UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055173 |
|---|---|
| Receipt number | R000063040 |
| Scientific Title | Preoperative biliary drainage by endoscopic ultrasound guided hepaticogastrostomy for resectable/resectable borderline pancreatic cancer with biliary obstruction: prospective observational study |
| Date of disclosure of the study information | 2024/08/13 |
| Last modified on | 2025/08/27 02:11:37 |
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Basic information
Public title
Preoperative biliary drainage by endoscopic ultrasound guided hepaticogastrostomy for resectable/resectable borderline pancreatic cancer with biliary obstruction: prospective observational study
Acronym
Preoperative biliary drainage by endoscopic ultrasound guided hepaticogastrostomy for resectable/resectable borderline pancreatic cancer with biliary obstruction: prospective observational study
Scientific Title
Preoperative biliary drainage by endoscopic ultrasound guided hepaticogastrostomy for resectable/resectable borderline pancreatic cancer with biliary obstruction: prospective observational study
Scientific Title:Acronym
Preoperative biliary drainage by endoscopic ultrasound guided hepaticogastrostomy for resectable/resectable borderline pancreatic cancer with biliary obstruction: prospective observational study
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and efficacy of preoperative biliary drainage by endoscopic ultrasound-guided hepaticogastrostomy in patients with resectable/resectable borderline pancreatic cancer with biliary obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical success 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patient is clinically judged to require biliary drainage due to biliary obstruction caused by pancreatic cancer.
2) The patient is scheduled for biliary drainage by EUS-HGS.
3) Biliary obstruction due to pancreatic cancer is 2 cm below the porta hepatis on the papillary side.
4) There is no history of endoscopic biliary drainage for biliary obstruction due to pancreatic cancer.
5) Invasive pancreatic ductal carcinoma is suspected based on contrast-enhanced CT scan.
If contrast-enhanced CT is not available, MRI or EUS is acceptable in addition to simple CT.
6) Pancreatic cancer is evaluated as resectable or borderline resectable by contrast-enhanced CT scan.
If contrast-enhanced CT is not available, MRI or EUS is acceptable in addition to simple CT.
7) One of the following (1), (2), or (3) is met.
(1) Total bilirubin greater than 1.5 mg/dl, (2) AST greater than 100 U/L, (3) ALT greater than 100 U/L
8) The patient does not have parenchymal jaundice.
9) If the patient is taking antithrombotic medication, it can be withdrawn according to our criteria.
10) No bleeding tendency.
11) ECOG Performance Status less than or equal to 2.
12) Patients must be at least 18 years of age at the time of consent.
13) Written consent for participation in the study has been obtained from the patient.
Key exclusion criteria
1) The patient is judged by a physician to be inappropriate for enrollment in this study.
2) The patient has a severe case of acute cholangitis according to the severity classification of acute cholangitis.
3) Patients with biliary obstruction due to pancreatic cancer within 2 cm just below the porta hepatis.
4) The patient has a reconstructed intestinal tract after upper gastrointestinal surgery and anatomy does not allow drainage of the biliary tract by EUS-HGS.
5) Patient is anatomically unable to puncture the bile duct in the outer left lobe of the liver, such as after hepatectomy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Hijioka |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
shijoka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Yagi |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
shyag@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
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
National Cancer Center Hospital
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
shijoka@ncc.go.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
| 2024 | Year | 08 | Month | 13 | 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
Deidentified individual participant data that support the findings of this study (including baseline characteristics, procedural details, and outcome measures) will be available from the corresponding author upon reasonable request. The study protocol and informed consent form will also be shared as supplementary materials. Data will be available beginning at the time of publication with no end date. Requestors will need to provide a methodologically sound proposal and obtain approval from the institutional review board.
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to evaluate the safety and efficacy of preoperative biliary drainage by endoscopic ultrasound-guided hepaticogastrostomy in patients with resectable/resectable borderline pancreatic cancer with biliary obstruction.
Management information
Registered date
| 2024 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063040
