Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors
Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors: a Multi-center, Prospective, Controlled Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
China is a country with a heavy burden of gastric cancer and esophageal cancer. In 2015, the incidence/mortality of gastric cancer and esophageal cancer in China were 680000/500000 and 220000/200000, respectively. Gastroscopy is the most important means to detect early cancer of gastrointestinal tract. However, due to various factors, the miss rate of clinical significant lesions by gastroscopy is innegligible. Our previous research results showed that the detection rate of early gastric cancer and early esophageal cancer in China was only about 15%. This study aims to include 2000 gastroscopic procedures and investigate the relationship between procedure time and lesion detection rate in tertiary endoscopic centers in China.
At the first stage, the researchers observe the actual procedure time of gastroscopies without affecting the natural behavior of endoscopists. Then, researchers collect the data (including focal lesion detection rate, procedure time, detection rate of early upper GI cancer, biopsy rate and adverse event rate) and analyze the minimal procedure time. At the second stage, a minimal time limit will be set for each procedure. Every stage last two months, and potential correlations between lesion detection rate and procedure time will be investigated through subsequent statistical analysis.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Shanghai, Chine, 200433
- Changhai Hospital, Second Military Medical University
-
Shanghai, Chine, 200433
- Changhai Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- No history of benign and malignant tumors (including carcinoma and adenoma) of upper GI (including esophagus, stomach and duodenum)
- undergo gastroscopy with intravenous anesthesia (or conscious sedation)
Exclusion Criteria:
- Subjects with focal lesions detected by gastroscopy within 1 year
- Subjects that cannot stand the gastroscopy procedure or cannot cooperate with endosccopists
- Emergency endoscopy and therapeutic endoscopy
- Subjects with history of esophageal or stomach surgery or endoscopic surgery
- Pregnant
- Subjects that taking antiplatelet or anticoagulant drugs which contradicts endoscopic biopsy
- Subjects with other serious complications that affect the speed of gastroscopy
- Subjects that refuse to cooperate with data collection or sign the informed consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Set the minimum time of gastroscopy
|
This study contains 2 stages.
At the first stage, no interventions are implemented.
The researchers just observe the actual procedure time of gastroscopy.
At the second stage, a minimal procedure time is set based on the observational results of the first stage.
|
|
Aucune intervention: Observe the procedure time of gastroscopy
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
focal lesion detection rate
Délai: two months
|
number of gastroscopy procedures that detects focal lesions divided by the number of all gastroscopy procedures
|
two months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
detection rate of high risk lesions
Délai: two months
|
number of gastroscopy procedures that detect upper GI cancers (gastric or esophageal cancer), dysplasia and intestinal metaplasia divided by the number of all gastroscopy procedures
|
two months
|
|
endoscopic biopsy rate
Délai: two months
|
number of gastroscopy procedures with biopsy divided by the number of all gastroscopy procedures
|
two months
|
|
detection rate of neoplastic lesions
Délai: two months
|
number of gastroscopy procedures that detect upper GI cancers divided by the number of all gastroscopy procedures
|
two months
|
|
mean (median) examination time for normal EGDs without biopsy
Délai: two months
|
mean (median) examination time for all normal EGDs without biopsy
|
two months
|
|
rate of procedures reaching the minimal time
Délai: two months
|
number of gastroscopy procedures that reach the minimal time divided by the number of all gastroscopy procedures
|
two months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ye Gao, Changhai Hospital
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
- gastroscopy time
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
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .