A study to evaluate the safety of eating a high-fat ice cream before surgery to prevent chyle leak after pancreatic surgery

A Phase I Clinical Trial of Preoperative High-Fat Ice Cream Administration for the Prevention of Chyle Leak After Pancreaticoduodenectomy - PD-ICE Phase I Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060604

Enrollment

Registered

2026-03-01

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic lesion

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The occurrence of aspiration or vomiting associated with gastric retention of ice cream.	—

Countries

Japan

Contacts

Public ContactJun Ishida

Kobe University Graduate School of Medicine Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery

jnishida38@gmail.com078-382-6302

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026