UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060604 |
|---|---|
| Receipt number | R000069321 |
| Scientific Title | A Phase I Clinical Trial of Preoperative High-Fat Ice Cream Administration for the Prevention of Chyle Leak After Pancreaticoduodenectomy |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/06 16:03:10 |
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Basic information
Public title
A study to evaluate the safety of eating a high-fat ice cream before surgery to prevent chyle leak after pancreatic surgery
Acronym
PD-ICE Study
Scientific Title
A Phase I Clinical Trial of Preoperative High-Fat Ice Cream Administration for the Prevention of Chyle Leak After Pancreaticoduodenectomy
Scientific Title:Acronym
PD-ICE Phase I Trial
Region
| Japan |
Condition
Condition
Pancreatic lesion
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the safety of preoperative intake of high-fat ice cream for the prevention of chyle leak after pancreaticoduodenectomy. As a phase I trial, a small number of patients will receive high-fat ice cream via a nasogastric tube before surgery, and the occurrence of aspiration or vomiting will be assessed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The occurrence of aspiration or vomiting associated with gastric retention of ice cream.
Key secondary outcomes
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
After induction of anesthesia, 50 mL of high-fat ice cream (Haagen-Dazs Macadamia Nut flavor; milk fat content 17.0%) will be administered via a nasogastric tube, followed by the planned pancreatic resection.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled to undergo pancreaticoduodenectomy.
2. Patients who have voluntarily provided written informed consent to participate in this study.
3. Patients aged 18 years or older and younger than 80 years.
Key exclusion criteria
1. Patients with a known allergy to dairy products, egg, or macadamia nuts.
2. Patients who have previously undergone total gastrectomy.
3. Patients with gastrointestinal obstruction (e.g., duodenal obstruction).
4. Patients with severe hiatal hernia.
5. Patients who are unable to adequately understand the study due to severe dementia or psychiatric disorders.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshihide |
| Middle name | |
| Last name | Nanno |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6302
ynanno@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Ishida |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6302
Homepage URL
jnishida38@gmail.com
Sponsor or person
Institute
Kobe University
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
Kobe University Hospital Clinical and Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-6669
kainyu@med.kobe-u.ac.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
| 2026 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2026 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069321
