Endoscopic full-thickness resection of gastric subepithelial tumors: a single-center series.

BACKGROUND AND STUDY AIMS: Endoscopic full-thickness resection of gastric subepithelial tumors with a full-thickness suturing device has been described as feasible in two small case series. The aim of this study was to evaluate the efficacy, safety, and clinical outcome of this resection technique. PATIENTS AND METHODS: After 31 patients underwent endoscopic full-thickness resection, the data were analyzed retrospectively. Before snare resection, 1 to 3 full-thickness sutures were placed underneath each tumor with a device originally designed for endoscopic anti-reflux therapy. RESULTS: All tumors were resected successfully. Bleeding occurred in 12 patients (38.7 %); endoscopic hemostasis could be achieved in all cases. Perforation occurred in 3 patients (9.6 %), and all perforations could be managed endoscopically. Complete resection was histologically confirmed in 28 of 31 patients (90.3 %). Mean follow-up was 213 days (range, 1 - 1737), and no tumor recurrences were observed. CONCLUSION: Endoscopic full-thickness resection of gastric subepithelial tumors with the suturing technique described above is feasible and effective. After the resection of gastrointestinal stromal tumors (GISTs), we did not observe any recurrences during follow-up, indicating that endoscopic full-thickness resection may be an alternative to surgical resection for selected patients.

Endoscopic full-thickness resection in the colorectum with a novel over-the-scope device: first experience.

BACKGROUND AND STUDY AIMS: Endoscopic full-thickness resection (EFTR) in the lower gastrointestinal tract may be a valuable therapeutic and diagnostic approach for a variety of indications. Although feasibility of EFTR has been demonstrated, there is a lack of safe and effective endoscopic devices for routine use. The aim of this study was to investigate the efficacy and safety of a novel over-the-scope device for colorectal EFTR. PATIENTS AND METHODS: Between July 2012 and July 2014, 25 patients underwent EFTR at two tertiary referral centers. All resections were performed using the full-thickness resection device (FTRD; Ovesco Endoscopy, Tübingen, Germany). Data were collected retrospectively. RESULTS: Indications for EFTR were: recurrent or incompletely resected adenoma with nonlifting sign (n = 11), untreated adenoma and nonlifting sign (n = 2), adenoma involving the appendix (n = 5), flat adenoma in a patient with coagulopathy (n = 1), diagnostic re-resection after incomplete resection of a T1 carcinoma (n = 2), adenoma involving a diverticulum (n = 1), submucosal tumor (n = 2), and diagnostic resection in a patient with suspected Hirschsprung's disease (n = 1). In one patient, the lesion could not be reached because of a sigmoid stenosis. In the other patients, resection of the lesion was macroscopically complete and en bloc in 20/24 patients (83.3 %). The mean diameter of the resection specimen was 24 mm (range 12 - 40 mm). The R0 resection rate was 75.0 % (18/24), and full-thickness resection was histologically confirmed in 87.5 %. No perforations or major bleeding were observed during or after resection. Two patients developed postpolypectomy syndrome, which was managed with antibiotic therapy. CONCLUSIONS: Full-thickness resection in the lower gastrointestinal tract with the novel FTRD was feasible and effective. Prospective studies are needed to further evaluate the device and technique.

Endoscopic removal of over-the-scope clips using a novel cutting device: a retrospective case series.

BACKGROUND AND STUDY AIMS: Over-the-scope clips (OTSCs; Ovesco Endoscopy, Tübingen, Germany) are extensively used for treatment of gastrointestinal perforations, leakages, fistulas, and bleeding. In this report, a new method of removing OTSCs using a prototype bipolar cutting device is described. PATIENTS AND METHODS: A total of 11 patients underwent endoscopic removal of an OTSC. The OTSC was cut at two opposing sites by a prototype device (DC ClipCutter; Ovesco Endoscopy). The remaining clip fragments were extracted using a standard forceps. RESULTS: Mean procedure time was 47 minutes (range 35 - 75 minutes). Cutting of the OTSC at two opposing sites was successful in all cases (100 %). Complete retrieval of all clip fragments was possible in 10 patients (91 %). The overall success rate for cutting and complete removal of the clip was 91 %. No major complications were observed. CONCLUSIONS: Removal of OTSCs with the prototype device was feasible and effective. The device may be valuable for OTSC removal in emergency as well as elective indications.

Student tutors for hands-on training in focused emergency echocardiography--a randomized controlled trial.

BACKGROUND: Focused emergency echocardiography performed by non-cardiologists has been shown to be feasible and effective in emergency situations. During resuscitation a short focused emergency echocardiography has been shown to narrow down potential differential diagnoses and to improve patient survival. Quite a large proportion of physicians are eligible to learn focused emergency echocardiography. Training in focused emergency echocardiography usually comprises a lecture, hands-on trainings in very small groups, and a practice phase. There is a shortage of experienced echocardiographers who can supervise the second step, the hands-on training. We thus investigated whether student tutors can perform the hands-on training for focused emergency echocardiography. METHODS: A total of 30 volunteer 4th and 5th year students were randomly assigned to a twelve-hour basic echocardiography course comprising a lecture followed by a hands-on training in small groups taught either by an expert cardiographer (EC) or by a student tutor (ST). Using a pre-post-design, the students were evaluated by an OSCE. The students had to generate two still frames with the apical five-chamber view and the parasternal long axis in five minutes and to correctly mark twelve anatomical cardiac structures. Two blinded expert cardiographers rated the students' performance using a standardized checklist. Students could achieve a maximum of 25 points. RESULTS: Both groups showed significant improvement after the training (p < .0001). In the group taught by EC the average increased from 2.3±3.4 to 17.1±3.0 points, and in the group taught by ST from 2.7±3.0 to 13.9±2.7 points. The difference in improvement between the groups was also significant (p = .03). CONCLUSIONS: Hands-on training by student tutors led to a significant gain in echocardiography skills, although inferior to teaching by an expert cardiographer.

Novel telemetric sensor capsule for EGD urgency triage: a feasibility study.

Background and study aims Upper gastrointestinal bleeding (UGIB) is a frequent cause of hospitalization. Because of the lack of reliable noninvasive diagnostic tools, the decision to proceed with emergency endoscopy in these cases is made based on clinical parameters. A novel non-imaging telemetric real-time sensor capsule (HemoPill Acute, Ovesco Endoscopy AG) has shown promising results for noninvasive detection of UGIB in preclinical studies. Patients and methods We conducted a prospective non-randomized, single center, open-label study to investigate feasibility and safety of the novel sensor capsule in patients with symptoms of UGIB. The primary aim of the first clinical study was to investigate feasibility and safety of the device in a clinical setting. All patients underwent endoscopy within 12 hours after capsule ingestion. Sensor data from the capsule within 10 minutes after ingestion were compared with endoscopic findings. Results From April 2015 to February 2016, 30 consecutive patients with symptoms of acute UGIB were included; 27 were eligible for analysis. Capsule ingestion was well tolerated in all patients and there were no device-related adverse events. Endoscopy showed blood or hematin in the upper gastrointestinal tract of 10 of 27 patients; in 2 of 10 patients it was estimated to be more than 20 mL; in 4 of 8 patients it was between 5 and 20 mL and in 4 of 8 it was estimated to < 5 mL. The sensor capsule was positive in 2 of 2 patients (100 %) with > 20 mL of blood or hematin and in 1 of 8 patients (12.5 %) between 5 and 20 mL. All patients (17/17; 100 %) were correctly identified as non-bleeders. Conclusion Both device and procedure proved to be safe and feasible. Larger studies will be necessary to evaluate the role of the sensor capsule in risk stratification of patients with acute UGIB.

Endoscopic full-thickness resection of duodenal lesions-a retrospective analysis of 20 FTRD cases.

BACKGROUND: Endoscopic resections in the duodenum harbor a significant risk of complications. The full-thickness resection device (FTRD) has shown favorable results concerning efficacy and safety in the resection of colorectal lesions. Data of its use in the duodenum are limited to a single, small case series (n = 4). METHODS: Data of all consecutive patients scheduled for endoscopic full-thickness resection (EFTR) of duodenal lesions by FTRD in our institution were collected and analyzed retrospectively. Primary endpoint was technical success. RESULTS: Between March 2014 and June 2017 EFTR of a duodenal lesion was planned in a total of 20 patients. Overall technical success was 17/20 (85.0%). Indication for EFTR was: adenomas (n = 13, seven treatment naïve, six pretreated), subepithelial tumors (n = 5) and T1 adenocarcinoma (n = 1). The FTRD could be advanced to the lesion in 19/20 cases (95.0%). R0-resection rate was 12/19 (63.2%). During follow-up after 3 and 12 months there were two recurrent adenomas that were successfully re-resected by FTRD. Minor bleedings occurred at the first postinterventional day in 3/19 (15.8%). There were no major bleedings and perforations. CONCLUSION: This study confirmed the feasibility of duodenal EFTR and indicates good efficacy and safety. Larger studies are needed to further investigate this novel technique.

Endoscopic removal of over-the-scope clips: Clinical experience with a bipolar cutting device.

BACKGROUND: Over-the-scope clips (OTSCs) are increasingly used for the closure of perforations/fistulae, hemostasis and endoscopic full-thickness resection (FTRD system). When OTSC-associated complications occur or re-therapy at the OTSC site is needed, OTSC removal may be indicated. An experimental study in an animal model and a case series have shown good results for OTSC removal with a bipolar cutting device. We present a larger clinical study using this device. METHODS: Data of all consecutive patients with indication for OTSC removal were collected and analyzed retrospectively. OTSCs were cut at two opposing sites using a bipolar grasping device to apply short direct current impulses. OTSC fragments were extracted with a standard forceps and a cap at the tip of the endoscope to avoid tissue damage. RESULTS: Between December 2012 and February 2016 a total of 42 OTSC removals in the upper (n = 25) and lower (n = 17) gastrointestinal tract have been performed at our department. Overall technical success, defined as cutting the OTSC at two opposing sites and extraction of both fragments, was achieved in 92.9% (39/42) of all cases. Successful fragmentation of the OTSC was achieved in 97.6% (41/42). Minor bleedings were rare and could be managed endoscopically in all cases. There were no perforations and no major or delayed bleedings. CONCLUSION: Endoscopic OTSC removal with a bipolar cutting device is feasible, effective and safe. This technique can be applied in the upper and lower gastrointestinal tract.

Effectiveness of TC-325 (Hemospray) for treatment of diffuse or refractory upper gastrointestinal bleeding - a single center experience.

BACKGROUND AND STUDY AIMS: TC-325 (Hemospray, Cook Medical) is a powder agent for endoscopic hemostasis in patients with upper gastrointestinal bleeding (UGIB). Although most publications are based on case-reports and retrospective studies, data on efficacy are promising. Here we report our experience with TC-325 for diffuse or refractory UGIB. PATIENTS AND METHODS: Data on patients receiving TC-325 for endoscopic hemostasis from November 2013 to February 2017 at our center were analyzed retrospectively. Primary endpoints were technical success (successful immediate hemostasis) and clinical success (effective hemostasis and no recurrent bleeding). Secondary endpoints were recurrent bleeding within 3 and 7 days, hospital mortality and TC-325 associated complications. TC-325 was used for bleeding not amenable to standard endoscopic treatment (e. g. diffuse bleeding) or as salvage therapy after failure of conventional methods. RESULTS: Fifty-two patients received TC-325 treatment. Most of the patients were treated for peptic ulcer bleeding (18/52 patients, 34.6 %) and post-interventional bleeding (13/52 patients, 25 %). Hemospray was used in 23/52 (44.2 %) patients as monotherapy and in 29/52 (55.8 %) patients as a salvage therapy. Application of the powder on the bleeding source was successful in all patients with no therapy-related adverse events (AEs). Immediate hemostasis was achieved in 51/52 (98.1 %) patients. Recurrent bleeding within 3 and 7 days was observed in 22/51 and 25/51 patients respectively (43.1 % and 49 %). The overall clinical success was 56.9 % on day 3 and 51 % on day 7. Total mortality was 15.4 % (8 patients), bleeding associated mortality was 3.8 % (2 patients). There were no therapy-related AEs. CONCLUSIONS: TC-325 showed a high technical success rate as monotherapy for bleeding sources not amenable to standard methods or as an "add-on" therapy after unsuccessful hemostasis. However, rebleeding was frequent in this cohort and further studies are warranted to exactly define a treatment algorithm for TC-325 use.

Non-Exposure, Device-Assisted Endoscopic Full-thickness Resection.

Recent developments have expanded the frontier of interventional endoscopy toward more extended resections following surgical principles. This article presents two new device-assisted techniques for endoscopic full-thickness resection in the upper and lower gastrointestinal tract. Both methods are nonexposure techniques avoiding exposure of gastrointestinal contents to the peritoneal cavity by a "close first-cut later" principle. The full-thickness resection device is a novel over-the-scope device designed for clip-assisted full-thickness resection of colorectal lesions. Endoscopic full-thickness resection of gastric subepithelial tumors can be performed after placing transmural sutures underneath the tumor with a suturing device originally designed for endoscopic antireflux therapy.

Endoscopic resection of subepithelial tumors.

Management of subepithelial tumors (SETs) remains challenging. Endoscopic ultrasound (EUS) has improved differential diagnosis of these tumors but a definitive diagnosis on EUS findings alone can be achieved in the minority of cases. Complete endoscopic resection may provide a reasonable approach for tissue acquisition and may also be therapeutic in case of malignant lesions. Small SET restricted to the submucosa can be removed with established basic resection techniques. However, resection of SET arising from deeper layers of the gastrointestinal wall requires advanced endoscopic methods and harbours the risk of perforation. Innovative techniques such as submucosal tunneling and full thickness resection have expanded the frontiers of endoscopic therapy in the past years. This review will give an overview about endoscopic resection techniques of SET with a focus on novel methods.