Sedation Versus No Sedation for Detection Rates of Precancerous Lesions and Cancer
1 other identifier
observational
200,000
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2019
CompletedFirst Submitted
Initial submission to the registry
August 24, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedAugust 30, 2019
August 1, 2019
1 year
August 24, 2019
August 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Detection rate of precancerous lesions and cancer of upper digestive system improvement
Detection rate of precancerous lesions and cancer of upper digestive system improvement
2020
Study Arms (2)
No sedation
The group of patients who did endoscopies without sedation.
Sedation
The group of patients who did endoscopies with sedation.
Interventions
The group of patients who did endoscopies with or without sedation. (This is a choice of themselves)
Eligibility Criteria
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.
You may qualify if:
- Patients aged more than 18 years with or without GI symptoms attending for endoscopy from 2012 to 2019.
You may not qualify if:
- Patients unable to cooperated the endoscopy or unable to complete it. People with endoscopy contraindications are naturally excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shandong Universitylead
- Weihai Municipal Hospitalcollaborator
- Binzhou Medical Universitycollaborator
- Qilu Hospital of Shandong University (Qingdao)collaborator
Study Sites (1)
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012, China
Related Publications (1)
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.
PMID: 34074827DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 24, 2019
First Posted
August 28, 2019
Study Start
June 2, 2019
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
August 30, 2019
Record last verified: 2019-08