Introduction

Endoscopic submucosal dissection (ESD) is a widely performed and minimally invasive treatment for superficial oesophageal cancer, offering a less invasive alternative to surgical resection. However, when pathological findings indicate non-curative resection, additional treatment becomes necessary.

Aims & Methods

This study aims to evaluate the clinical outcomes of chemotherapy in high-risk cases of oesophageal cancer following ESD. Among 761 patients who underwent oesophageal ESD at our institution between June 2006 and August 2023, 49 cases with squamous cell carcinoma or basaloid carcinoma, classified as pT1a-MM with lymphovascular invasion or pT1b-SM, were selected. These were divided into two groups: 16 patients who received additional chemotherapy (Group A) and 15 patients who underwent chemoradiotherapy (Group B). Group A was treated with 5-fluorouracil (5-FU) with or without cisplatin (CDDP), while Group B received a combination of 5-FU, CDDP, and radiotherapy.

Results

There were no significant differences in patient demographics, tumour characteristics, or pathological factors between the groups. The median age was 69 years in both groups, with 14 males in Group A and 12 in Group B. All patients had a performance status of 0–1. The Charlson Comorbidity Index scores (0/1/2–) were 9/5/2 in Group A and 6/7/2 in Group B. Tumour location (Ut/Mt/Lt) was 2/6/8 in Group A and 1/7/7 in Group B. The median tumour length was 26 mm in Group A and 24 mm in Group B. Tumour circumference of two-thirds or less was observed in 15 patients in Group A and 13 in Group B.
In terms of depth of invasion (MM/SM1/SM2), the distribution was 5/4/7 in Group A and 3/2/10 in Group B. Lymphovascular invasion (ly+/v+) was observed in 7/2 cases in Group A and 4/4 in Group B. Horizontal margin status (negative/positive/indeterminate) was 15/1/0 in Group A and 12/1/2 in Group B, while vertical margin status was 14/1/1 in Group A and 11/3/1 in Group B. Histologically, all cases in Group A were squamous cell carcinoma, while Group B included 14 squamous cell carcinoma and 1 basaloid carcinoma.
The median follow-up period was 6.79 years in Group A and 2.79 years in Group B. The five-year overall survival rate was significantly higher in Group A (100.0%) compared to Group B (77.7%; p<0.001, log-rank test). The five-year relapse-free survival rate was also significantly better in Group A (92.3%) than in Group B (84.8%; p=0.008). In Group B, there was one death due to the primary disease and four deaths from other causes. Both groups reported one case of lymph node recurrence.
The median length of hospital stay was significantly shorter in Group A (34 days) than in Group B (48 days; p<0.001). Grade 3 or higher adverse events occurred in 4 patients in Group A and 11 in Group B (p=0.012), indicating significantly higher toxicity in the chemoradiotherapy group.

Conclusion

These findings suggest that chemotherapy may serve as a viable option for additional treatment following non-curative ESD in high-risk oesophageal cancer cases. Chemotherapy was associated with favourable survival outcomes, fewer adverse events, and shorter hospitalisation compared to chemoradiotherapy.

Introduction

Opportunistic screening is one major screening approach for esophageal squamous cell carcinoma (ESCC). Risk stratification models could be used to assess each individual's risk using relevant predictors so that only those at high risk are recommended for further endoscopy ^1-2. This approach would allow the development of a cost-effective opportunistic screening strategy and promise to improve the sensitivity of endoscopic detection by alerting the endoscopists.

Aims & Methods

We aimed to develop a score-based clinical prediction model to assess the risk of ESCC and precancerous lesions in opportunistic screening and to validate it in an external population. The study was a secondary analysis of a published esophageal cancer screening trial ³. The trial was conducted in 39 secondary or tertiary hospitals in China, with 14,597 individuals enrolled for opportunistic screening. Additionally, questionnaires and endoscopy were performed. The primary outcome was histology-confirmed high-grade esophageal lesions, including high-grade intraepithelial neoplasia (HGIN) and ESCC. The predictors were selected using univariable and multivariable logistic regression. Model performance was primarily measured with the area under the receiver operating characteristic curve (AUROC).

Results

The score-based prediction model contained 8 variables on a 21-point scale. The model demonstrated an AUROC of 0.833 (95% CI, 0.803-0.862) and 0.828 (95% CI, 0.793-0.864) for detecting high-grade lesions in the development and validation cohorts, respectively. As shown in Table 1, using the score cut-off value determined in the development cohort (≥9), the sensitivity reached 70.0% (95% CI, 50.6%-85.3%), 81.3% (95% CI, 63.6%-92.8%), and 81.1% (95% CI, 64.9%-92.0%) in the validation cohort for detecting HGIN, early ESCC, and advanced ESCC, respectively, at a specificity of 76.4% (95%CI,75.4%-77.4%). The score-based model exhibited satisfactory calibration in the calibration plots. The score-based model could result in 75.6% fewer individuals subjected to endoscopies.

Conclusion

This score-based model demonstrated superior discrimination for high-grade esophageal lesions. It has the potential to inform referral decisions in the opportunistic screening setting.

References

1. Jiang H, et al. Performance of Prediction Models for Esophageal Squamous Cell Carcinoma in General Population: A Systematic Review and External Validation Study. Am J Gastroenterol 2024;119:814–22.
2. Zheng H, et al. Development and external validation of a quantitative diagnostic model for malignant gastric lesions in clinical opportunistic screening: A multicenter real-world study. Chin Med J (Engl) 2024;137:2343–50.
3. Gao Y, et al. Machine learning-based automated sponge cytology for screening of oesophageal squamous cell carcinoma and adenocarcinoma of the oesophagogastric junction: a nationwide, multicohort, prospective study. The Lancet Gastroenterology & Hepatology 2023;8:432–45.

Introduction

The primary treatment goals of gastroesophageal reflux disease (GERD) include resolving symptoms, preventing complications and symptom relapses, and healing erosive oesophagitis.^{1, 2} Heartburn and regurgitation are frequent and typical symptoms of GERD. Vonoprazan, a potassium-competitive acid blocker, is approved in China for the treatment of reflux oesophagitis.^{3, 4} However, there is a paucity of real-world data assessing the relief of typical daily symptoms achieved with vonoprazan in adult Chinese patients.

Aims & Methods

VIEW (NCT04501627) was a multicentre, single-arm, prospective, observational, real-world study conducted in China. Patients received 20 mg vonoprazan, orally, once daily for 4 weeks (8 weeks for insufficient healing). This post hoc subgroup analysis conducted in enrolled patients with GERD assessed changes in symptom scores for all-day or night-time heartburn and/or regurgitation during the first 14 days of treatment. A mixed-effects model for repeated measures assessed statistical differences in symptom scores from baseline for each day; least-squares mean (LSM) and its 95% confidence interval are reported (negative values indicate improvement).

Results

Among the 2214 patients included in the effectiveness analysis population of the GERD group, 86.7% were aged <65 years[A.G.1] and 60.8% were male. The LSM change in symptom scores from baseline demonstrated a significant improvement from day 1 of treatment in all-day heartburn and/or regurgitation, daytime heartburn or regurgitation, and night‑time heartburn or regurgitation (Table). Significant improvement continued to be observed on day 14 and throughout all previous days of treatment.

Conclusion

Vonoprazan provided rapid (from day 1), significant and durable symptom relief in patients with GERD.

Table: Improvement in symptom scores^a from baseline to day 14 of vonoprazan treatment (effectiveness analysis population; MMRM analysis)

References

1. Antunes C, Aleem A and Curtis SA. StatPearls. Treasure Island (FL), 2023.
2. Heidelbaugh JJ, Nostrant TT, Kim C, et al. Am Fam Physician 2003; 68: 1311-1318.
3. Xiao Y, Lu Y, Yang H, et al. Am J Gastroenterol 2023; 118: S345-S345.
4. Oshima T and Miwa H. J Neurogastroenterol Motil 2018; 24: 334-344.

Disclosure

This study was funded by Takeda (China) International Trading Co. Ltd. Yinglian Xiao, Dekui Zhang and Jianyong Chen have no conflicts of interest. Kailun Liang and Li Xie are Takeda employees and hold Takeda stock options. Minhu Chen received speaker honoraria from Takeda China, AstraZeneca China, Xian Janssen and Eisai China.

Introduction

Guidelines recommend independent auditing of diagnostic performance for clinical implementation of computer-aided optical polyp diagnosis (CADx).

Aims & Methods

This study aimed to evaluate diagnostic performance and interobserver agreement of auditors, and to offer guidance on conducting CADx audits. Images and videos of all ≤5-mm polyps from a large prospective study with systematic activation of CADx were audited by three expert endoscopists. Experts performed independent, blinded diagnostic review including documentation of confidence level. The primary outcome was sensitivity of audit by three experts for high-confidence adenomas compared with pathology. Secondary outcomes included the number of reviewers for optimal CADx auditing and interobserver agreement.

Results

487 diminutive polyps were audited (510 patients). Sensitivity was 99.4% (95%CI 96.0–100) using three experts (Strategy A); 88.7% (95%CI 84.1–92.1) using two experts and one referee (Strategy B); 99% (95%CI 96–99.8), 98.8% (95%CI 95.4–99.8), and 99.4% (95%CI 96.3–100) using two-expert combinations (Strategy C); and 98.2% (95% CI 95.1-99.4), 97.3% (95% CI 94.0-98.9), and 88.9% (95% CI 83.6-92.7) for each expert individually (Strategy D). Among 266 pathology-based adenomas, Strategy A evaluated 160 polyps versus 196, 172, and 170 in Strategy C; and 220, 223, and 207 in Strategy D. Strategy B evaluated all 266 adenomas. Overall interobserver agreement was moderate (kappa 0.52), but very high for high-confidence adenomas (kappa 0.89).

Conclusion

Expert audit for evaluating CADx resulted in high sensitivity and interobserver agreement for high-confidence adenomas. Audit by two experts, with a third expert for arbitration, permitted audit of all polyps and could effectively assess CADx within clinical studies.

Disclosure

Daniel von Renteln has received research funding from ERBE Elektromedizin GmbH, Ventage, Pendopharm, Satisfai, Fujifilm, and Pentax, and has received consultant or speaker fees from Boston Scientific Inc., ERBE Elektromedizin GmbH, Medtronic, and Pendopharm. Roupen Djinbachian has received speaker fees from Fujifilm. The remaining authors declare that they have no conflict of interest.

Introduction

The diagnosis of small bowel motility disorders currently relies on identifying abnormal contractile patterns through intestinal manometry, but the technique is restricted to referral centers. Conventional CT scanning, frequently performed in the routine evaluation of these patients, provides images of intestinal content, which might serve as a marker of intestinal dysfunction. We hypothesized that pooling of intestinal content, quantified through computerized analysis of abdominal CT images, could serve as an indirect marker of small intestinal motor dysfunction.

Aims & Methods

Consecutive patients with either a) chronic intestinal pseudo-obstruction (CIPO) or b) suspected small intestinal motor dysfunction, evaluated at our Motility Unit using high-resolution jejunal manometry, were prospectively included. Manometric tracings were categorized as
a) normal,
b) uncoordinated contractile activity with preserved amplitude, or
c) hypomotility (markedly diminished amplitude of contractile activity).
All patients also underwent an abdominal CT scan within three months of the manometric study, as part of the clinical evaluation of the motility disorder. CT images were analyzed using a validated software developed in our laboratory, which applies image processing techniques and deep-learning tools to identify and quantify intestinal content volumes in the small bowel and colon of:
a) gas,
b) chyme-type content (non-gaseous, homogeneous texture), and
c) fecal-type content (non-gaseous, heterogeneous texture).

Results

Of the 66 patients included, 9 had CIPO and 57 suspected dysmotility. Manometry was abnormal in all patients with CIPO and in 22 patients (39%) without CIPO. Total intestinal content was markedly increased in patients with CIPO as compared with patients with normal motility (3034±826 mL vs 398±43 mL, respectively; p<0.001), primarily due to an increase in gas (1086±325 mL vs 22±4; p<0.001) and chyme-type content in the small bowel (1282±544 mL vs 81±11; p<0.001).
Among patients without CIPO, the volume of small bowel content was increased in patients with dysmotility compared to those with normal motility, mainly of chyme-type content (191±39 vs 81±11 mL in normal motility; p=0.006). Colonic volumes of gas and fecal-type content were also higher in patients with dysmotility than in those with normal motility (gas 224±40 vs 115±18 mL, p=0.027; fecal-type 244±59 vs 115±19 mL, p=0.036). Dysmotility patients with hypomotility patterns had overall higher intestinal content volumes than patients with uncoordinated contractile patterns (Table 1).

Table 1. Intestinal content volumes in non-CIPO patients, classified by manometric patterns

Conclusion

Intestinal content, measured on conventional CT scans by a specific analysis program, provides a useful indication of intestinal dysmotility.

Introduction

While anatomical landmark identification and adequate inspection time are recognized as crucial quality indicators in upper endoscopy, they are difficult to document consistently and accurately based solely on endoscopist reports.

Aims & Methods

To address this issue at Assuta Healthcare, a multicenter organization with 20 endoscopy units and over 200 endoscopists, we implemented a video-based AI platform designed to measure total upper endoscopy time (EGD-T), assess photo documentation of landmarks, and streamline the photo labeling process. In the current study, we evaluated the platform and employed it to examine endoscopist-reported quality measures.
For all upper endoscopies performed at Assuta Healthcare in 2024 on patients 45 years and older, the Theator AI-based Surgical Intelligence platform automatically documented total procedure time as well as photo snapshots captured and labeled by endoscopists for seven landmarks: 1. esophagus, 2. gastroesophageal junction, 3. cardia or fundus, 4. body, 5. angulus, 6. antrum or pylorus, and 7. duodenum (second part). In a subset of procedures, the platform facilitated documentation by suggesting labels for captured snapshots. After validating platform accuracy, we examined platform-reported procedure times. We then assessed landmark photo documentation rates in procedures with and without platform labeling suggestions.

Results

The study included 21,989 upper endoscopies (60.7% female, median age of 62.2 years), of which 51.7% were conducted with platform labeling suggestions and the remaining 48.3% were conducted without. Validated platform accuracy was 98%. Median total procedure time measured by the platform was 3.18 minutes (IQR 2.18-4.25). When they did not receive suggestions, endoscopists did not label any landmarks in 25% of procedures. At 12%, this percentage was significantly lower (p < .001) when the platform did provided suggestions. This difference was also reflected in the median number of landmarks labeled, which was 2 (IQR 0-3) in procedures without labeling suggestions and 3 (IQR 1-4) in procedures with labeling suggestions (p < .001).

Conclusion

Implementing an AI tool to automatically assess procedure time in upper endoscopy provided accurate measurements, revealing durations considerably lower than recommended. It further revealed extremely low labeling rates, which increased when automated suggestions were provided. The results highlight critical gaps in the reporting of quality measures for upper endoscopy and indicate that AI-based documentation can be instrumental to quality assurance by identifying and addressing such gaps.

Disclosure

None

Introduction

Artificial Intelligence (AI) assisted reading in Small Bowel Capsule Endoscopy (SBCE) has recently been shown to achieve comparable and potentially superior accuracy compared to standard clinician reading. In Colon Capsule Endoscopy (CCE), AI algorithms have also demonstrated promising results. However, the extent of AI-assisted reading's advantage remains unclear, particularly regarding its performance across different polyp sizes, morphologies, locations, and other factors. A deeper understanding of these variables is crucial for optimising AI performance and facilitating its clinical integration.

Aims & Methods

This CESCAIL sub-analysis evaluates the per-polyp diagnostic accuracy of AI-assisted versus standard clinician assessment (readings) and identifies key factors influencing AI-assisted accuracy using AiSPEED^TM, the Computer-Aided Detection (CADe) system.
The CESCAIL study evaluated the diagnostic accuracy of AI-assisted CCE readings using AiSPEED™ compared to the standard readings. Standard readings were manually performed by clinicians, while AI-assisted readings incorporated an AI pre-review followed by clinician validation. A total of 1,803 polyps from 673 patients were analysed at the per-polyp level, focusing on sensitivity and positive predictive value. Factors influencing the improved accuracy of AI-assisted readings over standard clinician readings were also assessed, including polyp size, morphology, location, patient demographics (age and sex), bowel preparation quality, capsule excretion rates, comorbidities, medications, reading time, and video duration.

Results

AI-assisted reading demonstrated significantly higher sensitivity with clear superiority for smaller polyps (<10 mm) compared to larger ones (≥10 mm) (OR 2.27 vs 0.88, p<0.001) (see Table 1). While there was no observed difference in diagnostic accuracy between AI-assisted and standard clinician assessment for polyps ≥10 mm, non-inferiority was established. AI accuracy remained consistent between 6–9 mm and ≤5 mm polyps (p=0.64). The most notable improvement was observed with hyperplastic polyps (HPs) (OR 5.4, p<0.001). No significant differences were identified for pedunculated, sub-pedunculated, Lateral Spreading Tumours, or Sessile Serrated Lesions. Furthermore, AI-assisted readings were significantly more accurate for left-sided polyps than right-sided ones (OR 2.36 vs 1.66, p<0.0001), although AI-assisted reads outperformed standard reads in both locations.

Conclusion

This study highlights the performance and consistency of AI-assisted reading, particularly for detecting smaller adenomas and HPs, with notably improved accuracy in the left colon. Next-generation AI should focus on distinguishing significant from diminutive polyps and enhancing polyp characterisation, especially for right-sided lesions.

References

1. Spada C, Piccirelli S, Hassan C, Ferrari C, Toth E, Gonzalez-Suarez B, et al. AI-assisted capsule endoscopy reading in suspected small bowel bleeding: a multicentre prospective study. Lancet Digit Health. 2024;6(5):e345-e53.

Disclosure

Hagen Wenzek serves as the CEO, Elizabeth White is the Project Manager, and Pablo Laiz is the AI software engineer at Corporate Health International, which owns the intellectual properties of AiSPEED^TM.