Thermal in situ ablation techniques for the treatment of malignant hepatic tumors - experimental and clinical studies

Titelblatt und Inhaltsverzeichnis Einleitung Material und Methoden Ergebnisse Diskussion LiteraturverzeichnisSekundäre bösartige Neubildungen in der Leber stellen eine der häufigsten onkologischen Erkrankungen dar und beeinflussen wesentlich die Prognose der betroffenen Patienten. Bislang gilt lediglich das lokale Verfahren der chirurgischen Resektion als die einzige potentiell kurative Behandlungsoption für Lebertumoren. Zum Zeitpunkt der Diagnosestellung kann jedoch aus onkologischen oder operationstechnischen Gründen nur eine Minderheit der Patienten einer chirurgischen Therapie zugeführt werden. Zusätzliche Probleme stellen die vom Ausmaß der Parenchymverlustes abhängige Komplikationsrate der chirurgischen Therapie sowie das Risiko der intrahepatischen Rezidive nach erfolgter Resektion dar. Um diesen Problemen entgegenzuwirken, wurden in den letzten Jahren In-Situ-Ablationsverfahren als Alternative zur chirurgischen Resektion entwickelt, bei denen ein percutan, laparoskopisch oder per Laparotomie eingebrachter Applikator zur lokalen thermischen Zerstörung des Tumorgewebes verwendet wird. Vor allem die Radiofrequenztherapie und die laserinduzierte Thermotherapie haben dabei klinische Verbreitung gefunden. Diese lokalen Verfahren bieten die Möglichkeit, komplikationsarm und minimal invasiv Tumoren zu zerstören, ohne das umliegende gesunde Leberparenchym wesentlich zu beeinflussen und können im Falle eines Rezidivs wiederholt eingesetzt werden. Obwohl randomisierte Studien bislang fehlen, scheinen vor allem Patienten mit lokal begrenzter Tumorerkrankung von diesen Verfahren zu profitieren. Limitiert wird der sichere klinische Einsatz der In-Situ Ablation bislang vorwiegend durch technische und onkologische Kriterien. Zielsetzung der hier vorgestellten Arbeit war es, den genannten Limitierungen des klinischen Einsatzes thermischer Ablationsverfahren durch die experimentelle und klinische Evaluation neuer Applikationssysteme, Applikationsmodi und Planungsmöglichkeiten entgegen zu wirken, um das Spektrum der Therapiemöglichkeiten für die onkologisch sichere und effektive Behandlung von Lebertumoren auszuweiten.The term "in situ ablation" covers a number of therapeutic procedures for the treatment of liver tumors, which appear at first glance to be heterogeneous with little standardization. They include radio frequency ablation (RFA), laser-induced thermotherapy (LITT), cryotherapy, microwave coagulation and the instillation of alcohol and/or acetic acid (PEI/PAI). With the exception of PEI/PAI, the basis of all these methods is the application of energy in the tumor tissue with the aim of completely destroying the tumor cells with maximum protection of the healthy liver tissue. In contrast to hypothermal cryotherapy, the hyperthermal ablation techniques (RFA/LITT) have gained greater clinical importance and have been more extensively examined. The common basic principle of all thermal procedures is the destruction of biological tissue by a local temperature change. Of decisive importance for the effective clinical application of the aforementioned methods is the fact that all malignant cells in the target area must be completely destroyed. It still remains to be theoretically and clinically tested whether this objective can be achieved. In general, nonoperative ablation procedures are considered as purely palliative (in contrast to surgical liver resection). In contrast to surgical liver resection, whose oncological findings seem to have remained unchanged over the years, the nonoperative ablation methods have considerably changed technically and clinically in the last few years. To what extent it can still be asserted that surgical resection is the only curative intervention will be analyzed in the following on the basis of experimental and clinical data

Development of a clinical trial to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia: study protocol for a randomized controlled trial

Abstract Background Incisional hernia is a frequent complication in abdominal surgery. This article describes the development of a prospective randomized clinical trial designed to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia. Methods/Design This clinical multicenter trial has been designed to compare watchful waiting and surgical repair for patients with oligosymptomatic incisional hernia. Participants are randomized to watchful waiting or surgery and followed up for two years. The primary efficacy endpoint is pain/discomfort during normal activities as a result of the hernia or hernia repair two years after enrolment, as measured by the hernia-specific Surgical Pain Scales (SPS). The target sample size of six hundred thirty-six patients was calculated to detect non-inferiority of the experimental intervention (watchful waiting) in the primary endpoint. Sixteen surgical centers will take part in the study and have submitted their declaration of commitment giving the estimated number of participating patients per year. A three-person data safety monitoring board will meet annually to monitor and supervise the trial. Discussion To date, we could find no published data on the natural course of incisional hernias. To our knowledge, watchful waiting has never been compared to standard surgical repair as a treatment option for incisional hernias. A trial to compare the outcome of the two approaches in patients with oligosymptomatic incisional hernias is urgently needed to provide data that can facilitate the choice between treatment options. If watchful waiting was equal to surgical repair, the high costs of surgical repair could be saved. The design for such a trial is described here. This multicenter trial will be funded by the German Research Foundation (DFG). The ethics committee of the Charité has approved the study protocol. Approval has been obtained from ten study sites at time of this submission. The electronic Case Report Forms have been created. The first patient was to be randomized November 14th, 2011. An initiation meeting took place in Berlin January 9th, 2012. Trial Registration ClinicalTrials.gov: NCT01349400</p

Development of a clinical trial to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia: study protocol for a randomized controlled trial

BACKGROUND: Incisional hernia is a frequent complication in abdominal surgery. This article describes the development of a prospective randomized clinical trial designed to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia. METHODS/DESIGN: This clinical multicenter trial has been designed to compare watchful waiting and surgical repair for patients with oligosymptomatic incisional hernia. Participants are randomized to watchful waiting or surgery and followed up for two years. The primary efficacy endpoint is pain/discomfort during normal activities as a result of the hernia or hernia repair two years after enrolment, as measured by the hernia-specific Surgical Pain Scales (SPS). The target sample size of six hundred thirty-six patients was calculated to detect non-inferiority of the experimental intervention (watchful waiting) in the primary endpoint. Sixteen surgical centers will take part in the study and have submitted their declaration of commitment giving the estimated number of participating patients per year. A three-person data safety monitoring board will meet annually to monitor and supervise the trial. DISCUSSION: To date, we could find no published data on the natural course of incisional hernias. To our knowledge, watchful waiting has never been compared to standard surgical repair as a treatment option for incisional hernias. A trial to compare the outcome of the two approaches in patients with oligosymptomatic incisional hernias is urgently needed to provide data that can facilitate the choice between treatment options. If watchful waiting was equal to surgical repair, the high costs of surgical repair could be saved. The design for such a trial is described here. This multicenter trial will be funded by the German Research Foundation (DFG). The ethics committee of the Charité has approved the study protocol. Approval has been obtained from ten study sites at time of this submission. The electronic Case Report Forms have been created. The first patient was to be randomized November 14(th), 2011. An initiation meeting took place in Berlin January 9(th), 2012. TRIAL REGISTRATION: ClinicalTrials.gov: NCT0134940

Training strategies for a sustainable medical care: a survey among assistant and chief physicians in a tertiary care hospital in Germany

As an essential part of the health care system, the requirements for specialist training are subject to a continuous process of change. The aim of the present study was to evaluate the current specialist training situation of all departments in a tertiary care hospital in Germany. Differences between assistant and chief physicians should be pointed out

Risk Factor Identification for Delayed Gastric Emptying after Distal Pancreatectomy—An Evaluation of 1688 Patients Based on the German StuDoQ|Pancreas Registry

Delayed gastric emptying (DGE) ranks as one of the most frequent complications in pancreatic surgery. It leads to increased costs for healthcare systems, lengthened hospital stays and reduced quality of life. Data about DGE after distal pancreatectomy (DP) are scarce. The StuDoQ|Pancreas registry of the German Society of General and Visceral Surgery provided data of patients who underwent distal pancreatectomy from 1 January 2014 to 31 December 2018. The retrospective evaluation included comprehensive data: 1688 patients were enrolled; DGE occurred 160 times (9.5%); grade “A” was reported for 98 (61.3%), grade “B” for 41 (25.6%) and grade “C” for 21 (13.1%) patients. In univariate analysis pancreatic fistulas were associated with higher frequencies of intraabdominal abscesses (9.1% vs. 2%, p > 0.001), postpancreatectomy haemorrhage (8.1% vs. 3.7%, >0.001) and DGE (14.5% vs. 6%, p p p p p p = 0.007) were identified as independent risk factors for DGE. Perioperative and postoperative factors were identified as risk factors for DGE. Following research should examine this highly relevant topic in a prospective, register-based manner. As there is no causal therapy for DGE, its avoidance is of major importance

Utilization of in- and outpatient hospital care in Germany during the Covid-19 pandemic insights from the German-wide Helios hospital network.

BackgroundDuring the early phase of the Covid-19 pandemic, reductions of hospital admissions with a focus on emergencies have been observed for several medical and surgical conditions, while trend data during later stages of the pandemic are scarce. Consequently, this study aims to provide up-to-date hospitalization trends for several conditions including cardiovascular, psychiatry, oncology and surgery cases in both the in- and outpatient setting.Methods and findingsUsing claims data of 86 Helios hospitals in Germany, consecutive cases with an in- or outpatient hospital admission between March 13, 2020 (the begin of the "protection" stage of the German pandemic plan) and December 10, 2020 (end of study period) were analyzed and compared to a corresponding period covering the same weeks in 2019. Cause-specific hospitalizations were defined based on the primary discharge diagnosis according to International Statistical Classification of Diseases and Related Health Problems (ICD-10) or German procedure classification codes for cardiovascular, oncology, psychiatry and surgery cases. Cumulative hospitalization deficit was computed as the difference between the expected and observed cumulative admission number for every week in the study period, expressed as a percentage of the cumulative expected number. The expected admission number was defined as the weekly average during the control period. A total of 1,493,915 hospital admissions (723,364 during the study and 770,551 during the control period) were included. At the end of the study period, total cumulative hospitalization deficit was -10% [95% confidence interval -10; -10] for cardiovascular and -9% [-10; -9] for surgical cases, higher than -4% [-4; -3] in psychiatry and 4% [4; 4] in oncology cases. The utilization of inpatient care and subsequent hospitalization deficit was similar in trend with some variation in magnitude between cardiovascular (-12% [-13; -12]), psychiatry (-18% [-19; -17]), oncology (-7% [-8; -7]) and surgery cases (-11% [-11; -11]). Similarly, cardiovascular and surgical outpatient cases had a deficit of -5% [-6; -5] and -3% [-4; -3], respectively. This was in contrast to psychiatry (2% [1; 2]) and oncology cases (21% [20; 21]) that had a surplus in the outpatient sector. While in-hospital mortality, was higher during the Covid-19 pandemic in cardiovascular (3.9 vs. 3.5%, OR 1.10 [95% CI 1.06-1.15], PConclusionsThere have been varying changes in care pathways and in-hospital mortality in different disciplines during the Covid-19 pandemic in Germany. Despite all the inherent and well-known limitations of claims data use, this data may be used for health care surveillance as the pandemic continues worldwide. While this study provides an up-to-date analysis of utilization of hospital care in the largest German hospital network, short- and long-term consequences are unknown and deserve further studies