UMIN-CTR Clinical Trial

Public title

Establishment of Endoscopic Duodenal Observational Protocol on Duodenal Lesion Detection During Screening Esophagogastroduodenoscopy

Acronym

Endoscopic Duodenal Observational Protocol

Scientific Title

Establishment of Endoscopic Duodenal Observational Protocol on Duodenal Lesion Detection During Screening Esophagogastroduodenoscopy

Scientific Title:Acronym

Endoscopic Duodenal Observational Protocol

Region

Japan

Condition

Duodenal Lesion

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To propose endoscopic duodenal observational protocol on duodenal lesion detection

Basic objectives2

Others

Basic objectives -Others

To investigate the incidental rate of duodenal lesion by the observational protocol

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Phase I

Primary outcomes

The completion rate of established observational protocol

Key secondary outcomes

1.The incidental rate of duodenal lesion
2.The incidental rate of duodenal meoplasms which need treatment
3.The examination time of duodenum
4.Total examination time

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who undergo screening esophagogastroduodenoscopy

Key exclusion criteria

1)without informed consent
2)already detected duodenal neoplasm
3)past history of upper GI surgery
4)severe mental status
5)inproper indication judged by doctor

Target sample size

4000

Name of lead principal investigator

1st name	Hideki
Middle name
Last name	Kobara

Organization

Faculty of Medicine, Kagawa University

Division name

Gastroenterology and Neurology

Zip code

761-0793

Address

1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan

TEL

0878985111

Email

kobara@med.kagawa-u.ac.jp

Name of contact person

1st name	Masae
Middle name
Last name	Miyoshi

Organization

Faculty of Medicine, Kagawa University

Division name

Investigator

Zip code

761-0793

Address

1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan

TEL

0878985111

Homepage URL

Email

chosa@med.kagawa-u.ac.jp

Institute

Kagawa University

Institute

Department

Personal name

Organization

Gastroenterology and Neurology, Faculty of Medicine, Kagawa University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

KKR hospital Mitsugu Yasuda

Name of secondary funder(s)

Organization

Kagawa University

Address

1750-1 Ikenobe, Miki, Kita

Tel

0878912156

Email

kobara@med.kagawa-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

01

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

1549

Results

There were 1549 participants. The 7PR completion rate was 81.1% and the detection rate of overall neoplasms, adenomas, and carcinomas were 0.84, 0.71, and 0.06%, respectively. The area in which most neoplasms was detected was contralateral to the ampulla (69.2%), and the fewest the transverse duodenum (0%). 7PR is acceptable for duodenal examination and a potential quality indicator.

Results date posted

2022

Year

12

Month

26

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

This prospective observational study was conducted at two facilities and enrolled consecutive participants who had undergone screening EGD between April 2019 and August 2021. The inclusion criteria were age >20 years and screening EGD examination. The exclusion criteria were duplicated participants, previous diagnosis of UGI malignant neoplasms and duodenal tumors, history of resection of part of the UGI tract, and presence of psychosis or psychiatric symptoms.

Participant flow

Enrolled patients underwent our developed-comprehensive duodenal examination protocol, called the Seven Pictures Rule (7PR)

Adverse events

7PR procedure-associated complications

Outcome measures

The primary outcome was the 7PR completion rate. Completion of 7PR was defined as capture of the required seven photos in any sequence. Secondary outcomes were total rates of detection of lesions or neoplasms (adenomas, carcinomas, and others) requiring treatment overall and for each location, duodenal and total examination time, rates of completion of 7PR for S and U scopes, and 7PR procedure-associated complications. The total examination time was the duration between insertion of the scope into the mouth and its retrieval. Duodenal examination time was the duration between the first and seventh photo-documentation.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

12

Month

10

Day

Date of IRB

2019

Year

04

Month

18

Day

Anticipated trial start date

2019

Year

04

Month

18

Day

Last follow-up date

2022

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

none

Registered date

2018

Year

12

Month

22

Day

Last modified on

2022

Year

12

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040268