NCT04602299

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

October 20, 2020

Last Update Submit

March 4, 2022

Conditions

Gastroscopy TimeEarly Gastric CancerDetection Rate

Outcome Measures

Primary Outcomes (1)

  • focal lesion detection rate

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

    two months

Secondary Outcomes (5)

  • detection rate of high risk lesions

    two months

  • endoscopic biopsy rate

    two months

  • detection rate of neoplastic lesions

    two months

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

    two months

  • rate of procedures reaching the minimal time

    two months

Study Arms (2)

Set the minimum time of gastroscopy

EXPERIMENTAL
Other: Set the minimum time of gastroscopy

Observe the procedure time of gastroscopy

NO INTERVENTION

Interventions

Set the minimum time of gastroscopyOTHER

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.

Set the minimum time of gastroscopy

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

Location

Changhai Hospital

Shanghai, 200433, China

Location

Related Publications (1)

  • 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.

    PMID: 37307142DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Ye Gao

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology

Study Record Dates

First Submitted

October 20, 2020

First Posted

October 26, 2020

Study Start

November 1, 2020

Primary Completion

December 31, 2021

Study Completion

January 15, 2022

Last Updated

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)