Cold snare endoscopic resection for large colon polyps – a randomized trial
Bibliographic record
Abstract
Aims Despite improvements in technique, severe adverse events (SAE), including post-procedure bleeding, remain a major concern following endoscopic resection of large colorectal polyps. We examined whether cold resection without the use of electrocautery reduces the risk of SAE and affords completeness of resection. Methods We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 10 medical centers in North America from October 2019 through January 2023. Patients were randomly assigned to endoscopic mucosal resection (EMR) without electrocautery (cold EMR group) or with electrocautery (hot EMR group) and were followed until their first surveillance colonoscopy. Hot EMR included margin treatment and defect closure as indicated. The primary outcome were SAEs in intention to treat analysis, defined as an event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. The secondary outcome was the rate of polyp recurrence at surveillance colonoscopy. Because crossover from cold to hot EMR was expected (assumed 10%), we also performed a per protocol analysis. Additional subgroup analysis considered polyp characteristics and use of periprocedural antithrombotic medications. Results 660 patients were randomized, and 518 (78.5%) completed their first surveillance colonoscopy. Crossover occurred in 14.6% in the cold EMR group and in 13.4% in the hot EMR group. An SAE was observed in 2.1% of patients in the cold EMR group and in 4.3% in the hot EMR group (p=0.62) with postprocedure bleeding in 0.9% and 2.8%, respectively (p=0.52). When the analysis was restricted to patients who received the intervention as randomized (per protocol analysis), significantly fewer SAEs occurred in the cold EMR group as compared to the hot EMR group (1.4% vs 4.9%, p=0.017), with postprocedure bleeding in 1.1% and 2.5%, respectively (p=0.34). Polyp recurrence was detected in 28.0% in the cold EMR group and 14.2% in the hot EMR group (p<0.001). In the per protocol analysis recurrence rates were 28.7% and 15.4% (p<0.001), respectively. In subgroup analysis SAE risk differences between groups remained unchanged. However, risk of recurrence was similar for the subgroup of 20-29 mm polyps (18.5% vs 15.7%) and for sessile serrated polyps (15.0% vs 14.5%). The greatest recurrence risk was noted for adenomas with high grade dysplasia (46.5% vs 18.4%, respectively, p=0.004). Conclusions This large multicenter trial showed no significant safety benefit of universal cold EMR for large colorectal polyps. However, after accounting for a high crossover rate, cold EMR had a significantly lower SAE rate compared to hot EMR. This safety benefit of cold EMR is offset by a greater recurrence rate, particularly for advanced pathology. Our findings do not support the universal application of cold EMR for large non-pedunculated colorectal polyps. Publication History Article published online: 15 April 2024 © 2024. European Society of Gastrointestinal Endoscopy. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".