Introduction

Informed consent (IC) serves as the ethical foundation for all medical interventions, empowering patients to make informed, autonomous decisions while safeguarding clinicians. Barriers such as limited health literacy and document complexity may hinder comprehension^1,2. This study evaluated the comprehensibility, readability, and effectiveness of the documents provided for IC and instructions for endoscopic procedures.

Aims & Methods

Outpatients undergoing endoscopic procedures completed a questionnaire assessing their understanding of IC, preparation instructions, and adherence to guidelines. Patient confidence and document comprehensibility were assessed through self-reported scales. Readability was assessed using Flesch Reading Ease score adapted for portuguese (FRE-PT)³.

Results

Among 186 participants (mean age: 58.1 ± 16.1 years), 76.9% reported full-extent reading of the provided instructions and IC document. Patients with primary education (≤4th grade) were less likely to read the documents fully (59.2% vs. 83.2%, p < 0.001) and were independently associated with the need for additional assistance (OR 5.65, 95% CI: 1.92 - 16.68, p = 0.002). Full-extent reading was independently associated with greater risk awareness (OR 5.52, 95% CI: 2.37 - 11.55, p < 0.001), reduced need for additional assistance (OR 0.22, 95% CI: 0.09 - 0.51, p < 0.001), and higher compliance with medication guidelines (75.7% vs. 45.8%, OR 3.42, 95% CI: 1.28 - 9.20, p = 0.015). Patients with primary education rated document’s comprehensibility lower (median:8, IQR 7-10) compared to those with higher education (median: 10, IQR 8 - 10, p < 0.001) and reported lower levels of confidence and preparation for the procedure (median: 8, IQR 7 - 10 vs. median: 9, IQR 8 - 10; p = 0.018). Outcomes did not differ significantly between patients aged 65 years or older compared to younger patients. FRE-PT scores classified readability as ‘’very difficult’’ for both upper endoscopy (20.87) and colonoscopy (26.00).

Conclusion

Full-extent reading IC and instruction documents reduces the need for assistance, improves compliance with pre-procedural measures, risk awareness and patient confidence. However, the document’s complexity and difficult readability disproportionately challenge and discourage patients with limited education. Future research should explore strategies to foster more equitable informed decision-making.

References

1. Protheroe J, Rowlands G. Matching clinical information with levels of patient health literacy. Nurs Manag (Harrow). 2013;20(3):20-21. doi:10.7748/nm2013.06.20.3.20.e1095
2. Ley R, Forio T. The use of readability formulas in health care. Psychol Health Med. 1996;1(1):7-28.
3. Martins TBF, Ghiraldelo CM, Nunes MGV, Oliveira Junior ON. Readability formulas applied to textbooks in Brazilian Portuguese. 1996.

Introduction

Capsule Endoscopy (CE) is a minimally invasive technique that allows for detailed visualization of the small bowel mucosa. Anemia and gastrointestinal (GI) bleeding are among the primary indications for CE. Accurate detection of vascular lesions is critical in this context; however, CE interpretation is time-consuming and subject to human error. Artificial intelligence (AI) has the potential to assist in this task, yet real-world studies assessing its clinical impact remain limited.

Aims & Methods

This study aimed to evaluate the performance of a deep learning convolutional neural network in detecting and identifying vascular lesions—specifically red spots and angiectasias—in complete CE videos.
We conducted a multicenter, prospective validation study comparing AI-assisted CE reading with standard, conventional interpretation. A total of 211 CE videos, acquired using three different devices across seven centers in Portugal, Spain, Brazil, and the United States, were included. Following initial standard readings, an independent expert performed AI-assisted readings using a deep learning model designed to detect and classify small bowel vascular lesions. Both reports were reviewed by a third-party expert from an independent center who adjudicated discrepant cases to establish the reference standard. Diagnostic performance was evaluated using standard metrics and the area under the receiver operating characteristic curve (AUC-ROC).

Results

AI-assisted reading identified 241 confirmed vascular lesions, compared to 158 detected through conventional reading. Sensitivity was significantly higher for AI-assisted reading (96.4% vs. 67.7%), though specificity was lower (75.7% vs. 93.5%). Overall accuracy was also higher with AI (89.7% vs. 76.1%). The AUC-ROC was 0.93 for AI-assisted and 0.78 for standard reading. Moreover, AI-assisted reading reduced the mean examination time to 316 seconds per video.

Conclusion

AI-assisted interpretation of full-length CE videos significantly outperforms conventional reading in the detection and classification of vascular lesions. The inclusion of videos from multiple CE systems addresses interoperability challenges, and the involvement of patients from four countries across two continents supports the model's generalizability and real-world clinical applicability.

Clinical Case Summary

A 66-year-old female patient with a history of duodenal peptic ulcer disease was referred for evaluation of an 8 mm sessile polyp (Paris 0-ls) located in the terminal ileum. The polyp was excised during a colonoscopy with ileoscopy performed at a private facility in the context of colorectal cancer screening. Histological analysis revealed a well-differentiated NET (Grade 1) in the mucosal and submucosal layers of the terminal ileum, measuring 5.6 mm, with an endoscopic resection achieving R0 status (IVL0, 170 µm from the vertical margin). Following multidisciplinary discussion, staging was performed using CT of the abdomen and pelvis, enterography CT, and 68-Ga PET, which showed an ileocolic lymphadenopathy with high expression of somatostatin receptors and elevated serum Chromogranin A (238.7; N<85). A decision was made to reevaluate with 68-Ga PET in four months to determine the course of action regarding surgery versus chemotherapy. Due to the persistence of findings and after further multidisciplinary discussion, a right hemicolectomy with laparoscopic lymphadenectomy was performed. The procedure revealed no mural lesions; however, 5 out of 20 ileocolic lymph nodes were positive for TNE invasion (ypT1N1M0, Ki-67 <1%, mitotic index <1/10 HPF, stage III). The follow-up at five months showed no recurrence.
This case highlights the importance of ileoscopy during colonoscopy, even in the absence of symptoms, in order to exclude lesions of the small intestine. Given their aggressive nature, increasing incidence, and more frequent ileal location, the performance of ileoscopy during total colonoscopy offers significant clinical benefit without a substantial increase in procedure time, even in asymptomatic individuals.This case also highlights the challenge of histopathological criteria in defining curative disease after endoscopic resection and the discrepancy between pre- and post-operative imaging and functional staging, with prognostic and surveillance implications.

References

Joana Carvão, Mário Dinis-Ribeiro, Pedro Pimentel-Nunes, Diogo Libânio; Neuroendocrine Tumors of the Gastrointestinal Tract: A Focused Review and Practical Approach for Gastroenterologists. GE Port J Gastroenterol 1 September 2021; 28 (5): 336–348.

Introduction

Endoscopic submucosal dissection has become the preferred technique for managing large colonic lesions or those suspected of superficial tumor invasion. Macronodular lesions may present with a muscular retraction sign (MRS), which is associated with reduced curative resection rates due to lower R0 resection rates and increased rates of deep submucosal invasion. A few data are available about how to differentiate fibrosis and cancer and about technical and oncological outcomes of ESD in this situation.

Aims & Methods

We conducted a prospective study to evaluate the prevalence of the muscular retraction sign and its clinical outcomes in patients with colorectal macronodular lesions. This analysis utilized data from a large prospective French colorectal ESD cohort (FECCo).

Results

A total of 1,238 macronodular lesions were treated, of which 254 (20.5%) exhibited a muscular retraction sign. The prevalence of MRS increased with the size of the largest macronodule, reaching up to 50% for nodules larger than 40 mm. Enbloc, R0 and curative resection rates were significantly lower in the MRS+ group (82.68% vs 97.86%, 70.97% vs 89.76% and 56.31% vs 83.52%, p<0.001 respectively). MRS+ lesions were more frequently associated with at least submucosal cancer (30.32% vs 9.65%, p<0.001). Regardless of MRS, the presence of a nodule larger than 4cm is associated with a decrease in enbloc resection rates, particularly in the colon, as well as reductions in R0 resection rates and curative resection rates in comparison with nodules smaller than 4cm. The curative resection rate for lesions with ≥T1 cancer and presenting with MRS was 1.5% (p<0.001).
In multivariate analysis, protruding lesions (OR = 1.91 [1.19–3.06], p = 0.007) and nodules larger than 20mm (OR = 2.48 [1.74–3.52], p<0.001) or 40mm (OR 5.98 [3.55-10.08], p<0.001) were identified as risk factors for MRS. The size of the nodule did not increase the risk of submucosal cancer, unlike sigmoid location (OR 2.66 [1.15-6.17] p=0.022) and nodules classified as JNET 3 (OR 6.53 [2.07-20.57], p=0.001).

Conclusion

The prevalence of MRS is 20.5% in cases of macronodular lesions, a rate that increases significantly with the size of the macronodule. MRS negatively impacts the outcomes of ESD in terms of enbloc, R0 and curative resections. ESD should be reconsidered in cases of large macronodular colonic lesions, especially for sigmoid locations or in the presence of JNET 3 vascular pattern anomalies. For rectal large macronodular lesions, ESD should be proposed in expert centers with the option, if necessary, of intermuscular dissection to optimize the R0 resection rate and thereby improve the chances of proposing an organ-preservation strategy.