Sedation Versus No Sedation for Detection Rates of Precan... | NCT04069975

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

NCT04069975

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

Aug 30, 2019Actual

Enrollment

200,000Estimated

Phase

Not provided

Conditions

Early Detection of Cancer

Interventions

Sedation

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2, 2019Actual

Primary Completion Date

Jun 2020Estimated

Completion Date

Jun 2020Estimated

First Submitted Date

Aug 24, 2019

First Submission Date that Met QC Criteria

Aug 24, 2019

First Posted Date

Aug 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2019

Last Update Posted Date

Aug 30, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yanqing Li, Professor, Shandong UniversityPrincipal Investigator

Lead Sponsor

Shandong UniversityOTHER

Collaborators

Name	Class
Weihai Municipal Hospital	OTHER
Binzhou Medical University	OTHER
Qilu Hospital of Shandong University (Qingdao)	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No sedation		The group of patients who did endoscopies without sedation.
Sedation		The group of patients who did endoscopies with sedation.	Other: Sedation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sedation	Other	The group of patients who did endoscopies with or without sedation. (This is a choice of themselves)	Sedation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanqing LI, Doctor	Contact	13573106261		liyanqing@sdu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Qilu Hospital, Shandong University	Recruiting	Jinan	Shandong	250012	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34074827	Derived	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.

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases