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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Shanghai, Kina, 200433
- Changhai Hospital, Second Military Medical University
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Shanghai, Kina, 200433
- Changhai Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Set the minimum time of gastroscopy
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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.
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Ingen inngripen: Observe the procedure time of gastroscopy
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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focal lesion detection rate
Tidsramme: two months
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number of gastroscopy procedures that detects focal lesions divided by the number of all gastroscopy procedures
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two months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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detection rate of high risk lesions
Tidsramme: two months
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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
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two months
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endoscopic biopsy rate
Tidsramme: two months
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number of gastroscopy procedures with biopsy divided by the number of all gastroscopy procedures
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two months
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detection rate of neoplastic lesions
Tidsramme: two months
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number of gastroscopy procedures that detect upper GI cancers divided by the number of all gastroscopy procedures
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two months
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mean (median) examination time for normal EGDs without biopsy
Tidsramme: two months
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mean (median) examination time for all normal EGDs without biopsy
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two months
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rate of procedures reaching the minimal time
Tidsramme: two months
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number of gastroscopy procedures that reach the minimal time divided by the number of all gastroscopy procedures
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two months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ye Gao, Changhai Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- gastroscopy time
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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