Long-term Outcomes of Endoscopic Papillary Balloon Dilation for 8-12mm Bile Duct Stones: a Prospective Study
The investigators prospectively evaluated long-term outcomes of ELBPD+EST for CBD stones up to 8-12mm.
EPBD+EST in patients with CBD stones up to 8-12mm appears to be associated with a very low (<3%) rate of long-term stone recurrence. The efficacy of EPBD for 8-12mm stones warrants further exploration in randomized trials.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Consecutive patients with CBD stones up to 8-12mm successfully treated by EPBD+EST from September 2018 to August 2020 were prospectively followed for at least 12 months. CBD stone recurrence was defined as recurrent stones confirmed by ERCP during the follow-up period. The maximum diameter of the balloon used was 15mm.
Overall, 72 patients (mean age: 67 years, 52.8% males) were included, of whom 22 (30.5%) had multiple CBD stones, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%) had a periampullary diverticulum and 22 (30.5%) had a previous EST. The mean CBD diameter was 11.6±1mm, whereas a tapered duct was noted in 7 (9.7%). Post-procedural bleeding occurred in one case, treated successfully a with a fully covered metal stent. Mild cholangitis occurred in two cases. No cases with perforation or PEP were observed. During a mean follow-up of 22.4±6.2 months (range 13-36), CBD stones recurred in 2/72 (2.7%).
EPBD+EST in patients with CBD stones up to 8-12mm appears to be associated with a very low (<3%) rate of long-term stone recurrence. The efficacy of EPBD for 8-12mm stones warrants further exploration in randomized trials.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Heraklion, Grèce, 71409
- ''Benizelion" General Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:patients with ELBPD+EST for CBD stones up to 8-12mm from September 2018 to August 2020 -
Exclusion Criteria: Patients with bile duct stones less than 8mm or more than 12mm.
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Rétrospective
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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patients with CBD stones up to 8-12mm
72 patients (mean age: 67 years, 52.8% males) were included, of whom 22 (30.5%) had multiple CBD stones, 23 (31.9%) had a history of cholecystectomy, 13 (18.1%)
had a periampullary diverticulum and 22 (30.5%) had a previous EST
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endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Stone recurrence after endoscopic papillary balloon dilation (EPBD) with endoscopic sphincterotomy (EST) in prior ERCP.
Délai: 22.4±6.2 months
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Patients with CBD stones up to 8-12mm successfully treated by EPBD+EST from September 2018 to August 2020 were prospectively followed for at least 12 months.
CBD stone recurrence was defined as recurrent stones confirmed by ERCP during the follow-up period.
The maximum diameter of the balloon used was 15mm.
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22.4±6.2 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Gregorios Gregorios, Director, ''Benizelion" General Hospital, Heraklion, Crete
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Paspatis-balloon dilation
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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