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NCT Number: NCT04602299

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

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.

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Key information

Conditions

Gastroscopy Time Detection Rate Digestive System Diseases Digestive System Neoplasms Early Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital, Shanghai, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Set the minimum time of gastroscopy

Other

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.

Primary outcomes

  1. focal lesion detection rate

    Time frame: two months

    number of gastroscopy procedures that detects focal lesions divided by the number of all gastroscopy procedures

Secondary outcomes

  1. detection rate of high risk lesions

    Time frame: 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

  2. endoscopic biopsy rate

    Time frame: two months

    number of gastroscopy procedures with biopsy divided by the number of all gastroscopy procedures

  3. detection rate of neoplastic lesions

    Time frame: two months

    number of gastroscopy procedures that detect upper GI cancers divided by the number of all gastroscopy procedures

  4. mean (median) examination time for normal EGDs without biopsy

    Time frame: two months

    mean (median) examination time for all normal EGDs without biopsy

  5. rate of procedures reaching the minimal time

    Time frame: two months

    number of gastroscopy procedures that reach the minimal time divided by the number of all gastroscopy procedures

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 26, 2020
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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