Endoscopic gastrointestinal anastomoses with lumen-apposing metal stents: predictors of technical success.

BACKGROUND: Lumen-apposing metal stents (LAMS) may be inserted to create gastrointestinal anastomoses under endoscopic ultrasound (EUS) guidance. This new technique has mostly been evaluated as treatment for gastric outlet obstruction (GOO), especially of malignant origin. Technical success was high in the few and small available studies. Aim of this study was to report our experience with this technique and to identify predictors of success in the setting of a large teaching hospital in Germany. METHODS: All subsequent patients who underwent EUS-guided gastrointestinal anastomosis with LAMS from 02/2016 to 08/2019 were included. We performed a retrospective chart analysis including technical procedural details, basic demographic, and health characteristics. Technical success was defined as successful insertion of LAMS. In patients with GOO, the GOO Scoring System was used; an improvement ≥ 1 point was defined as clinical success. RESULTS: Thirty-five patients (22 female, median age: 79 years) were included. Indication for the anastomosis was malignant GOO in 33 patients. In ten patients LAMS was inserted over a guidewire, in 22 patients direct puncture with the electrocautery delivery system of LAMS was performed, and other techniques were used in two patients. Technical success rate was 80.0%. Adverse events occurred in 14.3%. Clinical success rate was 74.3%. Technical success increased and procedure time decreased significantly during the study period. Distance between the two lumina connected with LAMS was significantly shorter (median: 9 mm) in patients with technical success compared to those without (median: 20 mm, P = 0.004). This distance was identified as predictor of success on multivariate analysis. CONCLUSIONS: EUS-guided gastrointestinal anastomosis with LAMS is an emerging technique. Its success mainly depends on the distance between the two lumina that are going to be connected by the LAMS and is influenced by the endoscopist's experience.

Endoscopic full-thickness resection of gastric subepithelial tumors with the gFTRD-system: a prospective pilot study (RESET trial).

BACKGROUND: Gastric subepithelial tumors (SET) are rare and usually benign. However, up to 13% are malignant. Histology after conventional biopsy often is inconclusive. Surveillance endoscopies are the consequence in the majority of gastric SET cases. For SET arising from deeper layers endoscopic resection (ER) with the standard techniques is difficult and associated with the risk of perforation. The RESET trial further evaluates feasibility, efficacy and safety of clip-assisted endoscopic full-thickness resection (EFTR) for gastric SET using the novel gastric full-thickness-resection device (gFTRD). MATERIALS AND METHODS: The RESET trial was initiated in March 2017 (NCT03096236) and designed as prospective observational multicenter pilot trial. Gastric SET up to 15 mm were included. Primary endpoint was technical success (complete enbloc resection). Secondary endpoints were R0 resection, full-thickness resection, adverse events and recurrency at 3-months follow-up. For resection we used the gFTRD (Ovesco Endoscopy, Tübingen, Germany). RESULTS: 29 patients underwent gastric EFTR. Histology prior EFTR after conventional biopsy could define histological tumor type in only 31.2%. Primary endpoint was reached in 89.7%. Histology of the full-thickness-resection specimen could define histological tumor type in 100%. 76% of all SET could be resected histologically complete (R0) and a full-thickness-resection specimen could be obtained in 65.5%. In 31% periprocedural minor bleeding was observed and managed endoscopically. Follow-up was available in 79.3% (OTSC detachment in 78.3%, OTSC in position in 21.7%). No signs of residual or recurrent tumors were observed after 3 months. CONCLUSION: EFTR of gastric SET with gFTRD is feasible and safe. EFTR allows a definite histological diagnosis (including sufficient risk stratification in case of GIST or NET) in contrast to conventional biopsy. R0-resection is possible in most cases and might obviate the need for further surveillance endoscopies for selected patients.

Use of Ultrasound in the Diagnostic Work-Up of Adult Intussusception - A Multicenter Retrospective Analysis.

PURPOSE: To evaluate the use of ultrasound (US) in the diagnostic work-up of adult intussusception (AI). METHODS: This multicenter study includes 26 consecutive patients diagnosed with AI between January 2010 and November 2017. A retrospective chart analysis was conducted with a focus on abdominal US findings and diagnostic accuracy of different imaging modalities (ultrasound, computed tomography (CT), magnetic resonance imaging). If available, surgical and pathological findings served as the gold standard (76.9 %). US examiners certified according to DEGUM grade 2 or 3 were classified as experts. Otherwise, they were regarded to have basic skills. RESULTS: During diagnostic work-up, 92.3 % underwent abdominal US. US was the first-line imaging modality in 88.5 % of cases. The accuracy regarding the detection of AI (85 %), correct localization (95 %) and detection of complications (100 %) was excellent and comparable with CT (81 %, 90.5 %, and 91.7 %) when performed by experts. 72.7 % of tumorous lead points were detected by experienced examiners. In contrast, AI was detected in only 45.5 % of cases by examiners with basic skills. AI was diagnosed prior to surgery in all patients. CONCLUSION: US is reliable in the diagnostic work-up of AI when performed by experienced examiners with high-quality equipment. US, CT and MRI should be used in a complementary fashion since combination provides excellent sensitivity regarding the detection and correct localization of AI as well as the detection of complications. The impact of real-time imaging is illustrated by supplementary videos.

Transjugular portal vein recanalization with creation of intrahepatic portosystemic shunt (PVR-TIPS) in patients with chronic non-cirrhotic, non-malignant portal vein thrombosis.

PURPOSE: To determine safety and efficacy of transjugular portal vein recanalization with creation of intrahepatic portosystemic shunt (PVR-TIPS) in patients with chronic non-cirrhotic, non-malignant portal vein thrombosis (PVT). METHODS: This retrospective study includes 17 consecutive patients with chronic non-cirrhotic PVT (cavernous transformation n = 15). PVR-TIPS was indicated because of variceal bleeding (n = 13), refractory ascites (n = 2), portal biliopathy with recurrent cholangitis (n = 1), or abdominal pain (n = 1). Treatment consisted of a combination of transjugular balloon angioplasty, mechanical thrombectomy, and-depending on extent of residual thrombosis-transjugular intrahepatic portosystemic shunt and additional stenting of the portal venous system. RESULTS: Recanalization was successful in 76.5 % of patients despite cavernous transformation in 88.2 %. Both 1- and 2-year secondary PV and TIPS patency rates were 69.5 %. Procedure-related bleeding complications occurred in 2 patients (intraperitoneal bleeding due to capsule perforation, n = 1; liver hematoma, n = 1) and resolved spontaneously. However, 1 patient died due to subsequent nosocomial pneumonia. During follow-up, 3 patients with TIPS occlusion and PVT recurrence experienced portal hypertensive complications. CONCLUSIONS: PVR-TIPS is safe and effective in selected patients with chronic non-cirrhotic PVT. Due to technical complexity and possible complications, it should be performed only in specialized centers with high experience in TIPS procedures.

Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications.

OBJECTIVE: Endoscopic full-thickness resection (EFTR) is a novel treatment of colorectal lesions not amenable to conventional endoscopic resection. The aim of this prospective multicentre study was to assess the efficacy and safety of the full-thickness resection device. DESIGN: 181 patients were recruited in 9 centres with the indication of difficult adenomas (non-lifting and/or at difficult locations), early cancers and subepithelial tumours (SET). Primary endpoint was complete en bloc and R0 resection. RESULTS: EFTR was technically successful in 89.5%, R0 resection rate was 76.9%. In 127 patients with difficult adenomas and benign histology, R0 resection rate was 77.7%. In 14 cases, lesions harboured unsuspected cancer, another 15 lesions were primarily known as cancers. Of these 29 cases, R0 resection was achieved in 72.4%; 8 further cases had deep submucosal infiltration >1000 µm. Therefore, curative resection could only be achieved in 13/29 (44.8%). In the subgroup with SET (n=23), R0 resection rate was 87.0%. In general, R0 resection rate was higher with lesions ≤2 cm vs >2 cm (81.2% vs 58.1%, p=0.0038). Adverse event rate was 9.9% with a 2.2% rate of emergency surgery. Three-month follow-up was available from 154 cases and recurrent/residual tumour was evident in 15.3%. CONCLUSION: EFTR has a reasonable technical efficacy especially in lesions ≤2 cm with acceptable complication rates. Curative resection rate for early cancers was too low to recommend its primary use in this indication. Further comparative studies have to show the clinical value and long-term outcome of EFTR in benign colorectal lesions. TRIAL REGISTRATION NUMBER: NCT02362126; Results.

Transjugular local thrombolysis with/without TIPS in patients with acute non-cirrhotic, non-malignant portal vein thrombosis.

BACKGROUND & AIMS: Therapeutic anticoagulation is the standard treatment in patients with acute non-cirrhotic portal vein thrombosis (PVT). In critically ill patients, anticoagulation only may not suffice to achive rapid and stable recanalization. This study evaluates efficacy and safety of transjugular interventional therapy in acute non-cirrhotic PVT. METHODS: This retrospective study includes 17 consecutive patients with acute noncirrhotic, non-malignant PVT. Main indication for interventional therapy was imminent intestinal infarction (n=10). Treatment consisted of a combination of transjugular thrombectomy, local fibrinolysis and - depending on thrombus resolution - transjugular intrahepatic portosystemic shunt. RESULTS: Recanalization was successful in 94.1%. One- and two-year secondary PV patency rates were 88.2%. Major complications (n=3) resolved spontaneously in all but one patient (heparin induced thrombocytopenia type 2 with intestinal infarction). Symptoms improved in all patients. However, segmental bowel resection had to be performed in two (11.8%). During a median follow-up of 28.6 months, no patient experienced portal hypertensive complications. Presence of JAK2 V617F mutation predicted both short-term and long-term technical success. CONCLUSIONS: Transjugular recanalization is safe and effective in patients with acute non-cirrhotic, non-malignant PVT. It should be considered especially in patients with imminent bowel infarction and low likelihood of recanalization following therapeutic anticoagulation. Patients with JAK2 mutation ought to be followed meticulously.

Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study.

BACKGROUND AND STUDY AIMS: Previous studies have shown superior patency rates for self-expandable metal stents (SEMS) compared with plastic stents in patients with malignant biliary obstruction. The aim of this study was to compare stent patency, patient survival, and complication rates between a newly designed, wing-shaped, plastic stent and SEMSs in patients with unresectable, malignant, distal, biliary obstruction. PATIENTS AND METHODS: A randomized, multicenter trial was conducted at four tertiary care centers in Germany. A total of 37 patients underwent randomization between March 2010 and January 2013. Patients underwent endoscopic retrograde cholangiography with insertion of either a wing-shaped, plastic stent without lumen or an SEMS.  RESULTS: Stent failure occurred in 10/16 patients (62.5 %) in the winged-stent group vs. 4/18 patients (22.2 %) in the SEMS group (P = 0.034). The median time to stent failure was 51 days (range 2 - 92 days) for the winged stent and 80 days (range 28 - 266 days) for the SEMS (P = 0.002). Early stent failure (< 8 weeks after placement) occurred in 8 patients (50 %) vs. 2 patients (11.1 %), respectively (P = 0.022). After obtaining the results from this interim analysis, the study was discontinued because of safety concerns. CONCLUSIONS: The frequency of stent failure was significantly higher in the winged-stent group compared with the SEMS group. A high incidence of early stent failure within 8 weeks was observed in the winged-stent group. Thus, the winged, plastic stent without central lumen may not be appropriate for mid or long term drainage of malignant biliary obstruction. Study registration ClinicalTrials.gov (NCT01063634).

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 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.

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.

Transmural endoscopic necrosectomy of infected pancreatic necroses and drainage of infected pseudocysts: a tailored approach.

OBJECTIVE: Transmural endoscopic drainage and necrosectomy have become favored treatment modes for infected pancreatic pseudocysts and necroses. In this analysis, we summarize the outcome of 40 patients with complicated course of acute pancreatitis after endoscopic treatment. MATERIAL AND METHODS: From January 2006 through May 2011, 40 patients of our department with complicated pancreatitis were included in this retrospective analysis. All patients underwent endosonographic transgastric puncture followed by wire-guided insertion of one or more double pigtail stents. Patients with extensive necroses were treated repeatedly with transgastric necrosectomy. Treatment success was determined by clinical, laboratory, and radiological parameters. RESULTS: Nine patients had interstitial pancreatitis (IP) with pancreatic pseudocysts. Thirty-one patients had necrotizing pancreatitis (NP) with acute pancreatic necroses (n = 4) or walled-off pancreatic necrosis (n = 27). All patients with IP and nine patients with NP had pseudocysts without solid material and underwent transgastric drainage only. In this group major complications occurred in 11.1% and no mortality was observed. Twenty-two NP patients were treated with additional repeated necrosectomy. In patients with localized peripancreatic necroses (n = 10) no need of surgery or mortality was observed, major complications occurred in 10%. In patients with extensive necroses reaching the lower abdomen (n = 12), three needed subsequent surgery and three died. CONCLUSIONS: Transgastric endoscopy is an effective minimally invasive procedure even in patients with advanced pancreatic necroses. Complication rate is low particularly in patients with sole pseudocysts or localized necroses. The extent of the fluid collections and necroses is a new predictive parameter for the outcome of the patients.

Evaluating outcomes of endoscopic full-thickness plication for gastroesophageal reflux disease (GERD) with impedance monitoring.

BACKGROUND: Endoscopic full-thickness plication allows transmural suturing at the gastroesophageal junction to recreate the antireflux barrier. Multichannel intraluminal impedance monitoring (MII) can be used to detect nonacid or weakly acidic reflux, acidic swallows, and esophageal clearance time. This study used MII to evaluate the outcome of endoscopic full-thickness plication. METHODS: In this study, 12 subsequent patients requiring maintenance proton pump inhibitor therapy underwent endoscopic full-thickness plication for treatment of gastroesophageal reflux disease. With patients off medication, MII was performed before and 6-months after endoscopic full-thickness plication. RESULTS: The total median number of reflux episodes was significantly reduced from 105 to 64 (p = 0.016). The median number of acid reflux episodes decreased from 73 to 43 (p = 0.016). Nonacid reflux episodes decreased from 23 to 21 (p = 0.306). The median bolus clearance time was 12 s before treatment and 11 s at 6 months (p = 0.798). The median acid exposure time was reduced from 6.8% to 3.4% (p = 0.008), and the DeMeester scores were reduced from 19 to 12 (p = 0.008). CONCLUSION: Endoscopic full-thickness plication significantly reduced total reflux episodes, acid reflux episodes, and total reflux exposure time. The DeMeester scores and total acid exposure time for the distal esophagus were significantly improved. No significant changes in nonacid reflux episodes and median bolus clearance time were encountered.

Gastric full-thickness suturing during EMR and for treatment of gastric-wall defects (with video).

BACKGROUND: The endoscopic full-thickness Plicator device was initially developed to provide an endoscopic treatment option for patients with GERD. Because the endoscopic full-thickness Plicator enables rapid and easy placement of transmural sutures, comparable with surgical sutures, we used the Plicator device for endoscopic treatment or prevention of GI-wall defects. OBJECTIVE: To describe the outcomes and complications of endoscopic full-thickness suturing during EMR and for the treatment of gastric-wall defects. DESIGN: A report of 4 cases treated with the endoscopic full-thickness suturing between June 2006 and April 2007. SETTING: A large tertiary-referral center. PATIENTS: Four subjects received endoscopic full-thickness suturing. The subjects were women, with a mean age of 67 years. INTERVENTIONS: Of the 4 subjects, 3 received endoscopic full-thickness suturing during or after an EMR. One subject received endoscopic full-thickness suturing for treatment of a fistula. MAIN OUTCOME MEASUREMENTS: Primary outcome measurements were clinical procedural success and procedure-related adverse events. RESULTS: The mean time for endoscopic full-thickness suturing was 15 minutes. In all cases, GI-wall patency was restored or ensured, and no procedure-related complications occurred. All subjects responded well to endoscopic full-thickness suturing. LIMITATIONS: The resection of one GI stromal tumor was incomplete. Because of the Plicator's 60F distal-end diameter, endoscopic full-thickness suturing could only be performed with the patient under midazolam and propofol sedation. The durable Plicator suture might compromise the endoscopic follow-up after EMR. CONCLUSIONS: The endoscopic full-thickness Plicator permits rapid and easy placement of transmural sutures and seems to be a safe and effective alternative to surgical intervention to restore GI-wall defects or to ensure GI-wall patency during EMR procedures.