UMIN-ICDS Clinical Trial

Public title

A Study of the Outcomes and Safety of ESD Including the Papilla for Duodenal Tumors

Acronym

Endoscopic Treatment Study for Papilla-Involving Duodenal Tumors

Scientific Title

Efficacy and Safety of Endoscopic Submucosal Dissection Including the Papilla for Epithelial Neoplasms Involving the Major Duodenal Papilla: A Prospective Observational Study

Scientific Title:Acronym

ESDIP Cohort Study

Region

Japan

Condition

Ampullary or papilla-involving duodenal epithelial neoplasms

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To prospectively evaluate the efficacy of endoscopic submucosal dissection including the papilla (ESDIP) for ampullary neoplasms or duodenal epithelial neoplasms involving the major duodenal papilla, using the R0 resection rate as the primary outcome.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

R0 resection rate assessed at the time of final histopathological evaluation of the resected specimen after ESDIP for ampullary neoplasms or duodenal epithelial neoplasms involving the major duodenal papilla. R0 resection is defined as en bloc resection with histologically negative horizontal and vertical margins.

Key secondary outcomes

1. Technical success rate, en bloc resection rate, and curative resection rate.
2. Incidence of serious adverse events and prespecified individual adverse events.
3. Incidence of local residual disease or recurrence and recurrence-free survival rate.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

To be eligible for participation in this study, patients must meet all of the following criteria:
1.Aged 18 years or older at the time of obtaining informed consent.
2.A lesion diagnosed or suspected, based on endoscopic examination or biopsy findings, to be a tumor of the major duodenal papilla or a duodenal epithelial tumor involving the major duodenal papilla.
3.A lesion suspected, based on preoperative biopsy or endoscopic findings, to be an adenoma, high-grade dysplasia, carcinoma arising in an adenoma, intramucosal carcinoma, or superficial carcinoma limited to T1a.
4.No evidence of definite pancreatic invasion, invasion into or beyond the duodenal muscularis propria, lymph node metastasis, or distant metastasis on preoperative examinations performed as part of routine clinical practice, including endoscopy, endoscopic ultrasonography (EUS), intraductal ultrasonography (IDUS), computed tomography (CT), and magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP).
5.Scheduled to undergo ESD as part of routine clinical practice and considered by the treating physician to be technically amenable to endoscopic resection.
6.Eastern Cooperative Oncology Group Performance Status of 0-2.
7.Able to undergo follow-up for 3 years after treatment.
8.Written informed consent to participate in this study provided voluntarily by the patient after receiving an adequate explanation of the study and fully understanding its contents.

Key exclusion criteria

Patients who meet any of the following criteria are ineligible for participation in this study:
1.Preoperative evaluation suggests invasive carcinoma of T1b or deeper, definite pancreatic invasion, invasion into or beyond the duodenal muscularis propria, lymph node metastasis, or distant metastasis.
2.Extensive intraductal extension into the bile duct or pancreatic duct is present, and complete endoscopic resection is considered difficult by the treating physician.
3.Previous surgical or endoscopic resection of the major duodenal papilla is considered likely to interfere with the assessment of safety or efficacy in this study.
4.Appropriate perioperative management of antithrombotic agents, including interruption, continuation, or resumption of treatment, is considered difficult.
5.A severe bleeding tendency is present.
6.A severe infection requiring systemic treatment is present.
7.Unstable angina is present, or there is a history of myocardial infarction within the preceding 6 months.
8.A respiratory disorder requiring continuous oxygen therapy is present.
9.Severe hepatic or renal failure is present, and the patient is considered to be at high risk from ESD or sedation/anesthesia.
10.Poorly controlled hypertension, diabetes mellitus, or another serious comorbidity is present, making participation in the study difficult.
11.The patient is pregnant, breastfeeding, or may be pregnant.
12. Psychosis, psychiatric symptoms, dementia, or another condition is present that is considered likely to impair participation in the study, understanding of the informed consent process, or adherence to the follow-up schedule.
13.The principal investigator or a subinvestigator considers the patient unsuitable for participation in the study for any other reason.

Target sample size

30

Name of lead principal investigator

1st name	Yohei
Middle name
Last name	Ikenoyama

Organization

Mie University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

514-8507

Address

2-174 Edobashi, Tsu, Mie 514-8507, Japan

TEL

059-232-1111

Email

0801yohei@med.mie-u.ac.jp

Name of contact person

1st name	Shoma
Middle name
Last name	Sawai

Organization

Mie University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

514-8507

Address

2-174 Edobashi, Tsu, Mie 514-8507, Japan

TEL

059-232-1111

Homepage URL

Email

shoma-say@med.mie-u.ac.jp

Institute

Mie 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

Clinical Research Ethics Review Committee of Mie University Hospital

Address

2-174 Edobashi, Tsu, Mie 514-8507, Japan

Tel

059-232-1111

Email

kk-sien@mo.medic.mie-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

三重大学医学部附属病院（三重県）

Date of disclosure of the study information

2026

Year

08

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

2026

Year

07

Month

14

Day

Date of IRB

2026

Year

07

Month

31

Day

Anticipated trial start date

2026

Year

08

Month

02

Day

Last follow-up date

2032

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a prospective single-center observational study of patients scheduled to undergo endoscopic submucosal dissection (ESD) as part of routine clinical care at Mie University Hospital for tumors of the major duodenal papilla or duodenal epithelial tumors involving the major duodenal papilla. No treatment assignment, additional invasive examination, or additional treatment will be performed for research purposes. Eligible patients who provide written informed consent will be enrolled. Data on patient characteristics, preoperative assessment, treatment, histopathological findings, adverse events, additional treatment, and follow-up will be collected prospectively. The primary outcome is the R0 resection rate, and each patient will be followed for 3 years after treatment.

Registered date

2026

Year

08

Month

02

Day

Last modified on

2026

Year

08

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071460