UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039912
Receipt number R000045520
Scientific Title Retrospective Study of Endoscopic Transpapillary Gallbladder Drainage with Cholangioscopy-assisted Manipulation for Acute Cholecystitis
Date of disclosure of the study information 2020/03/24
Last modified on 2023/09/24 14:11:11

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Basic information

Public title

Retrospective Study of Endoscopic Transpapillary Gallbladder Drainage with Cholangioscopy-assisted Manipulation for Acute Cholecystitis

Acronym

Retrospective Study of Endoscopic Transpapillary Gallbladder Drainage with Cholangioscopy-assisted Manipulation for Acute Cholecystitis

Scientific Title

Retrospective Study of Endoscopic Transpapillary Gallbladder Drainage with Cholangioscopy-assisted Manipulation for Acute Cholecystitis

Scientific Title:Acronym

Retrospective Study of Endoscopic Transpapillary Gallbladder Drainage with Cholangioscopy-assisted Manipulation for Acute Cholecystitis

Region

Japan


Condition

Condition

Acute Cholecystitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the efficacy and safety of SpyGlass DS for ETGBD.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Success rate of ETGBD: Compare the success rate between pre-induction of SpyGlass DS and after application of SpyGlass DS.

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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

consecutive AC patients in whom ETGBD was attempted from April 1, 2008 to December 31, 2019.

Key exclusion criteria

The cases in whom ETGBD was terminated because of mechanical accidents of endoscopes were excluded in this study.

Target sample size

110


Research contact person

Name of lead principal investigator

1st name Michihiro
Middle name
Last name Yoshida

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Gastroenterology and Metabolism

Zip code

467-8601

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya 467-8601, Japan

TEL

+81-52-853-8211

Email

mityoshi@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name Michihiro
Middle name
Last name Yoshida

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Gastroenterology and Metabolism

Zip code

467-8601

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya 467-8601, Japan

TEL

+81-52-853-8211

Homepage URL


Email

mityoshi@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

N/A

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

Nagoya City University Graduate School of Medical Sciences

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya 467-8601, Japan

Tel

+81-52-851-5511

Email

clinical_research@med.nagoya-cu.ac.jp


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

2020 Year 03 Month 24 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/33402544/

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/33402544/

Number of participants that the trial has enrolled

101

Results

C-ETGBD was successful in 73 patients (72.3%). SG-ETGBD was successful in 11 of 13 patients (84.6%) who had C-ETGBD failure. Optional SG-ETGBD significantly increased the final success rate (94.1%) compared to C-ETGBD alone (p=0.003).

Results date posted

2023 Year 09 Month 24 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 05 Month 15 Day

Baseline Characteristics

A total of 101 patients undergoing ETGBD were retrospectively studied. The characteristics and technical outcomes of ETGBD with conventional ETGBD (C-ETGBD) and SpyGlass DS-assisted ETGBD (SG-ETGBD) were evaluated. The characteristics and technique-dependent factors of unsuccessful C-ETGBD/SG-ETGBD were evaluated using the classification based on the steps of the procedure. The predictive factors of successful C-ETGBD/SG-ETGBD were examined.

Participant flow

A total of 101 consecutive AC patients in whom ETGBD was attempted from April 1, 2008 to June 30, 2020 at Nagoya City University Graduate School of Medical Sciences were retrospectively evaluated.

Adverse events

CD injury was the most frequent adverse event in both procedures (C-ETGBD, 5.9%; SG-ETGBD, 7.7%), followed by post-ERCP pancreatitis (C-ETGBD, 3.0%), post-endoscopic sphincterotomy hemorrhage (C-ETGBD, 1.0%), and peritoneal perforation (C-ETGBD, 1.0%).

Outcome measures

First, patient characteristics, technical outcomes, and adverse events of all C-ETGBD were evaluated in this study. Second, patient characteristics, technical outcomes, and adverse events were compared between the earlier and later groups to elucidate the efficacy of optional cholangioscopic assistance.

Plan to share IPD

N/A

IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 03 Month 06 Day

Date of IRB

2020 Year 03 Month 19 Day

Anticipated trial start date

2020 Year 03 Month 23 Day

Last follow-up date

2022 Year 03 Month 22 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

IRB No. 60-19-0219


Management information

Registered date

2020 Year 03 Month 23 Day

Last modified on

2023 Year 09 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045520


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name