Gastroscopy TimeNCT04602299
Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors
A study testing Set the minimum time of gastroscopy in people with Gastroscopy Time and Early Gastric Cancer, run by Changhai Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroscopy Time, Early Gastric Cancer, Detection Rate
- What is being tested?
- Set the minimum time of gastroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2020to 15 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Changhai Hospital, Second Military Medical University
Shanghai, 200433
Changhai Hospital
Shanghai, 200433
About this study
Official title: 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.
Read the 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
- Being tested
- Set the minimum time of gastroscopy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Set the minimum time of gastroscopy | Experimental | Not described Receives: Other: Set the minimum time of gastroscopy |
| Observe the procedure time of gastroscopy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
focal lesion detection rate
number of gastroscopy procedures that detects focal lesions divided by the number of all gastroscopy procedures
Measured: two months
Secondary outcomes (5)
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
Measured: two months
endoscopic biopsy rate
number of gastroscopy procedures with biopsy divided by the number of all gastroscopy procedures
Measured: two months
detection rate of neoplastic lesions
number of gastroscopy procedures that detect upper GI cancers divided by the number of all gastroscopy procedures
Measured: two months
mean (median) examination time for normal EGDs without biopsy
mean (median) examination time for all normal EGDs without biopsy
Measured: 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
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroscopy TimeStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Ye Gao, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602299
- Sponsor's protocol ID
- gastroscopy time
- Status last verified
- Mar 2022
- First submitted
- 20 Oct 2020
- Last updated
- 18 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37307142
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Setting the Shortest Examination Time of Gastroscopy to Improve the Detection Rate of Upper Gastrointestinal Tumors: a Multi-center, Prospective, Controlled Study
- ClinicalTrials.gov ID
- NCT04602299
- Acronym / sponsor ID
- gastroscopy time
- Conditions
- Gastroscopy Time, Early Gastric Cancer, Detection Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Set the minimum time of gastroscopy | Experimental | Other: Set the minimum time of gastroscopy |
| Observe the procedure time of gastroscopy | No intervention | – |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Set the minimum time of gastroscopyThis 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. | Other | Set the minimum time of gastroscopy |
Primary outcome
focal lesion detection rate
Time frame: two months
number of gastroscopy procedures that detects focal lesions divided by the number of all gastroscopy procedures
5 secondary outcomes
detection rate of high risk lesions
Time frame: two months
endoscopic biopsy rate
Time frame: two months
detection rate of neoplastic lesions
Time frame: two months
mean (median) examination time for normal EGDs without biopsy
Time frame: two months
rate of procedures reaching the minimal time
Time frame: two months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Derived from this study: PubMed 37307142Gao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ye Gao principal investigator
Changhai Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Set the minimum time of gastroscopy in people with Gastroscopy Time and Early Gastric Cancer, run by Changhai Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
focal lesion detection rate (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04602299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.