Cold Versus Hot Snare Endoscopic Resection of Large Nonpedunculated Colorectal Polyps: Randomized Controlled German CHRONICLE Trial.

BACKGROUND & AIMS: Endoscopic mucosal resection (EMR) is standard therapy for nonpedunculated colorectal polyps ≥20 mm. It has been suggested recently that polyp resection without current (cold resection) may be superior to the standard technique using cutting/coagulation current (hot resection) by reducing adverse events (AEs), but evidence from a randomized trial is missing. METHODS: In this randomized controlled multicentric trial involving 19 centers, nonpedunculated colorectal polyps ≥20 mm were randomly assigned to cold or hot EMR. The primary outcome was major AE (eg, perforation or postendoscopic bleeding). Among secondary outcomes, major AE subcategories, postpolypectomy syndrome, and residual adenoma were most relevant. RESULTS: Between 2021 and 2023, there were 396 polyps in 363 patients (48.2% were female) enrolled for the intention-to-treat analysis. Major AEs occurred in 1.0% of the cold group and in 7.9% of the hot group (P = .001; odds ratio [OR], 0.12; 95% CI, 0.03-0.54). Rates for perforation and postendoscopic bleeding were significantly lower in the cold group, with 0% vs 3.9% (P = .007) and 1.0% vs 4.4% (P = .040). Postpolypectomy syndrome occurred with similar frequency (3.1% vs 4.4%; P = .490). After cold resection, residual adenoma was found more frequently, with 23.7% vs 13.8% (P = .020; OR, 1.94; 95% CI, 1.12-3.38). In multivariable analysis, lesion diameter of ≥4 cm was an independent predictor both for major AEs (OR, 3.37) and residual adenoma (OR, 2.47) and high-grade dysplasia/cancer for residual adenoma (OR, 2.92). CONCLUSIONS: Cold resection of large, nonpedunculated colorectal polyps appears to be considerably safer than hot EMR; however, at the cost of a higher residual adenoma rate. Further studies have to confirm to what extent polyp size and histology can determine an individualized approach. German Clinical Trials Registry (Deutsches Register Klinischer Studien), Number DRKS00025170.

Reducing scope 3 carbon emissions in gastrointestinal endoscopy: results of the prospective study of the 'Green Endoscopy Project Würzburg'.

OBJECTIVE: Carbon emissions generated by gastrointestinal endoscopy have been recognised as a critical issue. Scope 3 emissions are mainly caused by the manufacturing, packaging and transportation of purchased goods. However, to our knowledge, there are no prospective data on the efficacy of measurements aimed to reduce scope 3 emissions. DESIGN: The study was performed in a medium-sized academic endoscopy unit. Manufacturers of endoscopic consumables were requested to answer a questionnaire on fabrication, origin, packaging and transport. Based on these data, alternative products were purchased whenever possible. In addition, staff was instructed on how to avoid waste. Thereafter, the carbon footprint of each item purchased was calculated from February to May 2023 (intervention period), and scope 3 emissions were compared with the same period of the previous year (control period). RESULTS: 26 of 40 companies answered the questionnaire. 229 of 322 products were classified as unfavourable. A switch to alternative items was possible for 47/229 items (20.5%). 1666 endoscopies were performed during the intervention period compared with 1751 examinations during the control period (-4.1%). The number of instruments used decreased by 10.0% (3111 vs 3457). Using fewer and alternative products resulted in 11.5% less carbon emissions (7.09 vs 8.01 tons of carbon equivalent=tCO2 e). Separation of waste led to a reduction of 20.1% (26.55 vs 33.24 tCO2e). In total, carbon emissions could be reduced by 18.4%. CONCLUSION: Use of fewer instruments per procedure, recycling packaging material and switching to alternative products can reduce carbon emissions without impairing the endoscopic workflow.

Direct comparison of multiple computer-aided polyp detection systems.

BACKGROUND AND STUDY AIMS: Artificial intelligence (AI)-based systems for computer-aided detection (CADe) of polyps receive regular updates and occasionally offer customizable detection thresholds, both of which impact their performance, but little is known about these effects. This study aimed to compare the performance of different CADe systems on the same benchmark dataset. METHODS: 101 colonoscopy videos were used as benchmark. Each video frame with a visible polyp was manually annotated with bounding boxes, resulting in 129 705 polyp images. The videos were then analyzed by three different CADe systems, representing five conditions: two versions of GI Genius, Endo-AID with detection Types A and B, and EndoMind, a freely available system. Evaluation included an analysis of sensitivity and false-positive rate, among other metrics. RESULTS: Endo-AID detection Type A, the earlier version of GI Genius, and EndoMind detected all 93 polyps. Both the later version of GI Genius and Endo-AID Type B missed 1 polyp. The mean per-frame sensitivities were 50.63 % and 67.85 %, respectively, for the earlier and later versions of GI Genius, 65.60 % and 52.95 %, respectively, for Endo-AID Types A and B, and 60.22 % for EndoMind. CONCLUSIONS: This study compares the performance of different CADe systems, different updates, and different configuration modes. This might help clinicians to select the most appropriate system for their specific needs.

Closing the Gap: A Critical Examination of Adherence, Inconsistency, and Improvements in Colonoscopy Reporting Practices.

INTRODUCTION: Comprehensive and standardized colonoscopy reports are crucial in colorectal cancer prevention, monitoring, and research. This study investigates adherence to national and international guidelines by analyzing reporting practices among 21 endoscopists in 7 German centers, with a focus on polyp reporting. METHODS: We identified and assessed German, European, American, and World Health Organization-provided statements to identify key elements in colonoscopy reporting. Board-certified gastroenterologists rated the relevance of each element and estimated their reporting frequency. Adherence to the identified report elements was evaluated for 874 polyps from 351 colonoscopy reports ranging from March 2021 to March 2022. RESULTS: We identified numerous recommendations for colonoscopy reporting. We categorized the reasoning behind those recommendations into clinical relevance, justification, and quality control and research. Although all elements were considered relevant by the surveyed gastroenterologists, discrepancies were observed in the evaluated reports. Particularly diminutive polyps or attributes which are rarely abnormal (e.g., surface integrity) respectively rarely performed (e.g., injection) were sparsely documented. Furthermore, the white light morphology of polyps was inconsistently documented using either the Paris classification or free text. In summary, the analysis of 874 reported polyps revealed heterogeneous adherence to the recommendations, with reporting frequencies ranging from 3% to 89%. CONCLUSION: The inhomogeneous report practices may result from implicit reporting practices and recommendations with varying clinical relevance. Future recommendations should clearly differentiate between clinical relevance and research and quality control or explanatory purposes. Additionally, the role of computer-assisted documentation should be further evaluated to increase report frequencies of non-pathological findings and diminutive polyps.

Assisted documentation as a new focus for artificial intelligence in endoscopy: the precedent of reliable withdrawal time and image reporting.

BACKGROUND : Reliable documentation is essential for maintaining quality standards in endoscopy; however, in clinical practice, report quality varies. We developed an artificial intelligence (AI)-based prototype for the measurement of withdrawal and intervention times, and automatic photodocumentation. METHOD: A multiclass deep learning algorithm distinguishing different endoscopic image content was trained with 10 557 images (1300 examinations, nine centers, four processors). Consecutively, the algorithm was used to calculate withdrawal time (AI prediction) and extract relevant images. Validation was performed on 100 colonoscopy videos (five centers). The reported and AI-predicted withdrawal times were compared with video-based measurement; photodocumentation was compared for documented polypectomies. RESULTS: Video-based measurement in 100 colonoscopies revealed a median absolute difference of 2.0 minutes between the measured and reported withdrawal times, compared with 0.4 minutes for AI predictions. The original photodocumentation represented the cecum in 88 examinations compared with 98/100 examinations for the AI-generated documentation. For 39/104 polypectomies, the examiners' photographs included the instrument, compared with 68 for the AI images. Lastly, we demonstrated real-time capability (10 colonoscopies). CONCLUSION : Our AI system calculates withdrawal time, provides an image report, and is real-time ready. After further validation, the system may improve standardized reporting, while decreasing the workload created by routine documentation.

Artificial intelligence-based polyp size measurement in gastrointestinal endoscopy using the auxiliary waterjet as a reference.

BACKGROUND: Measurement of colorectal polyp size during endoscopy is mainly performed visually. In this work, we propose a novel polyp size measurement system (Poseidon) based on artificial intelligence (AI) using the auxiliary waterjet as a measurement reference. METHODS: Visual estimation, biopsy forceps-based estimation, and Poseidon were compared using a computed tomography colonography-based silicone model with 28 polyps of defined sizes. Four experienced gastroenterologists estimated polyp sizes visually and with biopsy forceps. Furthermore, the gastroenterologists recorded images of each polyp with the waterjet in proximity for the application of Poseidon. Additionally, Poseidon's measurements of 29 colorectal polyps during routine clinical practice were compared with visual estimates. RESULTS: In the silicone model, visual estimation had the largest median percentage error of 25.1 % (95 %CI 19.1 %-30.4 %), followed by biopsy forceps-based estimation: median 20.0 % (95 %CI 14.4 %-25.6 %). Poseidon gave a significantly lower median percentage error of 7.4 % (95 %CI 5.0 %-9.4 %) compared with other methods. During routine colonoscopies, Poseidon presented a significantly lower median percentage error (7.7 %, 95 %CI 6.1 %-9.3 %) than visual estimation (22.1 %, 95 %CI 15.1 %-26.9 %). CONCLUSION: In this work, we present a novel AI-based method for measuring colorectal polyp size with significantly higher accuracy than other common sizing methods.

Quality of life in benign colorectal disease-a review of the assessment with the Gastrointestinal Quality of Life Index (GIQLI).

BACKGROUND AND PURPOSE: The Gastrointestinal Quality of Life Index (GIQLI) is an instrument for the assessment of quality of life (QOL) in diseases of the upper and lower GI tract, which is validated in several languages around the world. The purpose of this literature review is the assessment of the GIQLI in patients with benign colorectal diseases. Reports on GIQLI data are collected from several institutions, countries, and different cultures which allows for comparisons, which are lacking in literature. METHODS: The GIQL Index uses 36 items around 5 dimensions (gastrointestinal symptoms (19 items), emotional dimension (5 items), physical dimension (7 items), social dimension (4 items), and therapeutic influences (1 item). The literature search was performed on the GIQLI and colorectal disease, using reports in PubMed. Data are presented descriptively as GIQL Index points as well as a reduction from 100% maximum possible index points (max 144 index points = highest quality of life). RESULTS: The GIQLI was found in 122 reports concerning benign colorectal diseases, of which 27 were finally selected for detailed analysis. From these 27 studies, information on 5664 patients (4046 female versus 1178 male) was recorded and summarized. The median age was 52 years (range 29-74.7). The median GIQLI of all studies concerning benign colorectal disease was 88 index points (range 56.2-113). Benign colorectal disease causes a severe reduction in QOL for patients down to 61% of the maximum. CONCLUSIONS: Benign colorectal diseases cause substantial reductions in the patient's QOL, well documented by GIQLI, which allows a comparison QOL with other published cohorts.

New Concept of External and Independent Next-to-the-Scope Intraluminal Grasping Device (EINTS).

Background: Interventional endoscopic procedures require complex manipulations and precise maneuvering of end-effectors. One focus in research on improved endoscopic instrument function was based on surgical experience to gain additional traction. The idea has emerged using assisting instruments by applying external tools next-to-the endoscope to follow surgical concepts. The aim of this study is the assessment of flexible endoscopic grasping instruments regarding their function and working-radius introducing the concept of an intraluminal "next-to the-scope" endoscopic grasper. Methods: In this study endoscopic graspers are evaluated (1:through-the-scope-grasper, TTSG; 2:additional-working-channel-system AWC-S;3:external-independent-next-to-the-scope-grasper EINTS-G) regarding their working-radius, grasping abilities, maneuverability and the ability to expose tissue with varying angulation. Results: The working radius of the tools attached or within the endoscope (TTS-G and AWC-S) benefit from the steering abilities of the scope reaching 180-210 degrees in retroflexion; EINTS-G is limited to 110-degrees. The robust EINTS-grasper has the advantage of stronger grip for grasping and pulling force, which enables manipulation of larger objects. The independent maneuverability during ESD-dissection provides better tissue-exposure by changing the traction-angulation. Conclusion: The working radius of tools attached to the endoscope benefit from scope- steering. The EINTS-grasper has the advantage of stronger grasping force and pulling within the GI-tract and independent maneuverability enables improved tissue-exposure. WC200.

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.

New concept for colonoscopy including side optics and artificial intelligence.

BACKGROUND AND AIMS: Adenoma detection rate is the crucial parameter for colorectal cancer screening. Increasing the field of view with additional side optics has been reported to detect flat adenomas hidden behind folds. Furthermore, artificial intelligence (AI) has also recently been introduced to detect more adenomas. We therefore aimed to combine both technologies in a new prototypic colonoscopy concept. METHODS: A 3-dimensional-printed cap including 2 microcameras was attached to a conventional endoscope. The prototype was applied in 8 gene-targeted pigs with mutations in the adenomatous polyposis coli gene. The first 4 animals were used to train an AI system based on the images generated by microcameras. Thereafter, the conceptual prototype for detecting adenomas was tested in a further series of 4 pigs. RESULTS: Using our prototype, we detected, with side optics, adenomas that might have been missed conventionally. Furthermore, the newly developed AI could detect, mark, and present adenomas visualized with side optics outside of the conventional field of view. CONCLUSIONS: Combining AI with side optics might help detect adenomas that otherwise might have been missed.

The influence of computer-aided polyp detection systems on reaction time for polyp detection and eye gaze.

BACKGROUND: Multiple computer-aided systems for polyp detection (CADe) have been introduced into clinical practice, with an unclear effect on examiner behavior. This study aimed to measure the influence of a CADe system on reaction time, mucosa misinterpretation, and changes in visual gaze pattern. METHODS: Participants with variable levels of colonoscopy experience viewed video sequences (n = 29) while eye movement was tracked. Using a crossover design, videos were presented in two assessments, with and without CADe support. Reaction time for polyp detection and eye-tracking metrics were evaluated. RESULTS: 21 participants performed 1218 experiments. CADe was significantly faster in detecting polyps compared with participants (median 1.16 seconds [99 %CI 0.40-3.43] vs. 2.97 seconds [99 %CI 2.53-3.77], respectively). However, the reaction time of participants when using CADe (median 2.90 seconds [99 %CI 2.55-3.38]) was similar to that without CADe. CADe increased misinterpretation of normal mucosa and reduced the eye travel distance. CONCLUSIONS: Results confirm that CADe systems detect polyps faster than humans. However, use of CADe did not improve human reaction times. It increased misinterpretation of normal mucosa and decreased the eye travel distance. Possible consequences of these findings might be prolonged examination time and deskilling.

A video based benchmark data set (ENDOTEST) to evaluate computer-aided polyp detection systems.

BACKGROUND AND AIMS: Computer-aided polyp detection (CADe) may become a standard for polyp detection during colonoscopy. Several systems are already commercially available. We report on a video-based benchmark technique for the first preclinical assessment of such systems before comparative randomized trials are to be undertaken. Additionally, we compare a commercially available CADe system with our newly developed one. METHODS: ENDOTEST consisted in the combination of two datasets. The validation dataset contained 48 video-snippets with 22,856 manually annotated images of which 53.2% contained polyps. The performance dataset contained 10 full-length screening colonoscopies with 230,898 manually annotated images of which 15.8% contained a polyp. Assessment parameters were accuracy for polyp detection and time delay to first polyp detection after polyp appearance (FDT). Two CADe systems were assessed: a commercial CADe system (GI-Genius, Medtronic), and a self-developed new system (ENDOMIND). The latter being a convolutional neuronal network trained on 194,983 manually labeled images extracted from colonoscopy videos recorded in mainly six different gastroenterologic practices. RESULTS: On the ENDOTEST, both CADe systems detected all polyps in at least one image. The per-frame sensitivity and specificity in full colonoscopies was 48.1% and 93.7%, respectively for GI-Genius; and 54% and 92.7%, respectively for ENDOMIND. Median FDT of ENDOMIND with 217 ms (Inter-Quartile Range(IQR)8-1533) was significantly faster than GI-Genius with 1050 ms (IQR 358-2767, p = 0.003). CONCLUSIONS: Our benchmark ENDOTEST may be helpful for preclinical testing of new CADe devices. There seems to be a correlation between a shorter FDT with a higher sensitivity and a lower specificity for polyp detection.

Pilot study of a new freely available computer-aided polyp detection system in clinical practice.

PURPOSE: Computer-aided polyp detection (CADe) systems for colonoscopy are already presented to increase adenoma detection rate (ADR) in randomized clinical trials. Those commercially available closed systems often do not allow for data collection and algorithm optimization, for example regarding the usage of different endoscopy processors. Here, we present the first clinical experiences of a, for research purposes publicly available, CADe system. METHODS: We developed an end-to-end data acquisition and polyp detection system named EndoMind. Examiners of four centers utilizing four different endoscopy processors used EndoMind during their clinical routine. Detected polyps, ADR, time to first detection of a polyp (TFD), and system usability were evaluated (NCT05006092). RESULTS: During 41 colonoscopies, EndoMind detected 29 of 29 adenomas in 66 of 66 polyps resulting in an ADR of 41.5%. Median TFD was 130 ms (95%-CI, 80-200 ms) while maintaining a median false positive rate of 2.2% (95%-CI, 1.7-2.8%). The four participating centers rated the system using the System Usability Scale with a median of 96.3 (95%-CI, 70-100). CONCLUSION: EndoMind's ability to acquire data, detect polyps in real-time, and high usability score indicate substantial practical value for research and clinical practice. Still, clinical benefit, measured by ADR, has to be determined in a prospective randomized controlled trial.

Gastrointestinal Quality of Life in Gastroesophageal Reflux Disease: A Systematic Review.

BACKGROUND: The Gastrointestinal Quality of Life Index (GIQLI) is a well-established instrument for the assessment of quality of life (QOL) in gastrointestinal (GI) diseases. The purpose of this literature review was to investigate QOL by means of GIQLI in patients with gastroesophageal reflux disease (GERD) prior to any interventional therapy. There are several reports on GIQLI data; however, comparisons from different countries and/or different GERD cohorts assessing the same disease have to date not been conducted. METHODS: The GIQLI uses 36 items around 5 dimensions (GI symptoms [19 items], emotional dimension [5 items], physical dimension [7 items], social dimension [4 items], and therapeutic influences [1 item]). A literature search was conducted on the application of GIQLI in GERD patients prior to interventional therapy using reports in PubMed. Data on the mean GIQLI as well as index data for the 5 dimensions as originally validated were extracted from the published patient cohorts. A comparison with the normal healthy control group from the original publication of the GIQLI validation conducted by Eypasch was performed. Data are presented descriptively as GIQLI points as well as a reduction from 100% maximum possible index points (max 144 index points = highest QOL). RESULTS: In total, 77 abstracts from studies using the GIQLI on patients with GERD were identified. After screening for content, 21 publications were considered for further analysis. Ten studies in GERD patients comprised complete calculations of all dimensions and were included in the analysis. Data from 1,682 study patients were evaluated with sample sizes ranging from 33 to 568 patients (median age of 789 females and 858 males: 51.8 years). The median overall GIQLI for the patient group was 91.7 (range 86-102.4), corresponding to 63.68% of the maximum GIQLI. The dimensions with the largest deviation from the respective maximum score were the physical dimension (55% of maximum) followed by the emotional dimension (60% of maximum). In summary, the GIQLI level in GERD cohorts was reduced to 55-75% of the maximum possible index. CONCLUSIONS: Severe GERD causes substantial reductions in the patient's QOL. The level of GIQLI can carry between different studied GERD cohorts from different departments and countries. GIQLI can be used as an established tool to assess the patient's condition in various dimensions.

Frame-by-Frame Analysis of a Commercially Available Artificial Intelligence Polyp Detection System in Full-Length Colonoscopies.

INTRODUCTION: Computer-aided detection (CADe) helps increase colonoscopic polyp detection. However, little is known about other performance metrics like the number and duration of false-positive (FP) activations or how stable the detection of a polyp is. METHODS: 111 colonoscopy videos with total 1,793,371 frames were analyzed on a frame-by-frame basis using a commercially available CADe system (GI-Genius, Medtronic Inc.). Primary endpoint was the number and duration of FP activations per colonoscopy. Additionally, we analyzed other CADe performance parameters, including per-polyp sensitivity, per-frame sensitivity, and first detection time of a polyp. We additionally investigated whether a threshold for withholding CADe activations can be set to suppress short FP activations and how this threshold alters the CADe performance parameters. RESULTS: A mean of 101 ± 88 FPs per colonoscopy were found. Most of the FPs consisted of less than three frames with a maximal 66-ms duration. The CADe system detected all 118 polyps and achieved a mean per-frame sensitivity of 46.6 ± 26.6%, with the lowest value for flat polyps (37.6 ± 24.8%). Withholding CADe detections up to 6 frames length would reduce the number of FPs by 87.97% (p < 0.001) without a significant impact on CADe performance metrics. CONCLUSIONS: The CADe system works reliable but generates many FPs as a side effect. Since most FPs are very short, withholding short-term CADe activations could substantially reduce the number of FPs without impact on other performance metrics. Clinical practice would benefit from the implementation of customizable CADe thresholds.

PLAFOKON: a new concept for a patient-individual and intervention-specific flexible surgical platform.

BACKGROUND: Research in the field of surgery is mainly driven by aiming for trauma reduction as well as for personalized treatment concepts. Beyond laparoscopy, other proposed approaches for further reduction of the therapeutic trauma have failed to achieve clinical translation, with few notable exceptions. We believe that this is mainly due to a lack of flexibility and high associated costs. We aimed at addressing these issues by developing a novel minimally invasive operating platform and a preoperative design workflow for patient-individual adaptation and cost-effective rapid manufacturing of surgical manipulators. In this article, we report on the first in-vitro cholecystectomy performed with our operating platform. METHODS: The single-port overtube (SPOT) is a snake-like surgical manipulator for minimally invasive interventions. The system layout is highly flexible and can be adapted in design and dimensions for different kinds of surgery, based on patient- and disease-specific parameters. For collecting and analyzing this data, we developed a graphical user interface, which assists clinicians during the preoperative planning phase. Other major components of our operating platform include an instrument management system and a non-sterile user interface. For the trial surgery, we used a validated phantom which was further equipped with a porcine liver including the gallbladder. RESULTS: Following our envisioned preoperative design workflow, a suitable geometry of the surgical manipulator was determined for our trial surgery and rapidly manufactured by means of 3D printing. With this setup, we successfully performed a first in-vitro cholecystectomy, which was completed in 78 min. CONCLUSIONS: By conducting the trial surgery, we demonstrated the effectiveness of our PLAFOKON operating platform. While some aspects - especially regarding usability and ergonomics - can be further optimized, the overall performance of the system is highly promising, with sufficient flexibility and strength for conducting the necessary tissue manipulations.

Evolution of endoscopic vacuum therapy for upper gastrointestinal leakage over a 10-year period: a quality improvement study.

BACKGROUND: Endoscopic vacuum therapy (EVT) is an effective treatment option for leakage of the upper gastrointestinal (UGI) tract. The aim of this study was to evaluate the clinical impact of quality improvements in EVT management on patients' outcome. METHODS: All patients treated by EVT at our center during 2012-2021 were divided into two consecutive and equal-sized cohorts (period 1 vs. period 2). Over time several quality improvement strategies were implemented including the earlier diagnosis and EVT treatment and technical optimization of endoscopy. The primary endpoint was defined as the composite score MTL30 (mortality, transfer, length-of-stay > 30 days). Secondary endpoints included EVT efficacy, complications, in-hospital mortality, length-of-stay (LOS) and nutrition status at discharge. RESULTS: A total of 156 patients were analyzed. During the latter period the primary endpoint MTL30 decreased from 60.8 to 39.0% (P = .006). EVT efficacy increased from 80 to 91% (P = .049). Further, the need for additional procedures for leakage management decreased from 49.9 to 29.9% (P = .013) and reoperations became less frequent (38.0% vs.15.6%; P = .001). The duration of leakage therapy and LOS were shortened from 25 to 14 days (P = .003) and 38 days to 25 days (P = .006), respectively. Morbidity (as determined by the comprehensive complication index) decreased from 54.6 to 46.5 (P = .034). More patients could be discharged on oral nutrition (70.9% vs. 84.4%, P = .043). CONCLUSIONS: Our experience confirms the efficacy of EVT for the successful management of UGI leakage. Our quality improvement analysis demonstrates significant changes in EVT management resulting in accelerated recovery, fewer complications and improved functional outcome.

Risk of recurrence after local resection of T1 rectal cancer: a meta-analysis with meta-regression.

BACKGROUND: T1 rectal cancer (RC) patients are increasingly being treated by local resection alone but uniform surveillance strategies thereafter are lacking. To determine whether different local resection techniques influence the risk of recurrence and cancer-related mortality, a meta-analysis was performed. METHODS: A systematic search was conducted for T1RC patients treated with local surgical resection. The primary outcome was the risk of RC recurrence and RC-related mortality. Pooled estimates were calculated using mixed-effect logistic regression. We also systematically searched and evaluated endoscopically treated T1RC patients in a similar manner. RESULTS: In 2585 unique T1RC patients (86 studies) undergoing local surgical resection, the overall pooled cumulative incidence of recurrence was 9.1% (302 events, 95% CI 7.3-11.4%; I2 = 68.3%). In meta-regression, the recurrence risk was associated with histological risk status (p < 0.005; low-risk 6.6%, 95% CI 4.4-9.7% vs. high-risk 28.2%, 95% CI 19-39.7%) and local surgical resection technique (p < 0.005; TEM/TAMIS 7.7%, 95% CI 5.3-11.0% vs. other local surgical excisions 10.8%, 95% CI 6.7-16.8%). In 641 unique T1RC patients treated with flexible endoscopic excision (16 studies), the risk of recurrence (7.7%, 95% CI 5.2-11.2%), cancer-related mortality (2.3%, 95% CI 1.1-4.9), and cancer-related mortality among patients with recurrence (30.0%, 95% CI 14.7-49.4%) were comparable to outcomes after TEM/TAMIS (risk of recurrence 7.7%, 95% CI 5.3-11.0%, cancer-related mortality 2.8%, 95% CI 1.2-6.2% and among patients with recurrence 35.6%, 95% CI 21.9-51.2%). CONCLUSIONS: Patients with T1 rectal cancer may have a significantly lower recurrence risk after TEM/TAMIS compared to other local surgical resection techniques. After TEM/TAMIS and endoscopic resection the recurrence risk, cancer-related mortality and cancer-related mortality among patients with recurrence were comparable. Recurrence was mainly dependent on histological risk status.

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.

Results in Antireflux Surgery, an Analysis of Case-Controlled Cohorts versus Multicenter Studies and Meta-Analyses.

Introduction: With the advent of minimally invasive techniques, laparoscopic Nissen fundoplication and Toupet partial fundoplication have been very successful in the management of GERD. In the past 10 years, a number of very attractive new technologies have entered the market around therapeutic GERD-management such as Transoral Incisionless Gastroplication, other endoscopic plication techniques, and the implantation of the magnetic sphincter augmentation (MSA). These new technologies are excessively promoted by the respective companies, propagating their techniques as causing fewer side effects. The purpose of this paper is an overview on the successrates of these differently used techniques and technologies and, in addition, different study-designs. Methods: A literature review was performed searching for publications on laparoscopic fundoplication (LF), Transoral Incisionless Fundoplication (TIF), and laparoscopic MSA. The reported classified were separated according to their design into (group 1) large case-controlled series or comparative studies (n 100 cases) from high-volume centers and into (group 2) trials between different technologies of antireflux procedures, multicenter-studies, and meta-analyses of GERD-trials. Results: In total, 4030 abstract were screened according to the selected key words. Following the section criteria, 19 publications were selected and analyzed. Regarding group 1 and LF (selected studies 2565 patients), the morbidity ranged from 2.0-4.8 % of cases. With a follow-up time of 36-222 months most of these patients were followed 5 years. In group 2, more than 150 studies and several multicenter-registries were summarized in these 9 selected publications. The overall follow-up periods were substantially shorter with a range of 7-48 months. Conclusions: It can be concluded that special efforts in patient management in high volume centers and a vast experience may substantially contribute to excellent results for several antireflux techniques, which may reach a level of quality above results of registries and meta-analyses.