UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045690 |
|---|---|
| Receipt number | R000052147 |
| Scientific Title | Efficacy of double-balloon enteroscopy-assisted fully-covered metal stent deployment for hepaticojejunostomy anastomotic stricture |
| Date of disclosure of the study information | 2021/11/30 |
| Last modified on | 2023/12/05 18:50:14 |
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Basic information
Public title
Efficacy of double-balloon enteroscopy-assisted fully-covered metal stent deployment for hepaticojejunostomy anastomotic stricture
Acronym
Efficacy of double-balloon enteroscopy-assisted fully-covered metal stent deployment for hepaticojejunostomy anastomotic stricture
Scientific Title
Efficacy of double-balloon enteroscopy-assisted fully-covered metal stent deployment for hepaticojejunostomy anastomotic stricture
Scientific Title:Acronym
Efficacy of double-balloon enteroscopy-assisted fully-covered metal stent deployment for hepaticojejunostomy anastomotic stricture
Region
| Japan |
Condition
Condition
hepaticojejunostomy anastomotic stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the safety and effectiveness of a metal stent for patient with an primary and recurrent hepaticojejunostomy anastomotic stricture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The outcome investigated is patency rate of hepaticojejunostomy anastomosis until 1-year after removal of metal stent.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were primary and recurrent hepaticojejunostomy anastomotic strictures, coupled with related signs (elevation of serum hepatobiliary enzymes with dilatation of the intrahepatic bile duct detected by abdominal ultrasonography or radiological studies, or fever). Hepaticojejunostomy anastomotic strictures was defined as a waist in the area of Hepaticojejunostomy anastomosis detected using cholangiography and endoscopic imaging.
Key exclusion criteria
(1)Patients with intrahepatic bile duct stenosis.
(2)A score of 4 or 5 according to the Eastern Cooperative Oncology Group Performance Status.
(3)Severe complications in other organs.
(4)Patients who underwent liver transplantation.
(5)Suspected malignant biliary stricture.
(6)Age younger than 20 years.
(7)Patient with severe blood coagulation disorder.
(8)Inability to provide written informed consent.
Target sample size
146
Research contact person
Name of lead principal investigator
| 1st name | Hironari |
| Middle name | |
| Last name | Kato |
Organization
Okayama University Hospital
Division name
Gastroenterology and Hepatology
Zip code
700-8558
Address
5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL
086-235-7219
katou-h@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Fujii |
Organization
Okayama University Hospital
Division name
Gastroenterology and Hepatology
Zip code
700-8558
Address
5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL
086-235-7219
Homepage URL
y_f1105@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
Okayama University Hospital
Address
5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
Tel
086-235-7219
y_f1105@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
| 2021 | Year | 11 | Month | 30 | 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
0
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
Terminated
Date of protocol fixation
| 2021 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 05 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 05 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 05 | Day |
Other
Other related information
(1) Stricture resolution rate at the time of metal stent removal.
(2)Technical success rate.
(3)Rate of removal of metal stent.
(4)Rate of recurrence of the anastomotic stricture.
(5)Rate of adverse events.
Management information
Registered date
| 2021 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052147
