UMIN-ICDS Clinical Trial

Public title

DPC study of endoscopic and surgical resection for rectal neuroendocrine tumors

Acronym

RECT-NET DPC study

Scientific Title

Short-term Outcomes of Endoscopic and Surgical Resection for Rectal Neuroendocrine Tumors: A DPC Database Study

Scientific Title:Acronym

RECT-NET DPC study

Region

Japan

Condition

Rectal neuroendocrine tumor

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the short-term outcomes of endoscopic and surgical resection for rectal neuroendocrine tumors using the DPC database.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Periprocedural adverse events common to endoscopic and surgical treatment.

Key secondary outcomes

Treatment-specific adverse events (surgery-related and endoscopy-specific events), additional surgery, total transfusion volume, in-hospital mortality, length of hospital stay, and total medical costs.

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

Patients with rectal neuroendocrine tumors registered in the DPC database who underwent endoscopic or surgical resection between January 2012 and December 2023.

Key exclusion criteria

- Patients who underwent simultaneous surgery for other diseases
- Patients with missing data

Target sample size

500

Name of lead principal investigator

1st name	Kenichiro
Middle name
Last name	Imai

Organization

Shizuoka Cancer Center

Division name

Division of Endoscopy

Zip code

411-8777

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

TEL

055-989-5222

Email

ke.imai@scchr.jp

Name of contact person

1st name	Kenichiro
Middle name
Last name	Imai

Organization

Shizuoka Cancer Center

Division name

Division of Endoscopy

Zip code

411-8777

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

TEL

055-989-5222

Homepage URL

Email

ke.imai@scchr.jp

Institute

Division of Endoscopy, Shizuoka Cancer Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

- Shonan Kamakura General Hospital
- Institute of Science Tokyo

Name of secondary funder(s)

Organization

Independent Ethics Committee of Shizuoka Cancer Center

Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan

Tel

055-989-5222

Email

tansaku_office@scchr.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

2026

Year

02

Month

15

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

2025

Year

12

Month

15

Day

Date of IRB

2026

Year

01

Month

21

Day

Anticipated trial start date

2026

Year

02

Month

16

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a large-scale retrospective observational study of patients with rectal neuroendocrine tumors registered in the DPC database who underwent endoscopic or surgical resection. The study includes cases registered in the DPC database from January 2012 to December 2023 who received endoscopic or surgical resection for rectal NET.
The analysis will use anonymized DPC data provided for research purposes through the Institute of Science Tokyo by hospitals participating in the Ministry of Health, Labour and Welfare survey on the impact of the DPC system.
Extracted variables include patient characteristics (diagnosis, age, sex, BMI, smoking history, comorbidities, TNM classification, stage, activities of daily living, dementia status, hospital size, medication history, etc.), treatment details (various types of endoscopic and surgical resection), and in-hospital course (complications, length of hospital stay, outcome, additional surgery, transfusion volume, and total medical costs).
The primary outcomes are adverse events that are comparable between endoscopic and surgical treatment. The secondary outcomes include treatment-specific adverse events related to surgery and endoscopy, as well as additional surgery, total transfusion volume, in-hospital mortality, length of hospital stay, and total medical costs.
Patient characteristics, treatment methods, and adverse events will be described. Multivariable analysis and propensity score methods will be used to adjust for baseline factors, medications, and comorbidities.

Registered date

2026

Year

02

Month

03

Day

Last modified on

2026

Year

02

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069253