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1.
J Gastroenterol Hepatol ; 39(5): 935-941, 2024 May.
Article in English | MEDLINE | ID: mdl-38267213

ABSTRACT

BACKGROUND: Collection of bile aspirate during endoscopic retrograde cholangiopancreatography (ERCP) is essential to identify pathogens responsible for acute cholangitis. Limited data are available on the risk factors for the presence of multidrug-resistant organisms (MDRO) in bile. METHODS: We conducted this retrospective, single-center study to assess the prevalence and susceptibility rates of bacteria in bile cultures, and the risk factors for the presence of pathogens, MDRO, and fungi in bile. All consecutive patients who underwent biliary drainage for acute cholangitis from January 2017 to December 2019 were included. RESULTS: 443/1610 ERCPs were performed for acute cholangitis. Bile culture was collected in 91.4% (405/443), of which 86.7% were positive. Most common isolates were Enterococcus faecalis (37.6%) and Escherichia coli (32.8%). Vancomycin resistance was found in 9.9% of Enterococcus species (spp.); extended-spectrum beta-lactamases (ESBL) and carbapenemases in 11.2% and 0.9% of Enterobacteriaceae, respectively. The empiric antimicrobial therapy was changed in 26.4% (n = 107) of cases, with a clinical response in 90.7%. In multivariate analysis, biliary stenting was an independent risk factor for positive bile culture (odds ratio [OR] 9.43; P < 0.01). Independent risk factors for MDRO in bile were patient age>60 years (OR 2.51; P = 0.03), previous sphincterotomy (OR 2.57; P = 0.02), and biliary stenting (OR 2.80; P < 0.01). Previous sphincterotomy was the only risk factor for isolation of fungi in bile (OR 1.61; P = 0.04). CONCLUSIONS: Our study showed an increasing prevalence of Enterococcus spp. and MDRO. Bile cultures should be routinely collected in cholangitis and in patients with repeated ERCPs to allow more efficient antimicrobial treatment.


Subject(s)
Bile , Cholangiopancreatography, Endoscopic Retrograde , Cholangitis , Tertiary Care Centers , Humans , Retrospective Studies , Cholangitis/microbiology , Cholangitis/epidemiology , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Male , Acute Disease , Risk Factors , Female , Bile/microbiology , Aged , Middle Aged , Drug Resistance, Multiple, Bacterial , Aged, 80 and over , Escherichia coli/isolation & purification , Prevalence , Anti-Bacterial Agents/therapeutic use
2.
Laryngorhinootologie ; 102(10): 742-753, 2023 10.
Article in German | MEDLINE | ID: mdl-37253378

ABSTRACT

Esophageal motility disorders are diseases in which there are malfunctions of the act of swallowing due to a change in neuromuscular structures. The main symptom is therefore dysphagia for solid and/or liquid foods, often accompanied by symptoms such as chest pain, regurgitation, heartburn, and weight loss. Esophageal manometry is the gold standard in diagnostics. Endoscopy and radiology serve to exclude inflammatory or malignant changes. With the introduction of high-resolution esophageal manometry (HRM), the diagnosis of esophageal motility disorders has improved and led to a new classification with the Chicago Classification, which has been modified several times in the last decade, most recently in 2021 with the Chicago Classification v4.0. Compared to the previous version 3.0, there are some important changes that are presented based on the most important esophageal motility disorders in everyday clinical practice.


Subject(s)
Deglutition Disorders , Esophageal Motility Disorders , Humans , Esophageal Motility Disorders/diagnosis , Deglutition Disorders/diagnosis , Deglutition Disorders/etiology , Deglutition , Manometry
3.
Radiol Case Rep ; 18(7): 2526-2530, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37235084

ABSTRACT

An aorto-esophageal fistula (AEF) is a rare and life-threatening situation, associated with aneurysms, foreign bodies, infiltrating tumors, and radiotherapy. The ideal management is unclear. Open surgery of AEF has a high mortality and morbidity. Thoracic endovascular aortic repair (TEVAR) of an AEF is an effective and safe emergency treatment for these patients. We describe a case of AEF due to esophageal cancer successfully treated the first time by total percutaneous TEVAR (pTEVAR). A 70-year-old male patient presented with massive hematemesis at the emergency department. The patient had a known history of esophageal cancer previously treated by radiochemotherapy which was completed 3 days before. Emergency upper gastrointestinal endoscopy failed to stop the bleeding. Subsequent contrast-enhanced computed tomography revealed an aorto-esophageal fistula and emergency pTEVAR was performed. The bleeding stopped directly after stent graft placement and the patient was discharged after 10 days later. He died 3 months after pTEVAR from cancer progression. pTEVAR is an effective and safe treatment option for AEF. It can be applied as a first-line treatment and offers the potential to improve survival in the emergency setting.

4.
Fam Cancer ; 22(3): 323-330, 2023 07.
Article in English | MEDLINE | ID: mdl-36717525

ABSTRACT

Familial pancreatic cancer (FPC) is a rare hereditary tumor entity with broad phenotypic heterogeneity, including colorectal carcinoma (CRC) in some families. The underlying factors for this co-occurrence are still not well evaluated. FPC families in the National Case Collection of Familial Pancreatic Cancer with an additional occurrence of CRC were analyzed regarding the phenotype, genotype and recommendation for a clinical screening program. The total cohort of 272 FPC families included 30 (11%) families with at least one CRC case. The proportion of affected family members with PDAC was 16.1% (73/451) compared to 9.3% of family members with CRC (42/451, p < 0.01). Females were affected with PDAC in 49% (36/73) and CRC in 38% (16/42). The median age of PDAC was 63 compared to 66 years in CRC, whereas 8 (26.6%) of families had an early onset of PDAC and 2 (6.7%) of CRC. Seventeen families had 2 or more affected generations with PDAC and 6 families with CRC. Eleven (9.6%) of affected patients had both PDAC and CRC. Potentially causative germline mutations (2 ATM, 1 CDKN2a, 1 MLH1, 1 PALB2) were detected in 5 of 18 (27.7%) analyzed cases. These findings provide a step forward to include the phenotypic and genotypic characteristics of FPC-CRC families for the genetic counseling and management of these families. Nevertheless, results need to be verified in a larger patient cohort beforehand.


Subject(s)
Genetic Predisposition to Disease , Pancreatic Neoplasms , Female , Humans , Pancreatic Neoplasms/diagnosis , Germ-Line Mutation , Genotype
5.
Z Gastroenterol ; 61(2): 183-197, 2023 Feb.
Article in German | MEDLINE | ID: mdl-35835360

ABSTRACT

Esophageal motility disorders are diseases in which there are malfunctions of the act of swallowing due to a change in neuromuscular structures. The main symptom is therefore dysphagia for solid and/or liquid foods, often accompanied by symptoms such as chest pain, regurgitation, heartburn, and weight loss. Esophageal manometry is the gold standard in diagnostics. Endoscopy and radiology serve to exclude inflammatory or malignant changes. With the introduction of high-resolution esophageal manometry (HRM), the diagnosis of esophageal motility disorders has improved and led to a new classification with the Chicago Classification, which has been modified several times in the last decade, most recently in 2020 with the Chicago Classification v4.0. Compared to the previous version 3.0, there are some important changes that are presented based on the most important esophageal motility disorders in everyday clinical practice.


Subject(s)
Deglutition Disorders , Esophageal Motility Disorders , Humans , Esophageal Motility Disorders/diagnosis , Esophageal Motility Disorders/therapy , Esophageal Motility Disorders/complications , Deglutition Disorders/diagnosis , Deglutition Disorders/etiology , Deglutition Disorders/therapy , Heartburn , Endoscopy , Manometry
6.
Z Gastroenterol ; 61(3): 284-296, 2023 Mar.
Article in German | MEDLINE | ID: mdl-35839796

ABSTRACT

Esophageal motility disorders are diseases in which there are malfunctions of the act of swallowing due to a change in neuromuscular structures. The main symptom is therefore dysphagia for solid and/or liquid foods, often accompanied by symptoms such as chest pain, regurgitation, heartburn, and weight loss. Esophageal manometry is the gold standard in diagnostics. Endoscopy and radiology serve to exclude inflammatory or malignant changes. With the introduction of high-resolution esophageal manometry (HRM), the diagnosis of esophageal motility disorders has improved and led to a new classification with the Chicago Classification, which has been modified several times in the last decade, most recently in 2021 with the Chicago Classification v4.0. Compared to the previous version 3.0, there are some important changes that are presented based on the most important esophageal motility disorders in everyday clinical practice.


Subject(s)
Deglutition Disorders , Esophageal Motility Disorders , Humans , Esophageal Motility Disorders/diagnosis , Deglutition Disorders/diagnosis , Deglutition Disorders/etiology , Heartburn , Chest Pain , Manometry
7.
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
9.
Endosc Int Open ; 10(5): E686-E693, 2022 May.
Article in English | MEDLINE | ID: mdl-35571474

ABSTRACT

Background and study aims Acute esophageal perforation is a potentially life-threating condition that demands a multidisciplinary approach. Based on recently published data indicating that EVT may be effective in managing esophageal perforation, we report our institution's experience with EVT in this clinical setting. Patients and methods We retrospectively analyzed all 10 patients with acute esophageal perforation from May 2018 to January 2021, using descriptive statistics. The primary outcome was successful closure of the perforation. Secondary outcomes included the length of treatment, number of endoscopic procedures required, and complication rate. Results All patients (site of perforation: 4 upper, 2 middle, 4 lower esophagus; etiology: 8 iatrogenic, 2 foreign body ingestion) were treated with EVT successfully. In eight cases, EVT was started immediately after the perforation, in the other two cases 1 and 2 days later. The median (interquartile range) number of endoscopic procedures was 2.5 (range, 2-3) and the median duration of treatment was 7.5 days (range, 7-11.5). The sponge was placed in eight cases intraluminally, in the other two cases initially intracavitary. No complication occurred. Conclusions EVT is highly effective for managing acute esophageal perforation within 1 to 3 weeks. Immediate start of EVT to prevent abscess formation and induce defect closure is crucial.

10.
Clin Endocrinol (Oxf) ; 95(3): 439-446, 2021 09.
Article in English | MEDLINE | ID: mdl-33506527

ABSTRACT

BACKGROUND: Gastric enterochromaffin-like cell (ECL) tumours can occur in patients with multiple endocrine neoplasia type 1 (MEN1), especially in those affected by Zollinger Ellison syndrome (ZES). Since the prevalence of ECL lesions is not well defined yet, the present study evaluated the presence and extent of ECL lesions in MEN1 patients with and without ZES. METHODS: Multiple endocrine neoplasia type 1 patients being part of a regular screening program (2014-2018) underwent gastroduodenoscopies with biopsies of the stomach and determination of serum gastrin and chromogranin A levels. Haematoxylin- and immunostaining with chromogranin A, gastrin and VMAT I and II (vesicular monoamine transporter I and II) of the biopsies were performed. RESULTS: Thirty-eight MEN1 patients, of whom 16 (42%) were diagnosed and treated earlier for ZES, were analysed. In ten of 16 (62.5%) ZES patients, a locally scattered, mixed image of diffuse, linear and micronodular mild hyperplasia was present. In addition, two of these patients (13%) showed small (max 1.5 mm in size) intramucosal ECL tumours. Neither ECL changes, nor tumours were found in MEN1 patients without ZES (n = 22). In MEN1/ZES patients, the median serum gastrin level was significantly elevated compared to MEN1 patients without ZES (206 pg/ml vs. 30.5 pg/ml, p < .001). A subgroup analysis of the serum gastrin and chromogranin A levels of MEN1/ZES patients with or without ECL hyperplasia did not show significant differences (gastrin level: p = .302, chromogranin A: p = .464). CONCLUSION: Enterochromaffin-like cell hyperplasia and gastric carcinoids occur only in MEN1 patients with ZES, but less frequently than reported.


Subject(s)
Carcinoid Tumor , Multiple Endocrine Neoplasia Type 1 , Stomach Neoplasms , Zollinger-Ellison Syndrome , Enterochromaffin-like Cells , Gastrins , Humans
12.
Liver Int ; 39(6): 1155-1164, 2019 06.
Article in English | MEDLINE | ID: mdl-30367552

ABSTRACT

BACKGROUND & AIMS: Biliary strictures are common complications after orthotopic liver transplantation. Endoscopic retrograde cholangiography evolved as standard and percutaneous transhepatic cholangiodrainage as alternative therapy. This study analysed predictors of long-term success of biliary strictures after endoscopic retrograde cholangiography and/or percutaneous transhepatic cholangiodrainage and its impact on patient survival. METHODS: All adult patients with biliary strictures receiving endoscopic retrograde cholangiography and/or percutaneous transhepatic cholangiodrainage between 2009 and 2015 at the University Medical Center Hamburg-Eppendorf were retrospectively analysed. Potential predictors of long-term success (≥12 months) were identified by univariate and logistic regression analyses. Patient survival was analysed by Kaplan-Meier method and log-rank test. RESULTS: Hundred and sixteen patients were treated with endoscopic retrograde cholangiography and/or percutaneous transhepatic cholangiodrainage, including 67 patients with anastomotic strictures, 22 with nonanastomotic strictures and 27 with both stricture types. Eighty-five patients received endoscopic retrograde cholangiography, 17 percutaneous transhepatic cholangiodrainage and 14 both techniques. Long-term success was achieved in 60 patients (52%). Predictors of treatment failure were a preinterventional C-reactive protein >8 g/dL in anastomotic strictures (P = 0.039) and a body mass index ≤21 kg/m2 in nonanastomotic strictures (P = 0.021). In patients who received endoscopic retrograde cholangiography only, balloon dilatation of anastomotic strictures with larger diameters favoured success (P = 0.015). Achievement of long-term success was associated with prolonged patient survival in anastomotic strictures (P = 0.036) and nonanastomotic strictures (P = 0.025), but not in combined strictures (P = 0.739). CONCLUSION: In post-orthotopic liver transplantation biliary strictures treated by endoscopic retrograde cholangiography and/or percutaneous transhepatic cholangiodrainage, patient BMI and preinterventional C-reactive protein may influence prognosis. Endoscopic retrograde cholangiography with larger balloon diameter may favour success in anastomotic strictures. Long-term success by endoscopic retrograde cholangiography and/or percutaneous transhepatic cholangiodrainage is associated with superior survival in patients with anastomotic strictures and nonanastomotic strictures only.


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Cholestasis/therapy , Liver Transplantation/adverse effects , Adult , Aged , Body Mass Index , C-Reactive Protein/analysis , Cholestasis/diagnostic imaging , Cholestasis/etiology , Constriction, Pathologic , Drainage , Female , Germany , Humans , Liver Transplantation/mortality , Male , Middle Aged , Prognosis , Retrospective Studies , Survival Analysis , Young Adult
13.
Gastrointest Endosc ; 85(4): 708-718.e2, 2017 Apr.
Article in English | MEDLINE | ID: mdl-27609778

ABSTRACT

BACKGROUND AND AIMS: The recently developed technique of per-oral endoscopic myotomy (POEM) has been shown to be effective for the therapy of esophageal motility disorders. Limited information is available about POEM adverse events (AEs). METHODS: POEM was performed on 241 patients (58% male; mean age, 47.4 ± 16.4 years) under general anesthesia over 61 months. The main outcome was the rate of intra- and post-procedural AEs. Post-procedural checks comprised clinical and laboratory examinations and endoscopy, with further follow-ups performed at 3, 6, and 12 months. RESULTS: Of the 241 procedures, 238 were successfully completed (mean procedure time, 100.2 ± 39.5 min). Reasons for abortion were excessive submucosal fibrosis preventing submucosal tunneling. Three patients had severe procedural-related AEs (SAE rate, 1.2%); 1 case of pneumothorax required intra-procedural drainage, and 2 patients had delayed SAEs (1 ischemic gastric cardia perforation and 1 hemothorax, both leading to surgery). The overall rate of minor AEs was 31.1%, mainly prolonged intra-procedural bleeding (>15 min hemostasis) and defects of the mucosa overlying the tunnel; none led to clinically relevant signs or symptoms. Patients experiencing any AE had a significantly prolonged hospital stay (P = .037) and a trend toward prolonged procedure time (P = .094). Neck/upper thoracic emphysema and free abdominal air were noted in 31.5% and 35.7%, respectively (95.3% drained), but without relevant sequelae. CONCLUSIONS: POEM has a low rate of SAEs; minor AEs are more frequent but lack a consistent definition. Therefore, based on our experience and literature analysis, we suggest a classification of AEs for POEM. (Clinical trials registration number: NCT01405417.).


Subject(s)
Endoscopy, Digestive System/methods , Esophageal Achalasia/surgery , Esophageal Sphincter, Lower/surgery , Intraoperative Complications/epidemiology , Natural Orifice Endoscopic Surgery/methods , Postoperative Complications/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , Blood Loss, Surgical , Cardia , Endoscopy, Digestive System/adverse effects , Esophageal Motility Disorders/surgery , Female , Hemothorax/epidemiology , Hemothorax/etiology , Humans , Intraoperative Complications/etiology , Ischemia/epidemiology , Ischemia/etiology , Length of Stay , Male , Middle Aged , Natural Orifice Endoscopic Surgery/adverse effects , Pneumothorax/epidemiology , Pneumothorax/etiology , Postoperative Complications/etiology , Stomach Diseases/epidemiology , Stomach Diseases/etiology , Treatment Outcome , Young Adult
14.
World J Gastroenterol ; 22(39): 8820-8830, 2016 Oct 21.
Article in English | MEDLINE | ID: mdl-27818598

ABSTRACT

AIM: To compare the aspiration needle (AN) and core biopsy needle (PC) in endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of abdominal masses. METHODS: Consecutive patients referred for EUS-FNA were included in this prospective single-center trial. Each patient underwent a puncture of the lesion with both standard 22-gauge (G) AN (Echo Tip Ultra; Cook Medical, Bloomington, Indiana, United States) and the novel 22G PC (EchoTip ProCore; Cook Medical, Bloomington, Indiana, United States) in a randomized fashion; histology was attempted in the PC group only. The main study endpoint was the overall diagnostic accuracy, including the contribution of histology to the final diagnosis. Secondary outcome measures included material adequacy, number of needle passes, and complications. RESULTS: Fifty six consecutive patients (29 men; mean age 68 years) with pancreatic lesions (n = 38), lymphadenopathy (n = 13), submucosal tumors (n = 4), or others lesions (n = 1) underwent EUS-FNA using both of the needles in a randomized order. AN and PC reached similar overall results for diagnostic accuracy (AN: 88.9 vs PC: 96.1, P = 0.25), specimen adequacy (AN: 96.4% vs PC: 91.1%, P = 0.38), mean number of passes (AN: 1.5 vs PC: 1.7, P = 0.14), mean cellularity score (AN: 1.7 vs PC: 1.1, P = 0.058), and complications (none). A diagnosis on the basis of histology was achieved in the PC group in 36 (64.3%) patients, and in 2 of those as the sole modality. In patients with available histology the mean cellularity score was higher for AN (AN: 1.7 vs PC: 1.0, P = 0.034); no other differences were of statistical significance. CONCLUSION: Both needles achieved high overall diagnostic yields and similar performance characteristics for cytological diagnosis; histological analysis was only possible in 2/3 of cases with the new needle.


Subject(s)
Endoscopic Ultrasound-Guided Fine Needle Aspiration/methods , Endosonography/methods , Pancreas/pathology , Pancreatic Neoplasms/pathology , Adolescent , Adult , Aged , Aged, 80 and over , Endoscopic Ultrasound-Guided Fine Needle Aspiration/instrumentation , Endosonography/instrumentation , Female , Humans , Male , Middle Aged , Needles , Pancreatic Neoplasms/diagnosis , Prospective Studies , Specimen Handling/methods , Young Adult
15.
PLoS One ; 11(10): e0164224, 2016.
Article in English | MEDLINE | ID: mdl-27723798

ABSTRACT

BACKGROUND: Patients with primary sclerosing cholangitis (PSC) develop progressive liver fibrosis and end-stage liver disease. Non-invasive and widely available parameters are urgently needed to assess disease stage and the risk of clinical progression. Transient elastography (TE) has been reported to predict fibrosis stage and disease progression. However, these results have not been confirmed in an independent cohort and comparison of TE measurement to other non-invasive means is missing. METHODS: In a retrospective study we collected data from consecutive PSC patients receiving TE measurements from 2006 to 2014 (n = 139). Data from 62 patients who also underwent a liver biopsy were used to assess the performance of TE and spleen length (SL) measurement for the staging of liver fibrosis. Follow-up data from this cohort (n = 130, Hamburg) and another independent cohort (n = 80, Paris) was used to compare TE and SL as predictors of clinical outcome applying Harrel's C calculations. RESULTS: TE measurement had a very good performance for the diagnosis and exclusion of higher fibrosis stages (≥F3: AUROC 0.95) and an excellent performance for the diagnosis and exclusion of cirrhosis (F4 vs. < F4: AUROC 0.98). Single-point TE measurement had very similar predictive power for patient outcome as previously published. In a combined cohort of PSC patients (n = 210), SL measurements had a similar performance as TE for the prediction of patient outcome (5 x cross-validated Harrel's C 0.76 and 0.72 for SL and TE, respectively). CONCLUSIONS: Baseline TE measurement has an excellent performance to diagnose higher fibrosis stages in PSC. Baseline measurements of SL and TE have similar usefulness as predictive markers for disease progression in patients with PSC.


Subject(s)
Cholangitis, Sclerosing/diagnosis , Liver Cirrhosis/pathology , Spleen/physiology , Adolescent , Adult , Aged , Area Under Curve , Cholangiopancreatography, Magnetic Resonance , Cholangitis, Sclerosing/diagnostic imaging , Cholangitis, Sclerosing/mortality , Cohort Studies , Elasticity Imaging Techniques , Female , Humans , Liver/physiopathology , Male , Middle Aged , Prognosis , ROC Curve , Retrospective Studies , Severity of Illness Index , Survival Rate , Young Adult
16.
Visc Med ; 32(1): 42-51, 2016 Feb.
Article in English | MEDLINE | ID: mdl-27588295

ABSTRACT

BACKGROUND: The verbalisation of quality standards and parameters by medical societies are relevant for qualitative improvement but may also be an instrument to demand more resources for health care or be a unique characteristic. Within the health care system 3 different quality levels can be defined: structure, process and result quality. METHODS: The current S2k guideline of the German Society for Gastroenterology (quality requirements for gastrointestinal endoscopy) AWMF registry no. 021-022 provides recommendations based on the available evidence for the structure quality (requirements for equipment, human resources) as well as for the process quality (patient preparation, conduct, documentation) and result quality (follow-up of specific endoscopic procedures). RESULTS: Based on these recommendations, measurable quality indicators/parameters for the endoscopy have been selected and formulated. General quality parameters for endoscopic examinations are given as well as quality parameters for specific procedures for the preparation, conduct, and follow-up of specific endoscopic interventions. CONCLUSION: Only the regular review of processes and courses by means of defined measurement parameters builds up the basis for corrections based on facts. In addition, the implementation of recommended standards may be an instrument in demanding more resources from the health care system and, therefore, should be embedded as routine.

18.
Hepatology ; 62(5): 1456-65, 2015 Nov.
Article in English | MEDLINE | ID: mdl-25990106

ABSTRACT

UNLABELLED: Photodynamic therapy using porfimer (P-PDT) improves palliation and survival in nonresectable hilar bile duct cancer. Tumoricidal penetration depth of temoporfin-PDT (T-PDT) is twice that of P-PDT. In a single-arm phase II study we investigated the safety, efficacy, survival time, and adverse events of T-PDT compared with previous data on P-PDT. Twenty-nine patients (median 71 [range 47-88] years) with nonresectable hilar bile duct cancer were treated with T-PDT (median 1 [range 1-4] sessions) plus stenting and followed up every 3 months. The PDT was well tolerated. In patients with occluded segments at baseline (n=28) a reopening of a median of 3 (range 1-7) segments could be achieved: n=16 local response and n=11 stable local disease, one progressive disease. Cholestasis and performance significantly improved when impaired at baseline. Time to local tumor progression was a median of 6.5 (2.7-41.0) months. Overall survival time was a median of 15.4 (range 4.4-62.4) months. Patients died from tumor progression (55%), cholangitis (18%), pneumonia (7%), hemobilia (7%), esophagus variceal hemorrhage (3%), and vascular diseases (10%). Adverse events were cholangitis (n=4), liver abscess (n=2), cholecystitis (n=2), phototoxic skin (n=5), and injection site reactions (n=7). Compared to previous P-PDT, T-PDT shows prolonged time to local tumor progression (median 6.5 versus 4.3 months, P<0.01), fewer PDT treatments needed (median 1 versus 3, P<0.01), a higher 6-month survival rate (83% versus 70%, P<0.01), and a trend for longer overall median survival (15.4 versus 9.3 months, P=0.72) yet not significantly different. The risk of adverse events is not increased except for (avoidable) subcutaneous phototoxicity at the injection site. CONCLUSION: Temoporfin-PDT can safely be delivered to hilar bile duct cancer patients and results in prolonged patency of hilar bile ducts, a trend for longer survival time, and similar palliation as with P-PDT.


Subject(s)
Biliary Tract Neoplasms/drug therapy , Mesoporphyrins/therapeutic use , Photochemotherapy , Aged , Aged, 80 and over , Biliary Tract Neoplasms/blood , Biliary Tract Neoplasms/mortality , Bilirubin/blood , Cause of Death , Female , Humans , Male , Middle Aged , Photochemotherapy/adverse effects
20.
J Clin Gastroenterol ; 49(2): 101-7, 2015 Feb.
Article in English | MEDLINE | ID: mdl-24618504

ABSTRACT

OBJECTIVES: Upper gastrointestinal endoscopy is mostly performed under sedation and has a low yield of relevant gastric lesions in patients without alarm symptoms. Simpler screening tests such as capsule endoscopy could be helpful, but gastric visualization is insufficient with the current passive capsules. A magnetically guided gastric capsule was prospectively evaluated in patients with routine indications for gastroscopy. METHODS: A total of 189 symptomatic patients (105 male; mean age 53 y) from 2 French centers subsequently and blindly underwent capsule and conventional gastroscopy by 9 and 6 examiners, respectively. The final gold standard was unblinded conventional gastroscopy with biopsy under propofol sedation. Main outcome was accuracy (sensitivity/specificity) of capsule gastroscopy for diagnosis of major gastric lesions, defined as those lesions requiring conventional gastroscopy for biopsy or removal. RESULTS: Twenty-three major lesions were found in 21 patients. Capsule accuracy was 90.5% [95% confidence interval (CI), 85.4%-94.3%] with a specificity of 94.1% (95% CI, 89.3%-97.1%) and a sensitivity of 61.9% (95% CI, 38%-82%). Accuracy did not correlate with lesion location, gastric luminal visibility, examiner case volume, or examination time. Of the remaining 168 patients, 94% had minor and mostly multiple lesions; the capsule made a correct diagnosis in 88.1% (95% CI, 82.2%-92.6%), with gastric visibility and lesion location in the proximal stomach having significant influence. All patients preferred capsule gastroscopy. CONCLUSIONS: In a prospective and strictly blinded study, magnetically guided capsule gastroscopy was shown to be feasible in clinical practice and was clearly preferred by patients. Improvements in capsule technology may render this technique a future alternative to gastroscopy.


Subject(s)
Capsule Endoscopy/methods , Early Detection of Cancer/methods , Gastroscopy/methods , Magnetics/methods , Stomach Neoplasms/diagnosis , Biopsy , Capsule Endoscopes , Capsule Endoscopy/instrumentation , Early Detection of Cancer/instrumentation , Equipment Design , Feasibility Studies , Female , Gastroscopy/instrumentation , Humans , Magnetics/instrumentation , Male , Middle Aged , Patient Preference , Predictive Value of Tests , Prognosis , Prospective Studies , Stomach Neoplasms/pathology
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