UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047631
Receipt number R000054307
Scientific Title Japanese nationwide survey of acute acalculous cholecystitis
Date of disclosure of the study information 2022/05/16
Last modified on 2024/01/05 19:12:44

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Basic information

Public title

Japanese nationwide survey of acute acalculous cholecystitis in the era of Tokyo guideline

Acronym

Japanese nationwide survey of acute acalculous cholecystitis in the era of Tokyo guideline

Scientific Title

Japanese nationwide survey of acute acalculous cholecystitis

Scientific Title:Acronym

Japanese nationwide survey of acute acalculous cholecystitis

Region

Japan


Condition

Condition

Patients who underwent treatment for acute acalculous cholecystitis

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to investigate the incidence, background factors, therapeutic modality, and outcomes of AAC in Japan

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Age, sex, comorbidity, American Society of Anesthesiologists physical status, Charlson comorbidity index, severity of acute cholecystitis, treatment, infectious complications, hospital stay, readmission, mortality

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent treatment for acute acalculous cholecystitis between January 2018 and December 2020

Key exclusion criteria

None

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Takanori
Middle name
Last name Morikawa

Organization

Tohoku University Hospital

Division name

Department of Surgery

Zip code

9808574

Address

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

TEL

022-717-7205

Email

t_morikawa@surg.med.tohoku.ac.jp


Public contact

Name of contact person

1st name Takanori
Middle name
Last name Morikawa

Organization

Tohoku University Hospital

Division name

Department of Surgery

Zip code

9808574

Address

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

TEL

022-717-7205

Homepage URL


Email

t_morikawa@surg.med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Hospita, Department of Surgery

Institute

Department

Personal name



Funding Source

Organization

Japanese Society for Abdominal Emergency Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee Tohoku University Graduate School of Medicine

Address

2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi

Tel

0227178007

Email

med-kenkyo@grp.tohoku.ac.pj


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2022 Year 05 Month 16 Day


Related information

URL releasing protocol

chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.med.tohoku.ac.jp/wp-content/uploads/

Publication of results

Published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/full/10.1002/jhbp.1401

Number of participants that the trial has enrolled

432

Results

In this study, 432 patients of acute acalculous cholecystitis were collected. According to the Tokyo guidelines severity grade, 167, 202, and 63 cases were classified as Grade I, II, and III, respectively. Eleven patients died and myocardial infarction/congestive heart failure was the only independent risk factor for in-hospital death. Cholecystectomy, especially the laparoscopic approach, had more preferable outcomes compared to their counterparts.

Results date posted

2024 Year 01 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with acute acalculous cholecystitis who were treated in Tohoku University and 41 board-certified hospitals of the Japanese Society for Abdominal Emergency Medicine, between January 2018 and December 2020.

Participant flow

We performed a questionnaire survey of acute acalculous cholecystitis and reviewed accumulated data from our institution and 41 board-certified hospitals in the Japanese Society for Abdominal Emergency Medicine. The questionnaire was framed to ask for detailed data on AAC cases and the number of AC patients who were treated from January 2018 to December 2020. Anonymous data collection was guaranteed by the study protocol, and opt-out method of informed consent were also used.

Adverse events

None

Outcome measures

Collected data on patient characteristics, diagnosis, and treatment are described below; patient characteristics included age, sex, height, body weight, comorbidity by the Charlson comorbidity index (CCI), use of anticoagulant, and American Society of Anesthesiologists physical status (ASA-PS); disease-related variables included date of onset, medical condition and comorbidity before treatment, body temperature, laboratory data (e.g. white blood cell (WBC), C-reactive protein (CRP), total bilirubin), and bile cultures; treatment-related factors included date of initial treatment and cholecystectomy, date of discharge, methods of treatment, the procedure of cholecystectomy, operation time, intraoperative blood loss, and need for conversion; post-treatment outcomes included prognosis, complications, mortality, length of hospital stay, and recurrence of AC within 90 days after discharge.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 11 Month 29 Day

Date of IRB

2021 Year 12 Month 21 Day

Anticipated trial start date

2022 Year 05 Month 16 Day

Last follow-up date

2022 Year 09 Month 26 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This observational study examines not only the frequency of acalculous acute cholecystitis in Japan, but also the correlation between prognosis and background factors, severity of cholecystitis, and treatment.


Management information

Registered date

2022 Year 04 Month 30 Day

Last modified on

2024 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054307


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name