Endoscopic full-thickness resection (EFTR) is a powerful option for resection of colorectal lesions not amenable to conventional endoscopic resection. The full-thickness resection device (FTRD) ...allows clip-assisted EFTR with a single-step technique. We report on results of a large nationwide FTRD registry.
The "German colonic FTRD registry" was created to further assess efficacy and safety of the FTRD System after approval in Europe. Data were analyzed retrospectively.
Sixty-five centers contributed 1,178 colorectal FTRD procedures. Indications for EFTR were difficult adenomas (67.1%), early carcinomas (18.4%), subepithelial tumors (6.8%), and diagnostic EFTR (1.3%). Mean lesion size was 15 × 15 mm and most lesions were pretreated endoscopically (54.1%). Technical success was 88.2% and R0 resection was achieved in 80.0%. R0 resection was significantly higher for subepithelial tumor compared with that for other lesions. No difference in R0 resection was found for smaller vs larger lesions or for colonic vs rectal procedures. Adverse events occurred in 12.1% (3.1% major events and 2.0% required surgical treatment). Endoscopic follow-up was available in 58.0% and showed residual/recurrent lesions in 13.5%, which could be managed endoscopically in most cases (77.2%).
To date, this is the largest study of colorectal EFTR using the FTRD System. The study demonstrated favorable efficacy and safety for "difficult-to-resect" colorectal lesions and confirms results of previous studies in a large "real-world" setting. Further studies are needed to compare EFTR with other advanced resection techniques and evaluate long-term outcome.
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.
ObjectiveEndoscopic 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.Design181 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.ResultsEFTR 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%.ConclusionEFTR 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 numberNCT02362126; Results.
Conventional endoscopic resection techniques such as endoscopic mucosal resection or endoscopic submucosal dissection are powerful tools for treatment of gastrointestinal neoplasms. However,those ...techniques are restricted to superficial layers of the gastrointestinal wall. Endoscopic full-thickness resection(EFTR) is an evolving technique,which is just about to enter clinical routine. It is not only a powerful tool for diagnostic tissue acquisition but also has the potential to spare surgical therapy in selected patients. This review will give an overview about current EFTR techniques and devices.
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.
Current international guidelines recommend endoscopic resection for T1 colorectal cancer (CRC) with low-risk histology features and oncologic resection for those at high risk of lymphatic metastasis. ...Exact risk stratification is therefore crucial to avoid under-treatment as well as over-treatment. Endoscopic full-thickness resection (EFTR) has shown to be effective for treatment of non-lifting benign lesions. In this multicenter, retrospective study we aimed to evaluate efficacy, safety, and clinical value of EFTR for early CRC.
Records of 1234 patients undergoing EFTR for various indications at 96 centers were screened for eligibility. A total of 156 patients with histologic evidence of adenocarcinoma were identified. This cohort included 64 cases undergoing EFTR after incomplete resection of a malignant polyp (group 1) and 92 non-lifting lesions (group 2). Endpoints of the study were: technical success, R0-resection, adverse events, and successful discrimination of high-risk versus low-risk tumors.
Technical success was achieved in 144 out of 156 (92.3%). Mean procedural time was 42 minutes. R0 resection was achieved in 112 of 156 (71.8%). Subgroup analysis showed a R0 resection rate of 87.5% in Group 1 and 60.9% in Group 2 (P < .001). Severe procedure-related adverse events were recorded in 3.9% of patients. Discrimination between high-risk versus low-risk tumor was successful in 155 of 156 cases (99.3%). In Group 1, 84.1% were identified as low-risk lesions, whereas 16.3% in group 2 had low-risk features. In total, 53 patients (34%) underwent oncologic resection due to high-risk features whereas 98 patients (62%) were followed endoscopically.
In early colorectal cancer, EFTR is technically feasible and safe. It allows exact histological risk stratification and can avoid surgery for low-risk lesions. Prospective studies are required to further define indications for EFTR in malignant colorectal lesions and to evaluate long-term outcome.
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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.
Historical data indicate that surgical resection may benefit select patients with metastatic gastric and gastroesophageal junction cancer. However, randomized clinical trials are lacking. The current ...RENAISSANCE trial addresses the potential benefits of surgical intervention in gastric and gastroesophageal junction cancer with limited metastases.
This is a prospective, multicenter, randomized, investigator-initiated phase III trial. Previously untreated patients with limited metastatic stage (retroperitoneal lymph node metastases only or a maximum of one incurable organ site that is potentially resectable or locally controllable with or without retroperitoneal lymph nodes) receive 4 cycles of FLOT chemotherapy alone or with trastuzumab if Her2+. Patients without disease progression after 4 cycles are randomized 1:1 to receive additional chemotherapy cycles or surgical resection of primary and metastases followed by subsequent chemotherapy. 271 patients are to be allocated to the trial, of which at least 176 patients will proceed to randomization. The primary endpoint is overall survival; main secondary endpoints are quality of life assessed by EORTC-QLQ-C30 questionnaire, progression free survival and surgical morbidity and mortality. Recruitment has already started; currently (Feb 2017) 22 patients have been enrolled.
If the RENAISSANCE concept proves to be effective, this could potentially lead to a new standard of therapy. On the contrary, if the outcome is negative, patients with gastric or GEJ cancer and metastases will no longer be considered candidates for surgical intervention.
The article reports of a health care intervention on human participants and is registered on October 12, 2015 under ClinicalTrials.gov Identifier: NCT02578368 ; EudraCT: 2014-002665-30.
Background & Aims In a recent randomized international clinical trial (RCT) in high-risk cirrhotic patients with acute variceal bleeding, the early use of transjugular intrahepatic portosystemic ...shunt (TIPS) was associated with marked and significant reductions in both treatment failure and mortality. The aim of this study was to confirm these results in clinical practice in the same centers of the RCT study. Methods We retrospectively reviewed patients admitted for acute variceal bleeding and high risk of treatment failure (Child C <14 or Child B plus active bleeding), treated with early-TIPS (n = 45) or drugs + endoscopic therapy (ET) (n = 30). Results Patients treated with early-TIPS had a much lower incidence of failure to control bleeding or rebleeding than patients receiving drug + ET (3 vs. 15; p <0.001). The 1-year actuarial probability of remaining free of this composite end point was 93% vs. 53% ( p <0.001). The same was observed in mortality (1-year actuarial survival was 86% vs. 70% respectively; p = 0.056). Actuarial curves of failure to control bleeding + rebleeding and of survival were well within the confidence intervals of those observed in the RCT. Conclusions This study supports the early use of TIPS in patients with cirrhosis and a high-risk variceal bleeding.
International guidelines propose color Doppler ultrasound (CDUS) and contrast-enhanced computed tomography (CT) as primary imaging techniques in the diagnosis of acute splanchnic vein thrombosis. ...However, their reliability in this context is poorly investigated. Therefore, the aim of our study was to validate CDUS and CT in the radiologic assessment of acute splanchnic vein thrombosis, using direct transjugular spleno-portography as gold standard.
49 patients with non-malignant acute splanchnic vein thrombosis were included in a retrospective, multicenter analysis. The thrombosis' extent in five regions of the splanchnic venous system (right and left intrahepatic portal vein, main trunk of the portal vein, splenic vein, superior mesenteric vein) and the degree of thrombosis (patent, partial thrombosis, complete thrombosis) were assessed by portography, CDUS and CT in a blinded manner. Reliability of CDUS and CT with regard to portography as gold standard was analyzed by calculating Cohen's kappa.
Results of CDUS and CT were consistent with portography in 76.6% and 78.4% of examinations, respectively. Cohen's kappa demonstrated that CDUS and CT delivered almost equally reliable results with regard to the portographic gold standard (k = 0.634 p < 0.001 vs. k = 0.644 p < 0.001). In case of findings non-consistent with portography there was no clear trend to over- or underestimation of the degree of thrombosis in both CDUS (60.0% vs. 40.0%) and CT (59.5% vs. 40.5%).
CDUS and CT are equally reliable tools in the radiologic assessment of non-malignant acute splanchnic vein thrombosis.
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