UMIN-ICDS Clinical Trial

Public title

Efficacy and safety of endoscopic transluminal abscess drainage for Hinchey Ib/II colonic diverticulitis.

Acronym

Efficacy and safety of endoscopic transluminal abscess drainage for Hinchey Ib/II colonic diverticulitis.

Scientific Title

Efficacy and safety of endoscopic transluminal abscess drainage for Hinchey Ib/II colonic diverticulitis.

Scientific Title:Acronym

Efficacy and safety of endoscopic transluminal abscess drainage for Hinchey Ib/II colonic diverticulitis.

Region

Japan

Condition

Hinchey Ib/II colonic diverticulitis

Classification by specialty

Surgery in general

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Acute diverticulitis is the most common clinical complication of diverticular disease. The incidence rate of acute diverticulitis, such as bleeding, perforation, fistulae, obstruction or stricture, is approximately 10-25% of patients with diverticula, and 1-2% patients require hospitalization, and 0.5% patients require surgery due to abscess or peritonitis. Minimally invasive imaging-guided drainage procedure with either CT or ultrasonography (US)-guided drainage methods are commonly used for Stage 1b and Stage 2 for the patients with abscess-forming colonic diverticulitis. In this study, we conducted a single-center, prospective pilot study to investigate the efficacy and safety of endoscopic transluminal abscess drainage for colonic diverticulitis accompanied by abscesses (Hinchey stage Ib/II).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

To investigate the success rate of endoscopic drainage for abscess-forming colonic diverticulitis. Success means reducing abdominal pain, reducing fever, and avoiding surgical treatment.

Key secondary outcomes

We will examine the complication rate such as bleeding and perforation after endoscopic drainage. To examine the long-term recurrence rate of colonic diverticulitis. The observation period will be 5 years after endoscopic drainage.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

If Hinchey Stage I or II is diagnosed by abdominal CT examination, conservative treatment such as fasting and administration of antibiotics is standard, but endoscopic examination is recommended in cases where symptoms such as abdominal pain and fever do not improve even with standard treatment. Consider mirror drainage. Although additional surgical treatment is standard, endoscopic drainage is intended for this group of cases and is performed to avoid surgical treatment. However, if the patient requests surgical treatment upon obtaining informed consent from the patient, surgical treatment shall be performed immediately without performing endoscopic drainage.
When obtaining informed consent, explain that surgical treatment is the standard treatment and present the possibility of avoiding surgical treatment with endoscopic drainage, but if this is not successful, We will explain what to do in situations where you can immediately proceed to surgical treatment. If endoscopic drainage is unsuccessful, surgical treatment should be initiated immediately.
On the 1st day after endoscopic drainage, physical examination, blood tests, and abdominal CT examination will be performed. If physical findings show no reduction in abdominal pain, fever does not subside, blood tests show no reduction in inflammatory findings, or abdominal CT shows findings suspicious of perforation, such as free air, surgery should be performed. Consider transitioning to clinical therapy. If inflammatory findings are reduced and fever is reduced, and no complications such as perforation are found in blood tests or abdominal CT scans, oral intake should be started.
Discharge will be determined when oral intake is possible and physical findings have disappeared. In addition, before discharge, the presence or absence of an abscess cavity will be evaluated again by abdominal CT examination.

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

15

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

Endoscopic drainage is performed for patients diagnosed with Hinchey Stage I or II by abdominal CT examination and whose symptoms such as abdominal pain and fever do not improve even with conservative treatment such as fasting and administration of antibiotics.

Key exclusion criteria

Under 15 years old and over 90 years old
Cases with obvious poor general condition such as deterioration of vital signs
Case complicated by obvious generalized peritonitis
Case with bleeding tendency

Target sample size

20

Name of lead principal investigator

1st name	Chihiro
Middle name
Last name	Kosugi

Organization

Teikyo University Chiba Medical Center

Division name

Department of Surgery

Zip code

299-0111

Address

3426-3 Anesaki, Ichihara, Chiba, Japan

TEL

0436621211

Email

ckosugi0126@yahoo.co.jp

Name of contact person

1st name	Chihiro
Middle name
Last name	kosugi

Organization

Teikyo University Chiba Medical Center

Division name

Department of Surgery

Zip code

299-0111

Address

3426-3 Anesaki, Ichihara, Chiba, Japan

TEL

0436621211

Homepage URL

Email

ckosugi0126@yahoo.co.jp

Institute

Teikyo University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

None

Co-sponsor

Name of secondary funder(s)

Organization

Ethics committee, Teikyo University

Address

2-11-1 Kaga, Itabashi-ku, Tokyo, Japan

Tel

03-3964-7256

Email

turb-office@teikyo-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

2026

Year

10

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

Open public recruiting

Date of protocol fixation

2018

Year

12

Month

10

Day

Date of IRB

2018

Year

12

Month

18

Day

Anticipated trial start date

2018

Year

12

Month

18

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

01

Month

04

Day

Last modified on

2026

Year

10

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059996