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

NCT ID: NCT04602299

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-01-15

Brief Summary

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.

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.

Conditions

Gastroscopy Time; Early Gastric Cancer; Detection Rate

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Set the minimum time of gastroscopy

Group Type: EXPERIMENTAL

Set the minimum time of gastroscopy

Intervention Type: 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.

Observe the procedure time of gastroscopy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhaoshen Li

Director of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ye Gao

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Changhai Hospital, Second Military Medical University

Shanghai, , China

Changhai Hospital

Shanghai, , China

Countries

China

References

Gao Y, Cai MX, Tian B, Lin H, Jiang ZY, Yang XC, Lu L, Li L, Shi LH, Liu XY, Wang YL, Li ZS, Xin L, Wang LW. Setting 6-Minute Minimal Examination Time Improves the Detection of Focal Upper Gastrointestinal Tract Lesions During Endoscopy: A Multicenter Prospective Study. Clin Transl Gastroenterol. 2023 Aug 1;14(8):e00612. doi: 10.14309/ctg.0000000000000612.

Reference Type: DERIVED

PMID: 37307142 (View on PubMed)

Other Identifiers

gastroscopy time

Identifier Type: -

Identifier Source: org_study_id