Type of submucosal injection solution for endoscopic resection of large colon polyps – results of a randomized trial
Notice bibliographique
Résumé
Aims The type of submucosal solution for endoscopic mucosal resection (EMR) of large colorectal polyps remains a matter of debate. Prior studies suggest that a viscous solution facilitates completeness of resection for any GI tract lesion compared to normal saline with a contrast agent (NS), however, data for large colorectal polyps are limited. The aim of the study was to examine safety and efficacy of performing EMR with normal saline (NS) compared to EMR with a viscous solution (VS). Methods In a multicenter trial, patients with a≥20 mm non-pedunculated colorectal polyp were randomized in a 2x2 design to cold or hot EMR (primary intervention, reported at DDW 2024) and to submucosal injection with VS (either Eleview, hydroxyethyl starch, EverLift, or ORISE) or NS with a contrast agent (secondary intervention). Low dose epinephrine (1:200000 to 1:500000) was added to all injection solutions. The primary outcome was the incidence of severe adverse events (SAE) within 30 days (per patient analysis). Secondary outcomes were technical resection characteristics and recurrence at first surveillance colonoscopy (per polyp analysis). Here we report results of the secondary intervention (there was no interaction between the two interventions). Results 660 patients were randomized, 557 patients were available for 30-day follow up, and 561 (91.2% of patients eligible for surveillance) completed their first surveillance colonoscopy after a median of 6.2 months. There was no difference in overall SAE (4% in the VS group and 2.4% in the NS group). However, postprocedure bleeding was more frequent following injection with VS (3.0%) compared to NS (0.6%, p=0.037). A reverse but non-significant difference was seen for perforation with 1 perforation in the VS group (0.3%) and 4 perforations in the NS group (1.2%, p=0.216). Polyp recurrence was not different between the groups (22.1% with VS and 19.7% with NS). Subgroup analysis by size, location, morphology, or histology showed not differences. Complete margin treatment reduced recurrence similarly in both groups to 10.9% and 10.3%, respectively. Technical outcomes showed that VS required less amount of injection volume and afforded longer lifting, while NS more often resulted in adequate coloring and facilitated assessment of the resection defect. Overall performance of NS was judged to be more often inadequate or poor compared to VS (9.0 vs 4.5%, p=0.015). Conclusions In this large randomized trial SAEs and recurrence rates were similar following EMR of large colon polyps using a viscous solution or NS with contrast. However, postprocedure bleeding was more frequent with a viscous solution, while perforation occurred numerically more often with NS. Technical outcomes favor a viscous solution. ClinicalTrials.gov no: NCT03865537. Publication History Article published online: 27 March 2025 © 2025. European Society of Gastrointestinal Endoscopy. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,004 | 0,006 |
| Méta-épidémiologie (sens strict) | 0,002 | 0,001 |
| Méta-épidémiologie (sens large) | 0,005 | 0,005 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,002 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,004 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,005 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».