Prospective randomized controlled trial comparing a novel and dedicated device with conventional endoscopic techniques for the treatment of buried bumper syndrome (with video).

BACKGROUND AND AIMS: Buried bumper syndrome (BBS) is a rare adverse event of PEG tubes. This study compared the newly developed Flamingo device (Fujifilm Medwork GmbH, Höchstadt, Germany) with conventional endoscopic techniques for BBS treatment. METHODS: This prospective, randomized controlled trial compared the Flamingo set (study group) with other endoscopic techniques (control group) for BBS treatment in 6 German hospitals. The primary endpoint was procedure time. Further outcome parameters were technical success, adverse event rate, and number and cost of devices used in each group. RESULTS: Thirty-six patients (18 in each group; mean age, 73 years; 12 women) were included in this study between March 2018 and December 2022. Median time since placement of the feeding tube was 30 months. The bumper was located in the gastric corpus in 27 patients, and the internal bumper was completely overgrown in 31 patients. The duration of the removal procedure was 17 minutes (range, 3-72) in the study group compared with 38 minutes (range, 12-111) in the control group (P = .046). The primary technical success rate was 77.8% in the study group and 55.6% in the control group (P = .157), whereas the overall technical success rate was 100% compared with 83.3% (P = .070). Adverse events occurred in 4 patients (11.1%). CONCLUSIONS: Endoscopic removal of the buried bumper using the Flamingo device was significantly faster than that with other endoscopic techniques and showed a higher technical success rate. This device may become the endoscopic treatment of choice for BBS. (Clinical trial registration number: NCT03186066.).

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.

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.

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.

Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2).

OBJECTIVE: Acute non-variceal upper gastrointestinal bleeding (NVUGIB) is managed by standard endoscopic combination therapy, but a few cases remain difficult and carry a high risk of persistent or recurrent bleeding. The aim of our study was to compare first-line over-the-scope-clips (OTSC) therapy with standard endoscopic treatment in these selected patients. DESIGN: We conducted a prospective, randomised, controlled, multicentre study (NCT03331224). Patients with endoscopic evidence of acute NVUGIB and high risk of rebleeding (defined as complete Rockall Score ≥7) were included. Primary endpoint was clinical success defined as successful endoscopic haemostasis without evidence of recurrent bleeding. RESULTS: 246 patients were screened and 100 patients were finally randomised (mean of 5 cases/centre and year; 70% male, 30% female, mean age 78 years; OTSC group n=48, standard group n=52). All but one case in the standard group were treated with conventional clips. Clinical success was 91.7% (n=44) in the OTSC group compared with 73.1% (n=38) in the ST group (p=0.019), with persistent bleeding occurring in 0 vs 6 in the OTSC versus standard group (p=0.027), all of the latter being successfully managed by rescue therapy with OTSC. Recurrent bleeding was observed in four patients (8.3%) in the OTSC group and in eight patients (15.4%) in the standard group (p=0.362). CONCLUSION: OTSC therapy appears to be superior to standard treatment with clips when used by trained physicians for selected cases of primary therapy of NVUGIB with high risk of rebleeding. Further studies are necessary with regards to patient selection to identify subgroups benefiting most from OTSC haemostasis. TRIAL REGISTRATION NUMBER: NCT03331224.

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.

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.

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.

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.

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.

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.

Global Policy Surveillance: Creating and Using Comparative National Data on Health Law and Policy.

Throughout the world, laws play an important role in shaping population health. Law making is an intervention with measurable effects yet often unfolds without evaluation or monitoring. Policy surveillance-the systematic, scientific collection and analysis of laws of public health significance-can help bridge this gap by capturing important features of law in numeric form in structured longitudinal data sets.Currently deployed primarily in high-income countries, methods for cross-national policy surveillance hold significant promise, particularly given the growing quality and accessibility of global health data. Global policy surveillance can enable comparative research on the implementation and health impact of laws, their spread, and their political determinants. Greater transparency of status and trends in law supports health policy advocacy and promotes public accountability. Collecting, coding, and analyzing laws across countries presents numerous challenges-especially in low-resource settings.With insights from comparative politics and law, we suggest methods to address those challenges. We describe how longitudinal legal data have been used in limited, but important, ways for cross-national analysis and propose incorporating global policy surveillance into core global public health practice.

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.

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.