UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022536 |
|---|---|
| Receipt number | R000025766 |
| Scientific Title | Comparison of Berizym and Pancrelipase for the effect to suppress onset of Hepatic Steatosis after Pancreaticoduodenectomy |
| Date of disclosure of the study information | 2016/05/31 |
| Last modified on | 2021/12/03 10:45:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of Berizym and Pancrelipase for the effect to suppress onset of Hepatic Steatosis after Pancreaticoduodenectomy
Acronym
ESOP Trial
Scientific Title
Comparison of Berizym and Pancrelipase for the effect to suppress onset of Hepatic Steatosis after Pancreaticoduodenectomy
Scientific Title:Acronym
ESOP Trial
Region
| Japan |
Condition
Condition
Patients who underwent pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether hepatic steatosis after pancreatectomy caused by impaired pancreatic excretory function can be more effectively suppressed by pancrelipase than conventional digestive enzymes, because the former has higher titer of enzymes than the latter.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hepatic steatosis free survival rate one year after the registration calculated as time to event
Key secondary outcomes
Following variables 3, 6, 9, and 12 months after the registration. 1. body weight, 2. worsening of diarrhea according to the definition of CTCAE-v4.0, 3. serum albumin value, 4. serum total cholesterol value, 5. serum triglyceride value, 6. serum total bilirubin value, 7. serum glutamate oxaloacetate transaminase value, 8. serum glutamic pyruvic transaminase value, 9. serum choline esterase value, 10. serum glycohemogrobin value.
In addition, incicence of diabetes mellitus, complianace of drug administration, overall survival, and cumulative incidence of hepatic steatosis one year after the regsitration.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Berizym.
Patients assigned to the standard treatment group start taking Berizym, which is conventional compound of digestive enzymes within 3 days after registration. Daily amount of 3 g of Berizym is taken during or after every meal. Each patient continues taking the drug until hepatic steatosis is recognized for one year at longest.
Interventions/Control_2
Administration of Pancrelipase.
Patients assigned to the investigational treatment group start taking pancrelipase within 3 days after registration. Daily amount of 1800 mg of pancrelipase of either capsule or granular formation is taken during or after every meal. Each patient continues taking the drug until hepatic steatosis is recognized for one year at longest.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who underwent pylorus preserving pancreaticoduodenectomy (PPPD) or substomach preserving pancreaticoduodenectomy (SSPPD) for periampullary tumor regardless of benign or malignant tumor including pancreas tumor, extrahepatic bile duct tumor, ampullary tumor, or duodenal tumor.
2) Patients who have started diet intake.
3) Age at the time of registration is between 20 and 80 years old.
4) Within 60 days after pancreaticoduodenectomy.
5) ECOG performance status is 0 or 1.
6) Blood examination performed within 30 days before registration satisfy all of the following criterion.
Leukocyte count (WBC) >= 3000 m3
Hemoglobin (Hb) >= 8.0 g/dl
Platelet count >= 50,000 /mm3
Total bilirubin <= 2.0 mg/dl
Creatinine <= 1.5 mg/dl
7) No hepatic steatosis confirmed by nonenhanced abdominal CT (attenuation of liver >= 40 HU) performed within 30 days before registration.
8) Patients with written informed consent.
Key exclusion criteria
1) Patients with history of taking any kind of digestive enzymes such as pancrelipase, berizym, excelase, or pancreatin within one year before registration.
2) Patients with history of allergy to bovine or porcine protein.
3) Patients with gastrointestinal comorbidities associated with malabsorption such as inflammatory bowel disease, short bowel syndrome, refractory gastrointestinal ulceration, or gastrointestinal stenosis due to esophageal, gastric or colorectal cancer.
4) Patients with history of esophagectomy of gastrectomy.
5) Patients with history of allergy to Berizym or pancrelipase.
6) Patients considered by attending doctors or psychiatrist to be unsuitable for registration due to psychological condition.
7) Pregnant or suspiciously pregnant women.
8) Patients considered by attending doctors to be unsuitable for enrollment due to any other reason.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Takamoto |
Organization
National Cancer Center Hospital
Division name
Hepatobiliary and Pancreatic Surgery Division
Zip code
104-0045
Address
5-1-1Tsukiji, Chuo-Ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
ttakamot@ncc.go.jp
Public contact
Name of contact person
| 1st name | Kazuaki |
| Middle name | |
| Last name | Shimada |
Organization
National Cancer Center Hospital
Division name
Hepatobiliary and Pancreatic Surgery Division
Zip code
104-0045
Address
5-1-1Tsukiji, Chuo-Ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
kshimada@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, National Cancer Center
Address
5-1-1Tsukiji, Chuo-Ku, Tokyo 104-0045, Japan
Tel
0335422511
NCC_IRBoffice@ml.res.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
| 2016 | Year | 05 | Month | 31 | 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
301
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Patient registration finished on May 31, 2020.
Management information
Registered date
| 2016 | Year | 05 | Month | 30 | Day |
Last modified on
| 2021 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025766
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/06/02 | ESOP計画書原稿3.1.0_clearcopy.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
