[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.

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.

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.

Time-saving polyp detection in colon capsule endoscopy: evaluation of a novel software algorithm.

BACKGROUND: Colon capsule endoscopy (CCE) is a reliable method to detect colonic polyps in the well-prepared colon. As CCE evaluation can be time consuming, a new software algorithm might aid in reducing evaluation time. OBJECTIVES: The aim of the study was to evaluate whether it is feasible to reliably detect colon polyps in CCE videos with a new software algorithm the "collage mode" (Rapid 8 Software, Covidien/Medtronic®). METHODS: Twenty-nine CCE videos were randomly presented to three experienced and to three inexperienced investigators. Videos were evaluated by applying the collage mode. Investigation time was documented and the results (≥one polyp vs. no polyp) were compared with the findings of two highly experienced central readers who read the CCE videos in the standard mode beforehand. RESULTS: It took a median time of 9.8, 3.5, and 7.5 vs. 4.3, 4.6 and 12.5 min for experienced vs. inexperienced investigators to review the CCE videos. For detecting ≥one polyp vs. no polyp, sensitivity of 93.3%, 73.3%, and 93.3% was observed for the experienced and sensitivity of 46.7%, 33.3%, and 93.3% for the inexperienced CCE readers. CONCLUSION: Collage mode might allow for a quick review of CCE videos with a high polyp detection rate for experienced CCE readers. Future prospective studies should include CCE collage mode for rapid polyp detection to further prove the feasibility of practical colon polyp detection by CCE and possibly support the role of CCE as a screening tool in CRC prevention.

[Cost assessment for endoscopic procedures in the German diagnosis-related-group (DRG) system - 5 year cost data analysis of the German Society of Gastroenterology project]. / Kosten endoskopischer Leistungen der Gastroenterologie im deutschen DRG-System ­ 5-Jahres-Kostendatenanalyse des DGVS-Projekts.

Background In the German hospital reimbursement system (G-DRG) endoscopic procedures are listed in cost center 8. For reimbursement between hospital departments and external providers outdated or incomplete catalogues (e. g. DKG-NT, GOÄ) have remained in use. We have assessed the cost for endoscopic procedures in the G-DRG-system. Methods To assess the cost of endoscopic procedures 74 hospitals, annual providers of cost-data to the Institute for the Hospital Remuneration System (InEK) made their data (2011 - 2015; §â€Š21 KHEntgG) available to the German-Society-of-Gastroenterology (DGVS) in anonymized form (4873 809 case-data-sets). Using cases with exactly one endoscopic procedure (n = 274 186) average costs over 5 years were calculated for 46 endoscopic procedure-tiers. Results Robust mean endoscopy costs ranged from 230.56 € for gastroscopy (144 666 cases), 276.23 € (n = 32 294) for a simple colonoscopy, to 844.07 € (n = 10 150) for ERCP with papillotomy and plastic stent insertion and 1602.37 € (n = 967) for ERCP with a self-expanding metal stent. Higher costs, specifically for complex procedures, were identified for University Hospitals. Discussion For the first time this catalogue for endoscopic procedure-tiers, based on §â€Š21 KHEntgG data-sets from 74 InEK-calculating hospitals, permits a realistic assessment of endoscopy costs in German hospitals. The higher costs in university hospitals are likely due to referral bias for complex cases and emergency interventions. For 46 endoscopic procedure-tiers an objective cost-allocation within the G-DRG system is now possible. By international comparison the costs of endoscopic procedures in Germany are low, due to either greater efficiency, lower personnel allocation or incomplete documentation of the real expenses.

Pan-intestinal capsule endoscopy in patients with postoperative Crohn's disease: a pilot study.

BACKGROUND: Patients are at increased risk of disease recurrence after surgical treatment of Crohn's disease. Endoscopic detection of postoperative, ileo-colonic inflammation is well established, but the potential of pan-intestinal endoscopy is yet unknown. METHODS: This prospective multicenter pilot study assessed the value of pan-intestinal capsule endoscopy using a colon capsule endoscope for the detection of inflammatory recurrence of Crohn´s disease. Patients who had been operatively treated for Crohn´s disease were included. Colon capsule endoscopy was performed 4-8 weeks (d1) and 4-8 months (d2) postoperatively together with ileo-colonoscopy at d2 using a modified Ruttgeerts index for evaluating disease activity. RESULTS: Twenty-two patients were included into this study. At d1, significant disease activity (Ruttgeerts index ≥2) was detected in 3/16 (19%) of the patients. At d2, half of the patients (6/12) showed active disease, whereas ileo-colonoscopy revealed significant inflammation in 5/15 (33%). All patients rated as having active disease by ileo-colonoscopy had been revealed by PICE as well. These findings influenced the medical treatment in every case. CONCLUSION: Pan-intestinal capsule endoscopy seems to be feasible in the postoperative surveillance of Crohn's disease. Disease activity is reliably detected. Especially, the findings in the small bowl might be a significant advantage in comparison to ileo-colonoscopy, as they can have significant impact on clinical management. Further studies with a larger number of patients are needed to confirm these findings and might lead to a replacement of the flexible ileo-colonoscopy with pan-intestinal capsule endoscopy in this indication in the future.

Eosinophilic cholangitis is a potentially underdiagnosed etiology in indeterminate biliary stricture.

AIM: To investigate presence and extent of eosinophilic cholangitis (EC) as well as IgG4-related disease in patients with indeterminate biliary stricture (IBS). METHODS: All patients with diagnosis of sclerosing cholangitis (SC) and histopathological samples such as biopsies or surgical specimens at University Hospital Frankfurt from 2005-2015 were included. Histopathological diagnoses as well as further clinical course were reviewed. Tissue samples of patients without definite diagnosis after complete diagnostic work-up were reviewed regarding presence of eosinophilic infiltration and IgG4 positive plasma cells. Eosinophilic infiltration was as well assessed in a control group of liver transplant donors and patients with primary sclerosing cholangitis. RESULTS: one hundred and thirty-five patients with SC were included. In 10/135 (13.5%) patients, no potential cause of IBS could be identified after complete diagnostic work-up and further clinical course. After histopathological review, a post-hoc diagnosis of EC was established in three patients resulting in a prevalence of 2.2% (3/135) of all patients with SC as well as 30% (3/10) of patients, where no cause of IBS was identified. 2/3 patients with post-hoc diagnosis of EC underwent surgical resection with suspicion for malignancy. Diagnosis of IgG4-related cholangitis was observed in 7/135 patients (5.1%), whereas 3 cases were discovered in post-hoc analysis. 6/7 cases with IgG4-related cholangitis (85.7%) presented with eosinophilic infiltration in addition to IgG4 positive plasma cells. There was no patient with eosinophilic infiltration in the control group of liver transplant donors (n = 27) and patients with primary sclerosing cholangitis (n = 14). CONCLUSION: EC is an underdiagnosed benign etiology of SC and IBS, which has to be considered in differential diagnosis of IBS.

Multiple plastic stents versus covered metal stent for treatment of anastomotic biliary strictures after liver transplantation: a prospective, randomized, multicenter trial.

BACKGROUND AND AIMS: Treatment of anastomotic biliary strictures (ABSs) after orthotopic liver transplantation by endoscopic insertion of multiple plastic stents (MPSs) is well established. The use of covered self-expandable metal stents (cSEMSs) for this indication is less investigated. METHODS: In an open-label, multicenter, randomized trial, patients with confirmed ABSs were randomly assigned 1:1 to receive either an MPS or a cSEMS. The primary endpoint was the number of endoscopic interventions until ABS resolution. Secondary endpoints were frequency of adverse events, treatment success rates, and time to treatment success and recurrence of ABS during follow-up of at least 1 year. RESULTS: Fifty-eight patients were included between 2012 and 2015, and 48 patients completed follow-up. Patients receiving MPS (n = 24) underwent a median of 4 (range, 3-12) endoscopic retrograde cholangiography examinations, whereas those in the cSEMS group (n = 24) underwent a median of 2 (range, 2-12) sessions until ABS resolution (P < .001). A median of 8 (range, 2-32) stents was used until ABS resolution within the MPS group and 1 (range, 1-24) in the cSEMS group (P < .0001). cSEMS migration occurred in 8 (33.3%) patients. Treatment duration did not differ significantly. Initial treatment success rates were high with 23 (95.8%) in the MPS group and 24 (100%) for cSEMSs (P = 1). Five (20.8%) patients in both groups showed stricture recurrence after a median follow-up of 500 days (range, 48-1317 days). CONCLUSIONS: cSEMSs for treatment of ABSs needed less endoscopic interventions to achieve similar efficacy as MPS and might become a new treatment standard. However, the optimal duration of cSEMS therapy and cost-efficacy have to be evaluated. (Clinical trial registration number: NCT01393067.).

Role of CD15 expression in dysplastic and neoplastic tissue of the bile duct - a potential novel tool for differential diagnosis of indeterminate biliary stricture.

BACKGROUND AND AIMS: CD15 is expressed by various cancer types; among these are intrahepatic and perihilar cholangiocarcinoma (CCA). The aim of this study was to elucidate CD15 expression in distal CCA as well as in dysplastic biliary tissue and to determine its prognostic significance. METHODS AND RESULTS: Tissue samples from patients with intrahepatic (iCCA, n = 22), perihilar (pCCA, n = 7) and distal CCA (dCCA, n = 15), who underwent surgical resection in the period from 2010 to 2015 were evaluated for CD15 expression. Tissue of synchronous lymph node metastasis (n = 13), CCA-associated dysplasia (n = 20), dysplasia in intraductal biopsies (n = 10) and benign proliferations (n = 12), as well as inflammatory biliary lesions (n = 28) and non-inflammatory bile ducts (n = 23), were evaluated equally for CD15 expression. CD15 was found to be expressed highly in iCCA (81.8%), pCCA (85.7%), dCCA (73.3%), CCA-associated dysplasia (70.0%), dysplasia in intraductal biopsies (100%) and metastatic tissue (84.6%). CD15 expression was negative in 58 of 64 benign bile duct alterations resulting in an overall sensitivity and specificity of CD15 in CCA of 80.7 and 90.6% patients, respectively. CD15 expression was correlated significantly with a decreased overall survival in patients with CD15-positive CCA associated dysplasia (P = 0.003). However, CD15 expression in the invasive tumour component was not correlated with clinical outcome. CONCLUSION: CD15 is a sensitive and specific marker for intraepithelial and invasive neoplasias of the bile duct. Therefore, it can be helpful in the delineation of dysplastic and neoplastic biliary cells from non-neoplastic tissue, which frequently causes a diagnostic problem in indeterminate biliary stricture.

Direct retrograde cholangioscopy with a new prototype double-bending cholangioscope.

BACKGROUND AND STUDY AIMS: Direct retrograde cholangioscopy (DRC) enables high quality video imaging of the bile ducts and allows intraductal treatment with optical control. We evaluated the feasibility, success, and complications of a new third-generation prototype cholangioscope. PATIENTS AND METHODS: All consecutive patients from two tertiary endoscopy centers who had undergone DRC with the prototype were included. Indications for DRC were: evaluation of indeterminate strictures, filling defects, and complex bile duct stones. Technical success was investigated in terms of indication and treatment performed. All adverse events were recorded. RESULTS: DRC with the prototype was performed in 74 patients. Therapeutic interventions included laser or electrohydraulic lithotripsy and stone removal, among others. The papilla was entered in 72/74 patients (97 %). The targeted bile duct segment was reached in 62 /74 patients (84 %), with an anchoring balloon catheter needed in 21/74 (28 %). Mean investigation time was 21 minutes (15 - 27 minutes) CONCLUSIONS: DRC using the prototype is feasible, safe, and attains access to the bile ducts in almost all patients, with less need of an anchoring balloon catheter compared with the standard technique and short investigation and fluoroscopy times.

Intraductal biopsies in indeterminate biliary stricture: Evaluation of histopathological criteria in fluoroscopy- vs. cholangioscopy guided technique.

BACKGROUND: Differentiating malignancy from benign disease in indeterminate biliary stricture by imaging modalities is limited. Definite diagnosis relies on histopathological diagnosis. AIMS: To assess accuracy of histopathological diagnosis of fluoroscopy-guided vs. cholangioscopy-directed intraductal biopsies in indeterminate biliary stricture. METHODS: All patients with indeterminate biliary stricture and fluoroscopically (n=68) or cholangioscopy-directed (working channel 2mm, n=38) biopsies were included. Histopathological results of biopsies were classified into inflammatory lesion (class 1), dysplasia/intraepithelial neoplasia (class 2) and malignancy (class 3) and results as well as macroscopic diagnosis were compared with final diagnosis. RESULTS: Sensitivity and specificity of fluoroscopy-guided vs. cholangioscopy-directed biopsies were 22.9% and 100% vs. 25.0% and 100% for class 1+2 vs. class 3 lesions, respectively. Sensitivity for class 1 vs. class 2+3 lesions was 45.7% (p=0.044) vs. 58.3% (p=0.214) for fluoroscopy-guided vs. cholangioscopy-directed biopsies, respectively, while specificity was 100% in both. There was no difference in size of the obtained sample (p=0.992). True positive diagnosis rate increased with the number of biopsies taken (p=0.028). CONCLUSION: Fluoroscopy-guided and cholangioscopy-directed intraductal biopsies are equally limited in establishing the diagnosis of malignancy in indeterminate biliary stricture. Categorizing dysplasia or intraepithelial neoplasia as malignancy increases sensitivity without decrease in specificity. By taking more biopsies, diagnostic yield is increased.

No Distal Migration in Unfixed Versus Fixed Cell Structure Covered Self-Expanding Metal Stents for Treatment of Benign Biliary Disease.

BACKGROUND: Fully covered self-expandable metal stents (FCSEMS) are increasingly used for treatment of benign common bile duct (CBD) stricture or leakage, but dislodgement of FCSEMS is frequent. AIMS: To compare dislocation rate and clinical outcome of a standard fixed cell structure FCSEMS (S-FCSEMS) to a novel FCSEMS with an unfixed cell structure (N-FCSEMS). METHODS: We performed a retrospective analysis of all patients with FCSEMS insertion for benign biliary disease at our Hospital from 03/2008 to 03/2014. Both stent types N-FCSEMS and S-FCSEMS were applied as available unrelated to the indication. RESULTS: Twenty-nine patients (S-FCSEMS: 18, N-FCSEMS: 11) were included. Stent placement was technically successful in 28/29 (96.6 %) patients; stent removal was successful in 26/27 (96.2 %). Two patients with N-FCSEMS were excluded due to unsuccessful placement and withdrawal of consent for stent removal, respectively. Stent migration into the duodenum (distal migration) was observed in 9/18 (50 %) in the S-FCSEMS group compared to 0/9 in the N-FCSEMS (p < 0.005). FCSEMS migration into the CBD (proximal migration) was found in 2/18 (11 %, S-FCSEMS) versus 2/9 (22 %, N-FCSEMS, p = 0.514). A foreshortening of the N-FCSEMS occurred in 3/9 patients (33 %) compared to 0/18 S-FCSEMS (p = 0.08). Clinical resolution of the treated CBD-disease was observed in 5/9 (56 %, N-FCSEMS) versus 12/18 (67 %, S-FCSEMS) at the time of stent removal (p = 0.604) and in 0/9 and 10/18 (56 %) cases during follow-up, respectively (p < 0.005). CONCLUSION: An unfixed cell structure of FCSEMS seems to prevent distal migration, but proximal migration still occurs and foreshortening of the N-FCSEMS constrains clinical outcome.

Indication for 'Over the scope' (OTS)-clip vs. covered self-expanding metal stent (cSEMS) is unequal in upper gastrointestinal leakage: results from a retrospective head-to-head comparison.

BACKGROUND: Intestinal perforation or leakage increases morbidity and mortality of surgical and endoscopic interventions. We identified criteria for use of full-covered, extractable self-expanding metal stents (cSEMS) vs. 'Over the scope'-clips (OTSC) for leak closure. METHODS: Patients who underwent endoscopic treatment for postoperative leakage, endoscopic perforation, or spontaneous rupture of the upper gastrointestinal tract between 2006 and 2013 were identified at four tertiary endoscopic centers. Technical success, outcome (e.g. duration of hospitalization, in-hospital mortality), and complications were assessed and analyzed with respect to etiology, size and location of leakage. RESULTS: Of 106 patients (male: 75 (71%), female: 31 (29%); age (mean ± SD): 62.5 ± 1.3 years, 72 (69%) were treated by cSEMS and 34 (31%) by OTSC. For cSEMS vs. OTSC, mean treatment duration was 41.1 vs. 25 days, p<0.001, leakage size 10 (1-50) vs. 5 (1-30) mm (median (range)), and complications were observed in 68% vs. 8.8%, p<0.001, respectively. Clinical success for primary interventional treatment was observed in 29/72 (40%) vs. 24/34 (70%, p = 0.006), and clinical success at the end of follow-up was 46/72 (64%) vs. 29/34 (85%) for patients treated by cSEMS vs. OTSC; p = 0.04. CONCLUSION: OTSC is preferred in small-sized lesions and in perforation caused by endoscopic interventions, cSEMS in patients with concomitant local infection or abscess. cSEMS is associated with a higher frequency of complications. Therefore, OTSC might be preferred if technically feasible. Indication criteria for cSEMS vs. OTSC vary and might impede design of randomized studies.