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Sedation Versus No Sedation for Detection Rates of Precancerous Lesions and Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069975
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
Weihai Municipal Hospital
Binzhou Medical University
Qilu Hospital of Shandong University (Qingdao)
Information provided by (Responsible Party):
Yanqing Li, Shandong University

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.

Condition or disease Intervention/treatment
Early Detection of Cancer Other: Sedation

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.

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Study Type : Observational
Estimated Enrollment : 200000 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Sedation Versus No Sedation for Diagnostic Esophagogastroduodenoscopies and Detection Rates of Precancerous Lesions and Cancer: a Case-control Study
Actual Study Start Date : June 2, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
No sedation
The group of patients who did endoscopies without sedation.
Sedation
The group of patients who did endoscopies with sedation.
Other: Sedation
The group of patients who did endoscopies with or without sedation. (This is a choice of themselves)




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

  • Patients aged more than 18 years with or without GI symptoms attending for endoscopy from 2012 to 2019.

Exclusion Criteria:

  • Patients unable to cooperated the endoscopy or unable to complete it. People with endoscopy contraindications are naturally excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069975


Contacts
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Contact: Yanqing LI, Doctor 13573106261 liyanqing@sdu.edu.cn

Locations
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China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, PhD. MD.    18678827666    liyanqing@sdu.edu.cn   
Sponsors and Collaborators
Shandong University
Weihai Municipal Hospital
Binzhou Medical University
Qilu Hospital of Shandong University (Qingdao)
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Responsible Party: Yanqing Li, Professor, Shandong University
ClinicalTrials.gov Identifier: NCT04069975    
Other Study ID Numbers: 2019SDU-QILU-09
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanqing Li, Shandong University:
Early Detection of cancer
Gastrointestinal Neoplasms
Endoscopy, Gastrointestinal