cervical Dysplasia/pathology
10.
Zentralbl Chir ; 139(1): 28-31, 2014 Feb.
Article in German | MEDLINE | ID: mdl-24585194

ABSTRACT

There is good evidence for the safety and efficacy of endoscopic treatment for early neoplasia in Barrett's oesophagus and in oesophageal squamous epithelium within defined margins, and this form of therapy is therefore the treatment of choice. With a low morbidity rate, it offers patients a good quality of life with preservation of the organ. The mortality risk is minimal. The decisive element for success is early diagnosis. Oesophageal resection and radiotherapy/chemotherapy are nowadays reserve procedures in the treatment of early oesophageal carcinoma and should only be used in patients in whom the tumour shows defined histological risk factors or endoscopic therapy has failed. Discussion is currently taking place on whether the criteria used to indicate endoscopic therapy for early Barrett's adenocarcinoma can be expanded to include lesions with superficial submucosal infiltration and no additional histological risk factors.


Subject(s)
Cardia/surgery , Esophageal Neoplasms/surgery , Esophagogastric Junction/surgery , Esophagoscopy/methods , Gastroscopy/methods , Stomach Neoplasms/surgery , Adenocarcinoma/pathology , Adenocarcinoma/surgery , Barrett Esophagus/pathology , Barrett Esophagus/surgery , Carcinoma, Squamous Cell/pathology , Carcinoma, Squamous Cell/surgery , Cardia/pathology , Esophageal Neoplasms/pathology , Esophagus/pathology , Esophagus/surgery , Humans , Neoplasm Staging , Precancerous Conditions/pathology , Precancerous Conditions/surgery , Prognosis , Stomach/pathology , Stomach/surgery , Stomach Neoplasms/pathology
11.
Z Gastroenterol ; 52(2): 187-92, 2014 Feb.
Article in German | MEDLINE | ID: mdl-24526403

ABSTRACT

With the increasing technological development of endoscopy in recent years the diagnosis of and endoscopic therapy for duodenal adenomas has gained in importance. Due to its potentially malignant transformation an effective and safe therapy is necessary. The endoscopic resection has been shown to be safe and effective, even in cases of resection of large duodenal adenomas. Several studies have supported this thesis but are based on relatively small numbers of patients. In our clinic we have performed endoscopic resections of 178 duodenal adenomas over a period of 14 years, including sporadic duodenal adenomas as well as adenomas in familial polyposis syndromes. The aim of this retrospective analysis was to determine the acute complications associated with this technique. The rate of severe complications such as major bleeding or perforations was 9%. Further complications were minor bleeding (15.7%), pain needing treatment with analgesia (6.7%), fever (2.8%) and pancreatitis (0.6%). Summing up our experience with the endoscopic resection of adenomas of the small bowel we also consider the endoscopic resection of duodenal adenomas in most cases as a safe and effective alternative to surgical therapy. Because of the potential complications and their management especially in the resection of large adenomas with a size more than 2 cm, the endoscopic resection should be performed on an inpatient basis in experienced centres.


Subject(s)
Adenoma/surgery , Duodenal Neoplasms/surgery , Duodenoscopy/adverse effects , Intestinal Perforation/etiology , Pain, Postoperative/etiology , Pancreatitis/etiology , Postoperative Hemorrhage/etiology , Acute Disease , Adenoma/complications , Adenoma/pathology , Aged , Duodenal Neoplasms/complications , Duodenal Neoplasms/pathology , Female , Humans , Intestinal Perforation/prevention & control , Male , Middle Aged , Pain, Postoperative/prevention & control , Pancreatitis/prevention & control , Postoperative Hemorrhage/prevention & control , Retrospective Studies , Treatment Outcome
12.
Internist (Berl) ; 54(6): 683-90, 2013 Jun.
Article in German | MEDLINE | ID: mdl-23657618

ABSTRACT

Modern high-resolution video endoscopes allow detailed examination of the esophageal mucosa and diagnosis of early neoplastic changes in the gastrointestinal tract. Whereas Barrett's esophagus is a precancerous condition that can develop into adenocarcinoma, there is no defined precancerous lesion for squamous cell carcinoma. Various diseases are associated with the development of esophageal squamous cell carcinoma. Chromoendoscopy has become an established method in the diagnostic work-up for better visualization of early neoplasia. If Barrett's esophagus is present, acetic acid spraying or virtual chromoendoscopy can be used to accentuate the display of superficial gyriform structures in the mucosa. The gold standard for detecting squamous cell carcinoma is still the use of Lugol solution. When early neoplasia is suspected, diagnostic endoscopic resection should be performed. This allows precise histological assessment of the tumor. Early diagnosis of neoplastic changes in the esophagus provides patients not only with the option of curative therapy but also with a good quality of life through preservation of the esophagus.


Subject(s)
Barrett Esophagus/diagnosis , Barrett Esophagus/therapy , Esophageal Neoplasms/diagnosis , Esophageal Neoplasms/prevention & control , Precancerous Conditions/diagnosis , Precancerous Conditions/therapy , Humans
13.
Clin Res Cardiol ; 102(6): 399-412, 2013 Jun.
Article in English | MEDLINE | ID: mdl-23669868

ABSTRACT

Dabigatran, apixaban, and rivaroxaban have been approved for primary and secondary stroke prevention in patients with atrial fibrillation. However, questions have arisen about how to manage emergency situations, such as when thrombolysis would be required for acute ischemic stroke or for the managing intracranial or gastrointestinal bleedings. We summarize the current literature and provide recommendations for the management of these situations. Peak plasma levels of the direct oral anticoagulants (DOACs) apixaban, dabigatran, or rivaroxaban are observed about 2-4 h after intake. Elimination of dabigatran is mainly dependent on renal function. Consequently, if renal function is impaired, there is a risk of drug accumulation that is highest for dabigatran followed by rivaroxaban and then apixaban and thus dosing recommendations are different. To date, no bedside tests are available that reliably assess the anticoagulatory effect of DOACs, nor are specific antidotes available. We recommend performing the following tests if DOAC intake is unknown: dabigatran-associated bleeding risk is minimized or can be neglected if thrombin time, Hemoclot test, or Ecarin clotting time is normal. Apixaban and rivaroxaban effects can be ruled out if findings from the anti-factor Xa activity test are normal. High plasma levels of DOAC are also mostly excluded if PTT and PTZ are normal four or more hours after DOAC intake. However, normal values of global coagulation tests are not sufficient if thrombolysis is indicated for treating acute stroke. The decision for or against thrombolysis is an individual decision; in these cases, thrombolysis use is off-label. In case of bleeding, prothrombin complex concentrates seems to be the most plausible treatment. For severe gastrointestinal bleeding with life-threatening blood loss, the bleeding source needs to be identified and treated by invasive measures. Use of procoagulant drugs (antifibrinolytics) might also be considered. However, there is very limited clinical experience with these products in conjunction with DOAC.


Subject(s)
Anticoagulants/adverse effects , Antithrombins/adverse effects , Hemorrhage/chemically induced , Administration, Oral , Animals , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Antithrombins/administration & dosage , Antithrombins/therapeutic use , Benzimidazoles/administration & dosage , Benzimidazoles/adverse effects , Benzimidazoles/therapeutic use , Dabigatran , Dose-Response Relationship, Drug , Hemorrhage/therapy , Humans , Morpholines/administration & dosage , Morpholines/adverse effects , Morpholines/therapeutic use , Pyrazoles/administration & dosage , Pyrazoles/adverse effects , Pyrazoles/therapeutic use , Pyridones/administration & dosage , Pyridones/adverse effects , Pyridones/therapeutic use , Renal Insufficiency/complications , Rivaroxaban , Thiophenes/administration & dosage , Thiophenes/adverse effects , Thiophenes/therapeutic use , beta-Alanine/administration & dosage , beta-Alanine/adverse effects , beta-Alanine/analogs & derivatives , beta-Alanine/therapeutic use
14.
Z Gastroenterol ; 51(5): 432-6, 2013 May.
Article in German | MEDLINE | ID: mdl-23681895

ABSTRACT

BACKGROUND: Gastrointestinal endoscopies are increasingly being carried out with sedation. All of the drugs used for sedation are associated with a certain risk of complications. Data currently available on sedation-associated morbidity and mortality rates are limited and in most cases have substantial methodological limitations. The aim of this study was to record severe sedation-associated complications in a large number of gastrointestinal endoscopies. METHODS: Data on severe sedation-associated complications were collected on a multicentre basis from prospectively recorded registries of complications in the participating hospitals (median documentation period 27 months, range 9 - 129 months). RESULTS: Data for 388,404 endoscopies from 15 departments were included in the study. Severe sedation-associated complications occurred in 57 patients (0.01 %). Forty-one percent of the complications and 50 % of all complications with a fatal outcome (10/20 patients) occurred during emergency endoscopies. In addition, it was found that 95 % of the complications and 100 % of all fatal complications affected patients in ASA class ≥ 3. CONCLUSIONS: Including nearly 400,000 endoscopies, this study represents the largest prospective, multicenter record of the complications of sedation worldwide. The analysis shows that sedation is carried out safely in gastrointestinal endoscopy. The morbidity and mortality rates are much lower than previously reported in the literature in similar groups of patients. Risk factors for the occurrence of serious complications include emergency examinations and patients in ASA class ≥ 3.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/mortality , Endoscopy, Gastrointestinal/mortality , Hypnotics and Sedatives/therapeutic use , Registries , Adult , Aged , Female , Germany/epidemiology , Humans , Incidence , Male , Middle Aged , Patient Safety , Prospective Studies , Risk Factors , Survival Rate
15.
Z Gastroenterol ; 50(9): 1002-7, 2012 Sep.
Article in German | MEDLINE | ID: mdl-22965630

ABSTRACT

BACKGROUND: The introduction of the S3 guideline on "Sedation in Gastrointestinal Endoscopy" in 2008 led to substantial organisational, structural, staffing-related, financial, and legal changes in the everyday work of departments of gastrointestinal endoscopy. This study examines the economic effects of this and the change in the legal situation. In addition, the extent to which the guideline has been implemented was assessed using an electronic questionnaire circulated to the members of the Working Group of Head Gastroenterologists in Hospitals (ALGK). METHODS: The increased financial burden in the area of staff costs resulting from correct compliance with the sedation guideline was calculated using research figures from an endoscopy department in a maximum-care non-university hospital, dating from 2009. Interpretation of the legal implications of the guideline was provided by lawyers familiar with medical legislation. The question of the extent to which the guideline has been implemented in everyday clinical practice in endoscopy departments in 2011 was investigated using an evaluation questionnaire sent to the members of the ALGK. RESULTS: Implementation of the S3 sedation guideline leads to a substantial increase in the financial burden in the area of staff costs. Assuming 8000 in-patient endoscopy procedures, a conservative estimate indicates extra costs amounting to € 257 462.- per year (gross costs for the employer). The analysis of the questionnaire sent to ALGK members on the implementation of the S3 guideline 3 years after its publication showed that its major points, particularly the deployment of a third staff member for sedation, have not been acted on. CONCLUSIONS: The S3 guideline on "Sedation in Gastrointestinal Endoscopy" leads to a substantial increase in the financial burden in the area of staff costs by requiring the presence of a third person exclusively concerned with sedation. This recommendation was issued by the authors of the guideline without any evidence being available. In addition, it leads to a clear change in the legal situation, which in case of claims arising is associated with substantial implications for the physician responsible. The questionnaire evaluation among the members of the ALGK showed that the guideline has not so far been implemented in in-patient gastroenterology.


Subject(s)
Conscious Sedation/economics , Conscious Sedation/statistics & numerical data , Endoscopy, Gastrointestinal/economics , Endoscopy, Gastrointestinal/standards , Health Care Costs/statistics & numerical data , Models, Economic , Practice Guidelines as Topic , Computer Simulation , Germany/epidemiology , Guideline Adherence/economics , Guideline Adherence/statistics & numerical data , Hospitalization
16.
Aliment Pharmacol Ther ; 36(10): 959-71, 2012 Nov.
Article in English | MEDLINE | ID: mdl-22998687

ABSTRACT

BACKGROUND: Sustained acid inhibition with PPI stimulates gastrin secretion, exerting a proliferative drive on enterochromaffin-like cells (ECL cells) of the oxyntic mucosa. It may also accelerate development of gastric gland atrophy in Helicobacter pylori-infected individuals. AIMS: To evaluate gastric exocrine and endocrine cell changes in GERD patients randomised to laparoscopic antireflux surgery (LARS, n = 288) or long-term (5 years) esomeprazole (ESO) treatment (n = 266). METHODS: Antral and corpus biopsies were taken at endoscopy and serum gastrin and chromogranin A levels were assayed, at baseline and after 1, 3 and 5 years' therapy. RESULTS: Biopsies were available at each time point for 158 LARS patients and 180 ESO patients. In H. pylori-infected subjects, antral mucosal inflammation and activity improved significantly (P < 0.001) and stabilised after 3 years on esomeprazole while no change in inflammation was observed after LARS. Oxyntic mucosal inflammation and activity remained stable on esomeprazole but decreased slightly over time after LARS. Neither intestinal metaplasia nor atrophy developed in the oxyntic mucosa. ECL cell density increased significantly after ESO (P < 0.001), corresponding with an increase in circulating gastrin and chromogranin A. After LARS, there was a significant decrease in ECL cell density (P < 0.05), accompanied by a marginal decrease in gastrin and chromogranin. CONCLUSIONS: Antral gastritis improved in H. pylori-infected GERD patients after 5 years on esomeprazole, with little change in laparoscopic antireflux surgery patients, who acted as a control. Despite a continued proliferative drive on enterochromaffin-like cells during esomeprazole treatment, no dysplastic or neoplastic lesions were found and no safety concerns were raised. NCT 00251927.


Subject(s)
Anti-Ulcer Agents/therapeutic use , Enterochromaffin-like Cells/pathology , Esomeprazole/therapeutic use , Gastroesophageal Reflux/drug therapy , Helicobacter Infections/drug therapy , Helicobacter pylori/isolation & purification , Proton Pump Inhibitors/therapeutic use , Adolescent , Adult , Aged , Chromogranin A/blood , Enterochromaffin-like Cells/metabolism , Female , Follow-Up Studies , Gastric Acid/metabolism , Gastric Mucosa/drug effects , Gastric Mucosa/metabolism , Gastrins/blood , Gastroesophageal Reflux/complications , Helicobacter Infections/complications , Humans , Laparoscopy , Male , Middle Aged , Time Factors , Treatment Outcome , Young Adult
17.
Z Gastroenterol ; 50(7): 670-6, 2012 Jul.
Article in English | MEDLINE | ID: mdl-22760678

ABSTRACT

BACKGROUND AND STUDY AIMS: Endoscopic treatment is increasingly being accepted for early Barrett's cancer (EBC), as it is associated with few complications, excellent long-term results, and almost no mortality. This study investigated current standards and treatment strategies for EBC in eight countries in Western Europe. METHODS: A standardized questionnaire with questions on the endoscopic diagnosis, staging, and treatment of EBC was developed and sent to 107 university gastroenterology departments. The data were analyzed anonymously. RESULTS: The response rate was 49 % (52/107). For work-up of early Barrett's neoplasia, 67 % of hospitals use high-resolution endoscopes, with routine four-quadrant and targeted biopsies of visible lesions in 94 % of the cases. Narrow-band imaging and chromoendoscopy are used in 67 % of the cases, and other advanced imaging and staining techniques in 65 %. Before treatment, 63 % of the respondents recommended conventional endosonography, 6 % miniprobe endosonography, and 19 % both. Endoscopic resection is carried out at 98 % of the hospitals. Argon plasma coagulation is used for ablation in 52 % of the cases and radiofrequency ablation in 27 %. An 80-year-old patient with localized mucosal EBC would be treated endoscopically in all of the hospitals. Endoscopic therapy was recommended for 50-year-old patients with mucosal EBC by 87 % of the hospitals; esophageal resection was recommended for multifocal EBC by 15 % in 80-year-old patients, by 63 % in 50-year-old patients and by 44 % in patients with incipient submucosal infiltration. CONCLUSIONS: About two-thirds of the university hospitals use high-resolution endoscopy and advanced imaging. Endoscopic therapy is the accepted standard for treating localized mucosal Barrett's cancer in Western Europe; esophageal resection is recommended by the majority (63 %) for a young patient with multifocal EBC.


Subject(s)
Barrett Esophagus/diagnosis , Barrett Esophagus/therapy , Endoscopy, Gastrointestinal/statistics & numerical data , Esophageal Neoplasms/diagnosis , Esophageal Neoplasms/therapy , Hospitals, University/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Barrett Esophagus/epidemiology , Comorbidity , Esophageal Neoplasms/epidemiology , Europe/epidemiology , Female , Gastroenterology/statistics & numerical data , Humans , Male , Prevalence , Treatment Outcome
18.
Chirurg ; 83(6): 568-71, 2012 Jun.
Article in German | MEDLINE | ID: mdl-22695813

ABSTRACT

Small bowel intussusception is a rare cause of abdominal pain in adult patients. Due to varying symptoms and different underlying causes its diagnosis and treatment is challenging for physicians. This case report describes recurrent intussusception in an adult female patient and celiac disease could only be diagnosed as the cause of these symptoms after surgery. In addition a review of the literature regarding adult intussusception is presented.


Subject(s)
Abdomen, Acute/etiology , Celiac Disease/complications , Celiac Disease/diagnosis , Intestine, Small , Intussusception/etiology , Abdomen, Acute/diagnostic imaging , Abdomen, Acute/pathology , Abdomen, Acute/surgery , Adult , Biopsy , Celiac Disease/pathology , Diagnosis, Differential , Female , Humans , Ileus/diagnostic imaging , Ileus/pathology , Ileus/surgery , Intestinal Mucosa/pathology , Intestine, Small/diagnostic imaging , Intestine, Small/pathology , Intestine, Small/surgery , Intussusception/diagnostic imaging , Intussusception/pathology , Intussusception/surgery , Laparoscopy , Recurrence , Tomography, X-Ray Computed , Ultrasonography
20.
Endoscopy ; 44(4): 422-4, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22407381

ABSTRACT

Placement of self-expanding metal stents (SEMSs) is a well-established treatment for esophageal stenosis and postoperative anastomotic leaks. Conventional endoscopic procedures for SEMS placement require fluoroscopic guidance, but transnasal endoscopy (TNE) with ultraslim endoscopes may allow precise stent release under direct visual control without the need for fluoroscopy. This prospectively collected data investigated the feasibility and safety of TNE-guided SEMS placement without fluoroscopy. Between March 2009 and February 2011, 20 consecutive patients underwent TNE-guided SEMS placement without fluoroscopy. The technical success rate was 100 % and no fluoroscopy was required during the procedures. Five patients underwent SEMS placement as a bedside procedure in the intensive care unit. The mean intervention time was 13.4 minutes (range 6 - 26) and there were no early complications. In summary, TNE-guided SEMS placement allows precise stent placement without fluoroscopic control and can therefore be performed as a simple bedside procedure.


Subject(s)
Anastomotic Leak/diagnosis , Anastomotic Leak/therapy , Esophageal Stenosis/diagnosis , Esophageal Stenosis/therapy , Esophagoscopy/methods , Natural Orifice Endoscopic Surgery/methods , Stents , Aged , Aged, 80 and over , Endoscopes , Feasibility Studies , Female , Fluoroscopy , Humans , Male , Middle Aged , Nasal Cavity
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