{"title":"Reposition-free thoraco-laparoscopic surgery for EGJ cancer in the right hemilateral position.","authors":"Toshikatsu Tsuji, Noriyuki Inaki, Jun Kinoshita, Hideki Moriyama, Daisuke Yamamoto, Hiroto Saito, Ryota Matsui, Saki Hayashi, Kengo Hayashi, Kenta Doden","doi":"10.1080/13645706.2025.2584282","DOIUrl":"10.1080/13645706.2025.2584282","url":null,"abstract":"<p><strong>Background: </strong>Esophagogastric junction (EGJ) cancer is becoming increasingly prevalent worldwide. Among surgical challenges, anastomotic leakage remains a significant concern. The optimal approach for Siewert type II tumors with an esophageal invasion of 2.1-4.0 cm is still debated. We employed a combined left thoracoscopic and laparoscopic approach with the patient in the right hemilateral position, enabling simultaneous thoracic and abdominal procedures without intraoperative repositioning.</p><p><strong>Methods: </strong>We retrospectively reviewed patients with EGJ cancer and an esophageal invasion length of 2.1 to 4.0 cm who underwent the combined left thoracoscopic and laparoscopic approach between January 2021 and December 2024. Clinicopathological characteristics and surgical outcomes were evaluated and compared with those of patients treated with conventional laparoscopic transhiatal surgery during the same period.</p><p><strong>Results: </strong>Eight patients underwent the combined approach. Surgical procedures included six proximal gastrectomies with single-flap esophagogastrostomy and two total gastrectomies. Compared with 12 patients who underwent conventional laparoscopic surgery, no anastomotic leakage was observed in the combined group, whereas leakage occurred in the conventional group.</p><p><strong>Conclusions: </strong>The combined left thoracoscopic and laparoscopic approach appears to be a feasible and safe option for EGJ cancer with esophageal invasion of 2.1-4.0 cm. No anastomotic leakage was observed, and this approach allows for stable anastomosis under direct visualization without repositioning.</p>","PeriodicalId":18537,"journal":{"name":"Minimally Invasive Therapy & Allied Technologies","volume":" ","pages":"55-60"},"PeriodicalIF":2.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145496080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Muhidin Hassan Ibrahim, Atinc Tozsin, Marie-Claire Rassweiler-Seyfried, Selim Soyturk, Nariman Gadzhiev, Panagiotis Kallidonis, Thomas Knoll, Selcuk Guven, Kamran Ahmed
{"title":"The optimal laser fiber core size for endourological performance: a systematic review.","authors":"Muhidin Hassan Ibrahim, Atinc Tozsin, Marie-Claire Rassweiler-Seyfried, Selim Soyturk, Nariman Gadzhiev, Panagiotis Kallidonis, Thomas Knoll, Selcuk Guven, Kamran Ahmed","doi":"10.1080/13645706.2025.2590481","DOIUrl":"10.1080/13645706.2025.2590481","url":null,"abstract":"<p><strong>Background: </strong>This review assesses how fiber core size impacts energy delivery, degradation, safety, durability, fracture resistance, retropulsion, and flexibility.</p><p><strong>Methods: </strong>A comprehensive search of PubMed and Cochrane databases identified 1,148 articles comparing fiber core sizes. After removing 109 duplicates and excluding 996 articles based on titles and abstracts, 43 full-text articles were reviewed. Of these, 30 were excluded for lacking relevant parameters or being review articles. One article was added manually, resulting in 14 studies in the final analysis.</p><p><strong>Results: </strong>Smaller core fibers (≤300 μm) provide higher energy delivery and greater flexibility, making them ideal for lithotripsy. However, they are more prone to tip degradation and have lower durability under high-power conditions. Larger fibers (≥300 μm) demonstrate better energy efficiency, reduced degradation, and higher fracture resistance, making them suitable for high-energy applications like prostate enucleation. Thermal safety is influenced by both fiber size and irrigation; smaller fibers maintain safer temperatures with adequate irrigation. Retropulsion is less in small and large fibers compared to medium-core fibers (365-550 μm). Smaller fibers (150 μm) generate larger bubbles than larger fibers (272 μm).</p><p><strong>Conclusion: </strong>Laser fiber core size influences energy delivery, durability, thermal safety, and flexibility, affecting endourological outcomes. Appropriate fiber selection improves procedural efficiency and safety.</p>","PeriodicalId":18537,"journal":{"name":"Minimally Invasive Therapy & Allied Technologies","volume":" ","pages":"8-17"},"PeriodicalIF":2.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145582524","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A cost-effective porcine training model for thermal ablation of thyroid nodules and subsequent transoral endoscopic thyroidectomy.","authors":"Lei Min, Yujing Weng, Weichun Chen, Debiao Chen, Qing Ai, Jiang Jiang, Zhiheng Huang","doi":"10.1080/13645706.2025.2598411","DOIUrl":"10.1080/13645706.2025.2598411","url":null,"abstract":"<p><strong>Background: </strong>Preclinical training is essential for thermal ablation (TA) of thyroid nodules; however, there is a lack of optimal simulators. We aimed to create a training model for TA using live pigs, followed by neck surgery.</p><p><strong>Methods: </strong>We recruited trainees from across China to participate in a workshop that included TA practice and subsequent transoral endoscopic thyroidectomy. The operative performance of trainees and any complications were documented. Following the workshop, participants completed online questionnaires using a 1-5 Likert Scale to evaluate their subjective experiences. The costs associated with the training were meticulously calculated.</p><p><strong>Results: </strong>Five pigs were utilized for the workshop. Eighteen trainees and six mentors from seventeen institutions participated in the study. Seventeen trainees (94.4%; 95% CI, 74.2-99.0) successfully visualized the needle tips within the thyroid gland, while one was unsuccessful. Two trainees (11.1%; 95% CI, 2.0-30.8) experienced trachea injury during the subsequent thyroidectomy assessment. No cases of recurrent laryngeal nerve (RLN) injury were reported, as evaluated by neuromonitoring. Participants rated their operational experience with a score of 3.33 ± 1.05 compared to human procedures. Excluding labor costs, the average expense for each trainee for TA training was 50.4 ± 4.0 euros.</p><p><strong>Conclusions: </strong>This study presents a cost-effective porcine training model for TA followed by neck surgery. The model provided a realistic simulation of human procedures and enabled immediate assessment of structural injuries, demonstrating its potential for use in TA training prior to human procedures.</p>","PeriodicalId":18537,"journal":{"name":"Minimally Invasive Therapy & Allied Technologies","volume":" ","pages":"79-86"},"PeriodicalIF":2.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145708565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Riccardo Vizza, Giacomo Corrado, Emanuela Mancini, Ermelinda Baiocco, Mario Russo, Cristina Vincenzoni, Valentina Bruno, Henrik Falconer, Enrico Vizza
{"title":"Feasibility, safety, and efficacy of robotic single-port hysterectomy (R-SPH) using the da Vinci SP system in low-risk endometrial cancer: a pilot study.","authors":"Riccardo Vizza, Giacomo Corrado, Emanuela Mancini, Ermelinda Baiocco, Mario Russo, Cristina Vincenzoni, Valentina Bruno, Henrik Falconer, Enrico Vizza","doi":"10.1080/13645706.2025.2538764","DOIUrl":"10.1080/13645706.2025.2538764","url":null,"abstract":"<p><strong>Background: </strong>The purpose of this study was to evaluate the feasibility, safety, and efficacy of robotic single-port hysterectomy (R-SPH) with the da Vinci SP in low-risk endometrial cancer.</p><p><strong>Methods: </strong>Patients with clinically confirmed endometrioid endometrial cancer, FIGO stages IA-IB, were enrolled for R-SPH. All surgical procedures were performed through a single 2.5 cm umbilical incision. An Intuitive Access Port of small size was placed into the incision, and pneumoperitoneum was established. Robotic instruments were inserted as described below through the Intuitive Access Port, which has four different channel ports: in the superior channel, a three-dimensional 8.5 mm optics; in channel 1, Cadiere Forceps; in channel 2, a Maryland Bipolar; and in channel 3, monopolar scissors.</p><p><strong>Results: </strong>From June 24 to November 13, 2024, a total of 25 patients were included in the study. The median age was 61 years, and median BMI was 25.9 kg/m<sup>2</sup>. The median docking time, console time, and total operative time were 10, 65, and 115 min, respectively. The median blood loss was 67.0 mL, and the median hemoglobin drop was 1.2 g/dL.</p><p><strong>Conclusions: </strong>R-SPH seems safe and feasible in endometrial cancer. The true benefit of the technique should be sought in larger comparative studies. ClinicalTrials.gov Protocol Record: NCT06681831.</p>","PeriodicalId":18537,"journal":{"name":"Minimally Invasive Therapy & Allied Technologies","volume":" ","pages":"433-440"},"PeriodicalIF":2.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144817107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tomas Lenssen, Roelf R Postema, Christian Camenzuli, Jean Calleja-Agius, Jenny Dankelman, Tim Horeman-Franse
{"title":"A pre-clinical application study of the SATA-LRS laparoscopic instrument in a human cadaver model.","authors":"Tomas Lenssen, Roelf R Postema, Christian Camenzuli, Jean Calleja-Agius, Jenny Dankelman, Tim Horeman-Franse","doi":"10.1080/13645706.2025.2554077","DOIUrl":"10.1080/13645706.2025.2554077","url":null,"abstract":"<p><strong>Background: </strong>To validate whether the SATA-LRS, a novel reusable articulating laparoscopic instrument, fits surgical practice, a pre-clinical study was performed.</p><p><strong>Methods: </strong>Thirteen medical doctors used the instrument in a laparoscopic endoscopic inguinal hernia repair (TEP)-like task inside a cadaver. A set of sensors on the instrument handle detected motion and articulation of the instrument tip. Data from the sensors and video recordings were used to assess the amount and type of movement of the instrument and the time spent on tasks. questionnaire was used to gain insight into the participants' perception of the contextual factors.</p><p><strong>Results: </strong>There was no difference between task time and instrument tip velocities when using articulation (or not) and all participants used articulation at least half of the task time. Instrument-handle movement, indicating the user's hand and arm movement, was significantly reduced when using articulation. The questionnaire indicated strong acceptance of the instrument and the experimental setup, and a desire to use the instrument in surgery by most participants.</p><p><strong>Conclusions: </strong>The added articulation feature of the SATA-LRS instrument was deemed beneficial by the participants, showed no increased handling complexity or time spent on the task and was used frequently when enabled, indicating intuitiveness.</p>","PeriodicalId":18537,"journal":{"name":"Minimally Invasive Therapy & Allied Technologies","volume":" ","pages":"447-455"},"PeriodicalIF":2.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145080979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Seoung Yoon Rho, Munseok Choi, Sung Hyun Kim, Seung Soo Hong, Hyoung-Il Kim, Yoo-Young Lee, Brian Goh Kim Poh, Yuichi Nagakawa, Minoru Tanabe, Daisuke Asano, Chang Moo Kang
{"title":"Comparative study of proficiency improvement in ArtiSential<sup>®</sup> according to conventional laparoscopic surgery experiences.","authors":"Seoung Yoon Rho, Munseok Choi, Sung Hyun Kim, Seung Soo Hong, Hyoung-Il Kim, Yoo-Young Lee, Brian Goh Kim Poh, Yuichi Nagakawa, Minoru Tanabe, Daisuke Asano, Chang Moo Kang","doi":"10.1080/13645706.2025.2557598","DOIUrl":"10.1080/13645706.2025.2557598","url":null,"abstract":"<p><strong>Background: </strong>This pilot study investigates the adaptability of the articulating instrument (ArtiSential) among surgeons with different levels of experience in conventional laparoscopic surgery.</p><p><strong>Methods: </strong>From June to November 2023, 18 laparoscopic surgeons participated in peg transfer and suture training using ArtiSential instruments. Participants were categorized into novice, intermediate, and expert groups. Peg transfer was repeated three times, comparing dominant and non-dominant hand. Suture training was conducted at four directional positions (1, 12, 3, and 5 o'clock) and analyzed across three trials.</p><p><strong>Results: </strong>In terms of peg transfer timing analysis, there are significant differences between the three groups in the first (<i>p</i> < 0.001) and second trials (<i>p</i> = 0.011). However, in the third trial, the gap between the three groups decreased. In all three groups, the suture times at 3 o'clock and 5 o'clock were consistently lower compared to the 1 o'clock and 12 o'clock directions. As the trials progressed, the time decreased for suturing in all directions. Among them, the novice group had reduced suture times at 3 o'clock and 5 o'clock direction.</p><p><strong>Conclusions: </strong>The ArtiSential instrument is adaptable even for novices. Its articulating features facilitate suturing in traditionally difficult directions (3 o'clock and 5 o'clock) for right-handed users.</p>","PeriodicalId":18537,"journal":{"name":"Minimally Invasive Therapy & Allied Technologies","volume":" ","pages":"468-475"},"PeriodicalIF":2.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145023619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alessandro Marquis, Francesco Soria, Marco Oderda, Daniele Dutto, Fulvia Colucci, Federico Lavagno, Livoti Simone, Matteo Rosazza, Marco Allasia, Paolo Destefanis, Beatrice Lillaz, Paolo Gontero
{"title":"Full retroperitoneoscopic radical nephroureterectomy with intracorporeal, extravesical bladder cuff excision - surgical technique and early outcomes.","authors":"Alessandro Marquis, Francesco Soria, Marco Oderda, Daniele Dutto, Fulvia Colucci, Federico Lavagno, Livoti Simone, Matteo Rosazza, Marco Allasia, Paolo Destefanis, Beatrice Lillaz, Paolo Gontero","doi":"10.1080/13645706.2025.2555427","DOIUrl":"10.1080/13645706.2025.2555427","url":null,"abstract":"<p><strong>Background: </strong>The purpose of this study was to illustrate the technique of our full retroperitoneoscopic radical nephroureterectomy (frRNU) involving an intracorporeal, extravesical bladder cuff excision (BCE) and assess its safety and early oncological outcomes.</p><p><strong>Methods: </strong>Between June 2020 and November 2023, 27 patients underwent frRNU for upper tract urothelial carcinoma. Surgical and oncological outcomes were assessed.</p><p><strong>Results: </strong>Two (7%) patients were converted to open distal ureterectomy due to extensive fibrosis of the iliac ureter. Lymph node dissection (LND) was performed in 85% of procedures. Median operative time and blood losses were 230 (IQR: 188, 255) minutes and 125 (IQR: 100, 150) mL, respectively. Complication rate was 33%, with only two (7%) Clavien Dindo ≥ 3 complications and two (7%) patients experienced urinary fistula. Catheter was removed after six (IQR: 5, 7) days. All patients had negative surgical margins and three (11%) were pN+, with 6.5 (IQR: 3, 14) nodes removed. At a median follow-up of 11 (IQR: 3, 25) months, four (15%) patients had bladder recurrence, while no retroperitoneal recurrence occurred.</p><p><strong>Conclusions: </strong>Our frRNU is feasible and safe, allowing for appropriate BCE and LND. Surgical outcomes are optimal, complication rate acceptable and short-term oncological outcomes promising.</p>","PeriodicalId":18537,"journal":{"name":"Minimally Invasive Therapy & Allied Technologies","volume":" ","pages":"476-483"},"PeriodicalIF":2.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145033641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lambros Athanasiou, Manivannan Senthil Kumar, Franklin King, Daniel A Wollin, Nobuhiko Hata
{"title":"Level I/II autonomy in robotically navigated lithotripsy: comprehensive system evaluation and performance assessment.","authors":"Lambros Athanasiou, Manivannan Senthil Kumar, Franklin King, Daniel A Wollin, Nobuhiko Hata","doi":"10.1080/13645706.2025.2568611","DOIUrl":"10.1080/13645706.2025.2568611","url":null,"abstract":"<p><strong>Background: </strong>Laser lithotripsy is a minimally invasive procedure performed by a urologist using a ureteroscope, a device composed of a flexible laser fiber and a camera. The camera is used to physically view and manually target the stone ablated by the laser. The procedure involves the risk of unintentional trauma caused by the laser when the stones are out of target due to their retro-pulsive movement.</p><p><strong>Methods: </strong>To minimize clinical complications, we propose a Level I/II autonomous system in robotic lithotripsy. The system consists of a robotic catheter and an integrated U-Net segmentation method. The system aims to automatically target the stones during lithotripsy and guide ureteroscope navigation autonomously.</p><p><strong>Results: </strong>The proposed system is designed and validated using a phantom specifically manufactured to investigate the feasibility of autonomous stone ablation. An overall target accuracy of 99.97% (leave-one-out: 99.971 min, 99.975 max) was reported.</p><p><strong>Conclusions: </strong>We successfully implemented a stone targeting method and integrated it with our robotic system to evaluate the level of success in autonomously targeting the stones. The results, indicate that autonomy in robot assisted lithotripsy is feasible.</p>","PeriodicalId":18537,"journal":{"name":"Minimally Invasive Therapy & Allied Technologies","volume":" ","pages":"484-492"},"PeriodicalIF":2.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145213012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"T-shaped functional end-to-end anastomosis as an alternative method for esophagojejunostomy after totally laparoscopic total gastrectomy for gastric cancer.","authors":"Vo Duy Long, Tran Quang Dat, Dang Quang Thong, Doan Thuy Nguyen, Tran Minh Vu, Nguyen Viet Hai, Nguyen Hoang Bac","doi":"10.1080/13645706.2025.2556883","DOIUrl":"10.1080/13645706.2025.2556883","url":null,"abstract":"<p><strong>Background: </strong>Functional end-to-end anastomosis (FEEA) and the overlap methods for reconstruction after totally laparoscopic total gastrectomy (TLTG) pose technical challenges. We developed a modified T-shaped FEEA to facilitate the procedure. This study aimed to evaluate the short- and long-term outcomes of the modified T-shaped FEEA compared to the overlap method following TLTG for gastric cancer (GC).</p><p><strong>Method: </strong>This cohort study enrolled 114 patients with middle- or upper-third GC who underwent TLTG with linear stapler for reconstruction between August 2015 and October 2020. Outcomes analyzed included operative characteristics, postoperative complications, one-year nutritional status, and long-term survival. Propensity score-matched (PSM) was applied to adjust for baseline differences between groups.</p><p><strong>Results: </strong>After PSM, 27 patients were included in each group. No significant differences were found between the two groups in terms of early surgical outcomes, including operating time, time of first flatus, overall morbidities and mortality, and postoperative hospital stays. However, the modified T-shaped FEEA group had a significantly shorter anastomosis time (37.2 vs. 50.7 min, <i>p</i> = 0.005). Changes in body weight, hemoglobin, and albumin levels one-year postoperatively were comparable. Similarly, there was no significant difference in five-year overall survival and disease-free survival between the two groups (60% vs. 53% and 49% vs. 40%, respectively).</p><p><strong>Conclusions: </strong>The modified T-shaped FEEA method offers a viable alternative to the overlap method for reconstruction after TLTG for GC, with shorter anastomosis time and comparable surgical and long-term outcomes.</p>","PeriodicalId":18537,"journal":{"name":"Minimally Invasive Therapy & Allied Technologies","volume":" ","pages":"456-467"},"PeriodicalIF":2.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145023617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
P A Boland, P D McEntee, J Cucek, S Erzen, E Niemiec, M Galligan, T Petropoulou, J B Burke, J Knol, R Hompes, J Tuynman, F Aigner, A Arezzo, R A Cahill
{"title":"Protocol for CLASSICA software as medical device trial.","authors":"P A Boland, P D McEntee, J Cucek, S Erzen, E Niemiec, M Galligan, T Petropoulou, J B Burke, J Knol, R Hompes, J Tuynman, F Aigner, A Arezzo, R A Cahill","doi":"10.1080/13645706.2025.2540482","DOIUrl":"10.1080/13645706.2025.2540482","url":null,"abstract":"<p><strong>Background: </strong>Contemporary methods for detecting cancer in significant rectal neoplasia before transanal excision are suboptimal. Fluorescence angiography (FA) coupled with artificial intelligence (AI) classification methods may add value. This regulated clinical trial stage of the CLASSICA Project will validate the concept using software as medical device.</p><p><strong>Methods/design: </strong>This multi-centre prospective study will validate a real-time AI-driven FA method for the digital detection of rectal cancer in-situ and endoscopic biopsy guidance. Traditional endoscopic biopsies and excision specimen pathology are the comparative standard aiming to enrol up to 127 patients from seven surgical cancer centres across five countries with trans-European data sharing protocols balancing General Data Protection Regulation (GDPR), Good Clinical Practice (GCP) and adherence to FAIR principles.</p><p><strong>Discussion: </strong>This CLASSICA phase builds on prior prospective multi-centre and multidisciplinary collaboration that has already recruited 130 patients demonstrating patient and physician capability for the fundamental technique and enlarging the prior training dataset (n = 200 FA videos). Alongside the development of a secure, online data-sharing platform and clinical-grade medical device software, trial protocols have begun institutional approval processes aiming to determine accuracy and further optimisation.</p><p><strong>Trial details and registration: </strong>The CLASSICA Project is registered with ClinicalTrials.gov [NCT05793554] and is funded by Horizon Europe [Project No.101057321]. CLASSICAPROJECT.EU.</p>","PeriodicalId":18537,"journal":{"name":"Minimally Invasive Therapy & Allied Technologies","volume":" ","pages":"441-446"},"PeriodicalIF":2.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144960789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}