Prospective randomized controlled trial for assessing the effect of kestose after pancreaticoduodenectomy

JRCT ID: jRCTs041240047

Registered date:14/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: The study focuses on diseases targeted for pancreaticoduodenectomy.
• Date of first enrollment: 14/06/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Oral administration of kestose.

Outcome(s)

• Primary Outcome: serum albumin level of 24 weeks after the operation

Secondary Outcome

The manifestation of fatty liver
Changes in glucose tolerance
The occupancy rate of beneficial microbiota in the oral and intestinal microbiota
The transition of nutritional status and sarcopenia 1 year and 3 years after surgery
Dose intensity of postoperative chemotherapy
Improvement in nutritional status 6, 12, and 24 weeks after kestose administration as indicated by biological marker scores, including changes in muscle mass evaluated using Inbody, CT, and changes in blood biochemical test values (albumin levels, total lymphocyte count, VitD3, Fe, UIBC, Zn, Mg, ferritin, transferrin, total cholesterol levels, LDL cholesterol levels, HDL cholesterol levels, triglycerides, blood glucose levels, HbA1c, cholinesterase)
Prognostic Nutritional Index (PNI)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both
• Include criteria: The patient who will undergo pancreaticodudodenectomy at Fujita Health University hospital with sufficient understanding of the study and having written informed consent. The patient age is between 20 and 90.
• Exclude criteria: Patients deemed unsuitable for this study by the principal investigator or co-investigators will be excluded from the study.

Related Information

• Primary Sponsor: Takahara Takeshi