UMIN-ICDS Clinical Trial

Public title

A randomized controlled trial comparing duodenal conventional EMR versus underwater EMR for superficial non-ampullary duodenal epithelial tumors 20 mm or less

Acronym

D-CURE trial

Scientific Title

A randomized controlled trial comparing duodenal conventional EMR versus underwater EMR for superficial non-ampullary duodenal epithelial tumors 20 mm or less

Scientific Title:Acronym

D-CURE trial

Region

Japan

Condition

Superficial non-ampullary duodenal epithelial tumors measuring 20 mm or less

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the clinical effectiveness and safety of underwater endoscopic mucosal resection (UEMR) through a randomized comparison trial with conventional endoscopic mucosal resection (CEMR) for superficial non-ampullary duodenal epithelial tumors (SNADET) measuring 20mm or less.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

1-year recurrence-free survival rate

Key secondary outcomes

1) En-bloc resection rate
2) Histologically complete resection rate (en-bloc resection with HM0 and VM0)
3) Adverse events (perforation, postoperative bleeding, etc.)
4) Technical success rate
5) Total procedure time
6) Resection time
7) Suturing time
8) Rate of complete suturing
9) Rate of complete suturing with conventional clips
10) 1-year duodenum preservation survival rate
11) Cost of the equipment used

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

A: Conventional EMR group

Interventions/Control_2

B: Under-water EMR group

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

18

years-old

<=

Age-upper limit

85

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Endoscopically diagnosed as adenoma or adenocarcinoma, or histologically confirmed as adenoma or adenocarcinoma through preoperative biopsy.
2) Lesion with a longitudinal diameter of 20mm or less.
3) Estimated tumor depth is limited to the mucosa.
4) Lesion is located in either the duodenal bulb, descending part, or horizontal part, without invasion into the major papilla or minor papilla.
5) Lesion is non-pedunculated.
6) Scheduled for endoscopic treatment for a single lesion.
7) No history of gastrectomy or duodenectomy.
8) Patient's age at the time of registration is 18 years or older and 85 years or younger.
9) Performance Status (ECOG) is 0, 1, or 2.
10) Has received adequate explanation regarding trial participation and has provided written consent.

Key exclusion criteria

1) Diagnosed with familial adenomatous polyposis (FAP).
2) Presents with systemic infections requiring systemic treatment.
3) Pregnant or breastfeeding women.
4) Complicated with psychiatric disorders, psychiatric symptoms, or dementia that would hinder participation in the trial.
5) Complicated with unstable angina (occurrence within the last 3 weeks or exacerbation of angina) or a history of myocardial infarction within the past 6 months.
6) Patients taking multiple antithrombotic drugs, for whom endoscopy is preferably delayed according to the guidelines for gastrointestinal endoscopic treatment of patients on antithrombotic agents.
7) Complicated with respiratory diseases requiring continuous oxygen therapy.
8) Cases with a prognosis of less than 1 year.
9) Other cases deemed inappropriate by the attending trial physician.

Target sample size

320

Name of lead principal investigator

1st name	Waku
Middle name
Last name	Hatta

Organization

Tohoku University Graduate School of Medicine

Division name

Division of Gastroenterology

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi

TEL

0227177171

Email

waku-style@festa.ocn.ne.jp

Name of contact person

1st name	Masao
Middle name
Last name	Yoshida

Organization

Shizuoka Cancer Center

Division name

Division of Endoscopy

Zip code

411-8777

Address

1007 Shimonagakubo, Nagaizumi, Shizuoka, Japan

TEL

0559895692

Homepage URL

Email

ma.yoshida@scchr.jp

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name

Organization

Tohoku University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical Research Ethics Committee Office of Tohoku University Hospital

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi

Tel

0227178007

Email

ec@rinri.hosp.tohoku.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

愛知県がんセンター/Aichi Cancer Center
石川県立中央病院/Ishikawa prefectural central hospital
茨城県立中央病院・茨城県地域がんセンター/Ibaraki Prefectural Central Hospital
岩手医科大学/Iwate Medical University
大阪医科薬科大学病院/Osaka Medical and Pharmaceutical University Hospital
大阪公立大学医学部附属病院/Osaka Metropolitan University Hospital
大阪国際がんセンター/Osaka International Cancer Institute
岡山大学病院/Okayama University Hospital
神奈川県立がんセンター/Kanagawa Cancer Center
関西労災病院/Kansai Rosai Hospital
北九州市立医療センター/Kitakyushu Municipal Medical Center
北里大学医学部/ Kitasato University School of Medicine
京都桂病院/Kyoto Katsura Hospital
京都大学医学部附属病院/Kyoto University Hospital
京都府立医科大学附属病院/University Hospital, Kyoto Prefectural University of Medicine
群馬大学医学部附属病院/Gunma University Hospital
慶應義塾大学医学部/Keio University School of Medicine
交雄会新さっぽろ病院/Kouyuukai Shin-Sapporo Hospital
神戸市立医療センター中央市民病院/Kobe City Medical Center General Hospital
国立がん研究センター中央病院/National Cancer Center
国立がん研究センター東病院/National Cancer Center East
国立病院機構四国がんセンター/Shikoku Cancer Center
静岡県立静岡がんセンター/Shizuoka Cancer Center
島根県立中央病院/Shimane Prefectural Central Hospital
総合川崎臨港病院/Kawasaki Rinko General Hospital
高槻病院/Takatsuki General Hospital
千葉県がんセンター/Chiba Cancer Center
津山中央病院/Tsuyama Chuo Hospital
東京都立墨東病院/Tokyo Metropolitan Bokutoh Hospital
東北大学病院/Tohoku University Hospital
富山県立中央病院/Toyama Prefectural Central Hospital
名古屋市立大学病院/Medical School Midori Municipal Hospital
名古屋大学医学部附属病院/Nagoya University Hospital
新潟県立がんセンター新潟病院/Niigata Cancer Center
広島市立北部医療センター安佐市民病院/Hiroshima City Asa Hospital
広島市立広島市民病院/Hiroshima City Hiroshima Citizens Hospital
広島大学病院/Hiroshima Unversity Hospital
兵庫医科大学/Hyogo Medical University
兵庫県立がんセンター/Hyogo Cancer Center
横浜市立大学附属市民総合医療センター/Yokohama City University Medical Center

Date of disclosure of the study information

2023

Year

11

Month

17

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

Preinitiation

Date of protocol fixation

2023

Year

11

Month

04

Day

Date of IRB

Anticipated trial start date

2024

Year

12

Month

10

Day

Last follow-up date

2027

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

13

Day

Last modified on

2023

Year

11

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060220