UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025463 |
|---|---|
| Receipt number | R000029295 |
| Scientific Title | Safety and efficacy of preoperative biliary drainage using plastic stent above the sphincter of Oddi (Inside-stent) in patients with malignant hilar biliary obstruction: A prospective study |
| Date of disclosure of the study information | 2017/01/30 |
| Last modified on | 2021/01/04 13:35:41 |
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Basic information
Public title
Safety and efficacy of preoperative biliary drainage using plastic stent above the sphincter of Oddi (Inside-stent) in patients with malignant hilar biliary obstruction: A prospective study
Acronym
Safety and efficacy of preoperative biliary drainage using plastic stent above the sphincter of Oddi (Inside-stent) in patients with malignant hilar biliary obstruction: A prospective study
Scientific Title
Safety and efficacy of preoperative biliary drainage using plastic stent above the sphincter of Oddi (Inside-stent) in patients with malignant hilar biliary obstruction: A prospective study
Scientific Title:Acronym
Safety and efficacy of preoperative biliary drainage using plastic stent above the sphincter of Oddi (Inside-stent) in patients with malignant hilar biliary obstruction: A prospective study
Region
| Japan |
Condition
Condition
Resectable malignant hilar biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficancy and safety of plastic stent placement above the sphincter of Oddi for patients of resectable malignant hilar biliary obstruction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Time to recurrent biliary obstruction of inside-sten
Key secondary outcomes
1. Overall number of re-intervention after initial biliary drainage
2. Success rate and complication rate of inside-stent placement
3. Recurrent biliary obstruction rate of inside-stent
4. Overall morbidity and infectious complication rate after surgery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In undrainage patients, the site of biliary structure was confirmed endoscopically and naso-biliary drainage (ENBD) was performed firstly. After relieve of jaundice, ENBD was exchanged for inside-stent. In patients who had undergone endoscopic biliary drainage in previous hospital, endoscopic examination is performed and the existing stent was exchanged for inside-stent.
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
1. Resectable biliary tract cancer (intrahepatic, perihilar, or distal cholangiocarcinoma, gallbladder carcinoma) with obstructive jaundice
2. Life expectancy > 3 months
3. Endoscopic preoperative biliary drainage or radical surgery can be performed safely.
4. Endoscopic cholangiography shows the distance from the stricture to the sphincter of Oddi is at least 3cm.
5. Patients of age >= 20 years
6. ECOG performance status of 0-2
7. ASA calassification of 0-2
8. Adequate organ function
9. Written informed consent is required from all patients.
Key exclusion criteria
1. History of radiotherapy, chemotherapy or immunotherapy for malignant disease before starting the study treatment
2. Preoperative biliary drainage is not needed.
3. PTBD has been performed at previous hospital.
4. Severe complications such as intestinal pneumonia, pulmonary fibrosis, and heart failure
5. Psychosis or severe mental disorder
6. Pregnant or lactating female and patients who is considering pregnancy
7. Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Saiura |
Organization
Japanese foundation for cancer research, Cancer institute hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo, Japan
TEL
+81-3-3520-0111
akio.saiura@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yu Takahashi |
Organization
Japanese foundation for cancer research, Cancer institute hospital
Division name
Department of Gastroenterological Surgery
Zip code
Address
3-8-31 Ariake, Koto-ku, Tokyo, Japan
TEL
+81-3-3520-0111
Homepage URL
yu.takahashi@jfcr.or.jp
Sponsor or person
Institute
Japanese foundation for cancer research, Cancer institute hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese foundation for cancer research, Cancer institute hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 01 | 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
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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 28 | Day |
Last modified on
| 2021 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029295
