[Impact Analysis of a new, Cross-sector Service Provision of Gastroenterologic Endoscopic Services in Accordance with 115f SGB V (Hybrid-DRG): Allocation Matrix and Cost Analysis]. / Auswirkungsanalyse einer neuen, sektorenübergreifenden Erbringung bisher stationärer endoskopischer gastroenterologischer Leistungen entsprechend §115f SGB V (Hybrid-DRG): Zuordnungsmatrix und Kostenanalyse.

BACKGROUND: With the introduction of §115f SGB V, the prerequisites for "sector-equal remuneration" ('Hybrid DRG') have been created. In an impact analysis, we assigned inpatient gastroenterological endoscopic (GAEN) cases in a matrix of future hybrid DRG versus outpatient surgery (AOP) or inpatient treatment. METHODS: In selected DRGs (G47B, G67A, G67B, G67C, G71Z, H41D, H41E) an allocation matrix of GAEN cases was created on medical grounds. For this purpose, service groups from the DGVS service catalog ('Leistungskatalog') were assigned to the groups: 'Hybrid-DRG', 'AOP' and 'Inpatient' by a group of experts based on the DGVS position paper. Cost data from the DGVS-DRG project for the 2022 data year from 36 InEK calculation hospitals with a total of 232,476 GAEN cases were evaluated. RESULTS: 26 service groups from the DGVS service catalog were assigned to a "Hybrid-DRG", 24 to the "inpatient" group, and 12 to the "AOP" group. 7 performance groups were splitted "depending on the OPS code" and classified at this level. Cases with additional fees were excluded from a hybrid DRG because these cannot be agreed there.The cost analysis shows that services that are already in the AOP have a similar cost level to services that have been classified as 'Hybrid-DRG'. With the cost calculation, a cost level could be presented for the hybrid DRGs formed. CONCLUSION: Based on clearly defined structural, procedural and personnel requirements, services from suitable DRGs can be transferred to a hybrid DRG. Assigning services without the involvement of clinical experts seems extremely difficult. Case assignment based on arbitrary contextual factors increases complexity without demonstrably increasing the quality of the assignment and needs to be further developed. A cost analysis can be derived from the known inpatient costs and must serve as the basis for the 2025 Hybrid DRG catalog.

Endoscopic ultrasound for structured surveillance after curative treatment of esophageal cancer.

BACKGROUND: Structured surveillance after treatment of esophageal cancer is not established. Due to a paucity of data, no agreement exists on how surveillance should be performed. The main argument against intensive follow-up in esophageal cancer is that it may not lead to true survival advantage. METHODS: Structured surveillance was performed in 42 patients after multimodal therapy with peri-operative chemotherapy (29) or definitive chemoradiotherapy (13) of esophageal cancer. The surveillance protocol included gastroscopy, endoscopic ultrasound, chest X-ray, abdominal ultrasound, and CEA measurement at regular intervals of up to five years. We analyzed relapse rate, time to relapse, localization of recurrence, diagnosis within or without structured surveillance, diagnostic method providing the first evidence of a relapse, treatment of recurrence, and outcome. RESULTS: Median follow-up was 48 months; 18/42 patients suffered from tumor relapse, with 16 asymptomatic patients diagnosed within structured surveillance. Median time to recurrence was 9 months. Isolated local or locoregional recurrence occurred in 6, and isolated distant relapse in 9 patients. All patients with isolated locoregional recurrence were exclusively diagnosed with endoscopic ultrasound. Six patients received curatively intended therapy with surgery or chemoradiation, leading to long-lasting survival. CONCLUSION: Structured surveillance offers the chance to identify limited and asymptomatic tumor relapse. Especially in cases of locoregional recurrence, long-lasting survival or even a cure can be achieved. Endoscopic ultrasound is the best method for the detection of locoregional tumor recurrence and should be an integral part of structured surveillance after curative treatment of esophageal cancer.

[A critical DRG-evaluation of cases with inflammatory bowel disease]. / Ein kritischer DRG-Blick auf Fälle mit chronisch entzündlichen Darmerkrankungen.

INTRODUCTION: Whether inpatients with inflammatory bowel disease (IBD) are reimbursed in a cost-covering manner in German hospitals has not yet been investigated. In this context, the present study analyses the reimbursement situation (cost-revenue comparison) of IBD in German hospitals with regard to the complexity of the disease and the type of care. METHODS: For this retrospective study, anonymized case data, including cost data from the InEK calculation (§ 21-4 KHEntgG) of the DRG project of the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS) from 2019, were available. 3385 cases with IBD the as main diagnosis from 49 hospitals were analyzed. To investigate the impact of disease complexity on reimbursement, different variables were analyzed, including gastroenterological complications, infections, the reason for admission, and additional charges. To investigate possible center effects, hospitals were grouped by type of care, mostly defined by the number of beds. RESULTS: The present study shows that all types of care can be classified as not cost-covering on average. The under-recovery is, on average, 10% (296 € absolute under-recovery) and varies between the types of care. Cases with higher complexity show a higher cost under-recovery than cases with lower complexity. At the DRG level, the analyzed costs of the three most common IBD DRGs for inlier patients are higher than the InEK costs; however, the difference is not significant. Nonetheless, cases with the admission reason transfer of specific DRGs bear significantly higher costs. DISCUSSION: Our results show that CED is not reimbursed in a cost-covering manner. This is due to inadequate reimbursement for gastroenterological complications, infections, specific procedures, and emergency and transfer cases. Transfer cases bear significantly higher costs.

[Structural, procedural, and personnel requirements for cross-sectoral provision of endoscopic gastroenterological procedures]. / Strukturelle, prozedurale und personelle Voraussetzungen für eine sektorenübergreifende Erbringung endoskopischer gastroenterologischer Leistungen.

Gastroenterology has made crucial advances in diagnostic and interventional endoscopic procedures, opening up improvements in the treatment of many patients. Thus, organ-preserving treatments are increasingly being made possible, replacing more invasive organ resecting surgical procedures. At the same time, the degree of complexity and risks varies widely between different endoscopic procedures. In many cases, simpler endoscopic procedures are now offered on an outpatient basis. Further potential for cross-sectoral performance of endoscopic procedures exists in the case of complex endoscopic procedures, which, however, require special structural, procedural and personnel requirements in order to provide quality-assured treatment, enable post-interventional monitoring and, if necessary, take measures to ensure the success of the treatment. We summarize the essential prerequisites and limitations for cross-sector performance of endoscopic procedures in gastroenterology.

Bile duct tissue acquisition by cholangioscopy-guided cryobiopsy technique: first-in-human application.

Video 1Case description and video in cholangioscopic view demonstrating bile duct tissue acquisition by cholangioscopy-guided cryobiopsy technique.

[Costs of potentially outpatient endoscopic procedures in cases with a 1-day hospital stay versus a longer stay]. / Kosten potenziell ambulant erbringbarer endoskopischer Leistungen in Fällen mit 1-Tages-Verweildauer gegenüber einer längeren Verweildauer.

INTRODUCTION: The transfer of patient care and medical interventions that was previously provided on an inpatient basis to outpatient settings is a stated goal of health politics. It is unclear to what extent costs of an endoscopic procedure and the disease severity depend on the duration of inpatient treatment. We therefore examined whether endoscopic services for cases with a one-day length of stay (VWD) are comparably expensive to cases with a longer VWD. METHODS: Outpatient services were selected from the DGVS service catalog. Day cases with exactly one such gastroenterological endoscopic (GAEN) service were compared with cases with VWD>1 day regarding their patient clinical complexity levels (PCCL) and mean costs. Data from the DGVS-DRG project with §21-KHEntgG cost data from a total of 57 hospitals from 2018 and 2019 served as the basis. Endoscopic costs were taken from cost center group 8 of the InEK cost matrix and plausibility checked. RESULTS: A total of 122,514 cases with exactly one GAEN service were identified. Statistically equal costs were shown in 30 of 47 service groups. In 10 groups, the cost difference was not relevant (<10%). Cost differences >10% existed only for EGD with variceal therapy, insertion of a self-expanding prosthesis, dilatation/bougienage/exchange with PTC/PTCD in place, non-extensive ERCP, endoscopic ultrasound in the upper gastrointestinal tract, and colonoscopy with submucosal or full thickness resection, or foreign object removal. PCCL differed in all but one group. CONCLUSION: Gastroenterology endoscopy services provided as part of inpatient care but potentially performable on an outpatient basis are predominantly equally expensive for day cases as for patients with a length of stay greater than one day. The disease severity is lower. Calculated §21-KHEntgG cost data thus form a reliable basis for the calculation of appropriate reimbursement for hospital services to be provided as outpatient services under the AOP in the future.

Angled-tip vs. straight-tip guidewire in ERCP: a randomized, multicenter study.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is the mainstay for interventional treatment of biliopancreatic diseases, and guidewires are decisive for successful treatment. METHODS: A randomized, multicenter, open-label study was conducted in patients in whom a guidewire was required in ERCP. Success rate and duration of the investigation were evaluated by randomly applying hydrophilic guidewires with a straight tip (ST) or an angled tip (AT) configuration, with normal (type NF) or enhanced (type EF) flexibility. Randomization was stratified by indication, i.e., stricture of the intra-hepatic bile ducts, stricture of the extrahepatic bile ducts, obstruction by bile duct stones, or interventions involving the pancreas. Cross-over was allowed if the initially allocated guidewire did not result in treatment success. RESULTS: Four hundred fifty-three patients were included, and 422 were finally analyzed. In 363 procedures (86%), the initially allocated wirés use resulted in treatment success. The success rate for using a guidewire with an angled tip configuration was 87.5 vs. 79.9% in a straight tip configuration (p = 0.049), and in negotiating an intrahepatic stricture the success rate was 90.7 vs. 69.1%, respectively (p = 0.008). No significant differences were observed in other indications. Procedural duration time did not differ in between the treatment groups. CONCLUSION: ERCP guidewires with an angled tip were more frequently successful when compared to straight tipped wires and most successful in treating intrahepatic strictures. Guidewires with standard vs. enhanced tip flexibility showed equal success rates in all indications.

Percutaneous transhepatic or endoscopic ultrasound-guided biliary drainage in malignant distal bile duct obstruction using a self-expanding metal stent: Study protocol for a prospective European multicenter trial (PUMa trial).

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

A new tool for bile duct tissue sampling: ex vivo clinical evaluation of intraductal cryobiopsy for cholangioscopy.

Background and study aims Indeterminate biliary strictures represent a major challenge in clinical diagnostics. Diagnostic yield of radiological, endoscopic imaging and histopathological diagnosis is insufficient. The cryobiopsy technique is a new method for tissue extraction already used in different clinical settings. The aim of this ex vivo clinical study was to investigate feasibility and tissue quality of cryobiopsy in the bile duct. Patients and methods We included 14 patients who underwent pancreaticoduodenectomy. Bile duct samples were taken with either a new prototype cryoprobe or one of two forceps types. Results were analyzed for general feasibility, specimen size, histological assessability as well as representativity of retrieved tissue. Results Feasibility of cholangioscopic forceps was poor compared to gastric biopsy forceps or cryobiopsy. Significantly larger tissue samples were obtained with cryobiopsy (5.6 ±â€Š4.5 mm 2 ) compared to gastric biopsy forceps (3.3 ±â€Š5.1 mm 2 , P  = 0.006). Furthermore, cryobiopsy was superior in histological assessment quality ( P  = 0.02) and concerning representativity ( P  = 0.03). Conclusions Cryobiopsy in the bile duct is feasible and the quality of the obtained tissue is high. Further investigation of bile duct cryobiopsy in vivo is warranted.

A Single-Center Case Series of Endoscopically Treated Aorto-Gastrointestinal Fistula after Endovascular Aortic Repair: Surgery Is Still the Only Valid Solution.

INTRODUCTION: Aortoesophageal fistula (AEF) is a life-threatening complication associated with endovascular aortic repair (EVAR) and occurs mostly in patients who undergo thoracic EVAR (TEVAR). To date, surgical treatment of AEF has been considered the most promising therapeutic approach. New endoscopic techniques could contribute to the therapy of AEF. The aim of this study was to analyze the outcome after endoscopic treatment of EVAR-associated AEF. METHODS: All patients who received endoscopic diagnostics and/or therapy for AEF after EVAR/TEVAR in our center between 2010 and 2019 were evaluated. RESULTS: Seven suitable patients were included. Six of them had undergone TEVAR and 1 had EVAR. Fistula occurred at an average of 307 days (range 21-2,774 days) post-EVAR. Endoscopic treatment was performed on 4 patients by using an over-the-scope clip (OTSC®). However, fistula recurred in all patients who were initially treated endoscopically. They were then treated either by sequential application of further OTSCs® or by implantation of a fully coated, self-expanding metal stent. One of these patients underwent a partial esophageal resection in a subsequent treatment approach. All patients died during the observational period, 5 as a direct consequence of the AEF/aortoduodenal fistula and 2 due to comorbidities. The median survival time after fistula occurrence was 120 days (range 5-823 days). CONCLUSION: Endoscopic treatment of AEF with OTSC® should be considered as a possible interim solution, especially in patients with severe comorbidities. However, surgical remediation still appears to be the only procedure with intermediate to long-term therapeutic success.

Second-generation colon capsule endoscopy for detection of colorectal polyps: Systematic review and meta-analysis of clinical trials.

Background and study aims Adherence to colorectal cancer (CRC) screening is still unsatisfactory in many countries, thereby limiting prevention of CRC. Colon capsule endoscopy (CCE), a minimally invasive procedure, could be an alternative to fecal immunochemical tests or optical colonoscopy for CRC screening, and might increase adherence in CRC screening. This systematic review and meta-analysis evaluates the diagnostic accuracy of CCE compared to optical colonoscopy (OC) as the gold standard, adequacy of bowel preparation regimes and the patient perspective on diagnostic measures. Methods We conducted a systematic literature search in PubMed, EMBASE and the Cochrane Register for Clinical Trials. Pooled estimates for sensitivity, specificity and the diagnostic odds ratio with their respective 95 % confidence intervals (CI) were calculated for studies providing sufficient data. Results Of 840 initially identified studies, 13 were included in the systematic review and up to 9 in the meta-analysis. The pooled sensitivities and specificities for polyps ≥ 6 mm were 87 % (95 % CI: 83 %-90 %) and 87 % (95 % CI: 76 %-93 %) in 8 studies, respectively. For polyps ≥ 10 mm, the pooled estimates for sensitivities and specificities were 87 % (95 % CI: 83 %-90 %) and 95 % (95 % CI: 92 %-97 %) in 9 studies, respectively. A patients' perspective was assessed in 31 % (n = 4) of studies, and no preference of CCE over OC was reported. Bowel preparation was adequate in 61 % to 92 % of CCE exams. Conclusions CCE provides high diagnostic accuracy in an adequately cleaned large bowel. Conclusive findings on patient perspectives require further studies to increase acceptance/adherence of CCE for CRC screening.

Colon Capsule Endoscopy: Indications, Findings, and Complications - Data from a Prospective German Colon Capsule Registry Trial (DEKOR).

BACKGROUND/AIMS: Reliable and especially widely accepted preventive measures are crucial to further reduce the incidence of colorectal cancer (CRC). Colon capsule endoscopy (CCE) might increase the screening numbers among patients unable or unwilling to undergo conventional colonoscopy. This registry trial aimed to document and determine the CCE indications, findings, complications, and adverse events in outpatient practices and clinics throughout Germany. METHODS: Patients undergoing CCE between 2010 and 2015 were enrolled in this prospective multicenter registry trial at six German centers. Patient demographics, outcomes, and complications were evaluated. RESULTS: A total of 161 patients were included. Of the CCE evaluations, 111 (68.9%) were considered successful. Pathological findings in the colon (n=92, 60.1%) and in the remaining gastrointestinal tract (n=38, 24.8%) were recorded. The main finding was the presence of polyps (n=52, 32.3%). Furthermore, five carcinomas (3.1%) were detected and histologically confirmed later. Adequate bowel cleanliness was more likely to be achieved in the outpatient setting (p<0.0001). Interestingly, 85 patients (55.6%) chose to undergo CCE based on personal motivation. CONCLUSION: CCE seems to be a reliable and safe endoscopic tool for screening for CRC and detecting other diseases. Its patient acceptance and feasibility seems to be high, especially in the outpatient setting.

Capsule Retention in Crohn's Disease: A Meta-analysis.

BACKGROUND: The main factor that limits wider utilization of capsule endoscopy (CE) in Crohn's disease (CD) is the potential risk of retention. The aim of this systematic review was to evaluate capsule retention rates in adult and pediatric CD and determine if retention risk is reduced in established CD (ECD) with patency capsule (PC) or magnetic resonance/computed tomography (MR/CT) enterography. METHODS: Studies of CD patients undergoing CE that reported retention were identified. Pooled estimates for retention rates and relative risk in ECD to suspected CD (SCD) were calculated. All hypothesis tests were 2-sided; statistical significance was set at a P value of <0.05. RESULTS: In the overall CD cohort, retention rates were 3.32% (95% confidence interval [CI], 2.62%-4.2%): 4.63% (95% CI, 3.42%-6.25%) and 2.35% (95% CI, 1.31%-4.19%) in ECD and SCD, respectively. Retention rates were 3.49% (95% CI, 2.73%-4.46%) and 1.64% (95% CI, 0.68%-3.89%) in adult and pediatric CD, respectively. Retention risk in adult ECD was 3.4 times higher than SCD, but there was no difference in retention risk in pediatric ECD compared with SCD. Retention rates in ECD were decreased after patency capsule (2.88%; 95% CI, 1.74%-4.74%) and MR/CT enterography (2.32%; 95% CI, 0.87%-6.03%). CONCLUSIONS: In comparison with older literature, this meta-analysis demonstrates lower CE retention rates in SCD and ECD. Retention rates in pediatric CD were lower than in adult CD. Retention rates in adult ECD were higher than SCD, but there were no differences between pediatric ECD and SCD. Retention rates in ECD were lower after negative PC or MR/CT enterography.