Project description:BackgroundTranscatheter arterial embolization (TAE) or surgery are standard treatment of peptic ulcer bleeding (PUB) refractory to endoscopic hemostasis. Over-the-scope clips (OTSC) have shown superiority to standard endoscopic treatment.ObjectiveTo compare OTSC treatment to TAE in refractory peptic ulcer bleeding.Patients and methodsIn this retrospective, multicenter study, 128 patients treated with OTSC (n = 66) or TAE (n = 62) for refractory PUB between 2009 and 2019 in four academic centers were analyzed. Primary endpoint was clinical success (hemostasis + no rebleeding within 7 days). Secondary endpoints were adverse events, length of ICU stay, and mortality. Propensity score matching was performed to adjust for differences in baseline characteristics.ResultsPatients characteristics were similar in both groups but ulcers in the TAE group were larger, more often located in the duodenal bulb (85.5% vs. 65.2%; p = 0.014), and that the proportion of Forrest Ia bleedings was higher (38.7% vs. 19.7%; p = 0.018). Clinical success was comparable in both groups (74.2% vs. 59.7%; p = 0.092). Stay on the intensive care unit (ICU) was significantly longer in the TAE group (mean 8.0 vs. 4.7 days; p = 0.002). Serious adverse events after re-therapy (12.9% vs. 1.5%; p = 0.042) and in-hospital mortality were significantly higher in the TAE group (9.1 vs. 22.6%, OR 2.92 [95% CI 1.04-8.16]; p = 0.05). After propensity score matching, the differences found regarding ICU stay (4.9± 5.9 and 9.2 ± 11.2; p = 0.009) and in-hospital mortality (5% vs. 22.5%; OR 5.52 [95% CI: 1.11-27.43]; p = 0.048) stayed significant.ConclusionsOTSC treatment for refractory PUB was superior to TAE in terms of ICU stay and in-hospital mortality.
Project description:Background:A recent prospective randomised controlled trial ('STING') showed superiority of over-the-scope clips compared to standard treatment in recurrent peptic ulcer bleeding. Cost-effectiveness studies on haemostasis with over-the-scope clips have not been reported so far. Objective:The aim of this study was to investigate whether the higher efficacy of the over-the-scope clips treatment outweighs the higher costs of the device compared to standard clips. Methods:For the analysis, the study population of the STING trial was used. Costs for the hospital stay in total as well as treatment-related costs were obtained. The average cost-effectiveness ratio, representing the mean costs per designated outcome, and the incremental cost-effectiveness ratio, expressing the additional costs of a new treatment strategy per difference in outcome were calculated. The designated outcome was defined as successful haemostasis without rebleeding within seven days, which was the primary endpoint of the STING trial. Average cost-effectiveness ratio and incremental cost-effectiveness ratio were calculated for total costs of the hospital stay as well as the haemostasis treatment alone. The cost-effectiveness analysis is taken from the perspective of the care provider.Results: Total costs and treatment-related costs per patient were 13,007.07?€ in the standard group vs 12,808.56?€ in the over-the-scope clip group (p?=?0.812) and 2084.98?€ vs 1984.71?€ respectively (p?=?0.663). The difference was not statistically significant. Total costs per successful haemostasis (average cost-effectiveness ratio) were 30,677.05?€ vs 15,104.43?€ and 4917.41?€ vs 2340.46?€ for the haemostasis treatment. The additional costs per successful haemostasis with over-the-scope clip treatment (incremental cost-effectiveness ratio) is -468.18?€ for the whole treatment and -236.49€ for the haemostasis treatment. Conclusions:Over-the-scope clip treatment is cost-effective in recurrent peptic ulcer bleeding.
Project description:BACKGROUND AND STUDY AIM: The novel over-the-scope clip (OTSC) allows for excellent apposition of tissue, potentially permitting hemostasis to be achieved in various types of gastrointestinal lesions. This study aimed to evaluate the usefulness and safety of OTSCs for endoscopic hemostasis in patients with upper gastrointestinal bleeding in whom traditional endoscopic methods had failed. PATIENTS AND METHODS: A retrospective case series of all patients who underwent placement of an OTSC for severe recurrent upper gastrointestinal bleeding over a 14-month period was studied. Outcome data for the procedure included achievement of primary hemostasis, episodes of recurrent bleeding, and complications. RESULTS: Twelve consecutive patients (67 % men; mean age 59, range 29 - 86) with ongoing upper gastrointestinal bleeding despite previous endoscopic management were included. They had a mean ASA score of 3 (range 2 - 4), a mean hemoglobin of 7.2 g/dL (range 5.2 - 9.1), and shock was present in 75 % of patients. They had all received packed red blood cells (mean 5.1 units, range 2 - 12). The etiology of bleeding was: duodenal ulcer (n = 6), gastric ulcer (n = 2) Dieulafoy lesion (n = 2), anastomotic ulceration (n = 1), Mallory - Weiss tear (n = 1). Hemostasis was achieved in all patients. Rebleeding occurred in two patients 1 day and 7 days after OTSC placement. There were no complications associated with OTSC application. CONCLUSIONS: OTSC use represents an effective, easily performed, and safe endoscopic therapy for various causes of severe acute gastrointestinal bleeding when conventional endoscopic techniques have failed. This therapy should be added to the armamentarium of therapeutic endoscopists.
Project description:Video 1Placing a standard endoclip at the papillary side of a duodenal perforation is a simple and effective technique for prevention of papillary obstruction when using the over-the-scope clip.
Project description:BACKGROUND:Surgical resection of upper gastrointestinal (GI) subepithelial tumors (SETs) is associated with significant morbidity and mortality. A new over-the-scope (OTS) clip can be used for endoscopic full-thickness resection (eFTR). We aimed to prospectively evaluate feasibility and safety of upper GI eFTR with a new, flat-based OTS clip. METHODS:Consecutive patients with a gastric or duodenal SET < 20 mm were prospectively included. After identification of the lesion, the clip was placed and lesions were resected. Patients were followed for 1 month to assess severe adverse events (SAEs); 3-6 months after eFTR, endoscopy was performed. RESULTS:eFTR was performed on 13 lesions in 12 patients: 7 gastric and 6 duodenal SETs. Technical success was achieved in 11 cases (85%). In all 11 cases, R0-resection was achieved. In all 6 duodenal cases and in one gastric case, FTR was achieved (64%). One SAE (pain) was observed after eFTR of a gastric SET. After eFTR of duodenal SETs, several SAEs were observed: perforation (n = 1), microperforation (n = 3), and hemorrhage (n = 1). During follow-up endoscopy, the clip was no longer in situ in most patients (7 of 10; 70%). CONCLUSIONS:eFTR with this new flat-based OTS clip is feasible and effective. Although gastric eFTR was safe, eFTR in the duodenum was complicated by (micro)perforation in several patients. Therefore, the design of the clip or the technique of resection needs further refinement to improve safety of resection of SET in thin-walled areas such as the duodenum before being applied in clinical practice. Dutch trial register: NTR5023.
Project description:BackgroundSurgery or transcatheter arterial embolization or are both considered as standard treatment of peptic ulcer bleeding (PUB) refractory to endoscopic hemostasis. Over-The-Scope clips (OTSC) have shown superiority to standard endoscopic treatment but a comparison with surgery has not been performed, yet.Patients and methodsIn this retrospective, multicenter study, 103 patients treated with OTSC (n = 66) or surgery (n = 37) for refractory PUB in four tertiary care centers between 2009 and 2019 were analyzed. Primary endpoint was clinical success (successful hemostasis and no rebleeding within seven days). Secondary endpoints were adverse events, length of ICU-stay and in-hospital mortality. Univariable and multivariable regression models were performed to define predictive factors for allocation to surgical therapy and for mortality.ResultsAge, comorbidities, anticoagulation therapy, number of pretreatments, ulcer location, and Rockall-Score were similar in both groups. In the surgical group, there were significantly more patients in shock at rebleeding (78.1% vs. 43.9%; p = 0.002), larger ulcers (18.6 ± 7.4 mm vs. 23.0 ± 9.4 mm; p = 0.017) and more FIa bleedings (64.9% vs. 19.7%; p < 0.001) were detected. Clinical success was comparable (74.2% vs. 83.8%; p = 0.329). In the surgical group, length of ICU-stay (16.2 ± 18.0 days vs. 4.7 ± 6.6 days; p < 0.001), severe adverse events (70.3% vs. 4.5%; p < 0.001) and in-hospital mortality (35.1% vs. 9.1%; p = 0.003) were significantly higher. Multivariable analysis defined shock at rebleeding as the main predictor for allocation to surgical therapy (OR 4.063, 95%CI {1.496-11.033}, p = 0.006). Postsurgical adverse events were the main reason for the in-hospital mortality (OR 5.167, 95% CI {1.311-20.363}, p = 0.019).ConclusionIn this retrospective study, OTSC compared to surgical treatment showed comparable clinical success but was associated with shorter ICU-stay, less severe adverse events and lower in-hospital mortality.