Propensity score-matched retrospective cohort study of endoscopic ultrasound-guided gastroenterostomy and enteral stenting for malignant gastric outlet.

BACKGROUND: Symptomatic malignant gastric outlet obstruction (GOO) significantly reduce patients' quality of life. Endoscopic treatment involves enteral stenting or endoscopic ultrasonography to perform gastroenterostomy (EUS-GE). Aim was to compare enteral stenting with EUS-GE for endoscopic treatment of malignant GOO. METHODS: We retrospectively compared enteral stenting with EUS-GE for the treatment of malignant GOO. Patients treated at our institution were identified and a propensity score matching analysis was performed. Treatment failure was the primary outcome, while the secondary endpoints were time until treatment failure, technical and clinical success rates, and adverse event rates. RESULTS: Eighty-eight patients were included in the final analysis. Of whom, 44 were included in each of the two treatment groups. Treatment failure occurred significantly more frequently in the enteral stenting group (13/44) compared with the EUS-GE group (4/44; hazard ratio: 4,9; 95% CI 1.6-15.1). A Kaplan-Meier analysis revealed a median time until treatment failure of 22.0 weeks (95% CI 4.6-39.4) in the enteral stenting group compared with 76.0 weeks (95% CI 55.9-96.1) in the EUS-GE group (P = .002). No difference in technical success and clinical success was detected. Technical success was achieved in 43/44 patients (97.7%) in the enteral stenting group compared with 41/44 patients (93.2%) in the EUS-GE group, while clinical success was achieved in 32/44 (72.7%) and 35/44 (79.5%) patients, respectively. Nine adverse events were observed (9/44, 10.2%). There were no differences in 30-day adverse event rate and 30-day mortality rate. CONCLUSION: EUS-GE was superior to enteral stenting in the treatment of malignant GOO in terms of treatment failure and time until treatment failure in a propensity score-matched cohort.

Endoscopic papillectomy for ampullary lesions of minor papilla.

BACKGROUND AND AIMS: Ampullary lesions (ALs) of the minor duodenal papilla are extremely rare. Endoscopic papillectomy (EP) is a routinely used treatment for AL of the major duodenal papilla, but the role of EP for minor AL has not been accurately studied. METHODS: We identified 20 patients with ALs of minor duodenal papilla in the multicentric database from the Endoscopic Papillectomy vs Surgical Ampullectomy vs Pancreatitcoduodenectomy for Ampullary Neoplasm study, which included 1422 EPs. We used propensity score matching (nearest-neighbor method) to match these cases with ALs of the major duodenal papilla based on age, sex, histologic subtype, and size of the lesion in a 1:2 ratio. Cohorts were compared by means of chi-square or Fisher exact test as well as Mann-Whitney U test. RESULTS: Propensity score-based matching identified a cohort of 60 (minor papilla 20, major papilla 40) patients with similar baseline characteristics. The most common histologic subtype of lesions of minor papilla was an ampullary adenoma in 12 patients (3 low-grade dysplasia and 9 high-grade dysplasia). Five patients revealed nonneoplastic lesions. Invasive cancer (T1a), adenomyoma, and neuroendocrine neoplasia were each found in 1 case. The rate of complete resection, en-bloc resection, and recurrences were similar between the groups. There were no severe adverse events after EP of lesions of minor papilla. One patient had delayed bleeding that could be treated by endoscopic hemostasis, and 2 patients showed a recurrence in surveillance endoscopy after a median follow-up of 21 months (interquartile range, 12-50 months). CONCLUSIONS: EP is safe and effective in ALs of the minor duodenal papilla. Such lesions could be managed according to guidelines for EP of major duodenal papilla.

Efficacy and safety of combined EMR and endoscopic full-thickness resection (hybrid EFTR) for large nonlifting colorectal adenomas.

BACKGROUND AND AIMS: Endoscopic full-thickness resection (EFTR) with a full-thickness resection device (FTRD) has become the standard technique for selected nonlifting colorectal adenomas, but tumor size is the major limitation. However, large lesions might be approached in combination with EMR. Herein, we report the largest single-center experience to date of combined EMR and EFTR (hybrid EFTR) in patients with large (≥25 mm) nonlifting colorectal adenomas not amenable to EMR or EFTR alone. METHODS: This is a single-center retrospective analysis of consecutive patients who underwent hybrid EFTR of large (≥25 mm) nonlifting colorectal adenomas. Outcomes of technical success (successful advancement of the FTRD with consecutive successful clip deployment and snare resection), macroscopic complete resection, adverse events, and endoscopic follow-up were evaluated. RESULTS: Seventy-five patients with nonlifting colorectal adenomas were included. Mean lesion size was 36.5 mm (range, 25-60 mm), and 66.6% were located in the right side of the colon. Technical success was 100% with macroscopic complete resection in 97.3%. Mean procedure time was 83.6 minutes. Adverse events occurred in 6.7%, leading to surgical therapy in 1.3%. Histology revealed T1 carcinoma in 16%. Endoscopic follow-up was available in 93.3% (mean follow-up time, 8.1 months; range, 3-36) and showed no signs of residual or recurrent adenoma in 88.6%. Recurrence (11.4%) was treated endoscopically. CONCLUSIONS: Hybrid EFTR is safe and effective for advanced colorectal adenoma that cannot be approached by EMR or EFTR alone. Hybrid EFTR expands the indication of EFTR substantially in selected patients.

Endoscopic papillectomy for ampullary lesions in patients with familial adenomatous polyposis compared with sporadic lesions: a propensity score-matched cohort.

BACKGROUND: Familial adenomatous polyposis (FAP) is a rare inherited syndrome that predisposes the patient to cancer. Treatment of FAP-related ampullary lesions is challenging and the role of endoscopic papillectomy has not been elucidated. We retrospectively analyzed the outcomes of endoscopic papillectomy in matched cohorts of FAP-related and sporadic ampullary lesions (SALs). METHODS: This retrospective multicenter study included 1422 endoscopic papillectomy procedures. Propensity score matching including age, sex, comorbidity, histologic subtype, and size was performed. Main outcomes were complete resection (R0), technical success, complications, and recurrence. RESULTS: Propensity score matching identified 202 patients (101 FAP, 101 SAL) with comparable baseline characteristics. FAP patients were mainly asymptomatic (79.2 % [95 %CI 71.2-87.3] vs. 46.5 % [95 %CI 36.6-56.4]); P < 0.001). The initial R0 rate was significantly lower in FAP patients (63.4 % [95 %CI 53.8-72.9] vs. 83.2 % [95 %CI 75.8-90.6]; P = 0.001). After repeated interventions (mean 1.30 per patient), R0 was comparable (FAP 93.1 % [95 %CI 88.0-98.1] vs. SAL 97.0 % [95 %CI 93.7-100]; P = 0.19). Adverse events occurred in 28.7 %. Pancreatitis and bleeding were the most common adverse events in both groups. Severe adverse events were rare (3.5 %). Overall, 21 FAP patients (20.8 % [95 %CI 12.7-28.8]) and 16 SAL patients (15.8 % [95 %CI 8.6-23.1]; P = 0.36) had recurrence. Recurrences occurred later in FAP patients (25 [95 %CI 18.3-31.7] vs. 2 [95 %CI CI 0.06-3.9] months). CONCLUSIONS: Endoscopic papillectomy was safe and effective in FAP-related ampullary lesions. Criteria for endoscopic resection of ampullary lesions can be extended to FAP patients. FAP patients have a lifetime risk of relapse even after complete resection, and require long-time surveillance.

Could international human rights obligations motivate countries to implement tobacco cessation support?

BACKGROUND AND AIMS: The World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) seeks to realize the right to health through national tobacco control policies. However, few states have met their obligations under Article 14 of the FCTC to develop evidence-based policies to support tobacco cessation. This article examines how human rights obligations could provide a legal and moral basis for states to implement greater support for individuals to overcome their addiction to tobacco. ANALYSIS: The United Nations (UN) has a well-established legal framework for promoting human rights, looking to the right to health to realize health autonomy. Where addiction undermines autonomy, it is widely acknowledged that addiction presents a significant barrier to cessation for individuals who use tobacco, undermining the right to health. The UN human rights system could, therefore, provide a complementary basis for monitoring state obligations under Article 14 of the FCTC, identifying challenges to FCTC implementation and motivating states to support tobacco cessation. CONCLUSIONS: The United Nations' human rights system offers a mechanism that could be used to monitor Framework Convention on Tobacco Control implementation in national policy, facilitating accountability for the progressive realization of cessation support.

Systematic review and meta-analysis on effectiveness and safety of the full-thickness resection device (FTRD) in the colon.

BACKGROUND: Endoscopic full-thickness resection (EFTR) has expanded the possibilities of endoscopic resection. The full-thickness resection device (FTRD, Ovesco Endoscopy, Tübingen, Germany) combines a clip-based defect closure and snare resection in a single device. METHODS: Systematic review and meta-analysis on effectiveness and safety of the FTRD in the colon. RESULTS: A total of 26 studies (12 published as full-text articles and 14 conference papers) with 1538 FTRD procedures were included. The pooled estimate for reaching the target lesion was 96.1 % (95 % confidence interval [95 % CI]: 94.6-97.1) and 90.0 % (95 % CI: 87.0-92.3) for technically successful resection. Pooled estimate of histologically complete resection was 77.8 % (95 % CI: 74.7-80.6). Adverse events occurred at a pooled estimate rate of 8.0 % (95 % CI: 5.8-10.4). Pooled estimates for bleeding and perforation were 1.5 % (95 % CI: 0.3-3.3) and 0.3 % (95 % CI: 0.0-0.9), respectively. The rate for need of emergency surgery after FTRD was 1.0 % (95 % CI: 0.4-1.8). CONCLUSION: The use of the FTRD in the colon shows very high rates of technical success and complete resection (R0) as well as a low risk of adverse events. Emergency surgery after colonic FTRD resection is necessary in single cases only.

Telemetric capsule-based upper gastrointestinal tract - blood detection - first multicentric experience.

INTRODUCTION: Risk stratification in upper gastrointestinal bleeding (UGIB) currently relies on clinical parameters and risk scores. HemoPill® acute (Ovesco Endoscopy, Tuebingen, Germany) is a pill-shaped, orally administered sensor capsule for real-time blood detection. The aim of this study was to evaluate the system in clinical routine. MATERIAL AND METHODS: Sixty-one consecutive patients in whom the HemoPill® had been used at 12 international hospitals between July 2019 and March 2020 were retrospectively analysed. Indications for application were the clinical suspicion of UGIB, small bowel bleeding, of rebleeding after hemostasis. Primary endpoints were technical success and bleeding detection/exclusion. Secondary endpoints included adverse events and change of clinical course. RESULTS: The capsule was used in 45 (73%) patients with UGIB, in 12 (20%) patients with small bowel bleeding and in four (7%) patients for exclusion of rebleeding. Technical success was 98%. 35/60 (58%) cases were capsule-positive and among these, endoscopy showed bleeding in 20/35 (57%) cases. None of the 25 capsule-negative patients rebled. Emergency endoscopy could be avoided in 18/25 (72%) cases. Serious adverse events did not occur. CONCLUSION: HemoPill®-based blood detection is feasible and safe. Negative capsule results might 'downgrade' the need for urgent endoscopy.

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.

Risk of appendicitis after endoscopic full-thickness resection of lesions involving the appendiceal orifice: a retrospective analysis.

BACKGROUND: Conventional endoscopic resection of lesions affecting the appendiceal orifice is difficult. Endoscopic full-thickness resection (EFTR) is a novel technique in interventional endoscopy. As EFTR near the appendiceal orifice is associated with a subtotal appendectomy, it remains unclear whether the risk of developing appendicitis is increased. We conducted a retrospective analysis of lesions involving the appendiceal orifice treated by EFTR. METHODS: This was a multicenter retrospective analysis of patients (n = 50) treated with EFTR for lesions involving the appendiceal orifice between 2014 and 2019. The objective was to evaluate the occurrence of appendicitis. RESULTS: Acute appendicitis occurred in seven patients (14 %) during follow-up. Conservative treatment was sufficient in four cases, and three patients underwent appendectomy. CONCLUSIONS: EFTR of lesions involving the appendiceal orifice may be associated with an imminent risk of developing appendicitis and a consecutive need for appendectomy. Patients should be informed about this specific risk prior to resection. It is unclear why some patients develop appendicitis while the majority remains asymptomatic.

Smartphone Application to Reinforce Education Increases High-Quality Preparation for Colorectal Cancer Screening Colonoscopies in a Randomized Trial.

BACKGROUND & AIMS: Sufficient bowel preparation is crucial for successful screening and surveillance colonoscopy. However, rates of inadequate preparation are still high. We investigated the effects of reinforced patient education using a smartphone application software (APP) for colonoscopy preparation in participants in a CRC screening program. METHODS: We performed a prospective, endoscopist-blinded study of 500 patients undergoing split-dose bowel preparation for CRC screening or surveillance colonoscopies at multiple centers in Germany, from November 2017 through January 2019. Participants (n = 500) were given oral and written instructions during their initial appointment and then randomly assigned (1:1) to groups that received reinforced education starting 3 days before the colonoscopy (APP group) or no further education (controls). The primary outcome was quality of bowel preparation according to the Boston bowel preparation scale. Secondary outcomes included polyp and adenoma detection rates, compliance with low-fiber diet, split-dose laxative intake, perceived discomfort from the preparation procedure. RESULTS: The mean Boston bowel preparation scale score was significantly higher in the APP-group (7.6 ± 0.1) than in the control group (6.7 ± 0.1) (P < .0001). The percentage of patients with insufficient bowel preparation was significantly lower in the APP group (8%) than in the control group (17%) (P = .0023). The adenoma detection rate was significantly higher in the APP group (35% vs 27% in controls) (P = .0324). Use of the APP was accompanied by a lower level of non-compliance with correct laxative intake (P =.0080) and diet instructions (P = .0089). The APP group reported a lower level of discomfort during preparation (P < .0001). CONCLUSIONS: In a randomized trial, reinforcing patient education with a smartphone application optimized bowel preparation in the 3 days before colonoscopy, increasing bowel cleanliness, adenoma detection, and compliance in patients undergoing CRC screening or surveillance. ClinicalTrials.gov no: NCT03290157.

Efficacy and Safety of Endoscopic Full-Thickness Resection in the Colorectum: Results From the German Colonic FTRD Registry.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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%). DISCUSSION: 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.

Stability of a Melt Pool during 3D-Printing of an Unsupported Steel Component and Its Influence on Roughness.

: The following work presents the results of an investigation of the cause-effect relationship between the stability of a melt pool and the roughness of an inclined, unsupported steel surface that was 3D-printed using the laser powder bed fusion (PBF-L/M) process. In order to observe the balling effect and decrease in surface quality, the samples were printed with no supporting structures placed on the downskin. The stability of the melt pool was investigated as a function of both the inclination angle and along the length of the melt pool. Single-track cross-sections were described by shape parameters and were compared and used to calculate the forces acting on the melt pool as the downskin was printed. The single-melt track tests were printed to produce a series of samples with increasing inclination angles with respect to the baseplate. The increasing angles enabled us to physically simulate specific solidification conditions during the sample printing process. As the inclination angle of the unsupported surface increased, the melt-pool altered in terms of its size, geometry, contact angles, and maximum length of stability. The balling phenomenon was observed, quantified, and compared using roughness tests; it was influenced by the melt track stability according to its geometry. The research results show that a higher linear energy input may decrease the roughness of unsupported surfaces with low inclination angles, while a lower linear energy input may be more effective with higher inclination angles.

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.

Full-thickness resection of neuroendocrine tumors in the rectum.

BACKGROUND: Rectal neuroendocrine tumors (NETs) are subepithelial tumors with potential for malignancy. Depending on tumor characteristics, endoscopic or surgical resection is recommended. However, the optimal endoscopic approach is not defined. This is the first larger study evaluating endoscopic full-thickness resection (EFTR) of rectal NETs. METHODS: For resection, the full-thickness resection device (FTRD) was used. A registry was created as part of post-market clinical follow-up. All cases of rectal NETs in the registry were analyzed retrospectively. RESULTS: 31 German centers entered data of 501 FTRD procedures and 40 cases of rectal NETs were identified. The median lesion size was 8 mm. All lesions could be resected using FTRD. The median procedure time was 18.5 minutes. Resection was macroscopically and histologically complete in all cases. Full-thickness resection was achieved in 95 %. No major adverse events occurred. Endoscopic follow-up showed no evidence of residual or recurrent tumor. CONCLUSION: EFTR is safe and effective for resection of smaller rectal NETs. Prospective comparative trials are needed to define the role of EFTR of rectal NETs.

Over-the-scope clips are cost-effective in recurrent peptic ulcer bleeding.

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.

Novel technique for endoscopic en bloc resection (EMR+) - Evaluation in a porcine model.

BACKGROUND: Endoscopic en bloc resection of larger polyps is relevant because risk of advanced neoplasia or malignancy correlates with tumor size. Recurrence rates after piecemeal endoscopic mucosal resection (EMR) are high and endoscopic submucosal dissection (ESD) is associated with higher complication rates in the western world. AIM: To develop a modified endoscopic en bloc resection technique using an external additional working channel and novel agent for submucosal injection. METHODS: EMR+ was considered as modified grasp and snare technique. For simultaneous use of a grasping and cutting device a novel additional working channel was used (AWC®, Ovesco Endoscopy, Tübingen, Germany). AWC® is installed on the outer surface of the endoscope, covered with a plastic sleeve and designed for single use. For submucosal injection a new agent consisting of poloxamers was used (LiftUp®, Ovesco Endoscopy, Tübingen, Germany). The agent is liquid at room temperature and forms a stable and permanent gel cushion after injection. Safety of LiftUp® has been shown in a pre-clinical study in domestic pigs. LiftUp® is commercially not yet available but approval is expected in early 2019. EMR+ was first developed ex vivo (explanted pig stomach) and subsequently evaluated in vivo (stomach, porcine model, 3 domestic pigs). Main outcome measurements were: Procedure time, macroscopic en bloc resection and adverse events. RESULTS: Concept of EMR+ was first developed ex vivo (explanted pig stomach). Ex vivo, 22 resections were performed after technique was established. Median procedure time (measured from begin of injection to extraction of resection specimen) was 7 min (range 5-11, SD 1.68) and median size of resection specimens was 30 mm × 26 mm × 11 mm ex vivo. Subsequently 13 resections were performed in vivo (stomach, porcine model, 3 domestic pigs). In vivo, median procedure time (measured from begin of injection to extraction of resection specimen) was 5 min (range 3-12, SD 2.72) and median size of resection specimens was 35 mm × 35 mm × 11 mm. In vivo, resection was macroscopic complete in 92.3%, major adverse events were not observed. In one case (7.7%) minor periprocedural bleeding was observed and managed by coagulation. CONCLUSION: EMR+ appeared to be effective and safe and was easy and fast to perform in the porcine model. EMR+ needs to be further evaluated clinically in comparative trials.

Endoscopic full-thickness resection for early colorectal cancer.

BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

A 'burning opportunity' for human rights: using human rights as a catalyst for policies to mitigate the health risk of household air pollution.

With over 3 billion people dependent on traditional cooking and heating technologies, efforts to address the health burden of exposure to household air pollution (HAP), as well as other sociodemographic impacts associated with energy poverty, are central to sustainable development objectives. Yet despite overwhelming scientific consensus on the health burden of HAP exposure, particularly harms to impoverished women and children in developing countries, advocates currently lack a human rights framework to mitigate HAP exposure through improved access to cleaner household energy systems. This article examines the role of human rights in framing state obligations to mitigate HAP exposure, supporting environmental health for the most vulnerable through intersectional obligations across the human right to health, the collective right to development, and women's and children's rights. Drawing from human rights advocacy employed in confronting the public health harms of tobacco, we argue that rights-based civil society advocacy can structure the multi-sectoral policies necessary to address the impacts of HAP exposure and energy poverty, facilitating accountability for human rights implementation through international treaty bodies, national judicial challenges and local political advocacy. We conclude that there is a pressing need to build civil society capacity for a rights-based approach to cleaner household energy policy as a means to alleviate the environmental health effects of energy poverty.