UMIN-CTR Clinical Trial

Basic information
Public title	Safety and efficacy of emergent endoscopic transpapillary gallbladder drainage complemented by endoscopic ultrasound guided gallbladder drainage
Acronym	Safety and efficacy of emergent ETGBD complemented by EUS-GBD
Scientific Title	Safety and efficacy of emergent endoscopic transpapillary gallbladder drainage complemented by endoscopic ultrasound guided gallbladder drainage
Scientific Title:Acronym	Safety and efficacy of emergent ETGBD complemented by EUS-GBD
Region	Japan

Condition
Condition	Acute cholecystitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of ETGBD complemented by EUS-GBD in the same session comparing to traditional ETGBD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Technical success rate Clinical success rate Procedure related adverse event rate
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	Moderate/severe acute cholecystitis patients with high-risk of surgery/PTGBD, due to high age, continuous antithrombotic therapies, severe comorbidities and physical conditions. Consecutive patients underwent traditional ETGBD (T-ETGBD) and a new drainage strategy; ETGBD complemented by EUS-GBD (C-ETGBD) for emergent initial gallbladder drainage.
Key exclusion criteria	Patients who underwent initial gallbladder drainage by other than ETGBD, and patients who underwent prior gallbladder drainage Patients with cholecystitis accompanied by choledocholithiasis were also excluded, since most cholecystitis caused by choledocholithiasis improve after common bile duct treatment.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Sagami
Organization	Oita San-ai Medical Center
Division name	Department of Gastroenterology
Zip code	8701151
Address	1213 Ichi, Oita, Japan
TEL	0975411311
Email	sagami1985@yahoo.co.jp

Public contact
Name of contact person	1st name Ryota Middle name Last name Sagami
Organization	Oita San-ai Medical Center
Division name	Department of Gastroenterology
Zip code	8701151
Address	1213 Ichi, Oita, Japan
TEL	0975411311
Homepage URL
Email	sagami1985@yahoo.co.jp

Sponsor
Institute	Oita San-ai Medical Center
Institute
Department

Funding Source
Organization	None
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	Oita San-ai Medical Center
Address	1213 Ichi, Oita, Japan
Tel	0975411311
Email	sagami1985@yahoo.co.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	2022 Year 06 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 03 Month 26 Day
Date of IRB	2021 Year 03 Month 26 Day
Anticipated trial start date	2022 Year 06 Month 07 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective observational study

Management information
Registered date	2022 Year 06 Month 07 Day
Last modified on	2022 Year 06 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054696