UMIN-ICDS Clinical Trial

Public title

A multicenter clinical study on local complications after acute pancreatitis and surgical resection

Acronym

WONDERFUL (WON anD pERipancreatic FlUid coLlection) study

Scientific Title

A multicenter clinical study on local complications after acute pancreatitis and surgical resection

Scientific Title:Acronym

WONDERFUL (WON anD pERipancreatic FlUid coLlection) study

Region

Japan

Condition

Patients who were diagnosed as local complications of acute pancreatitis or postoperative pancreatic fistula (POPF) and were treated by conservative management or non-surgical and/or surgical interventions. Local complications of acute pancreatitis are classified into four types according to the revised Atlanta classification; acute peripancreatic fluid collection (APFC) and acute necrotic collection (ANC) occurring within 4 weeks of the onset of acute pancreatitis, and pancreatic pseudocyst (PPC) and walled-off necrosis (WON) occurring after 4 weeks of the onset of acute pancreatitis. POPF are classified into three types; pancreatic fluid collection (PFC), internal pancreatic fistula (IPF) and external pancreatic fistula (EPF).

Classification by specialty

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

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate clinical features and treatment outcomes of local complications of acute pancreatitis and surgical resection by establishing a large multicenter cohort.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Clinical success

Key secondary outcomes

Interventions including procedure time and duration, technical success, adverse events, costs, recurrence, long-term outcomes, prognosis, association of concomitant medications with clinical outcomes.

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

Patients who were diagnosed with local complications of acute pancreatitis or surgical resection and needed treatment including conservative management and non-surgical and/or surgical interventions between 01/01/2006 and 4/30/2023.

Key exclusion criteria

Patients who did not want to be included in the study.

Target sample size

1500

Name of lead principal investigator

1st name	Yousuke
Middle name
Last name	Nakai

Organization

The University of Tokyo Hospital

Division name

Department of Endoscopy and Endoscopic Surgery

Zip code

113-8655

Address

7-3-1, Hongo Bunkyo-ku, Tokyo, JAPAN

TEL

03-3815-5411

Email

ynakai-tky@umin.ac.jp

Name of contact person

1st name	Tomotaka
Middle name
Last name	Saito

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Department of Gastroenterology

Zip code

113-8655

Address

7-3-1, Hongo Bunkyo-ku, Tokyo, JAPAN

TEL

03-3815-5411

Homepage URL

Email

tomsaito-gi@umin.ac.jp

Institute

The University of Tokyo

Institute

Department

Personal name

Yousuke Nakai

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Graduate School of Medicine, The University of Tokyo, Office for Human Research Studies

Address

7-3-1, Hongo Bunkyo-ku, Tokyo, JAPAN

Tel

03-3815-5411

Email

ethics@m.u-tokyo.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

東京大学医学部附属病院（東京都）、富山大学附属病院（富山県）、岐阜大学医学部附属病院（岐阜県）、神戸大学医学部附属病院（兵庫県）、近畿大学医学部附属病院（大阪府）、兵庫医科大学病院（兵庫県）、順天堂大学医学部附属順天堂医院（東京都）、金沢医科大学病院（石川県）、岐阜県総合医療センター（岐阜県）、岐阜市民病院（岐阜県）、埼玉医科大学総合医療センター（埼玉県）、がん研究会有明病院（東京都）、国立がん研究センター中央病院（東京都）、静岡県立静岡がんセンター（静岡県）

Date of disclosure of the study information

2023

Year

06

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

423

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

No longer recruiting

Date of protocol fixation

2023

Year

04

Month

18

Day

Date of IRB

2023

Year

06

Month

01

Day

Anticipated trial start date

2023

Year

06

Month

02

Day

Last follow-up date

2028

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study are conducted by the WONDERFUL (WON anD pERipancreatic FlUid coLlection) study group, which consists of endoscopists, gastroenterologists, interventional radiologists, and epidemiologists at high-volume centers in Japan.

Registered date

2023

Year

06

Month

26

Day

Last modified on

2023

Year

06

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058673