11 research outputs found
Computer-aided classification of colorectal segments during colonoscopy: a deep learning approach based on images of a magnetic endoscopic positioning device
Assessment of the anatomical colorectal segment of polyps during colonoscopy is important for treatment and follow-up strategies, but is largely operator dependent. This feasibility study aimed to assess whether, using images of a magnetic endoscope imaging (MEI) positioning device, a deep learning approach can be useful to objectively divide the colorectum into anatomical segments. Models based on the VGG-16 based convolutional neural network architecture were developed to classify the colorectum into anatomical segments. These models were pre-trained on ImageNet data and further trained using prospectively collected data of the POLAR study in which endoscopists were using MEI (3930 still images and 90,151 video frames). Five-fold cross validation with multiple runs was used to evaluate the overall diagnostic accuracies of the models for colorectal segment classification (divided into a 5-class and 2-class colorectal segment division). The colorectal segment assignment by endoscopists was used as the reference standard. For the 5-class colorectal segment division, the best performing model correctly classified the colorectal segment in 753 of the 1196 polyps, corresponding to an overall accuracy of 63%, sensitivity of 63%, specificity of 89% and kappa of 0.47. For the 2-class colorectal segment division, 1112 of the 1196 polyps were correctly classified, corresponding to an accuracy of 93%, sensitivity of 93%, specificity of 90% and kappa of 0.82. The diagnostic performance of a deep learning approach for colorectal segment classification based on images of a MEI device is yet suboptimal (clinicaltrials.gov: NCT03822390).</p
SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents*.
SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documents*.</p
Study flowchart.
PPI: proton pump inhibitor (esomeprazole) EBD: endoscopic balloon dilation POEM: Per oral endoscopic myotomy HRM: High resolution manometry pH-MII: 24 hour pH-impedance study EGD: esophagogastricduodenoscopy. *# depending on age: children ≥12 yrs receive EBD with a 40 mm balloon diameter ## depending on age: children ≥12 yrs receive EBD with 35 and 40 mm balloon diameter.</p
Achalasia subtypes.
1A: achalasia type 1: absent peristalsis and failure to relax LES. 1B: achalasia type 2 with panesophageal pressurization and failure to relax LES.</p
S1 File -
IntroductionAchalasia is a rare neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone and absence of esophageal peristalsis. Achalasia requires invasive treatment in all patients. Conventional treatment options include endoscopic balloon dilation (EBD) and laparoscopic Heller’s myotomy (LHM). Recently, a less invasive endoscopic therapy has been developed; Peroral Endoscopic Myotomy (POEM). POEM integrates the theoretical advantages of both EBD and LHM (no skin incisions, less pain, short hospital stay, less blood loss and a durable myotomy). Our aim is to compare efficacy and safety of POEM vs. EBD as primary treatment for achalasia in children.Methods and analysisThis multi-center, and center-stratified block-randomized controlled trial will assess safety and efficacy of POEM vs EBD. Primary outcome measure is the need for retreatment due to treatment failure (i.e. persisting symptoms (Eckardt score > 3) with evidence of recurrence on barium swallow and/or HRM within 12 months follow-up) as assed by a blinded end-point committee (PROBE design).DiscussionThis RCT will be the first one to evaluate which endoscopic therapy is most effective and safe for treatment of naïve pediatric patients with achalasia.</div
S2 File -
IntroductionAchalasia is a rare neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone and absence of esophageal peristalsis. Achalasia requires invasive treatment in all patients. Conventional treatment options include endoscopic balloon dilation (EBD) and laparoscopic Heller’s myotomy (LHM). Recently, a less invasive endoscopic therapy has been developed; Peroral Endoscopic Myotomy (POEM). POEM integrates the theoretical advantages of both EBD and LHM (no skin incisions, less pain, short hospital stay, less blood loss and a durable myotomy). Our aim is to compare efficacy and safety of POEM vs. EBD as primary treatment for achalasia in children.Methods and analysisThis multi-center, and center-stratified block-randomized controlled trial will assess safety and efficacy of POEM vs EBD. Primary outcome measure is the need for retreatment due to treatment failure (i.e. persisting symptoms (Eckardt score > 3) with evidence of recurrence on barium swallow and/or HRM within 12 months follow-up) as assed by a blinded end-point committee (PROBE design).DiscussionThis RCT will be the first one to evaluate which endoscopic therapy is most effective and safe for treatment of naïve pediatric patients with achalasia.</div
Study parameters of HRM, pH-MII and EGD.
IntroductionAchalasia is a rare neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone and absence of esophageal peristalsis. Achalasia requires invasive treatment in all patients. Conventional treatment options include endoscopic balloon dilation (EBD) and laparoscopic Heller’s myotomy (LHM). Recently, a less invasive endoscopic therapy has been developed; Peroral Endoscopic Myotomy (POEM). POEM integrates the theoretical advantages of both EBD and LHM (no skin incisions, less pain, short hospital stay, less blood loss and a durable myotomy). Our aim is to compare efficacy and safety of POEM vs. EBD as primary treatment for achalasia in children.Methods and analysisThis multi-center, and center-stratified block-randomized controlled trial will assess safety and efficacy of POEM vs EBD. Primary outcome measure is the need for retreatment due to treatment failure (i.e. persisting symptoms (Eckardt score > 3) with evidence of recurrence on barium swallow and/or HRM within 12 months follow-up) as assed by a blinded end-point committee (PROBE design).DiscussionThis RCT will be the first one to evaluate which endoscopic therapy is most effective and safe for treatment of naïve pediatric patients with achalasia.</div
SPIRIT checklist.
*Recommended content can be displayed using various schematic formats. See SPIRIT 2013 Explanation and Elaboration for examples from protocols.**List specific timepoints in this row.</p
Additional file 1: of Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial
Definitions of secondary endpoints. Table S1. Severity of PEP according to Cotton and revised Atlanta criteria. Table S2. Local and systemic complications according to (revised) Atlanta criteria. Table S3. ERCP-related complications (adopted from Cotton). SPIRIT checklist. (DOCX 40 kb
Additional file 1: Figure S1. of Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial
Flowchart APEC trial according to CONSORT [43]. (PDF 6 kb