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

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.

Study Overview

• Status: Completed
• Conditions: Early Gastric Cancer; Gastroscopy Time; Detection Rate
• Intervention / Treatment: Other: Set the minimum time of gastroscopy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Set the minimum time of gastroscopy	Other: 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.
No Intervention: Observe the procedure time of gastroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
focal lesion detection rate	number of gastroscopy procedures that detects focal lesions divided by the number of all gastroscopy procedures	two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
detection rate of high risk lesions	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	number of gastroscopy procedures with biopsy divided by the number of all gastroscopy procedures	two months
detection rate of neoplastic lesions	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	mean (median) examination time for all normal EGDs without biopsy	two months
rate of procedures reaching the minimal time	number of gastroscopy procedures that reach the minimal time divided by the number of all gastroscopy procedures	two months

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Ye Gao, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 15, 2022

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: gastroscopy time

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No