Introduction

Post endoscopy upper gastrointestinal cancers (PEUGIC) are often missed opportunities to diagnose earlier or even prevent cancer. A national process for identifying all PEUGIC in the English National Health Service (NHS) and performing root cause analysis was developed. In parallel, a survey of NHS endoscopy providers diagnostic and surveillance UGI endoscopy practices was undertaken to investigate organisational factors which may contribute to endoscopy quality and PEUGIC.

Aims & Methods

PEUGIC occurring 3-36 months after an index endoscopy without a cancer diagnosis between 2017 and 2023 were identified from National Cancer Registration and Hospital Episode Statistics datasets. Data from local root cause analysis were uploaded onto a secure portal for national analysis. Endoscopy providers taking part in the project were asked to complete an online organisational survey, covering diagnostic and surveillance endoscopic practices, equipment and the management of dysplasia and early cancer.

Results

3151 PEUGIC were examined by local reviewers in 144 hospitals in England. 635 (20%) were excluded on local review. Data were available for 2516 PEUGIC. 1897 PEUGIC (75.4%) were following diagnostic endoscopy and 618 (24.6%) were undergoing surveillance. 80% of endoscopy providers responded to the survey.
For diagnostic PEUGIC, less than 20 minutes being allocated to UGI endoscopy was associated with no abnormalities detected in the PEUGIC segment at index endoscopy OR 1.25 (95% CI 1.04-1.50). Oesophageal squamous cell PEUGIC were associated with less time allocated per endoscopy OR 1.28 (95% CI 1.03-1.59). Endoscopy providers with lower number of procedures during an endoscopy session were associated more frequently with adequate management of lesions OR 2.6 (95% CI 1.03-6.87). Patient harm and adverse treatment outcomes were associated with an inadequate index endoscopy OR 1.56 (95% CI 1.28-1.91). The most common reason for inadequate endoscopy was inadequate management of lesions identified, which were most likely to be cancer associated lesions OR 1.43 (95% CI 1.11-1.69), specifically oesophageal strictures (24%) and gastric ulcers (23%).
For surveillance PEUGIC, organisational factors associated with increased detection of stage 1 (success of surveillance) PEUGIC compared with stage ≥2 were: dedicated surveillance sessions OR 2.08 (95% CI 1.46-2.98), >20 minutes allocated per endoscopy OR 2.05 (95% CI 1.48-2.84) and surveillance in an endoscopic resection centre OR 3.50 (95% CI 1.99-6.13).
Booking delays and errors were noted in 12% of PEUGIC, patient factors (e.g. non-attendance) were noted in 11% and clinical error in 11.7% (inappropriate decision 7.5% and histology not actioned in 4.2%). Surveillance was delayed in 27% of PEUGIC and associated with adverse treatment outcomes OR 1.79 (95%CI 1.72-2.73).

Conclusion

A survey of endoscopy providers’ organisational structure has revealed factors which contribute to PEUGIC not captured during individual root cause analysis. Less time allocated for endoscopy was associated with no abnormalities being found during endoscopies that lead to PEUGIC. Surveillance outcomes were better in patients who had their endoscopies in dedicated surveillance sessions, with more time allocated and undertaken in endoscopic resection centres. Surveillance delays are common and associated with worse outcomes.

Introduction

​Transanal Minimally Invasive Surgery (TAMIS) and Endoscopic Submucosal Dissection (ESD) are minimally invasive techniques for en bloc resection of large non-pedunculated rectal lesions. While TAMIS has been widely adopted in the Netherlands, ESD uptake has been slower. No randomized trials have compared these methods, leaving the choice of technique dependent on local expertise rather than evidence.

Aims & Methods

This multicenter-randomized non-inferiority trial (NTR7281) aimed at comparing TAMIS and ESD regarding effectiveness, safety, patient burden, and costs. In total, 198 patients with non-pedunculated rectal lesions >2 cm, located ≤15 cm from the anal verge, were included. Patients were randomized in a 1:1 ratio to TAMIS or ESD, with stratification by polyp size (20–40 mm or >40 mm) and distance from the dentate line (<10 mm, 10–99 mm, 100–150 mm), after an expert panel had judged the lesions suitable for inclusion. Exclusion criteria included deep submucosal invasion on endoscopy or imaging (with endoscopy prioritized in case of discordant findings), prior endoscopic resection attempt, and an unfavorable risk-benefit ratio for local treatment (e.g., poor general condition or very short life expectancy). The primary endpoint was cumulative local recurrence at 12 months (non-inferiority margin: 6%). Secondary endpoints included radical (R0) resection rate, complications (AGREE classification), patient burden (COREFO, EQ-5D-5L, QLQ-CR29), and cost-effectiveness. Intention-to-treat analysis was performed.

Results

Of the 198 randomized patients (98 TAMIS, 100 ESD), 5 crossed over from TAMIS to ESD and 1 from ESD to TAMIS. One patient dropped out before treatment as result of non-related metastatic disease. Mean polyp size was 42.0 mm. Mean procedure time was 108.7 minutes for ESD and 78.1 minutes for TAMIS. In total, 156 benign and 41 malignant lesions (39 T1, 2 T2, and 1 T3) were resected. At 12 months, 6 recurrences occurred: 0 (0%) in the ESD group and 6 (6.4%) in the TAMIS group, all benign, with a 6.4% difference favoring ESD (95% CI: -11.8 to -1.5), confirming non-inferiority and also superiority. R0 resection rates were 83% for ESD and 71% for TAMIS (p = 0.047). Overall complication rates were similar (p = 0.33). Colorectal functional outcomes at 12 months were similar and comparable to baseline. Quality-adjusted life years were also similar (0.90 for ESD and 0.91 for TAMIS, p = 0.356). Despite a significant difference in the average initial procedure cost (€2.628 for ESD and €3365 for TAMIS, p < 0.001), the average total cost over 12 months was similar (€7.134 for ESD and €7216 for TAMIS, p = 0.934).

Conclusion

This trial is the first to show that ESD is non-inferior to TAMIS for local recurrence at 12 months in en bloc resection of large non-pedunculated rectal lesions. ESD showed superior radical resection rates and lower initial procedural costs, while both techniques had similar safety profiles, colorectal functional outcomes, quality-adjusted life years, and total 12-month costs.

Disclosure

The TRIASSIC study received funding by ZonMw and Applied medical.
A. Koch received consultancy fees from Microtech, Erbe and Fujifilm