Early Detection of CancerNCT04069975
Sedation Versus No Sedation for Detection Rates of Precancerous Lesions and Cancer
An observational study of Early Detection of Cancer, run by Shandong University at 1 site in China.
Trial summary
The influence of sedation on the endoscopic detection rate of the precancerous lesions and cancer of upper digestive system has not been assessed. In the daily medical routine of China, patients have the right to choose the sedation style according to his or her own situation, whose detailed endoscopic data of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Early Detection of Cancer
- What is being tested?
- Sedation
- How many people
- 200,000 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2019to Jun 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: After calulating, the sample size should be more than the largest number 23,000. As a retrospective study, the sample size may be more than 20,0000, according to our estimates.
Who may be able to join
- Patients aged more than 18 years with or without GI symptoms attending for endoscopy from 2012 to 2019.
Who cannot join
- Patients unable to cooperated the endoscopy or unable to complete it. People with endoscopy contraindications are naturally excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, PhD. MD., 18678827666, liyanqing@sdu.edu.cn
About this study
Official title: Sedation Versus No Sedation for Diagnostic Esophagogastroduodenoscopies and Detection Rates of Precancerous Lesions and Cancer: a Case-control Study
The influence of sedation on the endoscopic detection rate of the precancerous lesions and cancer of upper digestive system has not been assessed. In the daily medical routine of China, patients have the right to choose the sedation style according to his or her own situation, whose detailed endoscopic data of patients are recorded in the endoscopy quality control system. The aim of this research is to detect whether the use of sedation can help improve detection rate of precancerous lesions and cancer of upper digestive system.
Read the detailed description
The influence of sedation on the endoscopic detection rate of the precancerous lesions and cancer of upper digestive system has not been assessed. In the daily medical routine of China, patients have the right to choose the sedation style according to his or her own situation, whose detailed endoscopic data of patients are recorded in the endoscopy quality control system. The aim of this research is to detect whether the use of sedation can help improve detection rate of precancerous lesions and cancer of upper digestive system.
- Conditions
- Early Detection of Cancer
- Being tested
- Sedation
- Keywords
- Early Detection of cancer, Gastrointestinal Neoplasms, Endoscopy, Gastrointestinal
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedationOther
The group of patients who did endoscopies with or without sedation. (This is a choice of themselves)
| Study group | Role | What they receive |
|---|---|---|
| No sedation | The group of patients who did endoscopies without sedation. | |
| Sedation | The group of patients who did endoscopies with sedation. Receives: Other: Sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of precancerous lesions and cancer of upper digestive system improvement
Detection rate of precancerous lesions and cancer of upper digestive system improvement
Measured: 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start2 Jun 2019
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
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 Early Detection of CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Weihai Municipal Hospital, Binzhou Medical University, Qilu Hospital of Shandong University (Qingdao)
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069975
- Sponsor's protocol ID
- 2019SDU-QILU-09
- Status last verified
- Aug 2019
- First submitted
- 24 Aug 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou J, Li Z, Ji R, Wang P, Zhang A, Wu K, Liu C, Niu Q, Chu Y, Su X, Zuo X, Li Y. Influence of Sedation on the Detection Rate of Early Cancer and Precancerous Lesions During Diagnostic Upper Gastrointestinal Endoscopies: A Multicenter Retrospective Study. Am J Gastroenterol. 2021 Jun 1;116(6):1230-1237. doi: 10.14309/ajg.0000000000001201.
PubMed 34074827
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation Versus No Sedation for Diagnostic Esophagogastroduodenoscopies and Detection Rates of Precancerous Lesions and Cancer: a Case-control Study
- ClinicalTrials.gov ID
- NCT04069975
- Acronym / sponsor ID
- 2019SDU-QILU-09
- Conditions
- Early Detection of Cancer
- Keywords
- Early Detection of cancer, Gastrointestinal Neoplasms, Endoscopy, Gastrointestinal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Weihai Municipal Hospital, Binzhou Medical University, Qilu Hospital of Shandong University (Qingdao)
- Study start
- 2 Jun 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 28 Aug 2019 (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.
The influence of sedation on the endoscopic detection rate of the precancerous lesions and cancer of upper digestive system has not been assessed. In the daily medical routine of China, patients have the right to choose the sedation style according to his or her own situation, whose detailed endoscopic data of patients are recorded in the endoscopy quality control system. The aim of this research is to detect whether the use of sedation can help improve detection rate of precancerous lesions and cancer of upper digestive system.
Detailed description
The influence of sedation on the endoscopic detection rate of the precancerous lesions and cancer of upper digestive system has not been assessed. In the daily medical routine of China, patients have the right to choose the sedation style according to his or her own situation, whose detailed endoscopic data of patients are recorded in the endoscopy quality control system. The aim of this research is to detect whether the use of sedation can help improve detection rate of precancerous lesions and cancer of upper digestive system.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No sedation | – | –The group of patients who did endoscopies without sedation. |
| Sedation | – | Other: SedationThe group of patients who did endoscopies with sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- After calulating, the sample size should be more than the largest number 23,000. As a retrospective study, the sample size may be more than 20,0000, according to our estimates.
Key inclusion criteria (1 listed)
- Patients aged more than 18 years with or without GI symptoms attending for endoscopy from 2012 to 2019.
Key exclusion criteria (1 listed)
- Patients unable to cooperated the endoscopy or unable to complete it. People with endoscopy contraindications are naturally excluded.
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 |
|---|---|---|
| SedationThe group of patients who did endoscopies with or without sedation. (This is a choice of themselves) | Other | Sedation |
Primary outcome
Detection rate of precancerous lesions and cancer of upper digestive system improvement
Time frame: 2020
Detection rate of precancerous lesions and cancer of upper digestive system improvement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Derived from this study: PubMed 34074827Zhou J, Li Z, Ji R, Wang P, Zhang A, Wu K, Liu C, Niu Q, Chu Y, Su X, Zuo X, Li Y. Influence of Sedation on the Detection Rate of Early Cancer and Precancerous Lesions During Diagnostic Upper Gastrointestinal Endoscopies: A Multicenter Retrospective Study. Am J Gastroenterol. 2021 Jun 1;116(6):1230-1237. doi: 10.14309/ajg.0000000000001201.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Detection of Cancer, run by Shandong University at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqing LI, Doctor (13573106261, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of precancerous lesions and cancer of upper digestive system improvement (time frame: 2020). 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 NCT04069975, 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 30 Aug 2019.