UMIN-CTR Clinical Trial

Public title

The study for the cause of fever in the post EMR & ESD patients

Acronym

DEEP study

Scientific Title

Prospective exploratory study about the cause of fever in the post EMR & ESD patients

Scientific Title:Acronym

DEEP study

Region

Japan

Condition

Digestive epithelial tumor

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To unveil the cause of fever in the post EMR & ESD patients

Basic objectives2

Others

Basic objectives -Others

Epidemiological surveillance of disease prevalence

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The cause of fever after gastrointestinal tract ESD or duodenal EMR

Key secondary outcomes

1) The relationship between aspiration pneumonia and infused water volume, location, surgeon, age and operation time
2) The relationship between PECS (post-ESD coagulation syndrome)or mediastinitis and injected water volume, location, operator, age and operation time
3) The ratio and comparison of aspiration pneumonia by organ
4) The ratio and comparison of PECS or mediastinitis by organ

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 undergoing total gastrointestinal tract ESD or duodenal EMR at our hospital and providing written informed consent

Key exclusion criteria

1) Patients with multiple lesions
2) Patients with severe respiratory failure.
3) Patients with severe heart failure.
4) Patients with valvular disease.
5) Patients with uncompensated cirrhosis.
6) Patients on dialysis.
7) Patients with immunodeficiency or who taking continuous systemic administration of immunosuppressants.
8) Patients who taking antipyretic analgesics periodically.
9) Patients with perforation during procedure.
10) Patients who attending physicians consider to be inappropriate due to other reasons mentioned above.

Target sample size

800

Name of lead principal investigator

1st name	Motohiko
Middle name
Last name	Kato

Organization

Keio University School of Medicine

Division name

Gastroenterology / Cancer center

Zip code

160-8582

Address

35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan

TEL

03-5363-3437

Email

motohikokato@keio.jp

Name of contact person

1st name	Mari
Middle name
Last name	Mizutani

Organization

Keio University School of Medicine

Division name

Gastroenterology / Cancer center

Zip code

160-8582

Address

35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan

TEL

03-5363-3437

Homepage URL

Email

marimizutani6@keio.jp

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

Keio University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Keio University School of Medicine

Address

35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan

Tel

03-5363-3437

Email

marimizutani6@keio.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

慶應義塾大学病院

Date of disclosure of the study information

2020

Year

01

Month

06

Day

URL releasing protocol

https://onlinelibrary.wiley.com/doi/10.1111/den.14740

Publication of results

Published

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.1111/den.14740

Number of participants that the trial has enrolled

800

Results

Among the 822 patients included, aspiration pneumonia was the most common cause of fever and increased CRP levels after ER of the upper gastrointestinal tract (esophagus, 53%; stomach, 48%; and duodenum, 71%). Post-ER coagulation syndrome (PECS) was most common after colorectal ESD (38%).

Results date posted

2024

Year

01

Month

16

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The patient characteristics and results of the endoscopic procedures are summarized in Table 1. The clinical course of the patients after the endoscopic procedure during hospitalization is summarized in Table 2. Fever or increased CRP level was observed in 18.3% of cases.

Participant flow

Patients who consecutively underwent esophageal, gastric, duodenal, or colorectal ESD and duodenal endoscopic mucosal resection (EMR) at our hospital between January 2020 and April 2022 were included. Including hospitalized patients allowed for the close monitoring of the postoperative clinical course. We did not include colorectal EMR patients since they were not hospitalized; we also excluded patients with multiple lesions, those with perforation during the procedure, those receiving continuous systemic administration of immunosuppressants or antipyretic analgesics, and those with lesions involving the papilla or requiring drainage tubes to the bile and pancreatic duct after ER.13 Since we planned a protocol for administering antibiotics after diagnosis to reflect the natural course of adverse events, we also excluded patients with severe comorbidities; those on dialysis; and those with severe respiratory failure, severe heart failure, or uncompensated cirrhosis who may become critical without rapid administration of anti-biotics. We also excluded patients who had decreased peripheral oxygen saturation (SpO2) during the procedure and for whom prophylactic antibiotics were administered since they could affect the diagnosis of pneumonia confirmed by imaging. We also excluded patients who did not undergo computed tomography (CT) but presented with fever or showed increased C-reactive protein (CRP) level (>3 mg/dL) and no evidence of pneumonia on radiography, and those who underwent other procedures during hospitalization. Contrarily, we included the patients who received general anesthesia as these were patients with large lesions or were technically difficult cases, and the risk of adverse events other than aspiration pneumonia was high.

Adverse events

None

Outcome measures

The primary endpoint was the cause of fever or increased CRP levels following ER. The secondary endpoint was the relationship between aspiration pneumonia and patient background and treatment factors.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

01

Month

04

Day

Date of IRB

2018

Year

12

Month

08

Day

Anticipated trial start date

2020

Year

01

Month

04

Day

Last follow-up date

2022

Year

04

Month

30

Day

Date of closure to data entry

2022

Year

06

Month

30

Day

Date trial data considered complete

2022

Year

07

Month

30

Day

Date analysis concluded

Other related information

When the patient has over 37.5 degrees fever after gastrointestinal tract ESD / duodenal EMR, we perform CT scam.

Registered date

2020

Year

01

Month

04

Day

Last modified on

2024

Year

01

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044534