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ObjectiveEndoscopic full-thickness resection (EFTR) is a novel treatment of colorectal lesions not amenable to conventional endoscopic resection. The aim of this prospective multicentre study was to assess the efficacy and safety of the full-thickness resection device.Design181 patients were recruited in 9 centres with the indication of difficult adenomas (non-lifting and/or at difficult locations), early cancers and subepithelial tumours (SET). Primary endpoint was complete en bloc and R0 resection.ResultsEFTR was technically successful in 89.5%, R0 resection rate was 76.9%. In 127 patients with difficult adenomas and benign histology, R0 resection rate was 77.7%. In 14 cases, lesions harboured unsuspected cancer, another 15 lesions were primarily known as cancers. Of these 29 cases, R0 resection was achieved in 72.4%; 8 further cases had deep submucosal infiltration >1000 µm. Therefore, curative resection could only be achieved in 13/29 (44.8%). In the subgroup with SET (n=23), R0 resection rate was 87.0%. In general, R0 resection rate was higher with lesions ≤2 cm vs >2 cm (81.2% vs 58.1%, p=0.0038). Adverse event rate was 9.9% with a 2.2% rate of emergency surgery. Three-month follow-up was available from 154 cases and recurrent/residual tumour was evident in 15.3%.ConclusionEFTR has a reasonable technical efficacy especially in lesions ≤2 cm with acceptable complication rates. Curative resection rate for early cancers was too low to recommend its primary use in this indication. Further comparative studies have to show the clinical value and long-term outcome of EFTR in benign colorectal lesions.Trial registration numberNCT02362126; Results.

Background Recently, we presented Stroma AReactive Invasion Front Areas (SARIFA) as a new histomorphologic negative prognostic biomarker in gastric cancer. It is defined as direct contact between tumor cells and fat cells. The aim of this study was to further elucidate the underlying genomic, transcriptional, and immunological mechanisms of the SARIFA phenomenon. Methods To address these questions, SARIFA was classified on H&E-stained tissue sections of three cohorts: an external cohort ( n  = 489, prognostic validation), the TCGA-STAD cohort ( n  = 194, genomic and transcriptomic analysis), and a local cohort ( n  = 60, digital spatial profiling (whole transcriptome) and double RNA in situ hybridization/immunostaining of cytokines). Results SARIFA status proved to be an independent negative prognostic factor for overall survival in an external cohort of gastric carcinomas. In TCGA-STAD cohort, SARIFA is not driven by distinct genomic alterations, whereas the gene expression analyses showed an upregulation of FABP4 in SARIFA-positive tumors. In addition, the transcriptional regulations of white adipocyte differentiation, triglyceride metabolism, and catabolism were upregulated in pathway analyses. In the DSP analysis of SARIFA-positive tumors, FABP4 and the transcriptional regulation of white adipocyte differentiation were upregulated in macrophages. Additionally, a significantly lower expression of the cytokines IL6 and TNFα was observed at the invasion front. Conclusions SARIFA proves to be a strong negative prognostic biomarker in advanced gastric cancer, implicating an interaction of tumor cells with tumor-promoting adipocytes with crucial changes in tumor cell metabolism. SARIFA is not driven by tumor genetics but is very likely driven by an altered immune response as a causative mechanism.

Background Pancreatic ductal adenocarcinoma (PDAC) is a ‘difficult-to-treat’ entity. To forecast its prognosis, we introduced a new biomarker, SARIFA (stroma areactive invasion front areas), which are areas at the tumour invasion front lacking desmoplastic stroma reaction upon malignant invasion in the surrounding tissue, leading to direct contact between tumour cells and adipocytes. SARIFA showed its significance in gastric and colorectal carcinoma, revealing lipid metabolism alternations that promote tumour progression. Methods We reviewed the SARIFA status of 166 PDAC cases on all available H&E-stained tumour slides from archival Whipple-resection specimens. SARIFA positivity was defined as SARIFA detection in at least 66% of the available slides. To investigate alterations in tumour metabolism and microenvironment, we performed immunohistochemical staining for FABP4, CD36 and CD68. To verify and quantify a supposed delipidation of adipocytes, adipose tissue was digitally morphometrised. Results In total, 53 cases (32%) were classified as SARIFA positive and 113 (68%) as SARIFA negative. Patients with SARIFA-positive PDAC showed a significantly worse overall survival compared with SARIFA-negative cases (median overall survival: 11.0 months vs. 22.0 months, HR: 1.570 (1.082–2.278), 95% CI, p  = 0.018), which was independent from other prognostic markers ( p  = 0.014). At the invasion front of SARIFA-positive PDAC, we observed significantly higher expression of FABP4 ( p  < 0.0001) and higher concentrations of CD68 + macrophages ( p  = 0.031) related to a higher risk of tumour progression. CD36 staining showed no significant expression differences. The adipocyte areas at the invasion front were significantly smaller, with mean values of 4021 ± 1058 µm 2 and 1812 ± 1008 µm 2 for the SARIFA-negative and -positive cases, respectively ( p  < 0.001). Conclusions SARIFA is a promising prognostic biomarker for PDAC. Its assessment is characterised by simplicity and low effort. The mechanisms behind SARIFA suggest a tumour-promoting increased lipid metabolism and altered immune background, both showing new therapeutic avenues.

Reconstruction of bone defects represents a serious issue for orthopaedic and maxillofacial surgeons, especially in extensive bone loss. Adipose-derived mesenchymal stem cells (ADSCs) with tri-calcium phosphates (TCP) are widely used for bone regeneration facilitating the formation of bone extracellular matrix to promote reparative osteogenesis. The present study assessed the potential of cell-scaffold constructs for the regeneration of extensive mandibular bone defects in a minipig model. Sixteen skeletally mature miniature pigs were divided into two groups: Control group and scaffolds seeded with osteogenic differentiated pADSCs (n = 8/group). TCP-PLGA scaffolds with or without cells were integrated in the mandibular critical size defects and fixed by titanium osteosynthesis plates. After 12 weeks, ADSCs seeded scaffolds ( n  = 7) demonstrated significantly higher bone volume (34.8% ± 4.80%) than scaffolds implanted without cells ( n  = 6, 22.4% ± 9.85%) in the micro-CT ( p  < 0.05). Moreover, an increased amount of osteocalcin deposition was found in the test group in comparison to the control group (27.98 ± 2.81% vs 17.10 ± 3.57%, p < 0.001). In conclusion, ADSCs seeding on ceramic/polymer scaffolds improves bone regeneration in large mandibular defects. However, further improvement with regard to the osteogenic capacity is necessary to transfer this concept into clinical use.

Objective To evaluate the feasibility and accuracy of implementing three‐dimensional virtual surgical planning (VSP) and subsequent transfer by additive manufactured tools in the secondary reconstruction of residual post‐traumatic deformities in the midface. Methods Patients after secondary reconstruction of post‐traumatic midfacial deformities were included in this case series. The metrical deviation between the virtually planned and postoperative position of patient‐specific implants (PSI) and bone segments was measured at corresponding reference points. Further information collected included demographic data, post‐traumatic symptoms, and type of transfer tools. Results Eight consecutive patients were enrolled in the study. In five patients, VSP with subsequent manufacturing of combined predrilling/osteotomy guides and PSI was performed. In three patients, osteotomy guides, repositioning guides, and individually prebent plates were used following VSP. The median distances between the virtually planned and the postoperative position of the PSI were 2.01 mm (n = 18) compared to a median distance concerning the bone segments of 3.05 mm (n = 12). In patients where PSI were used, the median displacement of the bone segments was lower (n = 7, median 2.77 mm) than in the group with prebent plates (n = 5, 3.28 mm). Conclusion This study demonstrated the feasibility of VSP and transfer by additive manufactured tools for the secondary reconstruction of complex residual post‐traumatic deformities in the midface. However, the median deviations observed in this case series were unexpectedly high. The use of navigational systems may further improve the level of accuracy. To evaluate the feasibility and accuracy of implementing three‐dimensional virtual surgical planning (VSP) and subsequent transfer by additive manufactured tools in the secondary reconstruction of residual post‐traumatic deformities in the midface. This study demonstrated the feasibility of VSP and transfer by additive manufactured tools for the secondary reconstruction of complex residual post‐traumatic deformities in the midface. However, the median deviations observed in this case series were unexpectedly high. The use of navigational systems may further improve the level of accuracy.

Objective Despite high stand‐alone performance, studies demonstrate that artificial intelligence (AI)‐supported endoscopic diagnostics often fall short in clinical applications due to human‐AI interaction factors. This video‐based trial on Barrett's esophagus aimed to investigate how examiner behavior, their levels of confidence, and system usability influence the diagnostic outcomes of AI‐assisted endoscopy. Methods The present analysis employed data from a multicenter randomized controlled tandem video trial involving 22 endoscopists with varying degrees of expertise. Participants were tasked with evaluating a set of 96 endoscopic videos of Barrett's esophagus in two distinct rounds, with and without AI assistance. Diagnostic confidence levels were recorded, and decision changes were categorized according to the AI prediction. Additional surveys assessed user experience and system usability ratings. Results AI assistance significantly increased examiner confidence levels (p < 0.001) and accuracy. Withdrawing AI assistance decreased confidence (p < 0.001), but not accuracy. Experts consistently reported higher confidence than non‐experts (p < 0.001), regardless of performance. Despite improved confidence, correct AI guidance was disregarded in 16% of all cases, and 9% of initially correct diagnoses were changed to incorrect ones. Overreliance on AI, algorithm aversion, and uncertainty in AI predictions were identified as key factors influencing outcomes. The System Usability Scale questionnaire scores indicated good to excellent usability, with non‐experts scoring 73.5 and experts 85.6. Conclusions Our findings highlight the pivotal function of examiner behavior in AI‐assisted endoscopy. To fully realize the benefits of AI, implementing explainable AI, improving user interfaces, and providing targeted training are essential. Addressing these factors could enhance diagnostic accuracy and confidence in clinical practice.

Background In patients with malunited condylar fractures of the mandible surgical intervention is preferred when malocclusion and compromised masticatory function occur. This study evaluated the accuracy and clinical utility of virtual surgical planning (VSP) and CAD/CAM fabricated patient-specific implants (PSIs) for the secondary correction of post-traumatic mandibular condyle deformities. Methods Accuracy of condylar segment repositioning was quantified by comparing the virtually planned joint surface with the actual postoperative same surface of the condylar head using Mimics and 3-Matic software (Materialise, Leuven, Belgium). Deviation was calculated by two methods: the Part Comparison Analysis (PCA) function of the analysis software and by measuring distances between four corresponding reference points on the planned and final segments. Results The mean deviation between planned and final joint surfaces was 2.27 mm (range 4.69) with the PCA method and 2.56 mm (range: 8.99) with the reference-point method. No significant difference was observed between high and low condylar osteotomies. Accuracy was greatest along the lateromedial axis (1.83 mm; range: 6.98 mm) and lowest in the craniocaudal axis (3.30 mm; range: 6.75 mm). A good postoperative mandibular mobility was assessed in most cases with an average active mouth opening of 37 mm and no permanent sensory impairment was reported. Conclusion Virtual surgical planning combined with CAD/CAM PSIs provides a reliable option for secondary reduction and fixation of condylar fragments, achieving high positional accuracy, good postoperative mandibular mobility, and a low rate of major complications.

The impact of neck involvement and occult metastasis (OM) in patients with oral squamous cell carcinoma (OSCC) favors an elective neck dissection. However, there are barely any existing data on survival for patients with OM compared with patients with positive lymph nodes detected preoperatively. This study aims to compare survival curves of patients suffering from lymph nodal metastases in a preoperatively N+ neck with those suffering from OM. In addition, clinical characteristics of the primary tumor were analyzed to predict occult nodal disease. This retrospective cohort study includes patients with an OSCC treated surgically with R0 resection with or without adjuvant chemoradiotherapy between 2010 and 2016. Minimum follow-up was 60 months. Kaplan–Meier analysis was used to compare the survival between patients with and without occult metastases and patients with N+ neck to those with occult metastases. Logistic regression was used to detect potential risk factors for occult metastases. The patient cohort consisted of 226 patients. Occult metastases occurred in 16 of 226 patients. In 53 of 226 patients, neck lymph nodes were described as suspect on CT imaging but had a pN0 neck. Higher tumor grading increased the chance of occurrence of occult metastasis 2.7-fold (OR = 2.68, 95% CI: 1.07–6.7). After 12, 24, 48 and 60 months, 82.3%, 73.8%, 69% and 67% of the N0 patients, respectively, were progression free. In the group with OM occurrence, for the same periods 66.6%, 50%, 33.3% and 33.3% of the patients, respectively, were free of disease. For the same periods, respectively, 81%, 63%, 47% and 43% of the patients in the N+ group but without OM remained disease free. The predictors for progression-free survival were a positive N status (HR = 1.44, 95% CI: 1.08–1.93) and the occurrence of OM (HR = 2.33, 95% CI: 1.17–4.64). The presence of occult metastasis could lead to decreased survival and could be a burdening factor requiring treatment escalation and a more aggressive follow-up than nodal disease detected in the preoperative diagnostic imaging.

Introduction. Endoscopic resection (ER) exceeding ≥75% of the esophageal circumference is accompanied with a high stricture risk regardless of the resection method. The ideal strategy for stricture prevention is not well defined today. Different approaches have been reported but data are limited to the resection of squamous cell neoplasia. The aim of this study was to assess the efficacy of an individualized oral steroid regimen to prevent strictures after extensive ER in neoplastic Barrett’s esophagus (NBE). Materials and Methods. Over a 50-month period, endoscopic submucosal dissection (ESD) was performed in 193 patients with NBE. 23 patients with resections exceeding 75% of the circumference were included. 19 resection ulcers were noncircumferential (NCR) while 4 were circumferential (CR). Stricture prevention was performed using oral prednisolone starting with a daily dose of 50 mg and standard tapering over 8 weeks (50/40/30/25/20/15/10/5 mg). Tapering was individualized according to the ulcer healing process (assessed endoscopically in the first tapering period and before stopping the steroids). Data were analyzed retrospectively. Results. Stricture rates were 5.3% (1/19) for NCR and 100% (4/4) for CR (p<0.001). The only stricture in the NCR group was seen in a patient who had stopped steroids without any reason after few days. 12/19 patients received standard tapering over 8 weeks (63.1%). According to the individual ulcer healing, treatment was prolonged to 9-10 weeks in 4/19 (21.1%) and shortened to 7 weeks in another 2/19 (10.5%). After CR, all patients needed endoscopic balloon dilatation (median 6.5 sessions; range 3-14 sessions for 8-40 weeks). Side effects of the steroid therapy were not noted. Conclusion. Oral prednisolone therapy with an endoscopy-based individualized tapering regimen is effective in avoiding strictures after NCR of Barrett’s neoplasia. After CR, the stricture risk is not sufficiently decreased. CR should be restricted to circumferential neoplasia which is a very rare scenario in neoplastic BE.