Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060604) titled 'A study to evaluate the safety of eating a high-fat ice cream before surgery to prevent chyle leak after pancreatic surgery' on March 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Kobe University

Condition: Condition - Pancreatic lesion Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 18 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 Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 06 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069321

Disclaimer: Curated by HT Syndication.