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Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors

4. marts 2022 opdateret af: Zhaoshen Li, Changhai Hospital

Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors: a Multi-center, Prospective, Controlled Study

This multicenter, prospective, interventional 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. At the second stage, a minimal time limit will be set for each procedure based on the observational results of the first stage. The primary study outcome is focal lesion detection rate. Secondary outcomes include detection rate of early upper GI cancer, biopsy rate and adverse event rate.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
      • Shanghai, Kina, 200433
        • Changhai Hospital, Second Military Medical University
      • Shanghai, Kina, 200433
        • Changhai Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Set the minimum time of gastroscopy
Andet: 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.
Ingen indgriben: Observe the procedure time of gastroscopy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
focal lesion detection rate
Tidsramme: two months
number of gastroscopy procedures that detects focal lesions divided by the number of all gastroscopy procedures
two months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
detection rate of high risk lesions
Tidsramme: 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
Tidsramme: two months
number of gastroscopy procedures with biopsy divided by the number of all gastroscopy procedures
two months
detection rate of neoplastic lesions
Tidsramme: 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
Tidsramme: two months
mean (median) examination time for all normal EGDs without biopsy
two months
rate of procedures reaching the minimal time
Tidsramme: two months
number of gastroscopy procedures that reach the minimal time divided by the number of all gastroscopy procedures
two months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Changhai Hospital

Efterforskere

  • Ledende efterforsker: Ye Gao, Changhai Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2020

Primær færdiggørelse (Faktiske)

31. december 2021

Studieafslutning (Faktiske)

15. januar 2022

Datoer for studieregistrering

Først indsendt

20. oktober 2020

Først indsendt, der opfyldte QC-kriterier

20. oktober 2020

Først opslået (Faktiske)

26. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • gastroscopy time

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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