UMIN-ICDS Clinical Trial

Public title

Outcomes of underwater endoscopic mucosal resection (UEMR) for neoplastic lesions on or near the scar

Acronym

UEMR for scar lesion

Scientific Title

Outcomes of underwater endoscopic mucosal resection (UEMR) for neoplastic lesions on or near the scar

Scientific Title:Acronym

UEMR for scar lesion

Region

Japan

Condition

Tumors of the duodenum or colon

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To prospectively investigate the outcomes of underwater endoscopic mucosal resection (UEMR) for residual lesions after endoscopic treatment of the duodenum and colon, benign ulcer scars, and neoplastic lesions at or near post-surgical scars and anastomoses, and to evaluate its utility.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Proportion of residual or local recurrence in follow-up endoscopy

Key secondary outcomes

Complete resection rate
Association of endoscopic resection results with disease or treatment factors
Association of endoscopic resection or pathology results with local recurrence

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Neoplastic lesions of 2 cm or less in the duodenum and colon that meet either 1) or 2) and are expected to be difficult to resect due to severe fibrosis.
1) Residual or locally recurrent lesions after endoscopic treatment
2) Neoplastic lesions found at or near (within 1 cm) the site of a scar, such as a scar after endoscopic treatment, benign ulcer scar, or scar or anastomosis after surgical procedure

Key exclusion criteria

Patients with severe cardiopulmonary diseases.
Patients whose enrollment or participation in this study seem difficult due to concomitant psychiatric disorders.
Other patients that the physician judges inappropriate for the safe conduct of this study.

Target sample size

50

Name of lead principal investigator

1st name	Tetsuo
Middle name
Last name	Takehara

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL

+81--6-6879-3621

Email

takehara@gh.med.osaka-u.ac.jp

Name of contact person

1st name	Yoshiki
Middle name
Last name	Tsujii

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL

+81--6-6879-3621

Homepage URL

Email

yoshikitsujii1977@gh.med.osaka-u.ac.jp

Institute

Osaka University

Institute

Department

Personal name

Organization

Self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka University Hospital

Address

2-2 Yamadaoka, Suita, Osaka, Japan

Tel

+81-6-6210-8296

Email

rinri@hp-crc.med.osaka-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

2023

Year

06

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

05

Month

16

Day

Date of IRB

2023

Year

05

Month

16

Day

Anticipated trial start date

2023

Year

06

Month

02

Day

Last follow-up date

2026

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

<Study Design>
Multicenter prospective observational study
<Treatment Schedule>
Treatment will be administered after explaining the study to eligible patients and obtaining consent forms and enrolling patients who agree to participate in the study.
At the time of treatment, the lesions will be thoroughly observed and evaluated prior to resection, and the lesions will be resected by UEMR.
Post-treatment pathology results will then be collected.
Follow-up endoscopy is performed 2-15 months after UEMR to check for residual or recurrent disease at the resection site.

Registered date

2023

Year

06

Month

02

Day

Last modified on

2023

Year

06

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058433