Factors associated with non-participation and dropout among cancer patients in a cluster-randomised controlled trial.

We investigated the impact of demographic and disease related factors on non-participation and dropout in a cluster-randomised behavioural trial in cancer patients with measurements taken between hospitalisation and 6 months thereafter. The percentages of non-participation and dropout were documented at each time point. Factors considered to be potentially related with non-participation and dropout were as follows: age, sex, marital status, education, income, employment status, tumour site and stage of disease. Of 1,338 eligible patients, 24% declined participation at baseline. Non-participation was higher in older patients (Odds Ratio [OR] 2.1, CI: 0.6-0.9) and those with advanced disease (OR 2.0, CI: 0.1-1.3). Dropout by 6 months was 25%. Dropout was more frequent with increased age (OR 2.8, CI: 0.8-1.2), advanced disease (OR 3.0, CI: 1.0-1.2), being married (OR 2.4, CI 0.7-1.1) and less frequent with university education (OR 0.4, CI -1.3 to -0.8) and middle income (OR 0.4, CI -0.9 to -0.7). When planning clinical trials, it is important to be aware of patient groups at high risk of non-participation or dropout, for example older patients or those with advanced disease. Trial designs should consider their special needs to increase their rate of participation.

[Importance of functional diagnostics in gastroenterology]. / Stellenwert der Funktionsdiagnostik in der Gastroenterologie.

In this review article important and frequently used investigation methods for gastrointestinal functional diagnostics are presented. Some other rarely used special investigations are also explained. The hydrogen breath test is simple to carry out, ubiquitously available and enables the detection of lactose, fructose and sorbitol malabsorption. Furthermore, by the application of glucose, the test can be carried out when there is a suspicion of abnormal intestinal bacterial colonization and using lactulose for measuring small intestinal transit time. The 13C urea breath test is applied for non-invasive determination of Helicobacter pylori infections and assessment of gastrointestinal transit time, liver and exocrine pancreas functions. The secretin cholecystokinin test was the gold standard for the detection of exocrine pancreas insufficiency. However, measurement of pancreatic elastase in stool is less invasive but also less sensitive. Scintigraphy and capsule investigations with pH and temperature probes constitute important methods for determination of gastric emptying, intestinal and colon transit times. For evaluation of constipation panoramic abdominal images are taken after intake of radiologically opaque markers (Hinton test). For the diagnosis of functional esophageal diseases manometry is indispensable. In addition, manometry is only occasionally used for diagnosing a dysfunction of the sphincter of Oddi, due to the danger of inducing pancreatitis. A 24 h pH-metry is applied for the detection of non-erosive gastroesophageal reflux disease and, if necessary, with impedance measurements. Recent investigation procedures, e. g. specific MRI sequences, sonographic determination of gall bladder ejection fraction, analysis of gastric accomodation or real-time lumen imaging, require further evaluation prior to clinical application.

[Proctology for internists]. / Proktologie für Internisten.

In proctology patients can often be helped with very little effort. With knowledge of the most common disease symptoms the treating physician can in many cases correctly recognize the cause of the complaints and initiate the appropriate therapy or arrange referral to a proctological institution. This article aims to briefly and succinctly present the most common diseases in proctology (e.g. mariscae, hemorrhoids, anal fissures, perianal venous thrombosis, abscesses and fistulas, condyloma acuminatum and anal carcinoma) and to provide the treating internist, even outside of gastroenterology, assistance with the management of proctological symptoms.

[Fecal microbiota transplantation]. / Fäkaler Mikrobiomtransfer.

The human intestinal microbiome has important metabolic and immunological functions for the host and is part of the defense against pathogens in the gastrointestinal tract. Antibiotics, probiotics, dietary measures, such as prebiotics, and the relatively newly established method of fecal microbiota transplantation (FMT, also known as fecal microbiome transfer) all influence the intestinal microbiome. The FMT procedure comprises the transmission of fecal microorganisms from a healthy donor into the gastrointestinal tract of a patient. The aim of this intervention is to restore a normal microbiome in patients with diseases associated with dysbiosis. The only indication for FMT is currently multiple recurrence of Clostridium difficile infections. Approximately 85% of affected patients can be successfully treated by FMT compared to only about 30% treated conventionally with vancomycin. Other possible therapeutic applications are chronic inflammatory and functional bowel diseases, insulin resistance and morbid obesity but these have to be evaluated further in clinical trials. Knowledge on the optimal donor, the best dosage and the most appropriate route of administration is still limited. A careful donor selection is necessary. The implementation of FMT in Germany is subject to the Medicines Act (Arzneimittelgesetz, AMG) with a duty of disclosure and personal implementation by the attending physician. By documentation in a central register long-term effects and side effects of FMT have to be evaluated.

[S2k-guideline Helicobacter pylori and gastroduodenal ulcer disease]. / S2k-Leitlinie Helicobacter pylori und gastroduodenale Ulkuskrankheit.

In the line "bismuth-containing quadruple therapy" of Table 7 (p 342), in the column "dosage" incorrectly at the three antibiotics respectively 1-1-1-1. The correct is: 3-3-3-3.

[Endoscopic treatment of obesity and complications following bariatric surgery]. / Endoskopische Therapie von Adipositas und von Komplikationen nach bariatrischer Chirurgie.

The prevalence of obesity in the population has been increasing for many years. Due to associated comorbidities the treatment of obesity is becoming more important. Conservative treatment alone is often unsuccessful, particularly in cases of severe obesity. In these cases, multimodal therapy in specialized treatment units is warranted. Between conservative treatment and bariatric surgery, interventional endoscopic treatment options also play an increasing role. Nowadays, implantation of gastric balloons and duodenojejunal bypass liners (EndoBarrier) are the most often used endoscopic options. A further typical application of endoscopy in the treatment of obesity is the management of complications after bariatric surgery, such as stenosis and insufficiency. This article gives an overview on the currently available endoscopic options associated with treatment of obesity.

[Clinical impact of infections with carbapenem-resistant enterobacteriaceae in liver transplant recipients]. / Klinische Bedeutung von Infektionen durch Carbapenem-resistente Enterobakterien bei Lebertransplantierten.

Infections with carbapenem-resistant Enterobacteriaceae (CRE) are an emerging cause of morbidity and mortality among liver transplant recipients (LTR) worldwide, particularly Klebsiella pneumoniae carbapenemase (KPC)-producing organisms. Approximately 3 - 13 % of solid organ transplant recipients in CRE-endemic areas develop CRE infections, and the infection site correlates with the transplanted organ. The cumulative 30-day mortality rate of LTR infected with carbapenem-resistant K. pneumoniae is 36 %, and the 180-day mortality rate is 58 %. Awareness of the high vulnerability of LTR to fatal bacterial infection leads to the more frequent use of ultrabroad-spectrum empirical antibiotic therapy, which further contributes to the selection of extreme drug resistance. Moreover, it comprises a relevant risk of failure to initiate adequate empirical treatment due to the fact that culture-based techniques used to identify CRE imply a 48- to 72-hour delay from blood culture collection until administration of the targeted therapy. This vicious circle is difficult to avoid and leads to increased clinical intricacy and narrowed antimicrobial therapeutic options. Because available options are extremely limited, infection prevention measures have gained outstanding importance, particularly in the phase after liver transplant requiring intense immunosuppression early on. Improving clinical outcomes is a major challenge and involves a multi-targeted approach combining strictly applied hygiene measures, active surveillance tests, the use of modern, time-saving methods of molecular biology, and enforced antibiotic stewardship. This article reviews the current literature regarding the incidence and outcome of CRE infections in LTR, and it summarises current preventive and therapeutic recommendations to minimise the threat by CRE in real-life clinical transplant settings.

English language version of the S3-consensus guidelines on chronic pancreatitis: Definition, aetiology, diagnostic examinations, medical, endoscopic and surgical management of chronic pancreatitis.

Chronic pancreatitis is a disease of the pancreas in which recurrent inflammatory episodes result in replacement of pancreatic parenchyma by fibrous connective tissue. This fibrotic reorganization of the pancreas leads to a progressive exocrine and endocrine pancreatic insufficiency. In addition, characteristic complications arise, such as pseudocysts, pancreatic duct obstructions, duodenal obstruction, vascular complications, obstruction of the bile ducts, malnutrition and pain syndrome. Pain presents as the main symptom of patients with chronic pancreatitis. Chronic pancreatitis is a risk factor for pancreatic carcinoma. Chronic pancreatitis significantly reduces the quality of life and the life expectancy of affected patients. These guidelines were researched and compiled by 74 representatives from 11 learned societies and their intention is to serve evidence-based professional training as well as continuing education. On this basis they shall improve the medical care of affected patients in both the inpatient and outpatient sector. Chronic pancreatitis requires an adequate diagnostic workup and systematic management, given its severity, frequency, chronicity, and negative impact on the quality of life and life expectancy.

Esophageal intramural pseudodiverticulosis: endoscopic diagnosis and therapy.

Esophageal intramural pseudodiverticulosis is a rare disease that may lead to esophageal stenosis and dysphagia. The aim of the study was to evaluate the endoscopic diagnosis, treatment and clinical course of intramural pseudodiverticulosis. We retrospectively studied endoscopic criteria of intramural pseudodiverticulitis, associated diseases, and the clinical course, particularly in patients with dysphagia because of esophageal stenosis in a period from 2002 to 2012. In 23 patients, the diagnosis was made according to endoscopic criteria. As risk factors, alcohol and tobacco consumption were present in all patients. Concomitant candida infection was present in six (26%) patients. In 12 (52%) patients esophageal stenosis was present, which was localized in the upper half of the esophagus. In 11 patients bougienage has been performed with excellent improvement of the dysphagia score from 3.7 to 1.3 (P = 0.002). However, dysphagia was recurrent in four patients with need for repeated bougienage. About half of the patients with intramural pseudodiverticulosis present with stenosis of the esophagus at the time of diagnosis. In patients with proximal esophageal stenosis and a typical risk constellation, intramural pseudodiverticulosis should be suspected. Treatment of stenosis with bougienage is effective to resolve dysphagia, but repeated bougienage may be necessary.

[Clostridium difficile infection (CDI) in the course of time - an issue only for the internist?]. / Clostridium-difficile-Infektionen (CDI) im Wandel der Zeit - ein Thema nur für den Internisten?

BACKGROUND: Toxigenic strains of Clostridium (C.) difficile are the most prevalent pathogens of antibiotic associated intestinal disease and nosocomial diarrhoea. During the last 10 years, incidences of C. difficile infection (CDI) have increased worldwide. MATERIALS AND METHODS: With clinical and microbiological original data for 2002-2012 from the University Hospitals Leipzig and Halle (Saale), Germany, the authors illustrate the current situation regarding CDI in the states of Saxony and Saxony-Anhalt and exemplify the latest developments in terms of incidence, prevalence of resistance, diagnosis and treatment strategies regarding CDI with an emphasis on surgical options. RESULTS: Following the general trend, at the University Hospitals of Leipzig and Halle (Saale) there was also an increase in incidence of CDI, especially of severe clinical courses. In primary and secondary care facilities, prevention of CDI is based on hygiene management and restricted usage of antibiotics, preferably as "Antibiotic Stewardship" programmes. In 2012, the new macrocyclic antibiotic Fidaxomicin was approved in the European Union for the treatment of CDI. The therapeutic armamentarium, previously based on metronidazole or vancomycin, has now been enriched by a substance that presumably will reduce the rate of recurrence of CDI. Moreover, early data from case series and controlled trials suggest that the re-establishment of eubiosis in the colon of patients with recurrent CDI by stool transplantation from healthy donors is an alternative to antibiotics. Standard surgical intervention for refractory CDI is subtotal colectomy with terminal ileostomy. In patients with adequate life expectancy and without organ dysfunction, a colon-saving surgical technique should be considered. CONCLUSION: Taking antibiotics for most remains the main risk factor for suffering from symptomatic CDI. With the introduction of Fidaxomicin there is hope for an improvement in the conservative treatment of CDI. Stool transplants from healthy donors are now considered to be better than giving antibiotics for severe CDI, but this treatment has not found broad acceptance yet. In cases with a lack of early treatment success, the surgeon must be consulted. Here, the evidence for preferably colon-saving surgical procedures is so far unfortunately low.

[Acute pancreatitis: guideline-based diagnosis and treatment]. / Akute Pankreatitis: Leitlinienbasierte Diagnostik und Therapie.

Acute pancreatitis is most frequently of biliary or alcoholic origin and less frequently due to iatrogenic (ERCP, medication) or metabolic causes. Diagnosis is usually based on abdominal pain and elevation of serum lipase to more than three-times the normal limit. Acute pancreatitis can either resolve quickly following an oedematous swelling or present as a severe necrotizing form. A major risk is the systemic inflammatory response syndrome (SIRS), which can cause multi-organ failure. Prediction of disease course is initially difficult, thus necessitating immediate therapy and regular re-evaluation. In order to prove or exclude biliary genesis, abdominal ultrasonography should first be performed and endoscopic ultrasound may also be required. Primary therapy includes rapid and correctly dosed fluid substitution. Biliary pancreatitis requires causal treatment. In the case of cholangitis, stone extraction must be performed immediately; in the absence of cholangitis, it might be advisable to wait for spontaneous stone clearance. Timely cholecystectomy is necessary in all cases of biliary pancreatitis.

Acute cerebrovascular incident as a complication of TIPS procedure.

The formation of a transjugular intrahepatic portosystemic shunt (TIPS) is a well-established procedure in the management of complications of severe portal hypertension. It is also performed if portal hypertension is a result of acute portal vein thrombosis. We report the case of an acute cerebrovascular incident after TIPS formation in a patient with partial portal vein thrombosis. Even when no patent foramen ovale (PFO) is detectable the presence of PFO and thus the risk of cerebrovascular incident cannot be excluded. We therefore propose to inform patients with preexisting portal vein thrombosis prior to undergoing this intervention that TIPS procedure may be associated with the risk of cerebral embolization.

[Immunosuppressive treatment as a risk factor for the occurrence of clostridium difficile infection (CDI)]. / Immunsuppressive Behandlung als Risikofaktor für das Auftreten einer Clostridium-difficile-Infektion (CDI).

BACKGROUND: Toxigenic Clostridium difficile strains are known as the most common infectious cause of antibiotic-associated intestinal disease and nosocomial diarrhoea. The increased incidence of hypervirulent strains gives rise to worldwide concern. In particular, courses with multiple recurrences are observed in the presence of immunosuppression. METHODS: In this retrospective controlled observational study we aimed to determine immunosuppression as an independent risk factor for symptomatic CDI and to identify characteristics and differences of immunocompromised patients with respect to disease severity, disease progression, intestinal manifestations, recurrence rates and other factors. We compared symptoms and clinical features of 55 immunosuppressed patients with confirmed CDI with those of 50 patients without immunosuppressive medication (mean age 59.3 years ±â€Š16.2 vs. 69.2 years ±â€Š15.0) who were treated at the Departments of Internal Medicine I and IV of the University Hospital Halle (Saale), Germany, between 2006 and 2009. Multivariate analysis using binary logistic regression was performed for a control group of 105 patients without CDI. In this group, there were 62 patients without evidence of immunosuppression and 43 immunosuppressed patients (mean age 66.9 years ±â€Š12.4 vs. 56.0 years ±â€Š13.7). RESULTS: The clinical courses of the two groups differed considerably. Immunosuppressed patients were significantly more frequently colonised with Clostridium difficile without clinically detectable manifestation or only mild clinical symptoms not requiring therapy (22 vs. 2 %, p = 0.003), while there were similar numbers of moderate (46 vs. 52 %, p = 0.503) but less severe CDI cases (27 vs. 40 %, p = 0.167). Relapses were observed more frequently in the group of immunosuppressed patients (15 vs. 6 %, p = 0.153). Multivariate analysis using logistic regression identified immunosuppression as an independent risk factor for CDI (OR = 2.75), in addition to prior antibiotic therapy (OR = 10.15) and PPI intake (OR = 2.93). CONCLUSION: We conclude that immunosuppression has to be regarded as an independent risk factor for CDI. Immunosuppressive treatment increases the risk of colonisation and infection with Clostridium difficile and leads to a higher relapse rate in patients with CDI.

[The role of endoscopy in the therapy for perforations and leakages of the gastrointestinal tract]. / Endoskopische Therapieoptionen für Perforationen und Insuffizienzen des Gastrointestinaltrakts.

Perforations and leakages of hollow organs of the gastrointestinal tract can occur spontaneously among other causes. They can also develop as complications of an endoscopic intervention or after surgical construction of an anastomosis. For the patient, these situations usually are serious and life-threatening. Standard therapy has always been - and most of the time still is - major surgery. These procedures usually are technically difficult and their mortality and morbidity are not satisfactory due to, among others, the occurrence of local infections. Thus, various endoscopic techniques as therapy for perforations and leakages have been developed over the last years. These include above all the endoscopic placement of clip systems and stents and the relatively new vacuum drainage systems. In case of perforations and leakages of the bile duct and the rectum especially, these minimal invasive techniques are widely used, also increasingly in lesions of the esophagus. However, these new, endoscopic procedures suffer from a lack of evidence. This paper highlights the possibilities and limitations of endoscopic options in therapy for perforations and leakages of organs of the gastrointestinal tract.

[Genetically determined pancreatic diseases]. / Genetisch determinierte Pankreaserkrankungen.

Overall, genetically determined diseases of the pancreas are rare. Recently, it was demonstrated that in chronic pancreatitis many patients carry genetic changes in associated genes. Aside from chronic pancreatitis, cystic fibrosis is also characterized by exocrine insufficiency in many patients. Genetic alterations in CFTR can be found in patients suffering from chronic pancreatitis and in patients with cystic fibrosis. According to this fact, the analysis of CFTR alterations in both disease forms has improved the understanding of underlying pathogenetic mechanisms. Shwachman-Diamond and Johanson Blizzard syndrome are rare pancreatic disorders, characterized by exocrine pancreatic insufficiency in addition to other phenotypic features. As such, due to the early onset of both disease forms, diagnosis of cystic fibrosis has to be ruled out in patients with exocrine insufficiency, which can be achieved by performing sweat chloride tests. Even pancreatic cancer can accumulate in some families and a genetic basis was recently demonstrated for some patients. In all mentioned disease entities, a genetic analysis of associated genes has become essential for establishing the diagnosis. Although genetic knowledge and the finding of genetic alterations in different genes has not changed therapy of the mentioned diseases so far, the future will tell in which way genetic knowledge can be integrated to change modalities of therapy.